GMP Audit Checklist For Drug Manufacturers 1

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This 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, 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 Page 1


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?  


Organizational & Management Responsibilities



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



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



§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?



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



§211.22(b) 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 contractor's site and verified that the laboratory space, equipment, qualified personnel and procedures are adequate?



Date of last inspection:____________________



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



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



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



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



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



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


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