GMP Audit Checklist For Drug Manufacturers

Disclaimer

This GMP audit checklist is intended to aid in the systematic 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, ISPE and the GMP Institute accept no liability for any subsequent regulatory observations or actions stemming from the use of this audit checklist.

Instructions for Using 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 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", i.e., your superior or senior facility management, expect to learn from this 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 answer 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 thorough 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 recall.
  • 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 your 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 references 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 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 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.

GMP Audit Checklist

Question

Instructions/questions (note any exceptions and comments in notebook).

Yes, No, or NA
1.0 General Controls

 

  Does the facility and its many departments (organizational units) operate in a state of control as defined by the GMP regulations?  

1.1

Organizational & Management Responsibilities

 

1.101

Does this facility/business unit operate under a facility or corporate quality policy?

 

1.102

§211.22(a) Does a Quality Assurance unit (department) exist as a separate organizational entity?

 

1.103

§211.22(a) 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, labeling and drug products?

 

1.104

§211.22 Does the QA department or unit routinely review production records to ensure that procedures were followed and properly documented?

 

1.105

§211.22(b) Are adequate laboratory space, equipment, and qualified personnel available for required testing?

 

1.106

If any portion of testing is performed by a contractor, has the Quality Assurance unit inspected the contractor's site and verified that the laboratory space, equipment, qualified personnel and procedures are adequate?

 

1.107

Date of last inspection:____________________

 

1.108

§211.22(c) Are all QA procedures in writing?

 

1.109

§211.22(c) Are all QA responsibilities in writing?

 

1.110

Are all written QA procedures current and approved? (Review log of procedures)

 

1.111

Are the procedures followed? (Examine records to ensure consistent record-keeping that adequately documents testing.)

 

1.112

§211.25 Are QA supervisory personnel qualified by way of training and experience?

 

1.113

§211.25 Are other QA personnel, e.g., chemists, analysts, laboratory technicians) qualified by way of training and experience?

 

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?