Good Document Practices

Good Document practices are required by subpart J of 21 CFR 211.  The agency expects firms regulated by 21 CFR 210 and 211 to follow good document practices as this is the evidence that the API or Finished Pharmaceutical meets the Safety, Identify, Strength, Purity and Quality levels required of the cGMPs. A few days […]

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Five Things

Five things a Pharmacist should understand prior to writing that check for registration fees to the FDA for their brand new 503B outsourcing facility. Commissioning and Qualification Overview Planning Risk Management User Requirements Design Review/Qualification Have a question on 503B’s feel free to contact Dr. Van Doel, or use our Contact Us page to send us your questions.

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FDA Draft Guidance – Delaying, Denying, Limiting, or Refusing a Drug Inspection

The FDA issued draft guidance July 12, 2013 for comment.  The comment period closed in September and FDA is currently reviewing industry comments prior to publishing a final rule. This guidance attempts to clarify unreasonable conditions when an owner, operator or agent causes the delay of an inspection this may cause the drug to be adulterated under section […]

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False Claims Act

What could happen when a medical provider knowingly submits claims to the government for reimbursement that are not correct?  For example, a compounding pharmacy compounds drug  that does not meet USP, is manufactured under insanitary conditions, or for 503B under manufacturing conditions that do not meet cGMPs? An interesting read is Justice Thomas’ majority opinion in […]

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Facility Design

One of the key elements supporting commercial manufacturing of pharmaceutical or compounded products is the facility design.  This element is captured in the Drug cGMPs as subpart C Buildings and Facilities, and codified in 21 CFR 211.42 Design and construction features. Process Validation Guidance & Facility Design Facility Design is also a key element of the Jan 2011 […]

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Do you do API’s?

Do you do API’s?  Have questions?  If yes, you should check out – FDA’s Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients – Question and Answers. Per the intro section – Since the ICH Q7 Guidance was finalized, experience with implementing the guidance worldwide has given rise to requests for clarification of uncertainties due to the […]

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Data Integrity Final Guidance

FDA has issued the Data Integrity and Compliance with Drug cGMP final guidance on December 13, 2018.  The final guidance is available at the following link. As stated in the Introduction section of the guidance: FDA expects that all data be reliable and accurate (see the “Background” section). CGMP regulations and guidance allow for flexible and risk-based […]

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How not to craft a response to a FDA observation

In a recently posted FDA warning letter, the FDA cited a firm for failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation, as required by 21 CFR 820.30(b).  Items missing in the Standard Operating Procedure (SOP) included identifying who is responsible for the design […]

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Consensus Standards

The Center for Drug Evaluation and Research (CDER) releases the CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Guidance for Industry draft guidance for comment. This proposed guidance will address how CDER will informally recognize volunatry consensus standards. Historically concensus standards have been recognized and required to be used through […]

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Commissioning and Qualification – Planning

Prior to starting commissioning and qualification activities, a plan should be developed. The plan may be commonly referred to as a Commissioning Plan, Commissioning and Qualification Plan, Qualification Plan or Validation Plan. The name changes based on the overall intent of the activity, but the documents all serve the same purpose – to help guide […]

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