Use your intermediates before reviewing their batch records

According to the FDA Guidance Document,  Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, batch records should be prepared for each intermediate and API and should include complete information relating to the production and control of each batch. The batch records should be reviewed and approved to determine compliance of the intermediate or API with established specifications before a batch is released or distributed. Batch records and laboratory control records of critical process steps should be reviewed and approved by the quality unit(s) before an API batch is released or distributed. All deviation, investigation, and OOS reports should be reviewed as part of the batch record review before the batch is released.

A company recently received the following observation:

ā€¦.. Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.

Specifically, you lack adequate controls to ensure that production batch records for drug intermediates are reviewed and approved by the quality unit before such intermediates are forward processed in the next manufacturing stage. Furthermore, you released and distributed finished drug product before the production batch records for its intermediates were reviewed and approved by the quality unit. For example:

Six OTC … finished product lots were manufactured using drug intermediate … lots: … The finished drug products were released and shipped for distribution prior to granulation batch record review and approval by the quality unit.

To view more observations pertaining to review of batch records, refer to the following GMP TrendsĀ® Issues: 1082, 1055, 1049, 1026.

For more observations pertaining to manufacturing controls, see our new Issue 1117 available today.  It also has observations pertaining to quality systems, packaging and label controls, and medical devices.

Stay in Compliance! Subscribe today!

Become A Subscriber And Stay Ahead of the FDA

To get the most out of GMP TrendsĀ®, sign up to one of our subscription packages for valuable, up-to-date information you won't find anywhere else! Every subscription provides the most frequently cited FDA 483 observations taken from recent FDA Inspections. The non-essential information is redacted to streamline the facts in an easily readable format. Join the thousands of professionals who rely on GMP TrendsĀ® to keep them informed of the latest FDA Enforcement Trends!

SUBSCRIBE NOW