1、Records and ReportsGMP Training Module 3General RequirementsWhat are the general requirements for document control?How long do you keep records and reports related to production,control and distribution?General Requirementsa)Any production,control,or distribution record that is required to be mainta
2、ined in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or,in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under 211.13
3、7,3 years after distribution of the batch.a)任何生产、控制或销售记录任何生产、控制或销售记录，须依照本部分要求特别是与一批药品有关的上述记录，在该批药品有效期满后，保留一年以上保留一年以上。一些无有效期的非处方药品，由于它们符合211137的标准，在该批药品销售后，保留三年。Do you also keep records for all components,drug product containers,closures,and labeling?For how long?Where do you keep all these records?A
4、re they readily available?Show me all related records of a batch made on 10/10/2009(one year ago).(b)Records shall be maintained for all components,drug product containers,closures,and labeling for at least 1 year after the expiration date or,in the case of certain OTC drug products lacking expirati
5、on dating because they meet the criteria for exemption under 211.137,3 years after distribution of the last lot of drug product incorporating the component or using the container,closure,or labeling.(b)全部成份，药品容器、密封件及标签的记录全部成份，药品容器、密封件及标签的记录，在有效期满后，保留一年以上。一些无有效期的非处方药品，由于它们符合211137规定的免除的标准，故从销售最后一批药品计
6、，上述记录保留三年。(c)All records required under this part,or copies of such records,shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred.These records or copies thereof shall be subject to photocopying o
7、r other means of reproduction as part of such inspection.Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting the requirements of this paragraph.(c)本部分要求的全部记录或它们的拷贝，应能随时调出以便授权检查人员复核。这些记录应可以复印或其他方法复制。直接从电子计算机或其它设备中提出的记录，符
8、合本段的要求。(d)Records required under this part may be retained either as original records or as true copies such as photocopies,microfilm,microfiche,or other accurate reproductions of the original records.Where reduction techniques,such as microfilming,are used,suitable reader and photocopying equipment
9、 shall be readily available.(d)本部分要求的记录，可用原始记录或复印件，如光电复印、缩微胶卷和其他可以对文件精确复制的方式。如是缩微方式，应配备适合阅读和复印设备。Do you have an annual review to evaluate quality standards for each drug production?If so,how many batches do you review?How many batches did you review last year?Show me the annual review report on BZK
10、wipe product last year.Do you review complaints,recalls,returned or salvaged drug products,and investigations conducted under 211.192 for each drug product?Please show me an example of such investigation.(e)Written records required by this part shall be maintained so that data therein can be used fo
11、r evaluating,at least annually,the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures.Written procedures shall be established and followed for such evaluations and shall include provisions for:(1)A review of
12、a representative number of batches,whether approved or rejected,and,where applicable,records associated with the batch.(2)A review of complaints,recalls,returned or salvaged drug products,and investigations conducted under 211.192 for each drug product.(e)保留本部分所要求的文字记录，其中的资料可用作评价至少一个年度每个药品的质量标准，决定药品
13、的规格、生产或控制程序中需要更改的地方。根据这些评估制订文字程序，并包括下列条款：1)评估一定数量生产批次所有相关记录，无论这些批次是批准/拒收。2)投诉、撤销、退回或报废药品的复查，按211192对每个药品进行调查。Are responsible officials of your company notified in writing of any investigations conducted under 211.198(complaint),211.204(return),or 211.208(salvage)of these regulations,any recalls,repo
14、rts of inspectional observations issued by FDA,or any regulatory actions relating to GMP brought by FDA?(f)Procedures shall be established to assure that the responsible officials of the firm,if they are not personally involved in or immediately aware of such actions,are notified in writing of any i
15、nvestigations conducted under 211.198,211.204,or 211.208 of these regulations,any recalls,reports of inspectional observations issued by the Food and Drug Administration,or any regulatory actions relating to good manufacturing practices brought by the Food and Drug Administration.(f)应建立程序以确保以书面形式通知企
16、业负责人关于211198（投诉）、（投诉）、211204（退货）或（退货）或211208（报废）等条款的任何调查结果、以及任何产品召回、（报废）等条款的任何调查结果、以及任何产品召回、FDA发出的稽查报告或发出的稽查报告或FDA发出的关于发出的关于GMP生产相生产相关的法规和措施关的法规和措施。企业负责人如直接参与此类活动或立即知悉相关信息则不需要书面通报。Equipment cleaning and use logDo you have individual equipment log?If not,could you explain why?Can you show me a batch
17、record that has the information of cleaning,maintenance and use?Do you have two persons,one performs the cleaning/maintenance and the other one double check?Show me a cleaning/machine maintenance record on 10/6/2010.Equipment cleaning and use logA written record of major equipment cleaning,maintenan
18、ce(except routine maintenance such as lubrication and adjustments),and use shall be included in individual equipment logs that show the date,time,product,and lot number of each batch processed.If equipment is dedicated to manufacture of one product,then individual equipment logs are not required,pro
19、vided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence.In cases where dedicated equipment is employed,the records of cleaning,maintenance,and use shall be part of the batch record.The persons performing and double-checking the cleaning and mai
20、ntenance(or,if the cleaning and maintenance is performed using automated equipment under 211.68,just the person verifying the cleaning and maintenance done by the automated equipment)shall date and sign or initial the log indicating that the work was performed.Entries in the log shall be in chronolo
21、gical order.主要设备的清洁、维修（常规维修，如润滑、调整等除外）必须以文字记录在单独的设备记录内。必须以文字记录在单独的设备记录内。此记录列有日期、时间、产品和加工批号等内容此记录列有日期、时间、产品和加工批号等内容。若设备用于生产一种药品，并且药品按序生产，那么不要求单独设备记录。对于专一生产某种药品的设备，其清洁、维修和使用记录是生产记录的一部分。实施和复查清洁和维修的人员实施和复查清洁和维修的人员，填写日期、签名和填写工作记录。记录同日登记，按年月顺序进行。如果是机器自动清洗，则需一人员确认自动清洗和维护即可。Component,drug product container,
22、closure,and labeling recordsDo you keep record of each lot of components,drug product containers,closures,and labeling and the record has the following information:the name of the supplier;the suppliers lot number(s)if known;the receiving code/status;the date of receipt;The name and location of the
23、prime manufacturer,if different from the supplier,shall be listed if known.Component,drug product container,closure,and labeling records(a)The identity and quantity of each shipment of each lot of components,drug product containers,closures,and labeling;the name of the supplier;the suppliers lot num
24、ber(s)if known;the receiving code as specified in 211.80;and the date of receipt.The name and location of the prime manufacturer,if different from the supplier,shall be listed if known.a)每批成份、药品容器、密封件和标签的每一装货量的鉴别与数量，供应商名称；供应商的批号（如知道）、按2180指定的接收代码、接收日期。如生产商的名称和地址与供应商不同，亦应列出（如知道）。Testing and Examinati
25、onDo you do visual check of incoming materials?Do you do identification test?Do you have specs for incoming materials?Please show me testing records of 1)Incoming BZK material&Incoming PVP-I 2)Incoming containers(b)The results of any test or examination performed(including those performed as require
26、d by 211.82(a),211.84(d),or 211.122(a)and the conclusions derived therefrom.(b)任何检验结果（包括按21182（a）21184(d)或211122（a）的要求进行的检验结果）和由此得出的结论。Do you have an individual inventory record of each component,drug product container,and closure and,for each component?Please show me a record of the latest PVP-I re
27、ceived from your supplier:How much was received?How much has been used?How much left?Does the individual inventory record have correct numbers?Inventory Record(c)An individual inventory record of each component,drug product container,and closure and,for each component,a reconciliation of the use of
28、each lot of such component.The inventory record shall contain sufficient information to allow determination of any batch or lot of drug product associated with the use of each component,drug product container,and closure.（c)每个成份、药品容器、密封件的单独存货记录。存货和使用记录应该可以对账。根据此存货记录应可以确定各批（整批或小批）药品生产中所使用各成份、药品容器和密封件
29、的详细资料。How do you control labels and labeling materials?Where are they stored at?Who have accesses to that area?Who reviews them?Do you have a spec?Where do you keep the rejected materials?What will you do with the rejected materials?(d)Documentation of the examination and review of labels and labeli
30、ng for conformity with established specifications in accord with 211.122(c)and 211.130(c).(e)The disposition of rejected components,drug product containers,closure,and labeling.(d)按211122（c）和211130（c）制订的规定，检查或复查标签和贴标签所提供的文件。(e)拒收的成份、药品容 器、密封件和标签的处理。Master production and control recordsHow do you ass
31、ure the uniformity from batch to batch?Do you currently use double signature(second person verification)system for master production and control records?Show me an example of master production and control record for making BZK wipe.Master production and control records(a)To assure uniformity from ba
32、tch to batch,master production and control records for each drug product,including each batch size thereof,shall be prepared,dated,and signed(full signature,handwritten)by one person and independently checked,dated,and signed by a second person.The preparation of master production and control record
33、s shall be described in a written procedure and such written procedure shall be followed.(a)保障批与批间的一致性，制备各批药品的主要生产和控制记录（包括各批的量），由一人填写日期和签名（全名、手签）。由另一个单独核实，填写日期和签名。此主要生产和控制记录的建立程序应明文确定，并要遵循。Does your master production and control record contain the following information:(1)The name and strength of th
34、e product and a description of the dosage form;(2)The name and weight or measure of each active ingredient per dosage unit or per unit of weight or measure of the drug product,and a statement of the total weight or measure of any dosage unit;(3)A complete list of components designated by names or co
35、des sufficiently specific to indicate any special quality characteristicMaster production and control records shall include:(1)The name and strength of the product and a description of the dosage form;(2)The name and weight or measure of each active ingredient per dosage unit or per unit of weight o
36、r measure of the drug product,and a statement of the total weight or measure of any dosage unit;(3)A complete list of components designated by names or codes sufficiently specific to indicate any special quality characteristic;主要生产和控制记录包括：1.产品名称、强度和剂型的说明。2.药品各活性成份的名称和每剂量单位或每重量单位的重量或容量。任何剂量单位的总重量或容量的
37、说明。3.一个完整的，以名字或代码表示的成份清单，充分显示具体的质量特性。Does your master production and control record contain:(4)An accurate statement of the weight or measure of each component,using the same weight system for each component.(5)A statement concerning any calculated excess of component;(6)A statement of theoretical w
38、eight or measure at appropriate phases of processing;(4)An accurate statement of the weight or measure of each component,using the same weight system(metric,avoirdupois,or apothecary)for each component.Reasonable variations may be permitted,however,in the amount of components necessary for the prepa
39、ration in the dosage form,provided they are justified in the master production and control records;(5)A statement concerning any calculated excess of component;(6)A statement of theoretical weight or measure at appropriate phases of processing;4)准确表明各成份的重量或容量，各成份使用同一计量系统（公制、常衡或药衡制）。由于制备过程中引起该剂型中成分份量
40、的改变，只要它们在该主要生产和控制记录中被证明是正确的，这种合理的调整是允许的。5)有关任何成份的计算超过量的说明。6)在适当加工阶段，理论重量或容量的说明。Does your master production and control record contain:(7)A statement of theoretical yield,including the maximum and minimum percentages of theoretical yield;(8)A description of the drug product containers,closures,and pa
41、ckaging materials,including a specimen or copy of each label and all other labeling signed and dated by the person or persons responsible for approval of such labeling;(9)Complete manufacturing and control instructions,sampling and testing procedures,specifications,special notations,and precautions
42、to be followed.(7)A statement of theoretical yield,including the maximum and minimum percentages of theoretical yield beyond which investigation according to 211.192 is required;(8)A description of the drug product containers,closures,and packaging materials,including a specimen or copy of each labe
43、l and all other labeling signed and dated by the person or persons responsible for approval of such labeling;(9)Complete manufacturing and control instructions,sampling and testing procedures,specifications,special notations,and precautions to be followed.7)理论产量的说明，包括理论产量的最大和最小百分率。根据211192要求，产量不在此区间
44、需要详细调查。8)药品容器、密封件和包装材料的说明，包括标签和全部其它标签的样本或复制件的说明。这些样本或复制件经对此负责的人员签名和注明日期。9)完善的生产和控制指令，取样和检验程序、各种规格标准，各种特殊的注解和各种预防方法均需遵照执行。Batch production and control recordsDoes your batch production and control records contain:(a)An accurate reproduction of the appropriate master production or control record,check
45、ed for accuracy,dated,and signed;(b)Documentation that each significant step in the manufacture,processing,packing,or holding of the batch was accomplished,including:(see next pages)Show me a batch record on 10/05/2010 and match the list of requirements and your contents.Batch production and control
46、 recordsBatch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch.These records shall include:(a)An accurate reproduction of the appropriate master production or control r
47、ecord,checked for accuracy,dated,and signed;(b)Documentation that each significant step in the manufacture,processing,packing,or holding of the batch was accomplished,including:(see next pages)每批生产的药品有批的生产和控制记录，包括每批有关生产和控制的完整资料。这些记录包括：适当的主要生产或控制记录、复查、注明的日期及签名的准确复制件。完成本批的生产、加工、包装、贮存中各项重要措施须提供的资料，包括(见
48、下页）(1)Dates;(2)Identity of individual major equipment and lines used;(3)Specific identification of each batch of component or in-process material used;(4)Weights and measures of components used in the course of processing;(5)In-process and laboratory control results;(6)Inspection of the packaging an
49、d labeling area before and after use;(7)A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing;(8)Complete labeling control records,including specimens or copies of all labeling used;(9)Description of drug product containers and clo
50、sures;(10)Any sampling performed;(11)Identification of the persons performing and directly supervising or checking each significant step in the operation,or if a significant step in the operation is performed by automated equipment under 211.68,the identification of the person checking the significa
