文件/记录的GMP要求

Good documentation is an essential part of the quality assurance system and, as such, should exist for all aspects of GMP. Its aims are to define the specifications and procedures for all materials and methods of manufacture and control; to ensure that all personnel concerned with manufacture know what to do and when to do it; to ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a medicine for sale, to ensure the existence of documented evidence, traceability, and to provide records and an audit trail that will permit investigation. It ensures the availability of the data needed for validation, review and statistical analysis. The design and use of documents depend upon the manufacturer. In some cases some or all of the documents described below may be brought together, but they will usually be separate.

良好的文件系统是质量保证系统的基本部分，应当覆盖GMP的所有方面。其目标是制定所有物料的质量标准和规程以及生产和控制的方法，以保证生产相关的所有人员知道应做什么以及何时做；确保受权人了解产品所有信息以决定产品是否批准放行，保证书面记录的存在，可追溯性，保证提供相关记录和审计追踪以便调查。其确保验证、审查和统计分析所有数据的有效性。文件如何设计和使用取决于生产商。在某些情况下，下面描述的文件的一部分或全部可能在一起，但他们各自通常是相互独立的。

General

基本要求

Documents should be designed, prepared, reviewed and distributed with care. They should comply with the relevant parts of the manufacturing and marketing authorizations.

文件应当精心的设计、制定、检查和发放。其应当符合生产许可和销售许可相关部分的要求。

Documents should be approved, signed and dated by the appropriate responsible persons. No document should be changed without authorization and approval.

文件应当有合适的负责人批准、签字并注明日期。没有得到授权和批准，任何文件不得修改。

Documents should have unambiguous contents: the title, nature and purpose should be clearly stated. They should be laid out in an orderly fashion and be easy to check. Reproduced documents should be clear and legible. The reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process.

文件内容应当明确：应当阐明文件名称、性质和目的。文件布局应当有序，便于检查。复印文件应当清楚易读。从主文件复印工作文件时，不得产生任何差错。

Documents should be regularly reviewed and kept up to date. When a document has been revised, a system should exist to prevent inadvertent use of the superseded version. Superseded documents should be retained for a specific period of time.

文件应当定期审查并保持更新。当文件修订时，应有防止旧版本误用的系统。旧版本的文件应当保存一定时间。

Where documents require the entry of data, these entries should be clear, legible and indelible. Sufficient space should be provided for such entries.

当文件需要输入数据时，这些数据的输入应当清晰，易读和不易丢失。文档应当留有足够的空间填写这些数据。

Any alteration made to a document should be signed and dated; the alteration should be done in such a way as to permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.

文档的任何修改应当签名并标明日期；修改处应使原始信息清晰可读。适当时，应当记录修改的理由。

Records should be made or completed when any action is taken and in such a way that all significant activities concerning the manufacture of pharmaceutical products are traceable. Records should be retained for at least one year after the expiry date of the finished product.

生产过程中采取的每一项措施应当完整记录，才可追溯药品生产中涉及的所有关键步骤。记录应当保存至产品有效期后至少一年。

Data (and records for storage) may be recorded by electronic data processing systems or by photographic or other reliable means. Master formulae and detailed SOPs relating to the system in use should be available and the accuracy of the records should be checked. If documentation is handled by electronic data-processing methods, only authorized persons should be able to enter or modify data in the computer, and there should be a record of changes and deletions; access should be restricted by passwords or other means and the entry of critical data should be independently checked. Batch records stored electronically should be protected by back-up transfer on magnetic tape, microfilm, paper print-outs or other means. It is particularly important that, during the period of retention, the data are readily available.

应使用电子数据处理系统或照相或其他可靠的方式记录数据（储存记录）。应有主配方和与系统相关的详细的SOPs，记录的准确性应当核查。如果使用电子方法处理文件，只有授权人能够进入电脑或修改数据，应有变更和删除记录。应通过密码或其他方式限制他人登陆，关键数据的输入应由他人进行复核。用电子方法储存的批记录应备份到磁带、缩微胶卷、打印纸或其他介质上。尤其重要的是，在保留期间，数据应当易于查阅。

Documents required

必要的文件

Labels

标签

Labels applied to containers, equipment or premises should be clear, unambiguous and in the company’s agreed format. It is often helpful in addition to the wording on the labels to use colours to indicate status (e.g. quarantined, accepted, rejected, clean).

包装容器、设备或厂房的标签应清晰易读，并采用公司批准的格式。除了标签使用文字说明外，通常还可应使用不同的颜色表明状态（如，待验、合格、拒绝、清洁），这种做法是有用的。

All finished medicines products should be identified by labelling, as required by the national legislation, bearing at least the following information:

按照国家法规的要求，所有药品应当用标签进行标识，标签至少包括以下信息：

(a) the name of the medicines;

(a) 药品名称

(b) a list of the active ingredients (if applicable, with the INNs), showing the amount of each present and a statement of the net contents (e.g. number of dosage units, weight, volume);

(b) 原料药清单（如有，附上INN），说明每个的含量和净装量的说明（例如，单位剂量数、重量、体积）

(d) the expiry date in an uncoded form;

(d) 以非编码的形式说明药品有效期

(e) any special storage conditions or handling precautions that may be necessary;

(e) 特殊储存条件或必要的处理注意事项。

(f) directions for use, and warnings and precautions that may be necessary;

(f) 使用说明，警告和必要的注意事项。

(g) the name and address of the manufacturer or the company or the person responsible for placing the product on the market.

(g) 销售产品的生产商或公司或负责人的名称和地址。

For reference standards, the label and/or accompanying document should indicate potency or concentration, date of manufacture, expiry date, date the closure is first opened, storage conditions and control number, as appropriate.

对于标准品，标签和/或随同的文件应当标明效价或浓度、生产日期、有效期、首次打开的日期、储存条件和控制编号（适当时）。

Specifications and testing procedures

标准和检验规程

Testing procedures described in documents should be validated in the context of available facilities and equipment before they are adopted for routine testing.

用于常规检验前，文件所述检测规程应在现有的仪器和设备的范围内进行验证。

There should be appropriately authorized and dated specifications, including tests on identity, content, purity and quality, for starting and packaging materials and for finished products; where appropriate, they should also be available for intermediate or bulk products. Specifications for water, solvents and reagents (e.g. acids and bases) used in production should be included.

应有经适当批准和签字的标准，包括原材料、包装材料和成品的鉴别、含量、纯度和质量的检测；适当时，应有中间体或待包装产品的标准。还应包含生产过程所用的水、溶剂和试剂（例如，酸和碱）的标准。

Each specification should be approved, signed and dated, and maintained by the QC or QA units.

每个标准都应批准和签署（注明日期），并由QC或QA保存。

Periodic revisions of the specifications may be necessary to comply with new editions of the national pharmacopoeia or other official compendia.

需要定期修订标准以符合新版的国家药典或其他官方药典。

Pharmacopoeias, reference standards, reference spectra and other reference materials should be available in the QC laboratory.

QC实验室应当备有药典、标准品、标准图谱和其他参考材料。

Specifications for starting and packaging materials

原材料和包装材料的标准

Specifications for starting, primary and printed packaging materials should provide, if applicable, a description of the materials, including:

原材料、内包装材料和印刷包装材料的指标应提供物料的描述，包括：

(a) the designated name (if applicable, the INN) and internal code reference;

(a) 指定的名称（如有，附上INN）和内部代码

(b) the reference, if any, to a pharmacopoeial monograph;

(b) 参考的药典专论，如有

Depending on the company’s practice other data may be added to the specification, such as:

根据公司的实际情况，还可以加入以下内容：

(a) the supplier and the original producer of the materials;

(a) 物料的供应商和原始生产商

(b) a specimen of printed materials;

(b) 印刷材料的样品

(d) storage conditions and precautions;

(d) 储存条件和注意事项

(e) the maximum period of storage before re-examination.

(e) 复检前的最长储存期

Packaging material should conform to specifications, and should be compatible with the material and/or with the medicines it contains. The material should be examined for compliance with the specification, and for defects as well as for the correctness of identity markings.

包装材料应当符合标准，应当与其所含的物料和或药品兼容。应当检测包装材料的标准符合性、缺陷以及标识的正确性。

Documents describing testing procedures should state the required frequency for re-assaying each starting material, as determined by its stability.

描述检测方法的文件应说明再分析每个原料要求的频率，由其稳定性判定的。

Specifications for intermediate and bulk products

中间体和待包装产品的标准

Specifications for intermediate and bulk products should be available. The specifications should be similar to specifications for starting materials or for finished products, as appropriate.

应当制定中间体和待包装产品的标准。适当时，该标准应当与原材料或成品的标准相似。

Specifications for finished products

成品的标准

Specifications for finished products should include:

成品的标准应当包括：

(a) the designated name of the product and the code reference, where applicable;

(a) 产品指定名称和代码（如适用）

(b) the designated name(s) of the active ingredient(s) (if applicable, with the INN(s));

(b) 原料药指定名称（如有，附上INN）

(d) a description of the dosage form and package details;

(d) 对剂型和包装详情的描述

(e) directions for sampling and testing or a reference to procedures;

(e) 取样和检测方法或方法的参考

(f) the qualitative and quantitative requirements, with acceptance limits;

(f) 定性和定量的要求，有可接受限度。

(g) the storage conditions and precautions, where applicable;

(g) 存储条件和注意事项

(h) the shelf-life.

(h) 货架期

Master formulae

工艺规程

A formally authorized master formula should exist for each product and batch size to be manufactured.

每个产品应有正式批准的主配方和批量。

The master formula should include:

主配方应当包括：

(a) the name of the product, with a product reference code relating to its specification;

(a) 产品名称和质量标准相关的产品参考代码

(b) a description of the dosage form, strength of the product and batch size;

(b) 产品的剂型和规格描述，以及批量

(c) a list of all starting materials to be used (if applicable, with the INNs), with the amount of each, described using the designated name and a reference that is unique to that material (mention should be made of any substance that may disappear in the course of processing);

(d) a statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, where applicable;

(d) 产品最终收率的可接受限度、以及相关中间体收率的可接受限度（如适用）的说明

(e) a statement of the processing location and the principal equipment to be used;

(e) 加工场所和所用主要设备的说明

(f) the methods, or reference to the methods, to be used for preparing and operating the critical equipment, e.g. cleaning (especially after a change in product), assembling, calibrating, sterilizing, use;

(f) 用于关键设备的准备和运行的方法或参考方法，例如清洁（特别是更换产品后清洁）、组装、校准、灭菌、使用。

(g) detailed step-wise processing instructions (e.g. checks on materials, pretreatments, sequence for adding materials, mixing times, temperatures);

(g) 每步处理的详细的生产指令（如，物料的核对、预处理、加料顺序、混合时间、温度）

(h) the instructions for any in-process controls with their limits;

(h) 所有中间控制指令和限度

(i) where necessary, the requirements for storage of the products, including the container, the labelling, and any special storage conditions;

(i) 必要的产品储存要求，包括包装容器、标签和一些特殊储存条件。

(j) any special precautions to be observed.

(j) 必要的特别注意事项。

Packaging instructions

包装指令

Formally authorized packaging instructions should exist for each product, pack size and type. These should normally include, or make reference to:

每一产品、包装规格和包装类型都应有批准的包装指令。包装通常应包括或参考以下内容：

(a) the name of the product;

(a) 产品名称

(b) a description of its pharmaceutical form, strength and, where applicable, method of application;

(b) 药品剂型、含量和使用方法的描述

(d) a complete list of all the packaging materials required for a standard batch size, including quantities, sizes and types, with the code or reference number relating to the specifications for each packaging material;

(d) 标准批量所要求的所有包装材料的清单，包括包装材料的数量、规格和类型、以及每一个包装材料质量标准的代码或参考号

(e) where appropriate, an example or reproduction of the relevant printed packaging materials and specimens, indicating where the batch number and expiry date of the product have been marked;

(e) 印刷包装材料的样张或复制品和实样，注明产品批号、有效期。

(f) special precautions to be observed, including a careful examination of the packaging area and equipment in order to ascertain the line clearance before and after packaging operations;

(f) 特别注意事项，包括包装区域和设备应仔细检查以确保在包装前后已清洁。

(g) a description of the packaging operation, including any significant subsidiary operations, and equipment to be used;

(g) 包装操作的描述，包括所有重要的辅助操作和所用设备

(h) details of in-process controls with instructions for sampling and acceptance limits.

(h) 中间控制（包含取样和可接受限度的指令）的详情。

Batch processing records

批生产记录

A batch processing record should be kept for each batch processed. It should be based on the relevant parts of the currently approved specifications on the record. The method of preparation of such records should be designed to avoid errors. (Copying or validated computer programmes are recommended. Transcribing from approved documents should be avoided.)

每一批产品均应有相应的批生产记录。批生产记录应当以现行已批准的指标相关部分为依据。应有起草此类记录的方法，避免错误。（建议使用复印或以通过验证的计算机程序。应避免抄录已批准的文件）

Before any processing begins, a check should be made that the equipment and work station are clear of previous products, documents, or materials not required for the planned process, and that the equipment is clean and suitable for use. This check should be recorded.

在生产开始之前，应当检查确保仪器和工作平台干净，没有计划生产不需要的之前的产品、文件或物料，设备应干净并适合使用。此类检查应当记录。

During processing, the following information should be recorded at the time each action is taken, and after completion the record should be dated and signed by the person responsible for the processing operations:

生产过程中，采取每一步措施时，都应当记录以下信息，记录填写完毕后，应注明日期并由生产操作的负责人签名。

(a) the name of the product;

(a) 产品名称

(b) the number of the batch being manufactured;

(b) 批号

(d) the name of the person responsible for each stage of production;

(d) 每个生产阶段的负责人名称。

(e) the initials of the operator(s) of different significant steps of production and, where appropriate, of the person(s) who checked each of these operations (e.g. weighing);

(e) 各重要生产阶段操作人的姓名缩写，必要时，应有对每一操作（例如，称重）进行检查的操作人的姓名缩写。

(f) the batch number and/or analytical control number and the quantity of each starting material actually weighed (including the batch number and amount of any recovered or reprocessed material added);

(f) 每一批起始原料的批号和/或分析控制号以及实际质量（包括回收或返工物料的批号和数量）

(g) any relevant processing operation or event and the major equipment used;

(g) 所有相关的生产操作或事件和所用的主要设备。

(h) the in-process controls performed, the initials of the person(s) carrying them out, and the results obtained;

(h) 完成的中间控制，操作人员的姓名缩写，以及所得结果

(i) the amount of product obtained at different and pertinent stages of manufacture (yield), together with comments or explanations for significant deviations from the expected yield;

(i) 不同生产阶段或相关阶段，获得的产量，以及实际产量严重偏离预期收率的评价说明或解释

(j) notes on special problems including details, with signed authorization for any deviation from the master formula.

(j) 特殊问题的注释，包括偏离主配方的所有偏差情况的说明。

Batch packaging records

批包装记录

A batch packaging record should be kept for each batch or part batch processed. It should be based on the relevant parts of the approved packaging instructions, and the method of preparing such records should be designed to avoid errors. (Copying or validated computer programmes are recommended. Transcribing from approved documents should be avoided.)

生产的每批或批次的一部分批包装记录应保存，其应基于批准的包装指令的相关部分。应有起草此记录的方法以避免错误（建议使用复印或经过验证的计算机程序。应当避免抄录已批准的文件）。

Before any packaging operation begins, checks should be made that the equipment and work station are clear of previous products, documents or materials not required for the planned packaging operations, and that equipment is clean and suitable for use. These checks should be recorded.

包装操作开始之前，应当检查确保仪器和工作平台干净，没有计划包装操作不需要的产品、文件或物料，设备干净且适合使用。此类检查应当记录。

The following information should be recorded at the time each action is taken, and the date and the person responsible should be clearly identified by signature or electronic password:

采取每一步操作时，应当记录以下信息，应通过签名或电子密码清晰地标识日期和负责人。

(a) the name of the product, the batch number and the quantity of bulk product to be packed, as well as the batch number and the planned quantity of finished product that will be obtained, the quantity actually obtained and the reconciliation;

(a) 产品名称、批号和待包装产品数量，以及要得到的成品的批号和计划产量、实际产量和理论产量之间的平衡核算。

(b) the date(s) and time(s) of the packaging operations;

(b) 包装操作的日期和时间

(d) the initials of the operators of the different significant steps;

(d) 不同关键步骤的操作人员姓名缩写

(e) the checks made for identity and conformity with the packaging instructions, including the results of in-process controls;

(e)检查标识和与包装指令的一致性，包括中间控制的结果

(f) details of the packaging operations carried out, including references to equipment and the packaging lines used, and, when necessary, the instructions for keeping the product unpacked or a record of returning product that has not been packaged to the storage area;

(f) 包装操作的详情，包括所用设备的代号和包装线，必要时，保存未包装产品的产品不包装指令或退回产品至存储区的记录

(g) whenever possible, samples of the printed packaging materials used, including specimens bearing the approval for the printing of and regular check (where appropriate) of the batch number, expiry date, and any additional overprinting;

(g) 所用的印刷包装材料的样品，包括批号、有效期和其他额外的打印信息的印刷和定期检查的批准的样本。

(h) notes on any special problems, including details of any deviation from the packaging instructions, with written authorization by an appropriate person;

(h) 对于一些特殊问题的注释，包括由合适的人员书面批准的偏离包装指令的所有偏差的详细信息。

(i) the quantities and reference number or identification of all printed packaging materials and bulk product issued, used, destroyed or returned to stock and the quantities of product obtained to permit an adequate reconciliation.

(i) 发放、使用、销毁或退回库房的所有印刷包装材料和待包装产品的数量和参照号或标识以及产品数量，以便进行充分的物料衡算。

Standard operating procedures and records

标准操作规程和记录

SOPs and associated records of actions taken or, where appropriate, conclusions reached should be available for:

应有SOPs和采取相关措施的记录，必要时应有结论：

(a) equipment assembly and validation;

(a) 仪器组装和验证

(b) analytical apparatus and calibration;

(b) 分析仪器和校准

(d) personnel matters including qualification, training, clothing and hygiene;

(d) 人事相关问题，包括资质、培训、服装和卫生

(e) environmental monitoring;

(e) 环境监控

(f) pest control;

(f) 虫害控制

(g) complaints;

(g) 投诉

(h) recalls;

(h) 召回

(i) returns.

(i) 退货

There should be SOPs and records for the receipt of each delivery of starting material and primary and printed packaging material.

对于每一个原材料、内包装材料和印刷包装材料都应有物料接收的SOPs和记录。

The records of the receipts should include:

物料接收的记录应当包括：

(a) the name of the material on the delivery note and the containers;

(a) 发货单和包装容器上的物料名称

(b) the “in-house” name and/or code of material if different from (a);

(b) 公司内部使用的物料名称和/或代码,若不同于(a)

(d) the supplier’s name and, if possible, manufacturer’s name;

(d) 供应商的名称和生产商的名称（可能的话）

(e) the manufacturer’s batch or reference number;

(e) 生产商的批号或参考号

(f) the total quantity, and number of containers received;

(f) 接收的总量和包装容器的数量

(g) the batch number assigned after receipt;

(g) 接收后分配的批号

(h) any relevant comment (e.g. state of the containers).

(h) 有关说明（例如，包装容器的说明）

There should be SOPs for the internal labelling, quarantine and storage of starting materials, packaging materials and other materials, as appropriate.

应当有关于内部标签、原材料、包装材料和其他物料待验和储存的SOPs。

SOPs should be available for each instrument and piece of equipment (e.g. use, calibration, cleaning, maintenance) and placed in close proximity to the equipment.

对于每一个仪器和设备（如，使用、校准、清洁和维护），都应有相应的SOP，并放在每个设备的附近位置。

There should be SOPs for sampling, which specify the person(s) authorized to take samples.

应当有取样的SOPs，明确授权取样的人员。

The sampling instructions should include:

取样指令应当包括：

(a) the method of sampling and the sampling plan;

(a) 取样方法和取样计划

(b) the equipment to be used;

(b) 所用设备

(d) the amount(s) of sample(s) to be taken;

(d) 取样量

(e) instructions for any required subdivision of the sample;

(e) 分样操作指令

(f) the type of sample container(s) to be used, and whether they are for aseptic sampling or for normal sampling, and labelling;

(f) 所用样品容器的类型，是无菌取样容器还是正常取样容器，并贴签

(g) any specific precautions to be observed, especially in regard to the sampling of sterile or noxious material.

(g) 应采取特殊预防措施，特别是当涉及无菌取样或有毒物质。

There should be an SOP describing the details of the batch (lot) numbering system, with the objective of ensuring that each batch of intermediate, bulk or finished product is identified with a specific batch number.

应当有描述批号编制系统的SOP，以保证每一批中间体、待包装产品和成品都有特定的批号。

The SOPs for batch numbering that are applied to the processing stage and to the respective packaging stage should be related to each other.

适用于生产阶段和各自包装阶段批号编制的SOP应当彼此相互关联。

The SOP for batch numbering should ensure that the same batch numbers will not be used repeatedly; this applies also to reprocessing.

批号编制的SOP应当确保同一批号不会重复使用，这也适用于返工批次。

Batch-number allocation should be immediately recorded, e.g. in a logbook. The record should include at least the date of allocation, product identity and size of batch.

批号分配后应当立即记录，如记录在日志中。记录应当至少包括分配日期、产品标识和批量。

There should be written procedures for testing materials and products at different stages of manufacture, describing the methods and equipment to be used. The tests performed should be recorded.

应当制定适用于不同生产阶段的物料和产品检测的书面检验规程，描述所用的方法和仪器。应当记录实施的检测。

Analysis records should include at least the following data:

检验记录应至少包含以下数据：

(a) the name of the material or product and, where applicable, dosage form;

(a) 物料或产品的名称，如适用，应包括剂型

(b) the batch number and, where appropriate, the manufacturer and/or supplier;

(b) 批号，适当时，生产厂家和/或供应商的名称

(d) test results, including observations and calculations, and reference to any specifications (limits);

(d) 检测结果和所参照的标准（限度），包括观察和计算

(e) date(s) and reference number(s) of testing;

(e) 检测的日期和参考号

(f) the initials of the persons who performed the testing;

(f) 检验人员的姓名缩写

(g) the date and initials of the persons who verified the testing and the calculations, where appropriate;

(g) 对检验、计算进行核对的人的姓名缩写，并注明日期。

(h) a clear statement of release or rejection (or other status decision) and the dated signature of the designated responsible person.

(h) 放行或拒绝的明确声明（或其他决定），并有指定的负责人的签名和日期。

Written release and rejection procedures should be available for materials and products, and in particular for the release for sale of the finished product by an authorized person.

应当建立物料和成品的书面放行和拒绝程序。特别是由授权人决定成品销售放行的书面程序。

Records should be maintained of the distribution of each batch of a product in order, e.g. to facilitate the recall of the batch if necessary.

每一批产品的销售记录应当保存，例如，必要时方便相应批次的召回。

Records should be kept for major and critical equipment, as appropriate, of any validations, calibrations, maintenance, cleaning, or repair operations, including dates and the identity of the people who carried these operations out.

重要和关键设备有关验证、校准、维护、清洁或维修操作的记录应当保存，记录内容应包括实施这些操作的日期和操作人。

The use of major and critical equipment and the areas where products have been processed should be appropriately recorded in chronological order.

重要和关键设备的使用以及处理产品的区域应当按时间顺序记录。

There should be written procedures assigning responsibility for cleaning and sanitation and describing in sufficient detail the cleaning schedules, methods, equipment and materials to be used and facilities and equipment to be cleaned. Such written procedures should be followed.

应当有分配清洁和卫生以及详细描述清洁计划、方法、所用的设备和物料以及需要清洁的设备和设施的书面规程。此类书面规程应当遵循。

Maintenance Of Laboratory Records

微生物实验室记录要求

Proper recording of data andstudies is critical to the success of the microbiology laboratory. The over-riding principle is that the test should be performed as written in theSOP, the SOP should be written to reflect how the test is actually performed,and the laboratory notebook should provide a record of all critical detailsneeded to reconstruct the details of the testing and confirm the integrity ofthe data. At a minimum, the laboratory write-up should include the following:

对数据和研究进行适当的记录是微生物化验室成功的关键。首要原则是必须根据书面SOP要求进行检测，SOP必须是书面的，反映真实操作。化验室记录本应记录所有关键细节，以便重现检测操作，确认数据的完整性。化验室记录至少应包括以下内容

Date
日期
Material tested
检测样品名
Microbiologist's name
检验人员
Procedure number
规程编号
Document test results
记录检验结果
Deviations(if any)
偏差（如有）
Documented parameters (equipment used, microbial stock cultures used, media lots used)
记录参数（所用仪器、所用微生物库存培养、所用培养基批号）
Management/Secondreview signature
管理者/复核签字

Every critical piece ofequipment should be noted in the write-up, and all should be on a calibrationschedule documented by SOP and maintenance records. Where appropriate, logbooksor forms should be available and supportive of the laboratory notebook records.Equipment temperatures (water baths, incubators, autoclaves) should be recordedand traceable.

所有关键设备均应记录，且应具有SOP所规定的校正计划和维护记录。适当时，设备日志或记录表格应在现场，并与化验室记录本内容一致。设备温度（水浴、培养箱、灭菌器）应有记录并可追踪。

The governing SOP and revisionshould be clearly noted in the write-up. Changes in the data should be crossedoff with a single line and initialed. Original data should not be erased orcovered over.

所执行的SOP及其版本应记录清楚。数据修正应对原数据划单删除线，在旁边另书写正确认数据。原始数据应保持不被擦除或覆盖。

Test results should include theoriginal plate counts, allowing a reviewer to recreate the calculations used toderive the final test results. Methods for data analysis should be detailed incited SOPs. If charts or graphs are incorporated into laboratory notebooks,they should be secured with clear tape and should not be obstructing any dataon the page. The chart or graph should be signed by the person adding thedocument, with the signature overlapping the chart and the notebook page. Labnotebooks should include page numbers, a table of contents for reference, andan intact timeline of use.

检测结果应包括原始碟计数结果，使审核人员可以重新计算结果。数据分析方法应在SOP中详细说明。如果检验记录中需要引入图表，这些图表应采用透明胶带保护，且不能遮挡该记录页上的任何其它数据。将图表附入记录的人员应在图表上签字，签字应在图表和记录本之间骑缝。化验室记录本应编有页码，索引表，使用起止时间。

All laboratory records shouldbe archived and protected against catastrophic loss. A formal record retentionand retrieval program should be in place.

所有化验室数据应归档，并防止不可恢复的损坏。应有正式的记录保管和检索程序。

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