GUIDANCE FOR CONTRIBUTORS

社会实践活动内容英文作文Social Practice Activities: Enriching Experiences and Empowering Youth.Social practice activities, an integral component of youth development programs, provide invaluableopportunities for young people to engage with their communities, gain practical experience, and make a meaningful impact. Through a diverse range of initiatives, these activities foster a sense of civic responsibility, cultivate essential skills, and empower youth to become active contributors to society.Types of Social Practice Activities.Social practice activities encompass a wide spectrum of initiatives, each tailored to specific age groups and community needs. Some common types include:Community service: Engaging in volunteer work thatbenefits the local community, such as assisting at a soup kitchen, tutoring at an after-school program, or participating in environmental cleanup efforts.Community development: Participating in projects that aim to improve the living conditions or well-being of a community, such as revitalizing public spaces, organizing community events, or advocating for social change.Youth leadership: Developing leadership skills through involvement in youth organizations, running for student government, or initiating projects that address youth-specific issues.Social entrepreneurship: Starting or supporting social enterprises that combine business principles with a social mission, such as selling products or services to raise funds for a cause or creating a sustainable community garden.Arts and culture: Utilizing the power of art, music, and performance to engage with the community, promotedialogue, and address social issues.Peer support: Providing support and guidance to peers facing challenges or transitioning into adulthood, such as through mentoring, peer counseling, or support groups.Benefits of Social Practice Activities.Participating in social practice activities offers a multitude of benefits for youth, including:Increased civic engagement: Social practice activities foster a sense of belonging and responsibility towards the community, encouraging young people to become active and informed citizens.Skill development: These activities provide hands-on opportunities to develop practical skills, such as communication, problem-solving, leadership, and teamwork.Self-esteem and confidence building: By making a tangible impact on their communities, youth gain self-esteem and confidence in their abilities to make a difference.Empathy and perspective-taking: Social practice activities expose youth to diverse perspectives and challenges, cultivating empathy and a deeper understandingof the world.Career exploration: Through involvement in various projects and initiatives, youth can explore differentcareer paths and gain valuable work experience.How to Implement Effective Social Practice Activities.To ensure the success and impact of social practice activities, it is essential to adhere to the following principles:Youth-centered approach: Involve youth in the planning, implementation, and evaluation of activities to ensuretheir relevance and ownership.Community partnerships: Collaborate with local organizations, schools, and businesses to leverage resources and expertise and create meaningful connections between youth and the community.Meaningful experiences: Design activities that provide youth with genuine opportunities to make a difference and develop their skills.Reflection and evaluation: Regularly assess the impact of activities and make adjustments based on feedback from youth and other stakeholders.Conclusion.Social practice activities play a crucial role in empowering youth by fostering civic engagement, developing essential skills, and providing a platform for them to make a meaningful contribution to their communities. By embracing a youth-centered approach, partnering with community organizations, and creating meaningful experiences, educators and youth leaders can harness thetransformative power of these activities to cultivate a generation of socially responsible and active global citizens.。

如何在校内外开展劳动实践活动英语作文全文共3篇示例，供读者参考篇1How to Do Labor Practice Activities at School and in the CommunityHi there! My name is Emma and I'm a 10-year-old student. Today I want to tell you all about labor practice activities we do at my school and in the community. These activities are really fun and also teach us important life skills!At SchoolOur school has lots of cool labor practice activities for us to get involved in. One of my favorites is taking care of the school garden. We have a big vegetable garden right on the school grounds. A few times a week, my class goes out to the garden to water the plants, pull weeds, and harvest ripe vegetables like tomatoes, carrots, and beans. It's hard work, but so rewarding when you get to eat the fresh veggies we grew ourselves!We also help out by doing classroom chores. Each week, a few students are assigned jobs like cleaning the chalkboard, straightening up the book corner, and watering the classroomplants. I like doing these little jobs because it teaches us responsibility and how to work together to keep our environment clean and organized.Sometimes we get creative with labor practice too! Our art teacher collects recyclable materials like plastic bottles, cardboard boxes, and fabric scraps. Then we use those materials to make cool art projects and decorations for our classroom and the school halls. One time, we made huge flowers out of plastic bottles that we displayed all around the school. It was such a fun way to practice reusing and keep items out of the landfill.In the CommunityIn addition to the activities at school, we also do labor practice out in our local community. One of my favorite traditions is the annual Community Cleanup Day. On this day, all the students and teachers fan out across the neighborhood armed with gloves, trash bags, and pickup sticks. We walk through parks, along streets, and anywhere else to remove litter and spruce up the area. Seeing how much trash we collect is pretty shocking, but it feels good to make our community look nice and clean again.We also volunteer with local organizations that help others.A group from our class goes to the community garden once amonth to help out. We do all kinds of tasks like spreading new soil, planting seedlings, and harvesting fruits and veggies to donate to the food bank. The garden helpers are super nice and teach us about sustainable gardening.Another place we volunteer is the animal shelter. My best friend Sarah's mom works there, so she arranged for our class to come help out a few times. We got to replenish the food and water bowls, give treats to the dogs and cats, and even play with them! The animals were so cute and fun. It made me want to get a pet of my own someday.Benefits of Labor PracticeAs you can probably tell, labor practice activities teach us tons of valuable skills for life. We learn discipline by sticking to schedules and completing our assigned tasks. We build our teamwork abilities when we collaborate on group projects. Getting our hands dirty helps boost our problem-solving skills too.Doing physical work and spending time outdoors is also fantastic exercise that keeps us healthy and energetic. And on top of all that, we gain a stronger sense of community service and environmental stewardship. Understanding from a youngage how important it is to take care of our green spaces, reduce waste, and lend a hand to those in need.I feel really lucky that my school and community provide so many chances for us to get labor practice experience. Not only are the activities super engaging and fun, but they're setting me up with critical life skills I'll use forever. I can't wait to share more stories of my labor practice adventures with you soon!篇2How to Do Labor Practice Activities at School and OutsideHi there! My name is Emily and I'm a 10-year-old student. Today I want to tell you all about the labor practice activities we do at my school and in our community. Labor practice is when we get hands-on experience doing different kinds of work and chores. It teaches us important skills and values like responsibility, cooperation, and appreciation for labor.At my school, we have lots of cool labor practice activities built into our schedule. Let me tell you about some of my favorites!In the ClassroomOne thing we do is classroom duties. Each week, a few students are assigned jobs like washing the chalkboard, straightening up the book corner, watering the classroom plants, or cleaning up after art projects. We take turns so it's fair. Doing these simple classroom jobs teaches us to pitch in and take care of our shared space.We also have units where we learn skills like sewing, woodworking, gardening, and cooking. In sewing class, we made little bags to keep our pencils and supplies in. The woodworking unit taught us how to safely use tools to build simple objects like picture frames or birdhouses. Getting our hands dirty in the school garden taught us about planting, weeding, composting, and harvesting vegetables. And in cooking, we learned to follow recipes and prepare basic dishes like sandwiches, salads, and smoothies. Mastering hands-on skills like these gives us confidence.Around the SchoolThere are lots of ways we practice labor around our whole school too. A favorite is the recycling crew. Students take turns collecting paper, plastic, and aluminum from classrooms and offices to be recycled. This teaches us environmental responsibility.We also have grounds crews who help tidy up the playgrounds, fields, and outdoor common areas by picking up litter. Keeping our school clean and beautiful is something we all contribute to.For special events like festivals, concerts, or family fun nights, classes sign up for tasks like setting up chairs, decorating, running game booths, or passing out programs. It's so satisfying to see our hard work pay off in a successful, smooth-running event.Sometimes we even get to do bigger construction projects, like building new planter boxes for the garden, painting games onthe playground, or assembling outdoor furniture. With guidance from teachers and volunteers, we learn useful skills while improving our school.In the CommunityOur labor practice doesn't stop at the school doors either! We look for ways to lend a hand out in our local community.One thing we do is community beautification projects. Several times a year, we go on classroom outings to clean up parks, plant flowers around public buildings, or do gardeningwork at a community garden. It feels good to give back and make our town look nice.We also do volunteering activities that provide hands-on help. Classes might pack food boxes at a food bank, make arts and crafts for hospitalized kids, orwriteletters to isolated seniors. It's inspiring to use our talents and efforts to support people in need.Sometimes we go further afield on field trips to places like farms, factories, or businesses. Touring these work sites shows us the labor that goes into producing things we use every day. We come away with new appreciation for the workers who make our lives possible.For big community events like parades, fairs, or festivals, our schools pitch in with help like hanging decorations, staffing booths, cleaning up, and other tasks. By being involved, we learn what it takes to pull off a big celebration for the whole town.Bringing It All TogetherAs you can see, us kids get exposed to all kinds of labor practice through activities at school and in the community. Why is this so important? Well, there are lots of great reasons!First, it teaches us vital skills beyond just academic learning from books and lessons. Skills like cooperation, communication, discipline, and hands-on abilities. These will help us hugely as we grow up.Labor practice also builds character strengths like responsibility, perseverance, and appreciation for work. We learn firsthand that maintaining our shared spaces, putting in effort, and showing up to do our part is what allows communities tofunction smoothly.It nurtures values like environmental stewardship too. By doing things like recycling, gardening, and beautification projects, we develop a sense of respect and care for nature and our town.Ultimately, labor practice demystifies what it means to be a worker and contributing member of society. We start to understand that every job, no matter how big or small, is indispensable and worthy of dignity. These early experiences shape our future as employees, entrepreneurs, parents, volunteers, and citizens.So while it might not always be glamorous to pick up litter, move heavy objects, or get our hands dirty, we're building important foundations. Labor practice empowers us kids tomove from just being consumers to becoming producers and conscientious contributors.I feel really lucky that my school and town value exposing us to labor practice from an early age. It's making us intowell-rounded, hard-working, and civic-minded young people. By the time we're adults, doing our part to maintain our communities and support others will be second nature.Who knows, maybe I'll grow up to be a teacher, businessperson, tradesperson, or community organizer one day? Whatever path we each choose, the skills and values we're learning now through labor practice will make us all better workers and better citizens. Hard work, and working hard, is hugely important. That's the big lesson all us kids are picking up on by rolling up our sleeves and pitching in. Pretty great, right? Let's get to work!篇3How to Conduct Labor Practice Activities Inside and Outside SchoolHello friends! My name is Emma and I am a 5th grade student. Today, I want to share with you all about labor practice activities that we can do in school and outside of school. Theseactivities are not only fun, but they also teach us important lessons about hard work, responsibility, and appreciation for those who labor to make our lives better.At School ActivitiesOur school has lots of great opportunities for us to get involved in labor practice right on campus! One of my favorite activities is taking care of the school garden. We have a big vegetable garden where we grow tomatoes, carrots, lettuce, and many other yummy veggies. A group of students volunteers to water the plants, pull out weeds, and harvest the crops when they are ready. The food we grow gets served in our cafeteria so we can enjoy the fruits of our labor!Another cool activity is being part of the recycling team. We have big blue bins around the school for recycling paper, plastic and metal. Student volunteers empty the bins and bring the recyclables to the pickup area. It's hard work carrying those huge bins, but it makes me feel good to keep those materials out of the landfill. We also have a compost bin where we can put fruit and vegetable scraps from the cafeteria. Later, that compost gets put on the garden to help the plants grow!The custodial staff also sometimes lets students volunteer to help clean up the school grounds by picking up litter orsweeping outdoor hallways. It's tough work but it shows us how much effort the custodians have to put in every day to keep our school looking nice. I have a lot of respect for them after doing that job for just a few hours.Outside of School ActivitiesThere are also plenty of places in our community where kids can get labor practice experience by volunteering. One place I like to volunteer is at the local food bank. They need helpers to sort through donations, stock shelves, and bag up food to distribute to families in need. Even though it's not a paid job, it makes me feel proud to do my part in making sure no one goes hungry.During the summer, the parks department hires student workers to help maintain the parks and trails. This could involve jobs like picking up litter, painting benches and playground equipment, raking leaves, or assisting with landscaping projects. Not only do you get to enjoy being outside in nature, but you learn skills and make a little money too!Another great option is volunteering on a farm or at an animal shelter. Feeding animals, mucking stalls, and doing other farm chores teaches you about where our food comes from and how much work goes into caring for livestock. Animal sheltersalways need dog walkers, cat cuddlers, and helpers to clean kennels and replenish food and water bowls. It feels amazing to help out animals in need!What I've LearnedThrough all of these labor practice activities, I've learned so many valuable lessons. First, I've gained an appreciation for how hard people in certain professions like custodians, farmers, grocery workers, garbage collectors and many others have to work to make our lives easier and more comfortable. It makes me want to treat them with respect and not take their efforts for granted.I've also developed a stronger work ethic by experiencing firsthand how tiring physical labor can be. Even simple tasks like pulling weeds or carrying heavy objects make you realize that earning a paycheck is not easy! It motivates me to work hard in school so I can get an education and have more career options in the future.Doing these activities has built my confidence too. When I see that my hard work actually accomplished something like growing food, recycling materials, or cleaning up a mess, I feel proud of myself. It's very satisfying to see the actual results that your own two hands created.Finally, labor practice nurtures important values like teamwork, responsibility, and compassion. When we all work together toward a common goal like maintaining the school garden, it brings us closer as a community. Taking care of living things like plants and animals makes you feel responsible and nurturing. Volunteering to help those less fortunate like at a food bank or homeless shelter grows your sense of compassion.In conclusion, I cannot recommend labor practice activities enough! Whether it's right at school or out in the community, getting hands-on experience with hard work pays off in so many ways beyond just earning money. It shapes you into a better person with a strong moral compass. So grab some friends and get out there and get working - you'll be glad you did! Thanks for reading, friends!。

Q & AContent and Format of INDs for Phase 1 Studiesof Drugs, IncludingWell-Characterized, Therapeutic,Biotechnology-Derived ProductsU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biological Evaluation and Research (CBER)October 2000Pharmacology/ToxicologyQ & AContent and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived ProductsAdditional copies are available from:Office of Training and CommunicationsDivision of Communications ManagementDrug Information Branch, HFD-2105600 Fishers LaneRockville, MD 20857(Tel) 301-827-4573(Internet) /cder/guidance/index.htmorOffice of Communication, Training andManufacturers Assistance, HFM-40Center for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike, Rockville, MD 20852-1448Internet: /cber/guidelines.htm.Fax: 1-888-CBERFAX or 301-827-3844Mail: the Voice Information System at 800-835-4709 or 301-827-1800U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biological Evaluation and Research (CBER)October 2000Pharmacology/ToxicologyGuidance for Industry1Q & A onContent and Format of INDs for Phase 1 Studies of Drugs,Including Well-Characterized, Therapeutic,Biotechnology-Derived ProductsI.INTRODUCTIONThis guidance is intended to clarify when sponsors should submit final, quality-assured toxicology reports and/or update the Agency on any changes in findings since submission of non-quality-assured reports or reports based on non-quality-assured data.In November 1995, FDA published a guidance for industry entitled Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products. The guidance states that If final, fully quality-assured individual study reports are not available at the time ofIND submission, an integrated summary report of toxicologic findings based on theunaudited draft toxicologic reports of completed animal studies may besubmitted.… [...] full toxicology department individual study reports should beavailable to FDA, upon request, and individual study reports should be available toFDA, upon request, as final, fully quality-assured documents within 120 days ofthe start of the human study… [emphasis added].If the integrated summary is based upon unaudited draft reports, sponsors shouldsubmit an update to their integrated summary 120 days after the start of the humanstudy(ies) (2)1 This guidance has been prepared by the Pharmacology and Toxicology staff, Office of Review Management ORM), Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration.There has been some confusion over when the 120-day clock starts, specifically, whether it means 120 days after the start of the clinical trial, or 120 days after the submission of the toxicology information.Q:How does FDA measure the start of the 120-day period within which sponsors should submit updates to their integrated summaries?A:The Agency measures the 120-day period based on the Agency's receipt (date of receipt stamped on the IND submission) of the integrated summary report including the toxicology information. If the sponsor does not submit the final, quality-assured report and update at this time, the sponsor should make the final, quality-assured report available upon the request of the Agency and update the Agency on any changes in the findings. In any case, the final, quality-assured report should be submitted with the NDA.The Agency believes that 120 days from submission of an integrated toxicology summary should provide sponsors with adequate time to complete a final, quality-assured document. Because the Agency assumes that clinical studies will generally be initiated immediately following the initial 30-day clock (or upon submission of the protocol for an existing IND), the intention of the 120-day allowance is to encourage the initiation of clinical studies by, in effect, allowing earlier submissions of clinical protocols based on unaudited reports.2 See guidance, section III(G)(2), Toxicology: Integrated Summary.。

catalysis today 邀稿Guide for AuthorsCatalysis Today concentrates on the rapid publication of papers devoted to currently important topics in catalysis and related subjects. It differs from conventional journals in that each issue is dedicated to a distinct topic, with issues either being prepared under the guidance of (a) Guest Editor(s) or as a monograph.Both fundamental and applied aspects of catalysis are covered. While it is expected that many of the issues will be concerned with heterogeneous catalysis, subjects such as homogeneous catalysis and enzymatic catalysis will also be dealt with. Subjects related to catalysis such as techniques, adsorption processes and technology, etc., will also be included if there is a clear relationship with catalysis.Types of ContributionsThe types of publications covered by Catalysis Today are:(1) Collections of review articles or original publications on a common theme.(2) Monographs written by a single author or a group of authors covering a specific subject.(3) Proceedings of short meetings (symposia, workshops,etc.).The criteria for the inclusion of meetings, reviews or monographs in Catalysis Today are that a single topic is considered and that the contributions are original. The publication of material that has appeared (or is likely to appear) elsewhere is not permitted. As in conventional journals, a strict refereeing policy is applied.Contact Details for SubmissionAll possible contributions to Catalysis Today should first be discussed in detail with either the Editor or one of the Associate Editors. Those who would like to prepare an issue, either as a Guest Editor or as an author, should submit a draft proposal stating the title of the project and giving a brief outline of the scope of the material to be covered. For issues of type (1) and (3) mentioned above, it will also be necessary to provide a list of the proposed contributors and the expected titles of their papers. For monograph issues it will be necessary to give a brief breakdown of the manuscript into chapters or sections, etc.Template for Catalysis Today SI proposalsPlease submit proposals to one of the following:ProfessorJ.J.Spivey,Editor:****************Professor Miguel Bañares, Associate Editor:****************.esProfessorYongdanLi,AssociateEditor:************.cn Submission checklistYou can use this list to carry out a final check of your submission before you send it to the journal for review. Please check the relevant section in this Guide for Authors for more details.Ensure that the following items are present:One author has been designated as the corresponding author with contact details:E-mail addressFull postal addressAll necessary files have been uploaded:Manuscript:Include keywordsAll figures (include relevant captions)All tables (including titles, description, footnotes)Ensure all figure and table citations in the text match the files providedIndicate clearly if color should be used for any figures in printGraphical Abstracts / Highlights files (where applicable) Supplemental files (where applicable)Further considerationsManuscript has been 'spell checked' and 'grammar checked' All references mentioned in the Reference List are cited in the text, and vice versaPermission has been obtained for use of copyrighted material from other sources (including the Internet)A competing interests statement is provided, even if the authors have no competing interests to declareJournal policies detailed in this guide have been reviewed Referee suggestions and contact details provided, based on journal requirementsFor further information, visit our Support Center.Please remember to upload your 'Letter of Invitation' from the Special Issue Guest Editor as part of your submission to Editorial Manager. Submissions which do not include this'Letter of Invitation' will be returned to the author.。

余生请多指教英语作文Title: Please Advise Me on the Rest of My Life。

As I embark on the journey of the rest of my life, I am filled with a mixture of excitement, anticipation, and a hint of trepidation. The road ahead is unknown, and I am eager to seek guidance from those who have walked this path before me. I humbly ask for your advice, your wisdom, and your insights as I navigate the challenges andopportunities that lie ahead.First and foremost, I seek your counsel on how to live a life filled with purpose and meaning. How can I find my true calling, my passion, my reason for being? How can I make a positive impact on the world around me and leave a lasting legacy for future generations? Your guidance on these profound questions would be invaluable to me as I strive to live a life of significance.I also seek your advice on how to cultivate andmaintain meaningful relationships with others. How can I build strong connections with family, friends, colleagues, and acquaintances? How can I communicate effectively, resolve conflicts peacefully, and show empathy and understanding towards others? Your insights on these interpersonal skills would be greatly appreciated as I seek to create a supportive and nurturing network of relationships in my life.Furthermore, I seek your wisdom on how to achieve a healthy work-life balance. How can I pursue my career ambitions and personal goals while also taking care of my physical, mental, and emotional well-being? How can I prioritize self-care, relaxation, and leisure activities in a world that often glorifies busyness and productivity? Your advice on these matters would be crucial as I strive to lead a fulfilling and balanced life.In addition, I seek your insights on how to navigate the inevitable challenges and setbacks that life will throw my way. How can I cultivate resilience, perseverance, and a positive mindset in the face of adversity? How can I learnfrom my failures, grow from my mistakes, and emerge stronger and wiser from life's trials and tribulations? Your guidance on these coping strategies would be essential as I seek to overcome obstacles and thrive in the face of adversity.Lastly, I seek your advice on how to live a life filled with gratitude, joy, and fulfillment. How can I cultivate a sense of appreciation for the blessings in my life, big and small? How can I find happiness and contentment in the present moment, rather than constantly chasing after future goals and desires? Your insights on these practices of mindfulness and gratitude would be invaluable as I seek to savor the beauty and richness of life.In conclusion, I humbly ask for your guidance, your wisdom, and your insights as I embark on the journey of the rest of my life. Your advice on living a purposeful life, cultivating meaningful relationships, achieving work-life balance, navigating challenges, and finding happiness and fulfillment would be greatly appreciated. Please advise me on the path ahead, and I will be forever grateful for yoursupport and mentorship. Thank you for sharing your wisdom with me as I seek to make the most of the precious gift of life.。

英文回答：The term "guidance range" pertains to the parameters of advice, support, or instruction extended to individuals, groups, or organizations. It delineates the scope within which such guidance is dispensed and the specific areas it epasses. For instance, within a professional context, a mentor's guidance range may epass aspects such as career advancement, skills augmentation, and professional networking. Similarly, within an educational setting, a teacher's guidance range could epass academic reinforcement, personal growth, and behavioral counseling. It is imperative for those offering guidance to clearly articulate the boundaries of their services to ensure precision and efficacy.“指导范围”一词是指向个人、团体或组织提供交流、支持或指示的参数。

它规定了这种指导的分发范围及其通过的具体领域。

在专业范围内，导师的指导范围可能超越职业晋升、技能增强和专业网络等各个方面。

同样，在教育环境中，教师的指导范围可以通过学术强化、个人成长和行为交流。

Guidance for IndustryContainer Closure Systems for Packaging Human Drugs and Biologics Chemistry, Manufacturing and Controls Documentation行业指南人用药品及生物制品的包装容器和封装系统：化学，生产和控制文件指南发布者：美国FDA下属的CDER及CBER发布日期：May 1999TABLE OF CONTENTS目录I. INTRODUCTION介绍II. BACKGROUND 背景A. Definitions 定义B. CGMP, CPSC and USP Requirements on Containers and Closures。

CGMP，CPSC和USP对容器和密封的要求C. Additional Considerations 其他需要考虑的事项III. QUALIFICATION AND QUALITY CONTROL OF PACKAGING COMPONENTS包装组件的合格要求以及质量控制A. Introduction 介绍B. General Considerations 通常要求C. Information That Should Be Submitted in Support of an Original Application for AnyDrug Product 为支持任何药品的原始申请所必须提供的信息D. Inhalation Drug Products 吸入性药品E. Drug Products for Injection and Ophthalmic Drug Products 注射剂和眼科用药F. Liquid-Based Oral and Topical Drug Products and Topical Delivery Systems 液体口服和外用药品和外用给药系统G. Solid Oral Dosage Forms and Powders for Reconstitution 口服固体剂型和待重新溶解的粉末H. Other Dosage Forms 其他剂型IV. POSTAPPROVAL PACKAGING CHANGES 批准后的包装变更V. TYPE III DRUG MASTER FILES 药品主文件第III类A. General Comments 总体评述B. Information in a Type III DMF 第III类DMF中包括的信息VI. BULK CONTAINERS 大包装容器A. Containers for Bulk Drug Substances 用于原料药的容器B. Containers for Bulk Drug Products 用于散装药品的容器ATTACHMENT A 附件AREGULATORY REQUIREMENTS 药政要求ATTACHMENT B 附件BCOMPLIANCE POLICY GUIDES THAT CONCERN PACKAGING 关于包装，所适用的政策指南ATTACHMENT C 附件CEXTRACTION STUDIES “提取性"研究ATTACHMENT D 附件DABBREVIATIONS 缩略语ATTACHMENT E 附件EREFERENCES 参考文献GUIDANCE FOR INDUSTRY1Container Closure Systems for Packaging Human Drugs and Biologics Chemistry, Manufacturing and Controls DocumentationI．INTRODUCTION介绍This document is intended to provide guidance on general principles2 for submitting information on packaging materials used for human drugs and biologics。

AES11-2003 AES recommended practice fordigital audio engineering —Synchronization of digital audio equipmentin studio operationsPublished byAudio Engineering Society, Inc.Copyright © 2003 by the Audio Engineering SocietyAbstractThis standard provides a systematic approach to the synchronization of digital audio signals. Recom-mendations are made concerning the accuracy of sample clocks as embodied in the interface signal and the use of this format as a convenient synchronization reference where signals must be rendered cotimed for digital processing. Synchronism is defined, and limits are given which take account of relevant timing uncertainties encountered in an audio studio.An AES standard implies a consensus of those directly and materially affected by its scope and provisions and is intended as a guide to aid the manufacturer, the consumer, and the general public. The existence of an AES standard does not in any respect preclude anyone, whether or not he or she has approved the document, from manufacturing, marketing, purchasing, or using products, processes, or procedures not in agreement with the standard. Prior to approval, all parties were provided opportunities to comment or object to any provision. Attention is drawn to the possibility that some of the elements of this AES standard or information document may be the subject of patent rights. AES shall not be held responsible for identifying any or all such patents. Approval does not assume any liability to any patent owner, nor does it assume any obligation whatever to parties adopting the standards document. This document is subject to periodic review and users are cautioned to obtain the latest edition. Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation.Contents Foreword (3)1 Scope (4)1.1 General (4)1.2 Area of application (4)2 Normative references (5)3 Definitions (5)4 Modes of operation (5)4.1 General (5)4.2 Synchronising methods (5)4.3 DARS distribution (6)4.4 External signals (6)4.5 Video referencing (6)5 Recommended practice for equipment synchronization (7)5.1 DARS requirements (7)5.2 Sample frequency tolerances in equipment (7)5.3 Equipment timing relationships (8)5.4 System practice (9)6 Clock specifications for audio sampling clocks (10)6.1 Timing precision (10)7 Date and time (10)Annex A, Timing relationships (11)Annex B, Word Clock (12)Annex C, Informative References (13)Foreword[This foreword is not a part of AES recommended practice for digital audio engineering — Synchronization of digital audio equipment in studio operations, AES11-1997.]Foreword to second revisionThis document is a revision of AES11-1991. It provides operating standards and guidance for users needing to synchronize digital audio signals. This is an essential requirement in studios for the handling of remote program sources. The development of a working practice for this aspect of system engineering follows from the standardization of sampling frequencies and the international agreement on the serial transmission format for the professional environment.A working group was established in 1984 by the Subcommittee on Digital Audio of the AES Standards Committee to consider the topic with the possibility of formulating a policy on behalf of the industry. An approach was made to some 60 manufacturers of equipment to seek their advice and comment. Meetings were attended by engineers able to represent views from the Society of Motion Picture and Television Engineers (SMPTE), the European Broadcast Union (EBU), and the International Electrotechnical Commission (IEC). The final conclusions endorse the AES3 and AES5 standards and seek to address, primarily, the principles to be applied in synchronizing operations, thus allowing for future developments affecting digital audio systems. Following adoption in 1991, considerable interest developed in the use of AES3 signals for audio associated with digital video applications. In 1993, the AES published a proposal in the Journal of the Audio Engineering Society, vol. 41, no. 5. In 1994-10, a joint meeting was held between the working group and the corresponding SMPTE group. Other meetings were held with representatives of SMPTE, IEC, and EBU. This revision is the result of the proposal and the subsequent meetings.The following individuals have contributed directly to the writing of this revision: R. Cabot, R. Caine, J. Dunn, L. Fielder, R. Finger, N. Gilchrist, A. Griffiths, P. Lidbetter, J. Nunn, and G. Roe.Paul LidbetterChair, AESSC SC-02-05 Working Group on Synchronization of the SC-02 Subcommittee on Digital Audio 1996-08Foreword to third revisionThis document revises AES11-1997. The revision was undertaken as project AES11-R by the AES Standards Committee, Working Group SC-02-05 on Synchronisation. Development in working practices in digital audio and networking have given rise to more complex hierarchical systems of synchronisation, and the growth of metadata also makes more demands on reference signals. These developments are ongoing, but provision is made to expedite implementation of these when required. An annex is added by popular request to describe Word Clock, even though it has been found not to be possible to standardise it. This work has been carried out by a Task Group led by R. Caine, chair of SC-02-05. Contributors included: S. Dimond, R. Foss, J. Grant, R. Harris, B. Klinkradt, S. Lyman, A. Mason, J. Nunn, M. Poimboeuf, S. Scott, Y. Sohma, M. Yonge.Robin CaineChair, AESSC SC-02-05 Working Group on Synchronization of the SC-02 Subcommittee on Digital Audio 2003-06NOTE In AES standards documents, sentences containing the verb "shall" are requirements forcompliance with the standard. Sentences containing the verb "should" are strong suggestions(recommendations). Sentences giving permission use the verb "may." Sentences expressing a possibilityuse the verb "can."AES recommended practice fordigital audio engineering — Synchronization of digital audio equipment in studiooperations1 Scope1.1 GeneralThis document provides a recommended practice for manufacturers and users of digital audio equipment aimed at promoting economical and efficient methods for synchronizing interconnected digital audio equipment.Synchronization of digital audio signals is a necessary function for the exchange of signals between equipment. The objective of synchronization is primarily to time align sample clocks within digital audio signal sources. The provisions address only essential aspects necessary for successful studio operation.The provisions make use of the two-channel digital audio interface standard for professional use, AES3. It is expected that the recommendations will be adopted for synchronizing all other digital audio interfaces.The document addresses two groups of parameters. The first concerns the performance requirements for the successful interchange of digital audio data between equipment (5). The second concerns the performance requirements for the regeneration of clocks used for analog-to-digital and digital-to-analog, conversion (6).1.2 Area of applicationItems of stand-alone digital audio equipment interconnected via analog inputs and outputs require no consideration in this document.The primary area of application is the digital interconnection of digital audio equipment wholly contained within the studio environment. There is a further application in which signal sources and destinations external to the studio environment interface with the equipment within the studio environment.1.2.1 Digital interconnections within the studio environmentDigital audio equipment within a self-contained area, such as a studio or studio center, exchanges digital signals with the timing from all items of equipment controlled.1.2.2 Digital interconnections involving sources and destinations outside the studio environmentDigital interconnections involve equipment, either local or remote, with timing not under the control of the studio or studio center.1.2.3 Digital audio associated with videoDigital audio equipment within a self-contained area exchanges audio signals between audio and video equipment, or both, in which the timing is derived from a master video reference.2 Normative referencesThe following standards contain provisions that, through reference in this text, constitute provisions of this document. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this document are encouraged to investigate the possibility of applying the most recent editions of the indicated standards.AES3 AES recommended practice for digital audio engineering — serial transmission format for linearly represented digital audio data. Audio Engineering Society, New York, NY, US.AES5 AES recommended practice for professional digital audio applications employing pulse code modulation — Preferred Sampling Frequencies. Audio Engineering Society, New York, NY, US.3 DefinitionsFor the purposes of this document, the following definitions shall apply.3.1 synchronismCondition in which frame frequencies for two digital audio signals are identical (that is, both signals have the same number of frames over a defined period of time). Synchronism (as distinct from isochronism) further requires that the phase relationship between two signals shall be fixed.NOTE Provisions within this standard require that such signals be re-timed to meet this need.3.2 AES3 frameSequence of two subframes, each carrying audio sample data for each of two channels, and transmitted in one sample period.3.3 timing reference pointInitial transition of the X or Z preamble of the frame of a digital audio signal as specified in AES3.3.4 basic-rateSampling frequencies in the range 31 to 54 kHz3.5 double-rateSampling frequencies in the range 62 to 104 kHz3.6 quadruple-rateSampling frequencies in the range 124 to 208 kHz3.7 'DARS', or digital audio reference signalA reference signal conforming to AES114 Modes of operation4.1 GeneralEquipment should provide the ability to lock an internal sample-clock generator to a digital audio reference signal (DARS). It is advisable to provide a separate input socket reserved for the use of the DARS.4.2 Synchronising methodsEquipment should be synchronized by one of four methods:Note: in some circumstances, ‘word clock’ may be used in a manner similar to the DARS signal.Word clock is not part of this standard, but is described in Annex B.4.2.1DARS referencedEquipment is synchronised to a distributed DARS, which ensures that all input–output equipment sample clocks are locked to the same reference (this method is preferred for normal studio practice);It shall be possible to lock ‘double-rate’ and ‘quadruple-rate’ sampling devices to a ‘basic-rate’ DARS (see AES5).In situations where some 96kHz signals are carried in the mode described in AES3 as “single channel double sampling frequency mode” it is necessary that the synchronising reference frequency has a component at 48kHz or lower, in order that two channels comprising a stereo pair shall be correctly related. Annex A illustrates preferred phase relationships.Note: It is not possible to lock lower sampling frequencies to a DARS with predictable phase using multiples of the required frequency.4.2.2 Audio input referencedThe embedded sample-rate clock within a digital audio input signal, which may be program, is used to lock the input–output rate clock (this method may increase timing error between items of equipment in a cascaded implementation).4.2.3Video referencedA master video reference is used to derive a DARS, locking video and audio signals at the sample-rate level.4.2.4GPS referencedA GPS receiver is used to reference a DARS, providing frequency and phase (from one second pulses), and time-of-day sample address code in bytes 18 to 21 of channel status to support a time of day reference in locked equipment.4.3 DARS distributionThe DARS shall be distributed in compliance with AES3.4.4 External signals4.4.1 When connecting external signals to an otherwise synchronous digital audio studio or center, either 4.4.2 or 4.4.3 shall apply.4.4.2 Where the incoming signal is identical in sample frequency but is out of phase with the DARS, AES3 frame alignment shall be necessary.4.4.3 Where the incoming signal is not identical in sample frequency, sample-rate conversion shall be necessary.4.5 Video referencingIn the case of a combined video and audio environment, the source of the DARS shall be locked to the video source so that the mathematical relationships given in table 1 are obtained precisely.Table 1 — Audio–video synchronization.Sample ratekHzSamples per TV or film frame24-Hz 25-Hz PAL andSECAM 30-Hz 525 linemonochrome30/1.001-HzNTSC324000/312803200/316016/15 482000192016008008/5 44.13675/217641470147147/100 NOTE — NTSC is National Television Systems Committee. PAL is phase-alternation line. SECAM is sequential color with memory4.5.1 For video systems with an integer number of AES3 frames in one video frame, the AES3 audio can be locked synchronously to the video.4.5.2 For video systems with fractions of AES3 frames in one video frame, AES3 audio cannot be locked synchronously, unless an indicator is included in the video reference. Without such an indicator it is not possible for AES3 audio outputs from different video-locked equipment to meet the phasing requirements of 5.3.5 Recommended practice for equipment synchronization5.1 DARS requirements5.1.1 The DARS shall have the format and electrical configuration of the two-channel digital audio interface and use the same connector as given in AES3. However, the basic structure of the digital audio interface format, where only the preamble is active, is acceptable as a digital audio synchronizing signal.In varispeed applications, or otherwise when the sample frequency does not conform to AES5, 5.2 does not apply.5.1.2 A DARS may be categorized as either grade 1 or grade 2. See 5.2.5.1.2.1 A grade-1 DARS is a high-accuracy signal intended for synchronizing systematically a multiple-studio complex and may also be used for a stand-alone studio.5.1.2.2 A grade-2 DARS is the recognized accuracy signal intended for synchronizing within a single studio, where there are no technical or economic benefits from working to grade-1 standards.5.1.3 A DARS, which has the prime purpose of studio synchronization, shall be identified as to its intended use by byte 4, bits 0 and 1, of AES3 channel status:00 = default;01 = grade 1;10 = grade 2;11 = reserved for future use.5.1.4 A DARS shall be identified in channel status as 'not linear PCM' when it contains other data rendering it unusable as a normal audio signal. See AES3, channel status.5.1.5 Where a DARS is used to carry date and time information in the user channel, this shall be signaled in channel status using the bits specified in AES3 for the carriage of metadata in the user channel.5.1.6 Sampling frequencies distributed by a DARS should conform to AES5.5.1.7 A DARS generator should be capable of locking to a high precision or standard reference.5.2 Sample frequency tolerances in equipment5.2.1 Sample frequency tolerances in equipment are specified by the long-term frequency drift of internal oscillators when in free-running mode. This standard provides for two levels of equipment frequency tolerance, previously defined in 5.1 as grade 1 and grade 2.5.2.1.1 Grade 1A grade-1 reference signal shall maintain a long-term frequency accuracy within ± 1 part per million (ppm). Equipment designed to provide grade-1 reference signals shall only be required to lock to other grade-1 reference signals.NOTE — Even where the high accuracy specified in 5.2.1.1 has been implemented for individual equipment sample clocks, if these are free running, synchronism between independent equipment (or other similarly independent processes such as film or video) is not maintained.5.2.1.2 Grade 2The normal equipment free-running frequency tolerance shall be less than ± 10 ppm, as specified in AES5.NOTE — Frequency tolerances are necessarily a function of the environment in which the equipment is operated. Reference should therefore always be made to the manufacturer's recommended operating conditions.5.2.2 The minimum capture range of equipment oscillators designed to lock to external inputs should be as shown in 5.2.2.1 or 5.2.2.2.5.2.2.1 ± 2 ppm for grade-1 equipment;5.2.2.2 ± 50 ppm for grade-2 equipment and other apparatus of lower performance.5.3 Equipment timing relationships5.3.1 The timing-reference point is used to define the timing relationship between the DARS and digital audio input and output signals. An item of equipment is deemed to be synchronized when 5.3.1.1 and 5.3.1.2 are met in both static and dynamic modes.5.3.1.1 The difference between the timing-reference points of the digital audio synchronizing signal and all output signals, at the equipment connector points, shall be less than ± 5% (or ± 18 deg) of the AES3-frame period. See figure 2.5.3.1.2 Receivers shall be designed so that the number of samples of delay through a device remains constant and known while the difference between the timing-reference points of the DARS and all input signals is less than ± 25% (or ± 90°) of the AES3 frame period.NOTE — It is desirable that where a definable delay exceeding one AES3-frame period is introduced between the input and the output of equipment, the delay or range of delay should be documented in units of one frame.5.3.2 Where the input signal timing relationships are fixed but do not meet the conditions in 5.3.1, receivers shall accept randomly phased inputs and have sufficient hysteresis to avoid sample slips.NOTE Under these conditions, sample slips will occur at some specific phase and hysteresis should be sufficient to cover any jitter or drift in phase. Sufficient hysteresis is defined more fully in the receiver jitter tolerance specification in AES3.5.3.3 Table 2 specifies tolerances in 5.3.1.1 and 5.3.1.2 as absolute values for the sample frequencies defined in AES5.Table 2 — Synchronization of digital audio: limitsSynchronization WindowµsProfessional sampling frequencykHz 1/f s Permitted variation,Input (5.3.1.2)Permitted variation,Output (5.3.1.1)3231,25± 7,8± 1,6 44,122,68± 5,7± 1,1 4820,83± 5,2± 1,0 9610,41± 2,6± 0,55.3.4 In a system the DARS may be derived from a video reference such that the start of the X or Z preamble of the DARS shall be referenced to the half-amplitude point of the leading edge of the synchronization pulse of line 1 of the television signal on every video frame meeting the condition of 4.5.1 (see figure 1). For video frames meeting the condition of 4.5.2, this alignment will occur on every n th frame (n = 5 for NTSC) and will be that frame identified by any indicator included in the video reference. In this case the possibility of a ± 1 sample offset shall be accepted and care shall be taken to provide sufficient hysteresis to prevent random sample slips.Figure 1 — AES3 to video referenceNOTE: For 525/59,94 video systems the timing reference would be line 45.3.5 To aid practical implementations, there shall be a phase tolerance of ± 5% of the AES3 frame period (see figure 2) in addition to the ± 5% tolerance defined for digital audio synchronization at the system outputs in 5.3.1.1.5.4 System practiceGood engineering practice requires that timing differences between signal paths be minimized, to avoid timing errors accumulating with a risk of loss of synchronism.5.4.1 Timing toleranceThe timing tolerance permitted for synchronous signals under the definition given in 5.3.1.2 is less than ± 25% of the AES3-frame period. However, it is desirable that system synchronization be implemented to the closest limits possible so that subsequent timing offsets have minimum effect.5.4.2 Timing differences5.4.2.1 Delay effectsDelay effects consist ofa) instrumental delays in apparatus;b) residual errors in phase lock loops;c) cable delay in the transmission path.Variations in delay from these causes may result from changes in the configuration of the audio system.Figure 2 — Audio frame phase tolerancesNOTE: 360 degrees represents 100% or 1 AES3 frame5.4.2.2 Clock jitterJitter noise may be either random or in the form of modulation, which at frequencies less than sample rate will cause a timing error to accumulate according to the amplitude and frequency of the modulation waveform.NOTE — AES3 defines limits for jitter on the digital audio interface.6 Clock specifications for audio sampling clocks6.1 Timing precisionIn order to obtain the best performance from analog-to-digital and digital-to-analog converters, the sample conversion clock, when externally locked to the DARS, shall have increased timing accuracy above that specified for grade-1 and grade-2 signals in the areas of random jitter and jitter modulation.7 Date and timeFlagging of date and time in channel status is specified in 5.1.5. This may take a convenient form for transfer to an AES3 metadata stream.Annex A Informative Timing relationshipsAES11Video ReferenceWord ClockAES3 at 48 kHz AES3 at 96 kHzAES3 at 96 kHzSingle channel, double sampling frequency 2-channel, double clock frequency2-channelTiming values A 20,5 µs - frame period at 48 kHz sampling frequency B ± 1 µs tolerance C ± 0,5 µs toleranceFigure A.1Preferred phase relationships and channel usageNOTE: For 525/59,94 video systems the timing reference would be line 4.Annex BInformativeWord ClockIt is possible to meet all the timing requirements of AES11 by means of a square wave at sampling frequency basic rate, commonly called word clock. It is used between different pieces of equipment to provide sampling frequency locking of various sources.This signal is not standardised and the parameters quoted are merely typical. The signal is commonly carried on coaxial cable, so that a single output can synchronise several receiving equipments by looping the signal through each in turn, and terminating the cable with a 75 Ohm resistor at the far end.Each receiving device typically uses transistor-transistor-logic (TTL) on a coaxial connector, requiring a logic ‘low’ of less that 0,4 V and a logic ‘high’ greater than 2,4 V. Any practical technique may be used to detect the edges of the signal.The transmitter shall sustain TTL levels while driving a single 75 Ohm termination, and sink the necessary TTL current for a number of receivers.Other realisations may exist: for example, 1 V p-p square wave, AC coupled.It should be noted that TTL signals are difficult to distribute using amplifiers, and no common distribution amplifiers (video, AES3 or audio etc.) handle this signal, so that the loop-through architecture is the usual option.Where new equipment is designed to use this signal, it is recommended that the rising edge is treated as the timing reference point referred to in 3.3 and 5.3.The expression ‘word clock’ is also used at circuit-board level to describe various sampling-frequency logic signals.Word clock is commonly used with digital audio signals other than AES3.Annex CInformativeInformative ReferencesSMPTE 318M-1999 Synchronization of 59.94 or 50 Hertz related video and audio systems in analogue and digital areas: Society of Motion Picture and Television Engineers, White Plains, NY., US.SMPTE RP168, Definition of Vertical Interval Switching Point for Synchronous Video Switching: Society of Motion Picture and Television engineers, White Plains, NY., US.。