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Design Qualification from the FDA's Perspective

Is there a specific FDA requirement for a Design Qualification? The answer is (actually) No.

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What does "State of Control" mean for the FDA?

In the context of process validation, the FDA attaches considerable importance to a "state of control". The FDA expects evidence of this "state of control" as part of stage 3 "continued process verification" within the validation lifecycle. Now, what exactly does the FDA want to see? Parts of the answer to this question can be found in Warning Letters.

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How does the FDA deal with Processes that cannot be validated?

In an interesting Warning Letter, the FDA replies to a letter from a pharmaceutical manufacturer that had received a 483 deficiency report in which the FDA criticized, among other things, deficiencies in process validation. Read more about the correspondence.

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US Manufacturer of homeopathic Medicines and nutritional Supplements receives FDA Warning Letter

From inadequate cleaning to poor laboratory controls of quality and purity - a manufacturer of homeopathics in the U.S. received a Warning Letter from the FDA.

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cGMP Qualification/Running of Water Systems

Water systems are one of the most important systems in the pharmaceutical industry. What are the GMP requirements for the qualification and running of these systems? The US GMP regulations (21 Code of Federal Regulation (CFR) 210/211) do not provide much concrete information on this. There is still a Guide to Inspection for FDA inspectors from the early 90s. So, what does the FDA expect today? A current Warning Letter provides a few answers.

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FDA's Current Thinking on Process Validation

When it comes to process validation, FDA's Process Validation Guidance from 2011 is state-of-the-art. It is interesting to see how the FDA would like to see the guidance implemented. Here, the findings described in Warning Letters issued after FDA inspections can help. A recent Warning Letter regarding deficiencies to 21 CFR 211.100 from October 2019 mentions the following.

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Process Validation in Homeopathic Manufacturing - FDA's Perspective

In a current Warning Letter, the FDA describes the process validation requirements imposed on a contract manufacturer of homeopathic medicinal products.

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EMA website on Permitted Daily Exposure (PDE) limits

The issue of cross-contamination has been addressed by authorities since the publication of the first edition of the EU GMP Guidelines. The EMA has compiled everything essential on health-based exposure limits and PDE limits on their website.

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New Ph. Eur. chapter on statistical process control (SPC) planned

Process controls have become customary in pharmaceutical processes. The aim is to monitor a process and improve it if possible. Statistical process control (SPC) is viewed as one option to implement Ongoing/Continued Process Verification. PharmEuropa has now published a new draft chapter on the topic.

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What are suitable Cycles for Re-Qualification?

With the revision of Annex 15 in October 2015, the topic of requalification has become more important. Time intervals for the assessment of the equipment with regard to the qualification status and for the requalification itself should be justified. Criteria for the assessment should be defined. This is sometimes difficult. Chapter 9 of the revised ISPE Baseline No 5 Commissioning & Qualification of June 2019 on the periodic review can be helpful here.

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