墨西哥官方标准NOM -164 - SSA1 - 1998，药品良好生产规范（GMP）。（此段为修订历史，
乌克兰在哪里翻译略）
Mexican Official Standard NOM-164-SSA1-1998, Good Manufacturing Practices for pharmaceuticals. MEXICAN OFFICIAL STANDARD NOM-164-SSA1-1998, GOOD MANUFACTURING PRACTICES FOR DRUGS.
JAVIER CASTELLANOS Coutinho, President of the National Advisory Committee on Health Regulation and Development, bad on Article 39 of the Organic Law of Federal Public Administration; 4o. and 69-H of the Federal Administrative Procedure Act; 3rd., fractions XXIII and XXIV, 13, Section A), fraction II, 195, 201, 210, 212 and other applicable provisions of the General Health Law, 38, part
II , 40, ctions I and V, 41, 47 of the Federal Law on Metrology and Standardization, the 8th., 9o., 15, fraction V, 18 and 100 of the Regulations for Health Supplies, 28 and 34 of the Rules of the Law Federal Metrology and Standardization and 7, fractions V and XIX and 23 ction II of the Internal Regulations of the Ministry of Health, and
WHEREAS
That on October 19, 1998, pursuant to the provisions of Article 46, Section I of the Federal Law on Metrology and Standardization, DG Health Products submitted to the National Advisory Committee on Health Regulation and Development, the draft of the Official Mexican Standard.
That on December 16, 1998, pursuant to the agreement of the Committee and to the provisions of Article 47, Section I of the Federal Law on Metrology and Standardization, was published in the Official Journal of the Federation on the draft of this Official Statement Mexicana, to the effect that within the next sixty calendar days after such publication, interested parties submit their comments to National Advisory Committee on Health Regulation and Development.
Whether respons to comments received by the said Committee, were published prior to the issuance of this standard in the Official Journal of the Federation, under the terms of Article 47, paragraph III of the Federal Law on Metrology and Standardization.
That in view of the foregoing, with the approval of the National Advisory Committee on Health Regulation and Development, is issuing the following: NOM-164-SSA1-1998, Good Manufacturing Practices for pharmaceuticals.
PREFACE前言
In the preparation of this Official Mexican Norm took the following administrative units and institutions：下列政府部门和机构参与了本标准指导的编制：
SECRETARY OF HEALTH.
DG Health Supplies.
Legal Affairs Directorate.
DEPARTMENT OF TRADE AND INDUSTRIAL DEVELOPMENT.
DG Monitoring Analysis and International Trade Agreements.
Directorate General of Domestic Trade Policy.
MEXICAN PHARMACEUTICAL ASSOCIATION, B.C.
NATIONAL CHAMBER OF INDUSTRY TRANSFORMATION.
Section 89.
NATIONAL CHAMBER OF THE PHARMACEUTICAL INDUSTRY.
8个月宝宝NATIONAL ASSOCIATION OF CHEMICAL PHARMACEUTICAL BIOLOGOS MEXICO, AC INTERAGENCY COMMISSION Good Manufacturing Practices.
SOCIAL SECURITY MEXICAN INSTITUTE.
Technical Control Unit Inputs.
NATIONAL AUTONOMOUS UNIVERSITY OF MEXICO.
Faculty of Chemistry.
Zaragoza Faculty of Higher Education.
INDEX目录
0. introduction 介绍
1. Objective and scope目标和范围
2. References对照品
3. Definitions定义
仲恺农业工程学院研究生4. Abbreviations缩略词
童年趣事作文200字
5. general requirements总体要求
6. staff员工
7. Quality Unit质量部门
8. Production unit生产部
9. Facilities设备
10. team小组
11. Master Production Order主生产指令
12. Production by 生产
13. Batch Files and items批文件和项目
14. Control procedures production生产控制程序
15. Packaging and labeling of the drug药品的包装和贴签
16. Laboratory controls and inspection实验室控制和检验
今天高考
17. Homogenates混批
18. Recovery, rework and rework回收，返工和重加工
19. Storage and Distribution Control仓储和分发控制
20. validation验证
21. Returns and complaints退货和投诉
22. Destruction and disposal of waste废物销毁和处理
23. Compliance with international standards and Mexican与国际和墨西哥标准相符
24. bibliography参考书目
25. Obrvance of Standard标准仪式
26. validity 有效期
Health is a key factor for social development and welfare of the community, so it is up to the Ministry of Health to establish minimum requirements that must be met during the drug manufacturing process to ensure the quality of them, becau are the basis for the manufacture of medicaments.
健康是社会发展和社会福利的一个关键因素，所以它取决于卫生部在药品生产过程为确保药品的质量建立最低要求且必须满足这些最低要求，因为这是药品生产的基础。
The Good Manufacturing Practices therefore require control of personnel, equipment, facilities, documentation, materials, as well as all stages of the manufacturing process.
本药品良好生产规范（GMP）因此要求除了对药品生产的各步骤进行控制外，对人员，设备，设施，文件，物料也一样进行控制。
1. Objective and scope 目标和范围
1.1. target目标
This Mexican Official Standard establishes the minimum requirements for good manufacturing practices for active drug.
本墨西哥官方标准建立了活性药物良好生产规范（GMP）的最低要求。
1.2. Scope范围
This Standard is mandatory for establishments engaged in the manufacture of drugs or active ingredients.
本标准对涉及从事生产药物或活性成分的场所（机构）是强制性（必须满足的）。
2. References对照
For the correct application of this standard should consult the following Mexican Official Standards:
对于这个标准的正确应用应该参考下面的墨西哥官方标准：
2.1. NOM-002-SCFI-1993 Pre-packaged products yardage, tolerances and verification methods. NOM-002-SCFI-1993预包装产品码数，公差和检验方法
2.2. NOM-052-ECOL-1993, which establishes the characteristics of hazardous waste, the list of them and the threshold above which a hazardous waste becau of its toxicity.
NOM-052-ECOL-1993有害废物列表以及不同毒性特征的不同有害废物阈值
2.3. NOM-073-ECOL-1994, which establishes the maximum permissible limits of pollutants in wastewater discharges to receiving bodies from the pharmaceutical and pharmochemical.
NOM-073-ECOL-1994建立制药和医化排放的废水中污染物的最大允许限度
2.4. NOM-127-SSA1-1994, Environmental Health. Water for human u and consumption. Permissible limits of quality and must undergo treatment to the water to make it drinkable.
NOM-127-SSA1-1994，环境卫生，人用水，质量允许限度和经常处理使其可饮用
2.5. NOM-059-SSA1-1993, Good Manufacturing Practices for chemical industry establishments engaged in manufacturing pharmaceutical drugs.
NOM-059-SSA1-1993 化工企业涉及药品生产的良好生产规范。
3. Definitions定义
For purpos of this rule, the term:
本条令的目的，术语
3.1. Mother liquor, liquids obtained from parations made for obtaining intermediate products and finished products containing recoverable amounts and / or reusableof raw material, intermediate and / or finished product.
母液，从中间体或成品获取过程中分离出来的包含可回收数量和/或可再用物料，中间体和/或成品的液体。
3.2. Warehou, the area where you store raw materials, materials, intermediates and drugs under controlled conditions of order and cleanliness.
仓库，在受指令和清洁程度控制的用于储存原料，物料，中间体和成品的地方
3.3. Good Manufacturing Practice, the t of guidelines and monitoring activities related to personnel, equipment, facilities, documentation, materials, and all stages of the manufacturing process to ensure that drugs developed to comply with the specifications.
良好生产规范（GMP），是和人员，设备，设施，文件，物料以及生产过程的所有步骤相关的为保证药品发展最终符合它的质量标准的一套指导和监测活动。
3.4. Calibration to determine a t of operations under specific conditions, the relationship between the values indicated by an instrument, the measurement system, reprented by a measurement equipment and known values to a reference standard.
校验是在特定的条件下, 决定一个仪器和测量系统显示的数值之间的关系的一套操作，由测量设备和参考标准的已知值表示。
3.5. Quality, compliance with specifications established to ensure fitness for u.
质量，符合已建立的质量标准以保证适用。
3.6. Component, all the substances involved in the various stages of manufacturethe drug.
元件，构件（这里暂翻成物料），药品生产各阶段中涉及的所有物质。
3.7. Contamination, prence of physical entities, chemical or biological undesirable.
污染，不被需要的物理，化学或生物实体的存在。
3.8. Cross-contamination, the prence of physical entities, chemical or biological undesirable from other manufacturing process.
交叉污染，从其他生产工艺中来的不被需要的物理，化学或生物实体的存在。
3.9. Process control, the monitoring is performed in the process in order to insure that the specification is occurring.
工艺控制，工艺中为保证达到标准而进行的监测。
3.10. Post-harvest, the product recovered from the mother liquor.
收获后（暂翻译为‘后产品’），从母液中回收的产品。
3.11. Specification, the description of a material, substance or product, including quality parameters, acceptance limits and the reference methods ud for its determination.
质量标准，关于一个物料，物质或产品的描述，其中包含质量参数，可接受标准和用于用于检测的参考方法。
3.12. Critical stage to the production stage to be especially controlled to ensure that the intermediate or finished product meets your specifications.
生产过程的关键步需要进行特殊控制以保证中间体和成品符合质量标准。
3.13. Drug, all natural substance, synthetic or biotechnological that has some pharmacological activity, and is identified by its physical, chemical or biological actions, which are not prented in a dosage form that is eligible to be ud as a drug or ingredient a drug.
药品，所有具有一定的药理活性，并确定了它的物理，化学或生物作用的自然的，合成的或生物技术物质，不限定表现为被用作药物或成分药物的剂型。
3.1
4. Expiry date to the date shown in the primary packaging material and / or condary and determines the uful life of the drug, is established from the date of manufacture, bad on stability studies.
有效期为显示在第一包装材料和/或第二包装材料上的用来表示药品的使用寿命的日期，建立在稳定性研究的基础上，取决于生产日期。
3.15. Date of revaluation, at the date before which an intermediate or finished product meets all specifications and beyond which the intermediate or finished product can not be ud without a reasssment.
复验期，在此日期前，一个中间产品或成品符合所有质量标准，而在此日期后，该中间产品或成品在未经过重新评估不能使用。
3.16. Lot, the specific amount of any raw material or input, which is manufactured in a production cycle on equivalent terms of operation and during a given period.
批，在规定时期内经过系列等同的操作生产循环生产出来的规定数量的原料或投入料。
3.17. Raw material, the substance from any source that is ud for the manufacture of drugs or natural or synthetic drugs.我为你走过
原料，从某些来源得来的用于药品或自然或合成药品的生产的物质。
3.18. Shows the amount of material who composition is reprentative of the lot to be examined.
显示物料的数量，而该物料的成分是代表要被检验的该批
3.19. Lot number, the alphanumeric combination that specifically identifies a batch.
批号，用来专门鉴别一个批的字母数字组合。
3.20. Production Order, the master copy of the production order, which is assigned a lot number and is ud to guide and record-keeping for each production batch.
生产指令，生产记录母本的复印本，需注明批号，用来指导和保存每个生产批的记录。
川贝的作用3.21. Master production order to the document which indicates the specifications and amounts of each component ud and the following conditions for manufacturing the product.
主生产指令要做成文件，需要标明质量标准，每个用到的物料的数量和生产该产品的需遵守满足的条件。
3.22. Standard Operating Procedure (standard operating procedure), the document that contains the instructions needed to perform reproducibly an operation.
标准操作规程（SOP），是包含进行重复性操作的指令的文件。
3.23. Fabrication process, the realization of the operations necessary to carry out the processing of raw materials to intermediates and / or final.
制造过程，实现所需的操作对原料进行加工以获取中间体和/或最终产品。
3.2
4. Starting (sublot) to the quantity of a product or an intermediate product or drug which is produced in a single manufacturing operation and is identified by a key.
小批是产生在一个单一的生产操作，并确定为一个关键的产品或中间产物或药物。
3.25. Intermediate, partially procesd material shall be subject to later stages of production, before becoming a finished product.
中间体，进行了部分工艺在成为最终产品前需要遵从后续生产步骤的物料。
3.26. Finished, the drug or active ingredient that has fulfilled all its stages manufacturing.
成品，已经完成所有所有生产步骤的药品或活性成分。
什么是关节3.27. Traceability, the ability to reconstruct the history, location of an item or activity by means of identification records.
追溯性，根据记录的鉴定来重建历史，识别一个项目或行为的能力。
3.28. Recovery, treatment of materials by a process to make them suitable for u.
回收，通过一个工艺对物料进行处理使其适合使用。
3.29. Remaining, the amount of product remaining in the process equipment and / or in a container as a result of their manipulation during the production and / or packaging.
