GMP Audit Checklist For Drug Manufacturers page 2

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GMP Audit Checklist Page 2
Question Instructions/questions (note any exceptions and comments in notebook). Yes, No, or NA
1.201 §211.22(a) Does 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?  
1.202 §211.22(d) Does a written SOP, which identifies how the form is to be completed and who signs and countersigns, exist for each record or form?  
1.203 §211.165(a)(b)(c) Is the production batch record and release test results reviewed for accuracy and completeness before a batch/lot of finished product is released?  
 
1.3 Employee Orientation, Quality Awareness, and Job Training  
1.301 Circle the types of orientation provided to each new employee: (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.  
1.302 §211.25(a) Does each employee receive retraining on an SOP (procedures) if critical changes have been made in the procedure?  
1.303 Indicate how on-going, periodic GMP training is accomplished.  
1.304 §211.25 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?  
1.305 §211.25 Are training 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?  
1.306 Are GMP trainers qualified through experience and training?  
1.307 §211.25(a) Are supervisory 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 finished product?  
1.308 §211.28(d) 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?  
1.309 §211.25(a) Are temporary employees given the same orientation as permanent employees?  
1.310 §211.34 Are consultants, who are hired to advise on any aspect of manufacture, processing, packing or holding, of approval for release of drug products, asked to provide evidence of their education, training, and experience?  
1.311 §211.34 Are written records maintained stating the name, address, qualifications, and date of service for any consultants and the type of service they provide?  
1.4 Plant Safety and Security  
1.401 Does this facility have a facility or corporate safety program?  
1.402 Are safety procedures written?  
1.403 Are safety procedures current?  
1.404 Do employees receive safety orientation before working in the plant area?  
1.405 Is safety training documented in a readily retrievable manner that 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?  
1.406 Does this facility have a formal, written security policy?  
1.407 Is access to the facility restricted?  
1.408 Describe how entry is monitored/restricted:  
1.409 Is a security person available 24 hours per day?  
1.5 Internal Quality/GMP Audit Program  
1.501 Does this business unit/facility have a written quality policy?  
1.502 Is a copy of this quality policy furnished to all employees?  
1.503 If "yes" to above, when provided? __________________  
1.504 Is training provided in quality improvement?  
1.505 Does a formal auditing function exist in the Quality Assurance department?  
1.506 Does a written SOP specify who shall conduct audits and qualifications (education, training, and experience) for those who conduct audits?  
1.507 Does a written SOP specify the scope and frequency of audits and how such audits are to be documented?  
1.508 Does a written SOP specify the distribution of the audit report?  
1.6 Quality Cost Program  
1.601 Does this facility have a periodic and formal review of the cost of quality?  
1.602 Does this facility have the ability, through personnel, software, and accounting records, to identify and capture quality costs?  
1.603 Does this facility make a conscious effort to reduce quality costs?  


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Last Update: 19 August 2011

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