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USP 1079 Good Storage and Distribution Practices for Drug Products

USP 1079 Good Storage and Distribution Practices for Drug Products
USP 1079 Good Storage and Distribution Practices for Drug Products

5656?1079? Good Storage and Distribution Practices / General Information Second Supplement to USP 35–NF 30

General Chapters

General Information

environmental aspects (such as temperature, humidity,Change to read:

and/or other environmental factors) for the drug product and ensures that adequate processes to maintain that environment are in place.

?1079? s GOOD STORAGE AND Hazardous materials and/or dangerous goods:Any item or chemical which, when being transported or

DISTRIBUTION PRACTICES FOR

moved, is a risk to public safety or the environment, and is regulated as such under any of the following: Hazard-DRUG PRODUCTS

ous Materials Regulations (49 CFR 100–180); Interna-tional Maritime Dangerous Goods Code; Dangerous Goods Regulations of the International Air Transport As-sociation; Technical Instructions of the International Civil Aviation Organization; or the U.S. Air Force Joint Manual,INTRODUCTION

Preparing Hazardous Materials for Military Air Shipments.International Conference on Harmonization (ICH)This general information chapter describes good storage Guidance for Industry, Q10 Pharmaceutical Quality Sys-and distribution practices to ensure that drug products tem; ICH Q9, Quality Risk Management; and, ICH Q1A R2,(medicines) reach the end user (practitioners and patient/Stability Testing of New Drug Substances and Products :consumers) with quality intact.

Internationally harmonized documents intended to assist In the context of this chapter, the following definitions the pharmaceutical industry.

are used.

Mean Kinetic Temperature (MKT):The single calcu-lated temperature at which the total amount of degrada-tion over a particular period is equal to the sum of the Definitions

individual degradations that would occur at various tem-peratures.

Adulteration:FDA FDC Act, SEC. 501 (351), A drug Preventive actions:The measures to eliminate the or device shall be deemed to be adulterated, if (2)(A) It cause of a potential nonconformity or other undesirable has been prepared, packed, or held under insanitary potential situation.

conditions it may have been contaminated with filth, or Quality:The physical, chemical, microbiological, bio-whereby it may have been rendered injurious to health;logical, bioavailability, and stability attributes that a drug or (B) the methods used in, or the facilities or controls product should maintain in order to be deemed suitable used for, its manufacture, processing, packing, or hold-for therapeutic or diagnostic use. In this chapter, the ing do not conform to or are not operated or adminis-term is also understood to convey the properties of tered in conformity with current good manufacturing safety, identity, strength, quality, and purity.

practice to assure that such drug meets the requirements Quality Management System (QMS):In the context of this Act as to safety and has the identify and strength,of this chapter, minimally a set of policies, processes,and meets the quality and purity characteristics, which it and procedures that enable the identification, measure-purports or is represented to possess.

ment, control, and improvement of the distribution and Continuous improvement:Recurring activity to in-storage of drug product. It is the management system crease the ability to fulfill requirements (see Quality Man-used to direct and control a company with regard to agement Systems—Fundamentals and Vocabulary. ISO quality (see ICH Q10 model and Quality System—Funda-Standard 9000:2005).

mentals and Vocabulary, ISO Standard 9000:2005).

Distribution: Refers to elements such as shipping and Risk Management System: A systematic process used transportation activities that are associated with the to assess, control, communicate, and review risks to the movement and supply of drug products.

quality of a drug product across the product lifecycle.Distribution Management System: A program that Integral to an effective pharmaceutical quality system, it covers the movement, including storage and transporta-is a systematic and proactive approach to identifying, sci-tion, of drug products.

entifically evaluating, and controlling potential risks to Documentation:Recorded information.

quality as described in ICH Q10. It facilitates continual Drug products:Medicines, including marketed human improvement of process performance and product qual-and veterinary prescription finished dosage medications,ity throughout the product lifecycle. ICH Q9 Quality Risk in-process/intermediate/bulk materials, drug product

Management provides principles and examples of tools samples, clinical trial materials, over-the-counter products that can be applied to different aspects of pharmaceuti-(OTC).

cal quality.

End user:The patient as well as the healthcare pro-Written Agreement or Contract (commonly referred vider administering the drug product to the patient.to as a Quality Agreement, Technical Agreement, Ser-Environmental Management System: A management vice Level Agreement, or other): A negotiated, docu-system that allows for the identification of quality critical

mented agreement between the drug product owner

Second Supplement to USP 35–NF 30General Information / ?1079? Good Storage and Distribution Practices5657

and service provider that defines the common under-This general information chapter does not supersede or standing about materials or service, quality specifications,supplant any applicable national, federal, and/or state stor-responsibilities, guarantees, and communication mecha-age and distribution requirements, or USP monographs. The nisms. It can be either legally binding or an information Preservation, Packaging, Storage, and Labeling section of Gen-agreement. A Service Level Agreement may also specify eral Notices and Requirements provides definitions and re-the target and minimum level of performance, opera-quirements for storage conditions. This chapter is not in-tion, or other service attributes.tended to cover counterfeiting, falsified medicines, drug Storage Management System: A program that is used pedigrees, or other supply chain security, including chain of to control the storage of drug products.custody issues.

Supply chain:The continuum of entities spanning the

storage and distribution lifecycle of a product to the end BACKGROUND INFORMATION

user.

Temperature stabilizer: A material or combination of

Storage and distribution processes may involve a complex materials that stores and releases thermal energy used to

movement of product around the world, differences in doc-maintain a specified temperature range within an active

umentation and handling requirements, and communication or passive packaging container or system (e.g., water-,

among various entities in the supply chain. The translation chemical-, or oil-based phase change material, such as

of best practices into good storage and distribution meets carbon dioxide solid/dry ice and liquid nitrogen).

these challenges and sets forth a state of control.

Transport vehicles:Vehicles used in the supply chain

The good storage and distribution practices described in including semitrailer trucks, vans, trains, airplanes, sea

this chapter should facilitate the movement of drug prod-vessels, and mail delivery vehicles. Other vehicles, when

ucts throughout a supply chain that is controlled, measured, used to transport drug products are included here, such

and analyzed for continuous improvements and should as emergency medical service vehicles and industry rep-

maintain the integrity of the drug product in its packaging resentatives’ automobiles.

during storage and distribution.

SCOPE

RESPONSIBILITIES

Good storage and distribution practices apply to all orga-

The holder of the drug product application, the drug nizations and individuals involved in any aspect of the stor-

product manufacturer (in the case of many OTCs, where age and distribution of all drug products, including but not

there is no application) and the repackager bear primary limited to the following:

responsibility and accountability including but not limited to ?Manufacturers of drug products for human and veteri-

the following:

nary use where manufacturing may involve operations

?The decision for regulatory submissions, where applica-at the application holder’s facilities (i.e., facilities that

ble, relative to the contents of this chapter for the stor-belong to the holder of an approved New Drug Appli-

age and distribution of drug products. If breaches occur cation or Abbreviated New Drug Application) or at

in any of the QMS systems and cannot be justified or those of a contractor for the applicant holder

documented with scientific evidence, the appropriate ?Packaging operations by the manufacturer or a desig-

entity should consider action with the product to en-nated contractor for the applicant holder

sure the public safety.

?Repackaging operations in which the drug product may

?Determining proper storage and handling practices be owned by an organization other than the primary

?Communicating storage and distribution practices manufacturer

through the supply chain

?Laboratory operations at the manufacturer’s or at the

?Drug product stability profiles or the associated stability contractor’s site

information from the holder, inclusive of distribution ?Physician and veterinary offices

conditions and excursions that may be allowable should ?Pharmacies including but not limited to retail, com-

they occur. These stability profiles include the approved pounding, specialty, mail order, hospital, and nursing

storage conditions for the shelf life of the drug product home pharmacies

and, where appropriate, supporting data for the distri-?Importers and exporters of Record

bution conditions, if these differ from the storage ?Wholesale distributors; distribution companies involved

conditions.

in automobile, rail, sea, and air services

?Appropriate firms, such as an applicant holder, are to ?Third-party logistics providers, freight forwarders, and

convey relevant environmental requirements (e.g., consolidators

when appropriate, product-specific lifecycle stability ?Health care professional dispensing or administering the

data), when needed to support deviations or tempera-drug product to the end user

ture excursions. If stability data cannot be reviewed or ?Mail distributors including the U.S. Postal Service (USPS)

is not shared, an assessment may be needed to con-and other shipping services including expedited ship-

sider regulatory review or other appropriate actions ping services

(e.g., destruction of product or additional stability

The information is intended to apply to all drug products

testing).

regardless of environmental storage or distribution

?Recalling the drug product if it is found to be adulter-requirements.

ated in any part of the supply chain

It is recognized that conceivably there are special cases

However, all organizations along the supply chain bear and many alternative means of fulfilling the intent of this

responsibility for ensuring that they handle drug products chapter and that these means should be scientifically justi-

within adequate storage and distribution parameters that fied. Although this chapter is not intended to address the

will not affect the drug product identity, strength, quality, storage and distribution of active pharmaceutical ingredients

purity, or safety.

(APIs), excipients, radioactive products, reagents, solvents,

Each holder of drug product is responsible and accounta-medical devices, medical gases, or clinical trial materials for

ble for the receipt from an entity and transfer out of the which storage requirements may not yet be defined (e.g.,

drug product to the next entity.

Phase I clinical trial drug products), the general principles

outlined here may be useful if applied selectively or

comprehensively.

5658?1079? Good Storage and Distribution Practices / General Information Second Supplement to USP 35–NF 30

tions (CAPA), change management, deviation/investigation LABELING CONSIDERATIONS FOR DRUG

management, and the management review process.

PRODUCTS

Written agreements (e.g., Quality Agreement, Technical

Agreement, Service Level Agreements) should be in place The environmental requirements for drug product storage between applicable organizations involved in the drug prod-

conditions should be indicated on the drug product primary uct supply chain. This means that the originating manufac-container–closure system. If space on the immediate con-turer may not be required to hold a Written Agreement tainer is too small (e.g., an ampule) or is impractical for the with all parties in the supply chain. The use of written container–closure system (e.g., blister package), this infor-agreements ensures clarity and transparency, and delineates mation can be placed on the most immediate container of the responsibilities of each organization in the supply chain. appropriate size (e.g., carton). Environmental storage condi-

tions and/or environmental warning statements should be

evident, securely fixed, and indelible on the outermost con-Good Documentation Practices

tainer (generally the shipping container).

Products classified as hazardous materials and/or danger-Good documentation practices should be practiced in the ous goods by the U.S. Department of Transportation or QMS. This documentation includes standard operating pro-other relevant authorities or bodies should be labeled,cedures and corporate policies and standards, as well as stored, and handled in accordance with applicable federal/protocols and other written documents that delineate the state/local regulations. Drug products classified as controlled elements of the QMS. The QMS programs should describe substances by the U.S. Drug Enforcement Administration or events and actions that must be documented as well as the by individual state requirements should be labeled and han-proper verbiage to be used, the copies required, and any dled in accordance with applicable regulations.other items that will ensure adequate processing of the drug Good practices and controls for labeling should provide product and prevent delays. The documentation process the receiver with instructions for the correct handling of the should use a standard such as a quality manual or other drug product upon receipt. When a drug product’s storage practice and, should include routine assessment for review conditions are not readily available, use the storage condi-and update as needed.

tions described in USP’s General Notices and Requirements or Written procedures should ensure that drug products are the applicable USP monograph; or, contact the drug manu-held in accordance with their labeling instructions and asso-facturer for further information.ciated regulatory requirements. Procedures should provide Product labels with expanded information beyond the sin-the written steps needed to complete a process and ensure gle long-term storage temperature ensure ease of transport consistency and standard outcomes. The following elements and use for shippers, distributors, healthcare professionals,should be included: (1) how and when a product should be and patients. Product labels should clearly define the stor-moved from one transport container/vehicle into another, age temperature range, and broader distribution or in-use(2) how products are handled when equipment malfunc-temperature ranges where allowable. Products labeled tions or when there are delays in distribution due to Cus-“Keep in a cold place” or “Do not freeze” are subject to toms hold, and (3) how to communicate with the necessary interpretation and are discouraged if used without accompa-parties.

nying temperature ranges. USP storage definitions and tem-The QMS should require monitoring of processes to perature ranges are defined in General Notices and demonstrate that a state of control is being maintained, Requirements.where the set of controls consistently provides assurance of During international transport, the proper language(s)continued process performance and product quality (ICH should be used to ensure that handlers understand the re-Q10).

quirements set forth on drug product labeling. The use of If deviations occur, a nonconformance should be docu-symbols that are recognized by international organizations is mented, and investigation should be performed and docu-advisable.mented as appropriate. The investigative process should de-Drug products can be transported at temperatures termine the root cause(s) of the deviation. For example, the outside of their labeled storage temperatures if stability data following should be determined: whether the drug product and relevant scientific justification demonstrate that product experienced stress, damage, delays, or environmental lapses, quality is maintained. The length of the stability studies and or whether there were errors in documentation. The associ-the storage conditions for a drug product should be suffi-ated supply quality management staff should have final re-cient to cover the shipment, distribution, and subsequent sponsibility for approving or rejecting the investigation. The use of the drug product. The data gathered from ICH, Q1A investigation process should be linked to the risk manage-

R2, accelerated testing or from testing at an ICH intermedi-ment program to ensure that proper mitigation occurs and ate condition may be used to evaluate the effect of short-preventive measures are put in place.

term excursions outside of the label storage conditions that For example, a written investigation should be performed might occur during storage and/or distribution.if the receiving and/or transferring processes result in a drug

product being subjected to unacceptable temperature con-

ditions or contamination (e.g., pests, microorganisms, or QUALITY MANAGEMENT SYSTEM

moisture). Any breach of standard operating procedures

should be documented with a risk justification as needed. Good storage and distribution practices require that enti-This information should be forwarded to the appropriate or-

ties involved in the storage and/or distribution of drug prod-ganization responsible for the drug product. The drug prod-ucts maintain a Quality Management System (QMS) that is uct should be quarantined, and final disposition should be based on standard quality concepts, includes good manu-based on good science with appropriate evidence to justify facturing practice (GMP) in compliance with the appropriate the decision(s).

regulatory agency(s), and is complementary to the ICH Manufacturers should develop written procedures for re-quality guidances, including ICH Q10 Pharmaceutical Quality cording the security process that confirms container–closure System and ICH Q9 Quality Risk Management. In the context integrity for drug products that require special handling,

of this chapter, the QMS includes the following manage-such as security seals for controlled substances. Returned ment system programs: (1) Storage Management System, (2)and salvaged goods records should address how the drug Distribution Management System, (3) Environmental Manage-product is assessed through a written procedure. In addi-ment System, and (4) Risk Management System.tion, training on such procedures should be part of the

The storage and distribution QMS should, at minimum,QMS.

cover the following elements: corrective and preventive ac-Records should be retained for purchases and sales of

drug products and should show the date of purchase or

Second Supplement to USP 35–NF 30General Information / ?1079? Good Storage and Distribution Practices5659

supply; the name of the drug product and the amount; the to ensure minimal time outside specified storage conditions name and address of the supplier or consignee; and the as described in a written procedure.

associated lot numbers. These records should allow for the Relative to the incoming receipt of drug product, it is rec-traceability of a drug product in the supply chain.ognized that the process of product reaction to ambient

All records and documents should be maintained in accor-conditions begins immediately and may occur quickly (e.g., dance with a traceable records-retention program and reach temperature equilibrium within minutes to a few should be made available upon request to regulatory agen-hours depending on details such as the product mass, vol-cies. These documents should be approved, signed, and ume, and packaging density taking into account secondary dated by the department responsible for the QMS.and tertiary packaging)1. Time spent in a transport vehicle is

considered to be part of the distribution process and is not

a storage location.

Storage Management System Receiving docks should protect drug product deliveries

from inclement weather during unloading. Any storage area,

including loading and unloading docks for receipt and distri-

bution of drug products, should be clean, cleanable, and STORAGE LOCATIONS AND PROCESSES free from pests. The incoming receiving area should limit

access to authorized persons. Where appropriate, the deliv-It is important that each entity define their appropriate ery vehicle/container should be examined before unloading storage locations to ensure that adequate controls are in to ensure that adequate protection from contamination was place. These locations include buildings and facilities for maintained during transit. Deliveries should be examined at drug product storage (e.g., warehouse, storage or hold receipt in order to check that containers are not damaged area, the original manufacturer’s warehouses, contractor and that the consignment corresponds to the order. The warehouses, wholesale distribution warehouses, mail order results of this examination should be documented.

or retail pharmacy storage area, hospital or nursing home Areas should be designated to provide an adequate space pharmacy storage areas; and border Customs storage areas).in which containers of drug products can be cleaned and

In these locations, two basic processes can occur. First,opened for sampling. If sampling is performed in the receiv-receiving for storage is the act of bringing a drug product ing area, it should be done in a manner that prevents con-into a facility, while transferring refers to the moving of a tamination and cross-contamination and ensures that envi-drug product internally within a facility or into or out of a ronmental requirements for the drug product are not vehicle. Second, storing and holding refers to the act of breached.

maintaining temporary possession of a drug product in the Adequate precautions should be taken to prevent theft supply chain process, during which no movement of the and diversion of drug products. Drug products that have product will occur.been identified as counterfeit should be quarantined to pre-

vent further distribution. The appropriate regulatory agen-

cies should be contacted according to established STORAGE IN BUILDINGS AND FACILITIES

procedures.

Appropriate delivery records (e.g., as applicable, transport Drug product storage areas are required to maintain the

vehicle movement papers, receiving/delivery records, data product temperature between the limits as defined on the

logging records, temperature recorders and similar devices, product label. Buildings and facilities used for the ware-

bill of lading, house air waybill, master air waybill, etc.) housing, storage, and/or holding of drug products should

should be reviewed by each receiving entity in the supply be of adequate size for their intended use. These facilities

chain to determine if the product has been subjected to any should be adequate to prevent overcrowding. The building

transportation delays or other events that could have ex-and facility should be designed to control environmental

posed the product to undesirable conditions. Each entity conditions where necessary and should be made of readily

should ensure that their respective Service Level Agreement or easily cleanable materials. Sanitation and pest control

documents and supporting documents such as SOPs cover procedures should be written, indicating frequency of clean-

delivery and receiving responsibilities of the transactional ing and the materials and methods used. The pest-control

parties.

program should ensure the prevention of contamination as

Smoking, eating, and drinking should not be permitted in well as the safe use of pesticides. Records of all cleaning and

any storage/hold areas.

pest-control activities should be maintained.

Storage should be orderly and should provide for the seg-

regation of approved, quarantined, rejected, returned, or re-REFRIGERATORS AND FREEZERS

called drug product. If computerized systems are used for

the control of storage conditions, the software should be Refrigerators and freezers used to store drug products are appropriately qualified for its intended purposes. Facilities required to maintain the product temperature between the should have controls that mitigate risks such as fire, water,limits as defined on the product label. Typically, a refrigera-or explosion. Certain drug products may cause these risks tion unit specification would be set to 5° with an allowable and should be stored accordingly. Storage areas, when not range of ±3° to store products labeled 2°–8°. Freezer tem-computerized, should be appropriately visually labeled.peratures may vary and typically range from ?25° to ?10°. Storage facilities themselves, unless thermostatically con-Some frozen drug products, however, require lower temper-trolled, cannot be validated; however, they can be qualified atures, e.g., dry ice or liquid nitrogen temperatures.

via a mapping process. The generator back-up power supply Regular operating procedures and maintenance protocols should be qualified.should be in place along with written contractual agree-

ments for all maintenance and evaluation procedures includ-

ing the following:

RECEIVING AND TRANSFERRING DRUG PRODUCTS

1.Items should be stored in the units in a manner that

allows adequate air flow to maintain the specified Storage of a drug product includes not only the period

conditions.

during which the drug product is held in the manufacturer’s

2.Units should be positioned in the facility so that they storage areas but also time spent at the receiving bay area.

are not subjected to environmental extremes that When drug products arrive at warehouse loading docks and

could affect their performance. If this cannot be pre-other arrival areas, they should be transferred as quickly as

vented, the mapping protocol should include a provi-possible to a designated storage or within a time period

that is consistent with the risk and exposure of the product1JP Edmond, Study for Temperature Sensitive Product: Preliminary Testing, Oc-in the receiving area to a designated storage environment

tober 2009, University of Florida.

5660?1079? Good Storage and Distribution Practices / General Information Second Supplement to USP 35–NF 30

sion for testing during the anticipated environmental The type, size, location, and amount of the temperature extremes.stabilizers required to protect the product should be based

https://www.doczj.com/doc/871894987.html,rge commercial units such as walk-in cold rooms on documented studies of specific distribution environments

are qualified via a temperature mapping study or including domestic and international lanes, mode(s) of

other type of qualification process to determine the transport, duration, temperature, and other potential envi-unit’s suitability for storing drug products. A suitable ronmental exposures or sensitivities that may impact prod-number of temperature-recording devices should be uct quality. Transportation container materials such as

utilized to record temperatures and to provide tem-warm/cold packs and materials used to control temperature perature area maps. Thereafter, the units should be conditions should be properly conditioned before use. Bar-monitored as determined by the results of the map-rier protection may be important in helping to determine ping study. Refer to the Temperature Monitoring sec-the position of materials such as gel packs in order to avoid tion under Environmental Management System.direct contact with the drug product. It should be deter-

4.Units should utilize recording systems to log and mined if studies are required to ensure that the dry ice and

track temperatures. Alarm systems should be an inte-its vapors do not adversely affect the drug product, includ-gral part of the monitoring system for both refrigera-ing the drug product labeling.

tors and freezers. While automated systems monitor

units continuously, manual checks should be per-

VALIDATION AND THERMAL PERFORMANCE QUALIFICATION formed as appropriate to the validation program.

When automated systems are not available, manual FOR TRANSPORT SYSTEMS

systems may be used.

Drug product transport systems should be continuously

monitored by calibrated monitoring systems, (continuous Distribution Management System verification), or shipping systems should be qualified and

based on historical data relative to the process. However, it Distribution of drug products occurs within a facility or may be acceptable to use product stability data and supply location such as a manufacturer, wholesaler, pharmacy dis-chain risk assessment to justify shipping without either con-pensing area, retail site, clinic/hospital/nursing home phar-tinuous monitoring or qualification of the shipping system. macy, and the physician’s practice. Distribution of drug Operational and performance shipping studies should on products occurs as point-to-point movement within the sup- a generic level be part of a formal qualification protocol that ply chain between distribution facilities via semitrailer trucks,may use controlled environments or actual field testing, de-vans, emergency medical service vehicles, industry repre-pending on the projected transport channel. These studies sentatives’ automobiles, trains, aircraft, sea vessels, and mail should reflect actual load configurations, conditions, and ex-delivery vehicles.pected environmental extremes. Testing should be per-Communication within the supply chain should be coordi-formed on both active and passive thermal packaging nated to determine proper timing for drug products to be systems.

transported and received, taking into account holiday

schedules, weekends, or other forms of interruption. When

international distribution is required, alerts should be made Environmental Management System

in advance and proper language should be used to ensure

understanding of the requirements set forth on drug prod-While storage and distribution temperature ranges for

uct labeling.drug products are labeled on the packaging, relative humid-

ity effects occur over a much longer time frame. The pri-

mary container is designed and tested to protect the prod-PACKAGING FOR THE DISTRIBUTION AND TRANSPORTATION uct from moisture; therefore, humidity monitoring should PROCESSES be considered when a product will be stored in an uncon-

trolled facility.

Pharmaceutical manufacturers should consider primary,

secondary, and tertiary packaging that best protects the

TEMPERATURE MONITORING

drug product during storage and distribution. Package per-

formance testing should be documented as part of a manu-

Environmental conditions are important parameters to facturer’s QMS. Several standard test procedures are availa-

consider in the storage and distribution of all drug products ble for evaluating package performance for factors such as

and may require monitoring depending on the require-shock, vibration, pressure, compression, and other transit

ments. When specific storage conditions are required and events. Organizations with standard test methods include

transportation qualification has not been performed, and in the following: the American Society for Testing and Materi-

the absence of active or passive containers, environmental als (ASTM) Standard Practice for Performance Testing of Ship-

recorders or devices should be used to confirm that an ac-ping Containers and Systems, and the International Safe

ceptable range has been properly maintained during each Transit Association (ISTA) specifications for various types of

stage in the supply chain.

transit modes such as less-than-truckload, small package, rail

Temperature is one of the most important conditions to car, and air freight.

control, and requirements for each drug product should be It is important to be aware that removal or modification

based on stability data. Temperatures should be tracked us-of the original packaging may subject the product to unac-

ing a monitoring system, and the monitoring devices used ceptable conditions.

should be included in a calibration and/or preventive main-The packaging (tertiary or thereafter) for the distribution

tenance program. Environmental monitoring devices should of the drug product should be selected and tested to ensure

be calibrated for their range of operation. The monitoring that product quality is maintained and to protect the con-

devices used should provide an alert mechanism if the tents from the rigors of distribution including environmental

preset ranges are breached. The following practices and

or physical damage.

controls are examples of appropriate measures that should All drug products have storage requirements that may

be put in place to ensure environmental control (see also contain specific controls. The container used for transport-

Monitoring Devices—Time, Temperature, and Humidity

ing the drug product should be qualified on the basis of the

?1118?):

labeled conditions of the product as well as anticipated en-

?Temperature-monitoring equipment, a monitoring de-vironmental conditions. Consideration should be made for

vice, a temperature data logger, or other such device seasonal temperature differences, transportation between

that is suitable for its intended purpose should be used. hemispheres, and the routes and modes of transport.

Second Supplement to USP 35–NF 30General Information / ?1079? Good Storage and Distribution Practices5661

?An appropriate number of temperature monitors or place to ensure that the drug product is adequately pro-some other form of recordation or proof of temperature tected. Mapping by the shipper may not be necessary if the control. Temperature monitor(s) should be used with shipper uses a transport container that is properly insulated every distribution process unless another process has and has been previously qualified for the duration of the been put in place to ensure specified temperature distribution process by the transport container manufacturer ranges.via a mapping study or if drug products are continuously ?Electronic temperature monitors should be calibrated to monitored by calibrated monitoring systems (continuous National Institute of Standards and Technology (NIST)verification).

or other suitable standard.The vehicle in which drug products are transported ?Chemical temperature indicators may be used as should be mapped to determine the appropriate placement appropriate.of temperature-recording devices and to confirm that the ?Predetermined temperature ranges should be set for all load configuration is not restricting air flow. The following applicable areas, as well as a plan of action in the event are recommended practices and controls for vehicles that of an unacceptable excursion.receive and transfer drug products:

1.Transport containers/vehicles and equipment used to

store and transport drug products should be suitable TEMPERATURE MAPPING for their intended function.

2.Procedures should be established that describe how The basis of any temperature mapping in a temperature to operate, clean, and maintain transport containers/ controlled space (e.g., facility, vehicle, shipping containers,vehicles and equipment used in the storage and dis-refrigerator, freezer) is the identification and documentation tribution of drug products.

of a sound rationale used for a given mapping procedure. 3.Transport containers/vehicles should be designed to The temperature variability associated with mapped loca-prevent damage to the drug product, and pharma-tions and the level of thermal risk to the product should be ceutical manufacturers should collaborate with their defined, unless another process has been put in place to transporter to determine contingency response plans ensure environmental control.for how drug products are handled when equipment A temperature mapping study should be designed to as-malfunction.

sess temperature uniformity and stability over time and 4.When drug product must be moved from one trans-across a three-dimensional space. Completing a three-di-port container/vehicle into another, the proper load mensional temperature profile should be achieved by meas-configuration should be followed.

uring points at not less than three dimensional planes in 5.It should be understood how communication is made each direction/axis—top-to-bottom, left-to-right, front-to-to the necessary entities when such transfer occurs. back, where product will be present. 6.Subcontracted vehicles should be considered in con-When temperature mapping is necessary, it should begin tractual agreements and audits, and documentation with an inspection of the facility, equipment and/or vehicle should be maintained for their use.

and should be re-evaluated as appropriate. Environmental Temperature mapping should account for maximum and mapping also should be performed after any significant minimum loads to capture temperature variability resulting modification to the distribution system that could affect from variations in temperature mass of the payload. Perfor-drug product temperature.mance of equipment under extreme scenarios including Facility temperature mapping:The following factors,door open, door closed, and simulated equipment failure which may contribute to temperature variability, should be should be taken into account.

considered during the process of temperature mapping stor-Thermal mapping of vehicles should be representative of age locations: (1) size of the space; (2) location of HVAC the fleet with the intention of capturing variability across the equipment, space heaters, and air conditioners; (3) sun-fac-range of vehicles (type of vehicle including non-refrigerated ing walls; (4) low ceilings or roofs; (5) geographic location equipment, use, heating and/or cooling system). A periodic of the area being mapped; (6) airflow inside the storage requalification program should be documented. location; (7) temperature variability outside the storage loca-Mapping for both facilities and transportation containers/ tion; (8) workflow variation and movement of equipment vehicles should be done in a way that confirms their fitness (weekday vs. weekend); (9) loading or storage patterns of for operation during periods of expected extreme weather product; (10) equipment capabilities (e.g., defrost mode,(e.g., summer and winter). Facilities should be mapped cycle mode); and (11) SOPs.under varying operating conditions—ideally during periods The recording of temperatures during the thermal map-of greater variability, accounting for and capturing the result ping of a warehouse or cold room should be sufficient in of any seasonal fluctuations of inventory movement, equip-time frame to capture workflow variation that may impact ment movement, or workflow variation.

air flow and the resulting temperature fluctuation (i.e., a The temperature-mapping protocol and associated num-period of one week is recommended for data collection and ber of temperature data loggers used to map a three di-should capture workflow cycles).mensional space should meet the intent of demonstrating

three-dimensional uniformity and compliance with product Equipment (container/trailer) temperature mapping:To

requirements. For both facility and trailer/container temper-minimize risk of product exposure to damaging tempera-

ature mapping, the ambient conditions should be recorded tures during transport, dedicated containers/vehicles cargo

and correlations between ambient conditions and potential space should be mapped. When complete fleet mapping (i.

thermal risks inside the controlled space should be identi-e., wholesaler or distributor vehicles) is not realistic or ap-

fied. Drug products should not be stored in areas where a propriate, minimally at least one container/vehicle from the

thermal risk has been identified as a result of the tempera-fleet must be mapped. Thereafter, the following conditions

ture mapping. Areas identified as being unsuitable for stor-should be considered: (1) SOPs, including loading and un-

age should be clearly labeled as such to ensure that they are loading procedures; (2) route-specific operation of the tem-

not used.

perature control equipment; (3) seasonal effects encoun-

Temperature data loggers should be used for temperature tered on expected routes; (4) loading patterns; and (5)

mapping and PQ testing of facilities, equipment, and trans-transport durations.

portation containers used for storage or transportation of When nondedicated (i.e., mail carriers) transport contain-

temperature-sensitive medicinal products. Temperature data ers/vehicles and equipment are used, they should be de-

loggers and any associated software applications should be signed to minimize the risk of contamination of the product

appropriately validated. Certificates of calibration to an NIST being handled. If environmental mapping of such vehicles is

or other international traceable standard should be available not performed, some other means of control should be in

for individual monitoring devices.

5662?1079? Good Storage and Distribution Practices / General Information Second Supplement to USP 35–NF 30

Because MKT expresses the cumulative thermal stress a EXCURSIONS

drug product experiences, it is considered an acceptable

practice for storage, and it follows that it should be consid-The mapping process will help determine when excur-

ered for transit excursions in the process of distribution. sions could occur and are useful when pharmaceutical man-

The calculation must be justified for use with distribution ufacturers develop a plan for dealing with them. Alarms

excursions by confirming that the stability limiting charac-should be used to reveal environmental excursions during

teristic of the product follows first order kinetics over the operations. Temperature excursions for brief periods outside

temperature range encountered. The ICH stability-testing

of respective storage label conditions may be acceptable

guidelines define MKT as a “single” derived temperature, provided stability data and scientific/technical justification

which, if maintained over a defined period, would afford the exists demonstrating that product quality is not affected

same thermal challenge to a pharmaceutical product as (see Health Canada’s GUI 0069 entitled, Guidelines for Tem-

would have been experienced over a range of both higher perature Control of Drug Products During Storage and Trans-

and lower temperatures for an equivalent defined period. portation, 2011).

The MKT analysis must be based on good science and

should take into account the integrity of the product. The MEAN KINETIC TEMPERATURE(MKT)CALCULATION calculated MKT is not sensitive to the impact of excursions

that may occur if the baseline is a long period of time such The MKT is the single calculated temperature at which as a storage segment or the entire lifetime of the drug prod-the total amount of degradation over a particular period is uct. For shorter baseline periods of time, such as transport equal to the sum of the individual degradations that would segments, an excursion can have a significant impact on the occur at various temperatures. MKT may be considered as resulting MKT for that segment; however, this would not

an isothermal storage temperature that simulates the non-necessarily have a significant impact on product quality. isothermal effects of storage temperature variation. It is not The MKT analysis may be used for storage conditions that a simple arithmetic mean.have exceeded the acceptable parameters for a drug prod-The temperatures used for calculating MKT can be con-uct, for a short period of time and is not intended to be a veniently collected using electronic devices that measure measure for long-term storage.

temperatures at frequent intervals (e.g., every 15 minutes).Knowing the MKT for an excursion is useful for evaluating MKT can be calculated directly or the data can be the potential impact on product quality. However, it is also downloaded to a computer for processing. Software to essential to know the upper and lower temperature limits of compute the MKT is available commercially.any excursion. If these extreme temperatures are outside For dispensing sites, such as pharmacies and hospitals,available stability data, it may not be possible to predict the where the use of such instruments may not be feasible, de-quality impact of the excursion with any confidence regard-vices such as high-low thermometers capable of indicating less of the MKT. Although higher temperatures are given weekly high and low temperatures may be employed. The greater weight in the calculation, the calculation of MKT for arithmetic mean of the weekly high and low temperatures is nonfrozen product that becomes frozen for any amount of then used in the calculation of MKT. MKT is calculated by time may not result in an acceptable temperature although the following equation (derived from the Arrhenius the product may not be adulterated. At higher temperatures equation):the kinetics of degradation may change or new degradation

reactions may occur; at lower temperatures (near freezing) a

phase change may occur that is known to have a negative

impact on the quality of some drug products (e.g., some

proteins and vaccines). For an example of a calculation, see

Pharmaceutical Calculations in Prescription Compounding

?1160?.

where T k is the mean kinetic temperature; ?H is the heat of

activation, 83.144 kJ·mole–1 (unless more accurate informa-Emergency Medical Service Vehicles,

tion is available from experimental studies); R is the univer-

Automobiles, and Van Transportation

sal gas constant, 8.3144 × 10–3 kJ·mole–1·degree–1; T1 is

the value for the temperature recorded during the first time

Road vehicles used to transport drug products (e.g., am-period, e.g., the first week; T2 is the value for the tempera-

bulances and other emergency response vehicles, vans, or ture recorded during the second time period, e.g., second

automobiles, including those used by sales representatives week; and T n is the value for the temperature recorded dur-

to transport physicians’ samples) should be suitable for their ing the n th time period, e.g., n th week, n being the total

purpose. Monitoring devices should be placed in different number of storage temperatures recorded during the obser-

areas of the trunk or cabin where the drug product will be vation period. [N OTE—All temperatures, T, are absolute tem-

positioned during seasonal extremes (e.g., summer and win-peratures in degrees Kelvin (K).]

ter). The monitor should be secured so that it is immobile,

and there should be no ambiguity about its exact position MKT DURING STORAGE AND DISTRIBUTION within the payload so that the monitor is always placed in

the same position. Monitoring devices used on or in pack-The holding of a drug may occur as part of storage and ages or on containers may also be used. Suitable measures distribution practices. Drug products in the distribution sup-should be taken to maintain the drug product within the ply chain may be held at temperatures outside their labeled allowable limits of the labeled storage requirements. Storage storage requirements as determined by an appropriate sta-of physician drug product samples by sales representatives is bility study. Drug products stored either in warehouse con-regulated under 21 CFR Part 203.34(b)(4).

ditions or in transportation modes may experience excur-

sions from their acceptable temperature ranges. Each

Mail Order Pharmacy Distribution product excursion must be evaluated to determine the final

product effect. The means of evaluation must be scientifi-

The mailing party is accountable for the appropriate mail-cally sound with documented technical justification that the

ing process. Mail distributors including the U.S. Postal Ser-integrity of the drug product has not been affected. One

vice (USPS) and other shipping services including expedited method of analysis for drug product stored outside its re-

shipping services are responsible to provide the service spective label storage conditions is the use of an MKT

contracted.

calculation.

Second Supplement to USP 35–NF 30General Information / ?1088? In Vitro and In Vivo Evaluation5663

In the event that the package cannot be delivered as

scheduled, the package should be returned to the mailing?1088? IN VITRO AND IN VIVO pharmacy.EVALUATION OF DOSAGE FORMS

Risk Management System

Risk Management System strategies should ensure that

each organization’s best interests are served by adhering to Change to read:

proper practices, controls, and procedures, including but

not limited to the following: the nature of the drug prod-

ucts; distribution requirements on the readable container la-

beling; exposure to adverse environmental conditions; num-s PURPOSE

ber of stages/receipts in the supply chain; manufacturer’s

written instructions; contractors; and drugs at risk from This chapter provides an overview of the methodology for freezing (vaccines, insulin, and biological products) or ele-characterizing the physicochemical properties of a drug sub-vated temperatures (fatty-based suppositories, vaccines, in-stance as well as its associated drug product and discusses sulin, and biological products).the relationship of these methods and properties to the Examples of risks include the following: (1) vibration that pharmacokinetic and pharmacodynamic properties of the can cause aggregation of some drug products such as pro-drug product. Results of in vitro methods are linked with teins and peptide-based drugs; (2) temperature excursions information from in vivo evaluations through an in vitro–in that may lead to phase changes (melting or freezing); (3)vivo correlation (IVIVC).

loss of container–closure integrity in transit that could cause

glass fractures or loss of sterility in sterile drug product con-

SCOPE

tainers; and (4) ingress of water or oxygen that could lead

to an increase in degradation products. Appropriate firms

The ultimate goal of these characterization studies is an such as applicant holders are recommended to convey rele-

understanding of the relationship between the physico-vant environmental requirements when needed to support

chemical and pharmacological properties of the drug sub-deviations or excursions. There may be alternate ways of

stance to the pharmacokinetic properties and in vitro perfor-determining acceptable environmental conditions and these

mance of the drug product. This chapter outlines the in should be documented and justified.

vitro and in vivo testing that goes into the development of Pharmaceutical manufacturers should ensure that suppliers

the body of data that informs decision making relating to

of drug product transportation are monitored. Auditing

the formulation, manufacturing, and related regulatory ac-transportation firms should be carried out routinely to en-

tivities necessary for the development, regulatory approval, sure adequate product handling. The manufacturer’s change

and marketing of any drug product. The chapter comple-control system should capture and evaluate changes in lo-

ments the information in general chapters, Assessment of gistic factors such as warehouse or receiving areas and vehi-

Drug Product Performance—Bioavailability, Bioequivalence, and cle changes.

Dissolution ?1090? and The Dissolution Procedure: Develop-

ment and Validation ?1092? by detailing the essential in vitro CONCLUSION and in vivo data elements underlying an understanding of

bioequivalence and bioavailability. The chapter text recog-The practices and processes set forth in this general infor-nizes that regulatory guidances and a wealth of text books mation chapter apply to storage and distribution as part of are available to elaborate on the content provided, and it is the life-cycle management of drug products. All involved not the purpose to provide an exhaustive disquisition on the should ensure the product to its point of use, creating a subjects presented but rather to provide a guide and listing contiguous supply network that is collaborative and empha-of the issues of interest.

sizes preventive measures to protect drug product quality.

The increase in global processes coupled with products re-

BACKGROUND INFORMATION

quiring special environmental controls highlights the need

for a strong QM program. QM should provide the founda-

Establishing a meaningful relationship between dissolution tion for maintaining the storage and distribution practices in

behavior and in vivo drug performance (i.e., IVIVC) has long a continual improvement program and part of an overall

been sought from the perspectives of both bioavailability management system review by each entity, as appropriate,

(BA) and bioequivalence (BE) and quality control considera-in the supply chain.

tions. In setting dissolution acceptance criteria for a product It is equally important to stay current and be ready to

monograph, USP’s policy has been to give predominant change as new solutions evolve. These new technologies

consideration to valid BA or BE studies, when available. should be considered in developing strategies for good dis-

The earliest achievable in vitro characteristic thought to tribution practices, controls, and procedures.s2S(USP35)

predict an acceptable in vivo performance was tablet and

capsule disintegration. A test for disintegration was adopted

in USP XIV (1950). At that time, no quantitative work was

done to attempt to demonstrate such a relationship, espe-

cially with regard to in vivo product performance. Advances

in instrumental methods and analytical precision ultimately

opened up prospects for this work. The USP–NF Joint Panel

on Physiologic Availability recognized that the disintegration

test was insufficiently sensitive and in 1968 directed the

identification of candidate articles for the first 12 official dis-

solution tests that used Apparatus 1.

USP requires drug release testing via the USP performance

test in the majority of monographs for non-solution oral,

sublingual, and transdermal dosage forms. In the current

state of science, in vivo testing is necessary during the de-

velopment and evaluation of both immediate-release and

实验四 药物的一般鉴别实验

实验四药物的一般鉴别实验 [实验目的] 1、掌握钠盐钙盐乳酸盐硫酸盐磷酸盐氯化物溴化物等药物的一般鉴别性原理和鉴 别方法。 2、掌握一般鉴别实验操作的基本方法及常用的试剂。 [实验原理] 1、钠盐的鉴别:钠盐的中性溶液+醋酸氧铀锌-----黄色的结晶性沉淀 2、钙盐的鉴别:钙盐的中性或碱性溶液+草酸铵----白色沉淀+盐酸----溶解 3、乳酸盐的鉴别:乳酸盐的酸性溶液+溴---乙醛+氨+亚硝基铁氰化钠----暗绿色 4、硫酸盐的鉴别:硫酸盐+钡离子---白色沉淀(不溶于盐酸) 硫酸盐+醋酸铅----白色沉淀(即能溶于醋酸,也能溶于氢氧化钠) 5、磷酸盐的鉴别:磷酸盐溶液+硝酸银----黄色沉淀(能溶于氨试液中和稀硝酸试液中) 磷酸盐溶液+氯化铵镁试液----白色沉淀 6、氯化物的鉴别:氯化物溶液+硝酸银----白色沉淀(能溶于氨试液中,不溶于稀硝酸试液中) 氯化物溶液+二氧化锰试液----氯气(淀粉碘化钾试纸变蓝) 7.溴化物的鉴别:溴化物溶液+硝酸银----淡黄色沉淀(能部分溶于氨试液中,不溶于稀硝酸试液中) 溴化物+氯试液中----溴(溶于氯仿,氯仿层显橘黄) [试药、试剂和仪器] 1、试药:水杨酸钠、乳酸钙、硫酸阿托品、磷酸可待因、溴新斯的明、维生素B1 2、试剂:盐酸稀盐酸稀硫酸醋酸硝酸氢氧化钠浓氨试液氨试液醋酸氧铀锌醋酸 铅醋酸铵试液甲基红指示液草酸铵试液硫酸铵溴试液10%亚硝基铁氰化钠的稀硫酸试液氯化钡试液氯化铵镁试液二氧化锰氯试液氯仿碘化钾淀粉试纸 3、仪器:试管小烧杯铂金丝酒精喷灯 [操作步骤] 一、对乙酰水杨酸钠中钠离子的鉴别 1、取对氨基水杨酸钠0、1克,置试管中,加纯化水2毫升使溶解,然后滴加醋酸氧铀锌 试液,即生成黄色沉淀。 2、取铂金丝,用盐酸浸润,在无色火焰中燃烧,冷却后,蘸取供试品,在无色火焰中燃烧, 火焰即显鲜黄色。 二、乳酸钙中的钙离子和乳酸根离子的鉴别 1、取乳酸钙约0、1克,置试管中,加纯化水2毫升使溶解,加甲基红指示液2滴,用氨试液中和,再滴加盐酸至恰呈酸性,加草酸铵试液,即生成白色沉淀,分离沉淀,将沉淀分置于两支试管中,分别加入醋酸和盐酸,沉淀能溶于盐酸,不溶于醋酸。 2、取铂金丝,用盐酸湿润,蘸取供试品,在无色火焰中燃烧,火焰即显砖红色。 3、取乳酸钙约0、1克,置小烧杯中,加纯化水60毫升使溶解,从中取出溶液5毫升,置试管中,加溴试液1毫升和稀硫酸0、5毫升,置水浴上加热,并用玻璃小心搅拌至退色,再加硫酸铵4克,摇匀,沿管壁逐滴加入10%亚硝酸铁氰化钠的稀硫酸试液0、2毫升和浓氨试液1毫升,使成两液层,在放置30分钟内,在放置30分钟内,两液层的交界处出现一暗绿色的环。 三、硫酸阿托品中的硫酸根的鉴别 取硫酸阿托品0、5克,加纯化水10毫升使溶解,使溶液分置两个试管中,向其中一支试

最新邮政金融高端客户的维护策略

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目录 1背景信息....................................................... 2技术指标列表................................................... 大型号指标列表 ............................................ 小型号指标列表 ............................................ 3体系结构分析................................................... HDS USP V/USP VM体系结构——先进的统一星型网络架构.......... EMC DMX-4/DMX-4 950体系结构................................. IBM DS8300 Turbo/DS8100 Turbo体系结构——落后的双控制器结构. 4Cache技术分析................................................. HDS USP V/VM缓存技术........................................ EMC DMX-4缓存技术........................................... IBM DS8000缓存技术.......................................... 5缓存并发访问能力比较........................................... HDS USP V缓存并发数......................................... HDS USP VM缓存并发数........................................ EMC DMX-4/DMX-4 950缓存并发数............................... DS8300缓存并发数............................................ 小结 ...................................................... 6IO性能........................................................ 测试结果公开网站 .......................................... DS8300测试结果.............................................. USP V测试结果............................................... 对比 ...................................................... DMX-4/950测试结果........................................... 7存储虚拟化整合技术.............................................

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版权所有? 华为技术有限公司2016。保留一切权利。 非经本公司书面许可,任何单位和个人不得擅自摘抄、复制本文档内容的部分或全部,并不得以任何形式传播。 商标声明 和其他华为商标均为华为技术有限公司的商标。 本文档提及的其他所有商标或注册商标,由各自的所有人拥有。 注意 您购买的产品、服务或特性等应受华为公司商业合同和条款的约束,本文档中描述的全部或部分产品、服务或特性可能不在您的购买或使用范围之内。除非合同另有约定,华为公司对本文档内容不做任何明示或默示的声明或保证。 由于产品版本升级或其他原因,本文档内容会不定期进行更新。除非另有约定,本文档仅作为使用指导,本文档中的所有陈述、信息和建议不构成任何明示或暗示的担保。 华为技术有限公司 地址:深圳市龙岗区坂田华为总部办公楼邮编:518129 网址:https://www.doczj.com/doc/871894987.html, 客户服务邮箱:support@https://www.doczj.com/doc/871894987.html, 客户服务电话:4008302118

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