Do you do Cleanrooms?

If you are responsible for a cleanroom or a cleanroom environment then you need to know that ISO 14644-1 and -2 have reached Final Draft International Standard (FDIS) status and are out to the member states for final vote. According to some sources these new ISO standards could be contractually invoked as early as October […]

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Certificate of Analysis

Question: Can I use my vendor’s Certificate of Analysis when making a pharmaceutical product or compounding a product as a 503B outsourcing facility?  Yes – BUT in accordance with 21 CFR 211.84(d)(1) and (2): (d) Samples shall be examined and tested as follows: (1) At least one test shall be conducted to verify the identity of each component of […]

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For-Cause Facility Inspections

As identified in the Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A concept of Operations published June 6, 2017 a for-cause facility inspection may be initiated: In response to a new registrant or a specific event or information that brings into question the compliance and/or quality of a manufacturing practice, facility, process or […]

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Do you do API?

ICH has released a new Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients on 10 June 2015.  The Q&A document is intended to respond to the requests received by ICH for guidance concerning implementation of Q7. The document is 18 pages in length and the annex provides a cross-reference of the Q&A sections to […]

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Alarm Management

21 CFR 211.192 requires a thorough review of any unexplained discrepancy whether or not the batch has been distributed.  Lack of / or poor Alarm management was identified by the FDA during an inspection of a 503B Outsourcing Facility (Observation 2, Form 483). The firms Building Maintenance System had logged ~766 alarms since March 8, […]

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503B Registrations and Inspections

As of November 13, 2015—54 facilities have been registered as Human Drug Compounding Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Nine of these registered facilities have not yet been inspected by USFDA. The balance of the registered facilities have been inspected by USFDA with 100% of these facilities […]

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