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药品生产质量管理规范(GMP)中英文对照三

(2007-07-29 21:36:25)
 

Chapter 7: Validation第七章  验   

Article 57: The validation of drug production refers to: installation qualification of building and facilities (IQ), operational qualification (OQ), performance qualification (PQ) and product validation (PV). 第五十七条 药品生产验证应包括厂房、设施及设备安装确认、运行确认、性能确认和产品验证。

Article 58: The validation of production process and key facilities and equipment shall be conducted according to a protocol. Re-validation shall be conducted at defined intervals or after any significant modifications that may affect the product quality, e.g. manufacturing process, quality control method, important raw material and excipient, or equipment, etc. 第五十八条 产品的生产工艺及关键设施、设备应按验证方案进行验证。当影响产品质量的主要因素,如工艺、质量控制方法、主要原辅料、主要生产设备等发生改变时,以及生产一定周期后,应进行再验证。

Article 59: The items to be validated, validation protocol and its implementation shall be made on the basis of the validation objectives. A validation report shall be written after validation is finished, which shall be reviewed and approved by the responsible person. 第五十九条 应根据验证对象提出验证项目、制定验证方案,并组织实施。验证工作完成后应写出验证报告,由验证工作负责人审核、批准。

Article 60: The data and content of analysis obtained in the validation process shall be recorded and filed. The files should include validation protocol, validation report, evaluation and suggestions, approval person, etc. 第六十条 验证过程中的数据和分析内容应以文件形式归档保存。验证文件应包括验证方案、验证报告、评价和建议、批准人等。

Chapter 8 Documentation第八章  文   

Article 61: Drug manufacturing enterprises shall have the following management documents and records for production and quality control: 第六十一条 药品生产企业应有生产管理、质量管理的各项制度和记录:

1. written procedures and records for use, maintenance and repair of buildings, facilities and equipment; 1、厂房、设施和设备的使用、维护、保养、检修等制度和记录;

2. written procedures and records for material checking and acceptance, production operation, testing, material dispatching, releasing, finished product distribution and consumer complaints, etc; 2、物料验收、生产操作、检验、发放、成品销售和用户投诉等制度和记录;

3. written procedures and records for control of unqualified materials and products, return of goods to the warehouse, disposal reports, and handling of emergencies, etc. 3、不合格品管理、物料退库和报废、紧急情况处理等制度和记录;

4. written procedures and records for hygiene and sanitation of the environment, building, equipment and personnel, etc, and4、环境、厂房、设备、人员等卫生管理制度和记录;

5. written procedures and records for GMP and professional technical training. 5、本规范和专业技术培训等制度和记录。

Article 62: Production control documents mainly include: 第六十二条 产品生产管理文件主要有:

1. Master formula, job position instructions or standard operating procedures. Master formula includes: drug name, dosage form, formula, the operational requirements of process, quality standards of materials, in-process product and finished product, technical parameter as well as storage precautions, reconciliation of materials, requirements of packaging materials and container for finished products. 生产工艺规程的内容包括:品名,剂型,处方,生产工艺的操作要求,物料、中间产品、成品的质量标准和技术参数及储存注意事项,物料平衡的计算方法,成品容器、包装材料的要求等。

Job position instructions include: production operation methods and key points, checking and review of critical operations, specification and its control of in-process products, safety and labor protection, maintenance and cleaning of equipment, treatment and report of abnormal situation, process and environmental sanitation, etc. 岗位操作法的内容包括:生产操作方法和要点,重点操作的复核、复查,中间体、产品质量标准及控制,安全和劳动保护,设备维修、清洗,异常情况处理和报告,工艺卫生和环境卫生等。

Standard operating procedure includes: title, numbering code, writer, date of establishing, reviewer and reviewing date, approval person and approving date, issuing department, date of effect, receiving and distributing departments, heading and text. 标准操作规程的内容包括:题目、编号、制定人及制定日期、审核人及审核日期、批准人及批准日期、颁发部门、生效日期、分发部门,标题及正文。

2. Batch production records 2、批生产记录

Batch production records include: product name, batch number, production date, signature of operator and checker, a description of related operations and equipment, quantity in relevant production stages, reconciliation of material, process control records as well as records of special problems. 批生产记录内容包括:产品名称、生产批号、生产日期、操作者、复核者的签名,有关操作与设备、相关生产阶段的产品数量、物料平衡的计算、生产过程的控制记录及特殊问题记录。

Article 63: The product quality control documents mainly include: 第六十三条 产品质量管理文件主要有:

1. all application and approval documents of the drug; 1、药品的申请和审批文件;

2. specification of materials, in-process products and the finished product and their test procedures; 2、物料、中间产品和成品质量标准及其检验操作规程;

3. stability testing records of the product; and, 3、产品质量稳定性考察;

4. batch test records. 4、批检验记录。

Article 64: Written procedures for drafting, revising, reviewing, approving, withdrawing, distributing and retaining of documents shall be established in drug manufacturing enterprises. Only the approved current documents may be distributed and used. Withdrawn and out-of-dates documents shall not be present at work site, except those maintained in archives for reference purposes. 第六十四条 药品生产企业应建立文件的起草、修订、审查、批准、撤销、印制及保管的管理制度。分发、使用的文件应为批准的现行文本。已撤销和过时的文件除留档备查外,不得在工作现场出现。

Article 65: The requirements for establishing production and quality control documents are as follows: 第六十五条 制定生产管理文件和质量管理文件的要求:

1. the title shall clearly describe the nature of the document; 1、文件的标题应能清楚地说明文件的性质;

2. the documents shall have a numbering code system as well as date to identify their version and category ; 2、各类文件应有便于识别其文本、类别的系统编码和日期;

3. the language used in documents shall be exact and understandable; 3、文件使用的语言应确切、易懂;

4. the documents shall have a sufficient space to fill in the data; 4、填写数据时应有足够的空格;

5. the responsibility for drafting, reviewing and approving documents shall be clearly defined, and there shall be the signature of the responsible person on documents.  5、文件制定、审查和批准的责任应明确,并有责任人签名。

 

Chapter 9: Production Management第九章  生产管理

 

Article 66: Master formula, post instruction or standard operating procedures shall not be changed arbitrarily. If there is a necessity to revise, the amendment to such documents shall be reviewed and approved in accordance with the same procedures as in the preparation of the original documents. 第六十六条 生产工艺规程、岗位操作法和标准操作规程不得任意更改。如需更改时,应按制定时的程序办理修订、审批手续。

Article 67: Checks on yields and reconciliation of quantities should be carried out for each batch. If there is a significant difference, the cause shall be identified and products shall not be treated as normal products unless the cause is rationally explained and no potential quality risk is confirmed. 第六十七条 每批产品应按产量和数量的物料平衡进行检查。如有显著差异,必须查明原因,在得出合理解释,确认无潜在质量事故后,方可按正常产品处理。

Article 68: The batch production record shall be completed in a timely manner, written clearly, truthful in content and complete in data and shall be signed by both the operator and checker. The records shall be kept clean and tidy, and shall not be destroyed and changed arbitrarily. When there is a revision, the reading of the original information shall be permitted and the person making the revision shall sign his name at the place of the revision.

Batch production records shall be filed with batch number and kept one year after the expiration date of the product. The production records of the drugs without expiration date shall be kept at least for three years. 第六十八条 批生产记录应字迹清晰、内容真实、数据完整,并由操作人及复核人签名。记录应保持整洁,不得撕毁和任意涂改;更改时,在更改处签名,并使原数据仍可辩认。

批生产记录应按批号归档,保存至药品有效期后一年。未规定有效期的药品,批生产记录至少保存三年。

 

Article 69: A defined quantity of drug product with identical properties and quality within a specified limit, produced continuously in a same production cycle is called a batch. A batch number shall be assigned to each batch of product. 第六十九条 在规定限度内具有同一性质和质量,并在同一连续生产周期中生产出来的一定数量的药品为一批。每批药品均应编制生产批号。

Article 70: The production operations shall adopt the following measures to prevent drugs from contamination and mix-ups: 第七十条 为防止药品被污染和混淆,生产操作应采取以下措施:

1. confirm before production that there are no residues from the previous batch; 1、生产前应确认无上次生产遗留物;

2. prevent the generation and spreading of particulates; 2、应防止尘埃的产生和扩散

3. products of different varieties and specifications shall not be produced in the same room at the same time. When several package lines are in operation at the same time, segregation or other measures shall be adopted to prevent contamination or mix-up; 3、不同产品品种、规格的生产操作不得在同一生产操作间同时进行;有数条包装线同时进行包装时,应采取隔离或其它有效防止污染或混淆的设施;

4. during production, the cross-contamination caused by gas, vapor, spraying substances or biological bodies generated from materials and products shall be prevented; 4、生产过程中应防止物料及产品所产生的气体、蒸汽、喷雾物或生物体等引起的交叉污染;

5. each production room, equipment and container shall be labeled with the name of product or material, batch number and quantity, etc. 5、每一生产操作间或生产用设备、容器应有所生产的产品或物料名称、批号、数量等状态标志;

6. circulating water is required for the washing of selected crude drugs, recovered water is not allowed to be used for washing of other crude drugs. Crude drugs of different properties may not be washed together. Outdoor drying is not appropriate for washed, sliced, and processed crude drugs.

The sterilization of crude drugs and in-process products shall not change their effect and quality. A micro-biological test shall be conducted before directly injecting drugs with crude drug powder and preparation materials. 6、拣选后药材的洗涤应使用流动水,用过的水不得用于洗涤其它药材。不同药性的药材不得在一起洗涤。洗涤后的药材及切制和炮制品不宜露天干燥。

 

    药材及其中间产品的灭菌方法应以不改变药材的药效、质量为原则。直接入药的药材粉末,配料前应做微生物检查。

Article 71: Processing water shall be selected in accordance with the master formula which shall comply with quality specifications, be tested and recorded periodically. The test interval shall be defined in accordance with validation results. 第七十一条 根据产品工艺规程选用工艺用水。工艺用水应符合质量标准,并定期检验,检验有记录。应根据验证结果,规定检验周期。

Article 72: A batch package record shall be provided for each batch of products. The record shall include: 第七十二条 产品应有批包装记录。批包装记录的内容应包括:

1. the name, batch number and specification of the bulk product; 1、 待包装产品的名称、批号、规格;

2. label with batch number, insert sheet as well as product quality certificate; 2、 印有批号的标签和使用说明书以及产品合格证;

3. the received quantities of bulk product and package materials, signatures of the dispatcher, the receiver and the checker; 3、 待包装产品和包装材料的领取数量及发放人、领用人、核对人签名;

4. the quantities of packaged product; 4、 已包装产品的数量;

5. line-clean record of previous packaging batch (duplicate original) and the record of this batch (original); 5、 前次包装操作的清场记录(副本)及本次包装清场记录(正本);

6. the post completion inspection and checking results of this packaged batch and signature of the checker; 6、 本次包装操作完成后的检验核对结果、核对人签名;

7. the signature of the person responsible for the production operation. 7、 生产操作负责人签名。

Article 73: Line-clean must be conducted and recorded by operators after completion of each production stage. The record shall include section (stage), name of the product, production batch, line-clean date, items of examination and their results, signatures of the person performing the line-clean and the checker. The line-clean records shall be included in the batch record. 第七十三条 每批药品的每一生产阶段完成后必须由生产操作人员清场,填写清场记录。清场记录内容包括:工序、品名、生产批号、清场日期、检查项目及结果、清场负责人及复查人签名。清场记录应纳入批生产记录。

 

Chapter 10: Quality Management第十章  质量管理

 

Article 74: The quality control department of drug manufacturing enterprises shall be responsible for the quality management and testing of the whole process of drug production and shall be directly led by the enterprise leaders. Quality control department shall be staffed by an adequate number of quality management and testing personnel and shall be provided with the space, facilities, instruments and equipment adapted to the requirements of production scale of the drug, product variety and tests. 第七十四条 药品生产企业的质量管理部门应负责药品生产全过程的质量管理和检验,受企业负责人直接领导。质量管理部门应配备一定数量的质量管理和检验人员,并有与药品生产规模、品种、检验要求相适应的场所、仪器、设备

Article 75: The main responsibilities of quality control department are as follows:  第七十五条 质量管理部门的主要职责:

1. to establish and revise in house specification and analytical operational procedure of materials, in-process and finished products, and to establish sampling and sample retention procedures; 1、制定和修订物料、中间产品和成品的内控标准和检验操作规程,制定取样和留样制度;

2. to establish the procedures for controlling testing equipment, instrument, reagent, testing solution, standard substance (or reference substance), titration solution, culture medium, experiment animals, etc; 2、制定检验用设备、仪器、试剂、试液、标准品(或对照品)、滴定液、培养基、实验动物等管理办法;

3. to decide the use of material and in-process products; 3、决定物料和中间产品的使用

4. to review the batch production record before releasing a finished product and to decide the release of a finished product; 4、审核成品发放前批生产记录,决定成品发放;

5. to review the treatment procedure of rejected products; 5、审核不合格品处理程序;

6. to sample, test, retain samples and issue analytical reports for materials, in-process and finished products; 6、对物料、中间产品和成品进行取样、检验、留样,并出具检验报告;

7. to monitor the number of particulates and microorganisms in the clean room (area); 7、监测洁净室(区)的尘粒数和微生物数;

8. to evaluate the stability of raw material, in-process and finished product and to provide data for determining the storage period of materials and expiration date of a drug; and, 8、评价原料、中间产品及成品的质量稳定性,为确定物料贮存期、药品有效期提供数据;

9. to establish the responsibilities of the people engaged in quality management and quality test. 9、制定质量管理和检验人员的职责。

Article 76: The quality control department together with other related departments shall audit the quality system of suppliers of main materials. 第七十六条 质量管理部门应会同有关部门对主要物料供应商质量体系进行评估。

Chapter 11: Product Distribution and Recall第十一章  产品销售与收回

Article 77: Distribution records shall be available for every batch of finished product. The marketing of each batch of drugs shall be traced according to the distribution record and, if necessary, the batch shall be duly recalled. The distribution record shall include: drug name; dosage form, batch number, specifications; quantity, unit receiving goods and its address and dates of distribution. 第七十七条 每批成品均应有销售记录。根据销售记录能追查每批药品的售出情况,必要时应能及时全部追回。销售记录内容应包括:品名、剂型、批号、规格、数量、收货单位和地址、发货日期。

Article 78: Distribution records shall be kept for one year after expiration date of the product. The records of the drugs with no expiration date shall be kept for five years. 第七十八条 销售记录应保存至药品有效期后一年。未规定有效期的药品,销售记录应保存三年。

Article 79: A drug manufacturing enterprise shall establish the written procedures and records of drug return and recall. Drug return and recall record shall include: drug name, batch number, specifications, quantity, units from whom the product is returned or recalled and their address, the reason and date of return and recall and suggestions of treatment. 第七十九条 药品生产企业应建立药品退货和收回的书面程序,并有记录。药品退货和收回记录内容应包括:品名、批号、规格、数量、退货和收回单位及地址、退货和收回原因及日期、处理意见。

If drug preparations are returned or recalled for quality problems, then, under the supervision of quality control department, the drugs shall be destroyed. If other batches are affected, they should also be handled at the same time. 因质量原因退货和收回的药品制剂,应在质量管理部门监督下销毁,涉及其它批号时,应同时处理。

Chapter 12: Complaints and Adverse Reactions Report第十二章  投诉与不良反应报告

 

Article 80: A drug manufacturing enterprise shall establish a reporting system for supervising drug adverse reactions. The designated technical organization or personnel shall be responsible for the management of the system. 第八十条 企业应建立药品不良反应监察报告制度,指定专门机构或人员负责管理。

  Article 81: Any complaints on drug quality from the consumer and drug adverse reactions shall be recorded in detail and treated based on thorough investigation. Drug adverse reactions shall be duly reported to the local drug administration authorities. 第八十一条 对用户的药品质量投诉和药品不良反应应详细记录和调查处理。对药品不良反应应及时向当地药品监督管理部门报告。

Article 82: A report shall be provided to local drug regulatory authorities whenever any serious problems in drug production occur. 第八十二条 药品生产出现重大质量问题时,应及时向当地药品监督管理部门报告。

 

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