GMP News - Analytical Quality Control

We recently reported that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) had published four Japanese Pharmacopoeia (JP) drafts of General Tests and General Information related to Chromatography. The agency has now released a slightly modified version of the draft of new General Test “<2.00> Chromatography”. Comments can be submitted until November 30, 2021.

Recently the FDA issued a Warning Letter due to lack of control over computer systems and violation of data integrity. During the inspection the use of multi user access to raw data files and falsification of records were observed.

A few but fundamental GMP requirements for pharmaceutical quality control laboratories are a frequent focus of regulatory inspections. During a visit to a U.S. contract laboratory, FDA inspectors found serious deficiencies in these requirements, resulting in a Warning Letter due to inadequate handling of OOS results, lack of electronic system security and data manipulation.

The "OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING" document No. 22 is a comprehensive, well-written, fluently readable guide to data integrity in the Good Laboratory Practice area.

The United States Food and Drug Administration (FDA) has recently published a Warning Letter to a manufacturer of over-the-counter (OTC) drug products. The letter summarizes significant violations of current good manufacturing practices (CGMP) concerning finished drug product testing, identity testing of active pharmaceutical ingredients (APIs), and stability testing.

Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. An evaluation of the last two fiscal years shows that a lack of scientifically sound laboratory controls and not following/documenting laboratory controls are often mentioned in such FDA 483s.

More than a year after the publication of the draft of Chapter <1220> on Life Cycle Management of Analytical Procedures, the USP has announced the final version for 01 November.