teachingprocedures

Guidance for Industry

Analytical Procedures andMethods Validation

Chemistry, Manufacturing, and Controls DocumentationDRAFT GUIDANCEThis guidance document is being distributed for comment purposes ments and suggestions regarding this draft document should be submitted within 90 days ofpublication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docketnumber listed in the notice of availability that publishes in the Federal Register. For questions on the contents of this draft document contact (CDER) Radhika Rajagopalan, 301-827-5849 or (CBER) Alfred Del Grosso, 301-435-4988.U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)August 2000CMC #Guidance for Industry

Book 2 Unit 2 Words and phrases

Teaching Objectives

Knowledge objectives: Get Ss to master 7 words and phrases as follows

(1) The important words ;

compete, take part in, admit, host, athelete, deserve and responsibility

(2) The imprtant phrases: compete in/for/with,

take part in/ join in/ join/attend,

be admitted into/as, admit doing

deserve doing=deserve to be done

have/take responsibility for

Ability Objectives: To train Ss’ ability of speaking accurately

To train Ss’ ability of writing properly

Emotional Objectives: After learning the words related with the Olympics, Ss are expected to develop the

spirit of hard—working

Teaching Key and Difficult Points:

How to use the above phrases correctly and properly

Quality Assurance (QA) Management Procedures

In this episode you will find procedures and practical work instructions on every aspect of Quality

Assurance and Technical areas to build up a highly effective Quality Management System for

your pharmaceuticals business.

In this area you will find Standard Operating Procedures for establishing quality assurance

practices, such as preparation, maintenance, definition, classification and change Control of

Quality and Master file documentation necessary for your products; recording and reporting

procedure for deviations management; quality concern investigation Process; customer complaint

handling procedure; quality audit procedures; vendor assessment, evaluation and certification

procedure; rework procedures for the defective manufactured products; procedures on training for

982〈1223〉 Validation of Alternative Microbiological Methods / General InformationUSP 36TYPES OF TRANSFERS OF ANALYTICALLinearityPROCEDURESThe linearity of a quantitative microbiological test is itsTAP can be performed and demonstrated by several ap-ability to produce results that are proportional to the con-proaches. The most common is comparative testing per-centration of microorganisms present in the sample within aformed on homogeneous lots of the target material fromgiven range. The linearity should be determined over thestandard production batches or samples intentionally pre-range of the test. A method to determine this would be topared for the test (e.g., by spiking relevant accurateselect at least 5 concentrations of each standard challengeamounts of known impurities into samples). Other ap-microorganism and conduct at least 5 replicate readings ofproaches include covalidation between laboratories, theeach concentration. An appropriate measure would be tocomplete or partial validation of the analytical procedurescalculate the square of the correlation coefficient, r2, from aby the receiving unit, and the transfer waiver, which is anlinear regression analysis of the data generated above. Whileappropriately justified omission of the transfer process. Thethe correlation coefficient does not provide an estimate oftests that will be transferred, the extent of the transfer activ-linearity, it is a convenient and commonly applied measureities, and the implementation strategy should be based on ato approximate the relationship. The alternate methodrisk analysis that considers the previous experience andshould not have an r2 value less than 0.95.knowledge of the receiving unit, the complexity and specifi-cations of the product, and the procedure.Limit of DetectionComparative TestingSee Limit of Detection under Validation of Qualitative Testsfor Demonstration of Viable Microorganisms in a parative testing requires the analysis of a predeter-mined number of samples of the same lot by both thesending and the receiving units. Other approaches may beRangevalid, e.g., if the receiving unit meets a predetermined ac-ceptance criterion for the recovery of an impurity in aThe operational range of a quantitative microbiologicalspiked product. Such analysis is based on a preapprovedmethod is the interval between the upper and lower levelstransfer protocol that stipulates the details of the procedure,of microorganisms that have been demonstrated to be de-the samples that will be used, and the predetermined ac-termined with precision, accuracy, and linearity.ceptance criteria, including acceptable variability. Meetingthe predetermined acceptance criteria is necessary to assureRuggednessthat the receiving unit is qualified to run the procedure.See Ruggedness under Validation of Qualitative Tests forCovalidation Between Two or MoreDemonstration of Viable Microorganisms in a boratoriesRobustnessThe laboratory that performs the validation of an analyti-cal procedure is qualified to run the procedure. The transfer-See Robustness under Validation of Qualitative Tests forring unit can involve the receiving unit in an interlaboratoryDemonstration of Viable Microorganisms in a Sample.covalidation, including them as a part of the validation teamat the transferring unit and thereby obtaining data for theassessment of reproducibility. This assessment is made usinga preapproved transfer or validation protocol that providesthe details of the procedure, the samples to be used, andthe predetermined acceptance criteria. The general chapterValidation of Compendial Procedures 〈1225〉 provides usefulguidance about which characteristics are appropriate for〈1224〉 TRANSFER OFtesting.ANALYTICAL PROCEDURESRevalidationRevalidation or partial revalidation is another acceptableapproach for transfer of a validated procedure. Those char-INTRODUCTIONacteristics described in 〈1225〉, which are anticipated to beaffected by the transfer, should be addressed.Testing to the specification of an ancillary material, inter-mediate, and/or ingredient and product is critical in estab-Transfer Waiverlishing the quality of a finished dosage form. The transfer ofanalytical procedures (TAP), also referred to as methodThe conventional TAP may be omitted under certain cir-transfer, is the documented process that qualifies a labora-cumstances. In such instances, the receiving unit is consid-tory (the receiving unit) to use an analytical test procedureered to be qualified to use the analytical test proceduresthat originated in another laboratory (the transferring unit),without comparison and generation of interlaboratory com-thus ensuring that the receiving unit has the proceduralparative data. The following examples give some scenariosknowledge and ability to perform the transferred analyticalthat may justify the waiver of TAP:procedure as intended.•The new product’s composition is comparable to thatThe purpose of this general information chapter is toof an existing product and/or the concentration ofsummarize the types of transfers that may occur, includingactive ingredient is similar to that of an existing prod-the possibility of waiver of any transfer, and to outline theuct and is analyzed by procedures with which thepotential components of a transfer protocol. The chapterreceiving unit already has experience.does not provide statistical methods and does not encom-•The analytical procedure being transferred is describedpass the transfer of microbiological or biological procedures.in the USP–NF, and is unchanged. Verifiction shouldapply in this case (see 〈1226〉).