欧洲GMP药品现场检查项目表.docx

1、欧洲GMP药品现场检查项目表Audit Checklist for Drug IndustryDisclaimerThe following checklist is intended to aid in the systematic GMP audit of a facility that manufactures drug components or finished products.The adequacy of any procedures is subject to the interpretation of the auditor. Therefore, the author a

2、ccepts no liability for any subsequent regulatory observations or actions stemming from the use of this audit checklist.Instructions for Using this Audit Checklist:Before starting an on-site audit, plan the audit. Review past audits, note indications of possible problem areas and items, if any, that

3、 were identified for corrective action in a previous audit. If you are not already familiar with this facility, learn the type of product produced here and how it is organized by personnel and function. What does your customer, ., your superior or senior facility management, expect to learn from thi

4、s audit? The checklist is to be used with a notebook into which detailed entries can be made during the audit. While the checklist is to guide the auditor, is not intended to be a substitute for knowledge of the GMP regulations. Although a single question may be included about any requirement, the a

5、nswer will usually be a multi-part one since the auditor should determine the audit trail for several products that may use many different components. Enter details in your notebook and cross reference your comments with the questions. At least three production batches should be selected for thoroug

6、h analysis to include: (a) traceability of all components or materials used in the subject batches, (b) documentation of raw material or component, in-process, and finished goods testing for the subject product batches, (c) warehousing and distribution records as they would relate to a possible reca

7、ll. Responses entered on the checklist should be consistent. X is recommended for NO; a checkmark for YES; n/a for not applicable to questions that do not apply. An asterisk and notebook page number should be entered on the checklist to identify where relevant comments or questions are recorded in y

8、our notebook. The notebook used should be a laboratory-type notebook with bound pages. the notebook should be clearly labeled as to the audit type, date, and auditor(s). Many auditors prefer to use a notebook for a single audit so it may be filed with the checklist and the final report. The referenc

9、es to sections in the GMP regulation are for your convenience should a question arise. In some instances, two or more sections within the GMP regulation may have bearing on a specific subject. The headings in the GMP regulation will usually offer some guidance on the areas covered in each section. A

10、 general suggestion for a successful audit is to spend most of your time on major issues and a smaller portion of your time on small issues. there may be observations that you may wish to point out to supervisory personnel that deserve attention, but do not belong in an audit report because they are

11、 relatively insignificant. By the same token, too many small items suggests a trend of non-compliance and deserve attention as such. When citing these, be specific.QuestionInstructions/questions (note any exceptions and comments in notebook).Yes, No, or NADocument N; archiving areaGeneral ControlsDo

12、es the facility and its departments (organizational units) operate in a state of control as defined by the GMP regulations?Organizational & Management ResponsibilitiesDoes this facility/business unit operate under a facility or corporate quality policy?Does a Quality Assurance unit (department) exis

13、t as a separate organizational entity?Does the Quality Assurance unit alone have both the authority and responsibility to approve or reject all components, drug product containers and closures, in-process materials, packaging materials, labelling and drug products?Does the QA department or unit rout

14、inely review production records to ensure that procedures were followed and properly documented?Are adequate laboratory space, equipment, and qualified personnel available for required testing?If any portion of testing is performed by a contractor, has the Quality Assurance unit inspected the contra

15、ctors site and verified that the laboratory space, equipment, qualified personnel and procedures are adequate?Date of last inspection:_Are all QA procedures in writing?Are all QA responsibilities in writing?Are all written QA procedures current and approved? (Review log of procedures)Are the procedu

16、res followed? (Examine records to ensure consistent record-keeping that adequately documents testing.)Are QA supervisory personnel qualified by way of training and experience?Are other QA personnel, ., chemists, analysts, laboratory technicians) qualified by way of training and experience?Document C

17、ontrol ProgramDoes the QA unit have a person or department specifically charged with the responsibility of designing, revising, and obtaining approval for production and testing procedures, forms, and records?Does a written SOP, which identifies how the form is to be completed and who signs and coun

18、tersigns, exist for each record or form?Is the production batch record and release test results reviewed for accuracy and completeness before a batch/lot of finished product is released?Employee Orientation, Quality Awareness, and Job TrainingCircle the types of orientation provided to each new empl

19、oyee: (1) Company brochure (2) Literature describing GMP regulations and stressing importance of following instructions. (3) On-the-job training for each function to be performed (before the employee is allowed to perform such tasks). (4) Other: enter in notebook.Does each employee receive retrainin

20、g on an SOP (procedures) if critical changes have been made in the procedure?Indicate how on-going, periodic GMP training is accomplished.Is all training documented in writing that indicates the date of the training, the type of training, and the signature of both the employee and the trainer?Are tr

21、aining records readily retrievable in a manner that enables one to determine what training an employee has received, which employees have been trained on a particular procedure, or have attended a particular training program?Are GMP trainers qualified through experience and training?Are supervisory

22、personnel instructed to prohibit any employee who, because of any physical condition (as determined by medical examination or supervisory observation) that may adversely affect the safety or quality of drug products, from coming into direct contact with any drug component or immediate containers for

23、 finished product?Are employees required to report to supervisory personnel any health or physical condition that may have an adverse effect on drug product safety and purity?Are temporary employees given the same orientation as permanent employees?Are consultants, who are hired to advise on any asp

24、ect of manufacture, processing, packing or holding, of approval for release of drug products, asked to provide evidence of their education, training, and experience?Are written records maintained stating the name, address, qualifications, and date of service for any consultants and the type of servi

25、ce they provide?Plant Safety and SecurityDoes this facility have a facility or corporate safety program?Are safety procedures written?Are safety procedures current?Do employees receive safety orientation before working in the plant area?Is safety training documented in a readily retrievable manner t

26、hat states the name of the employee, the type of training, the date of the training, and the name of the trainer and the signature of the trainer and the participant?Does this facility have a formal, written security policy?Is access to the facility restricted?Describe how entry is monitored/restric

27、ted:Is a security person available 24 hours per day?Internal Quality/GMP Audit ProgramDoes this business unit/facility have a written quality policy?Is a copy of this quality policy furnished to all employees?If yes to above, when provided? _Is training provided in quality improvement?Does a formal

28、auditing function exist in the Quality Assurance department?Does a written SOP specify who shall conduct audits and qualifications (education, training, and experience) for those who conduct audits?Does a written SOP specify the scope and frequency of audits and how such audits are to be documented?

29、Does a written SOP specify the distribution of the audit report?Quality Cost ProgramDoes this facility have a periodic and formal review of the cost of quality?Does this facility have the ability, through personnel, software, and accounting records, to identify and capture quality costs?Does this fa

30、cility make a conscious effort to reduce quality costs?Design ControlNot directly related to the Drug RegulationFacility ControlFacility Design and LayoutAre all parts of the facility constructed in a way that makes them suitable for the manufacture, testing, and holding of drug products?Is there su

31、fficient space in the facility for the type of work and typical volume of production?Does the layout and organization of the facility prevent contamination?Environmental Control ProgramThe facility is NOT situated in a location that potentially subjects workers or product to particulate matter, fumes, or infestations?Are grounds free of standing water?Is lighting adequate in all areas?Is adequate ventilation provided?