FDA Inspection of HPLC – Part I

The US health authority Food and Drug Administration (FDA) carries out domestic and foreign inspections to investigate whether an organization works in accordance with the US law (Code of Federal Regulations, CFR) and international guidelines. For the production and control of classically and biotechnologically manufactured pharmaceuticals, the American laws Current Good Manufacturing Practices in Manufacturing, Processing, Packaging or Holding of Drugs: General and 21 CFR Part 211 cGMP Current Good Manufacturing Practices For Finished Pharmaceuticals constitute the essential legal framework for manufacturers and test laboratories.

For the handling of electronic records and the use of electronic signatures, the law 21 CFR Part 11 Electronic Records, Electronic Signatures applies. In addition, adherence to a number of guidelines is mandatory, concerning the development, manufacture, packaging, labeling, storage, logistics, and testing. In the course of the submission of a new product to the US FDA, all participating companies and contractors must be inspected for compliance with these laws and regulations.

Practical Tips: Materials, Reagents, Reference Standards

Delivery notes of materials received shall be provided on request.

Goods receipts are clearly documented (paper and/or electronic version).

All reference substances are tested for validity, certificates are complete, and invalid substances are removed.

Material safety data sheets are available for all reference substances.

Mixed solutions, reagents, and mobile phases are clearly documented; all used test equipment such as balances, pipettes, refrigerators, and freezers are identified and calibrated.

Reagents, solvents, and mobile phases are controlled regarding expiration date and replaced if necessary, including laboratory water and other solvents.

Samples, reagents, solvents, and mobile phases on laboratory benches and shelves are labeled clearly and in accordance with (legal) requirements.

Samples and specimens in refrigerators and freezers, are checked, for example, for expiration date, clear labeling.

Labels on solvent and reagent flasks are as specified, for example, not manually overwritten.

Reference standards of the US Pharmacopoeia (USP) must be used, even if there are other alternatives.

…To be Continued