API Process Inspection –what does the FDA expect?




API Process Inspection –what does the FDA expect?

Ironical as it may sound; there is no API-specific GMP guideline from the FDA! It has only some broad, yet clearly laid out rules and expectations, which have to be adhered to.

The FDA and API Process Inspection

Rules regarding what the FDA expects are mentioned clearly in the document that lays down the principles of an FDA API process inspection, namely FDA Program Guidance Manual (Program 7356.002F). So, the FDA sticks to what is prescribed in this document:

–        GMP is a must for the FDA

–        It recognizes Q 7 as the primary API GMP. If you cannot follow Q 7, you can expect an equivalent activity, but are expected to demonstrate that the alternative activity you used did not in any way violate the basic requirements set out in this document.

–        This program manual is applicable for API manufactured by synthesis/fermentation and not for dosage forms

–        This document applies to domestic and foreign inspections

–        Uses a six-system approach

Other requirements

–        Expects compliance with FDA regulations

–        Compliance with Q 7 or equivalent

–        Procedures and documents must be clearly written down

–        Should have appropriate Quality System in conformance with Q 7, to ensure that an international or domestic guidance is adhered to

–        Should have sound Quality Practices

–        A sound and documented QMS that is “shown to work”

–        Appropriate Change Control Systems

–        Cleaning systems and records

–        Appropriate Validation and Qualification performed and documented

–        Written contracts and Quality Agreements where appropriate

–        Auditing programs and documentation

Systems that will be examined

During an FDA API process inspection, it inspects the following types of systems:

–        Quality System

–        Facilities and Equipment

–        Materials System

–        Production

–        Packing and labeling

–        Laboratory Control System





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