API Facility Questionnaire and Audit Checklist

Health authorities often rely on audit reports from third-party auditors when assessing an API manufacturer, so having an industry standard for audits would be immensely helpful to MAHs.

Certain manufacturing activities involve specific GMP considerations, such as producing NIMPs containing penicillin. Any observations must also be assessed and documented in an audit report.

1. General Information

Create and implement an efficient pharmaceutical quality system by clearly outlining all management responsibilities. Document and evaluate manufacturing processes with regards to this quality system.

Make sure that all procedures and documents are clearly written, understandable by local personnel, and regularly updated. All associates should take personal responsibility to follow official SOPs when performing work – any deviations must be reported immediately to their supervisor and recorded.

Consider hiring professional technical writers to compose your documents. Their clear, logical prose will be easier for readers and auditors alike to follow and less prone to misinterpretation. Dedicate more time on major issues while spending less on minor ones.

2. Process Controls

According to currently accepted standards (Lege artis), each API with an associated risk profile, which may also be manufactured into parenteral finished drug forms, must undergo more comprehensive examination during an audit for both systems conformity and product or registration conformity considerations. This applies for both product conformity audits as well as registration conformity audits.

Inspectors conduct inspections in four key areas: facilities & equipment, materials, production, and laboratory controls – to evaluate whether the manufacturer is operating within GMP guidelines.

Consistency of performance is at the heart of good manufacturing practices, and is best achieved through standardised procedures that have been meticulously documented. For optimal results, professional technical writing services should be hired to craft these documents.

3. Personnel

The initial section of the checklist addresses more general GMP audit inquiries, such as those regarding responsibilities, authorizations and documentation.

There are also questions surrounding training of personnel involved with GMP activities. Every employee who performs GMP-related duties must receive initial and ongoing GMP training that covers regulations as well as any written procedures related to their tasks.

The next section of the template covers inspections and record keeping. Make sure that regular inspections are conducted, and accurate records are kept. This should include an audit of facility grounds and equipment as well as review of physical environment for drug production. Furthermore, have a system in place for managing product complaints with serious investigations of each claim that arises as well as keep accurate documentation regarding equipment use and cleanliness.

4. Laboratory

The laboratory section of this template poses questions regarding equipment maintenance, sanitation standards and other factors essential to pharmaceutical manufacturing. In addition, this checklist section also asks about testing and inspections.

Observations made in this section should be recorded in a lab notebook with bound pages to ensure they can be preserved and used as future references, or an electronic audit log can also be utilized.

This audit checklist is tailored for facilities that produce drug components and active pharmaceutical ingredients (API), although other manufacturers may find its usefulness. The GMP audit checklist template was created specifically to facilitate systematic, in-depth inspections that ensure compliance with GMP regulations.

5. Documentation

Documentation is at the core of Good Manufacturing Practice (GMP). Documents must be written clearly and directly related to manufacturing process, with quality manual providing details regarding management responsibilities for system.

SOPs (Standard Operating Procedures) represent a higher level of documentation. These documents offer more granular instructions for carrying out policies discussed in a quality manual and will often be specific to one department or function.

Finalizing records must be organized properly. Each entry in your laboratory notebook should clearly state the date and audit type (spot check or full inspection), along with any questions or comments recorded using an asterisk and page number of said notebook. This allows auditors to quickly locate relevant sections of their checklist.