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PIC/S publishes Aide-Memoire for the Inspection of Health Based Exposure Limit

In June, the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) re-issued document PI 052-1. What is in it?

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Publication of the WHO Document on Limits in Cleaning Validation

The issue of (cross-) contamination and, in this context, cleaning validation have played an important role in the GMP environment for decades. For some years now, health-based exposure limits have been added as a possible alternative. In a draft guideline, the WHO has addressed this topic.

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Derogations for Equipment Qualification due to COVID-19

End of May, another new part under the heading "GMP Flexibilites" was added to the Questions & Answers document prepared by the EC, the CMDh, the Inspectors Working Group and the EMA. This new part now includes special features for the qualification of equipment (question 6.2).

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New Chapter in the European Pharmacopoeia on Multivariate Statistical Process Control

In our News dated 19.08.19, we had mentioned the draft of a new Ph. Eur. chapter  (5.28) regarding Multivariate Statistical Process Control. This chapter has now been adopted and will be published in the October 2020 issue.

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Derogation for Process Validation due to Covid-19

In order to be able to continue to provide the population with high-quality, effective and safe medicinal products during the Covid-19 pandemic, Europe is taking exceptional measures. A Q&A document has been prepared in cooperation between the European Commission, the Coordination Group on Mutually Recognised and Decentralised Procedures (CMDh), the Inspectors Working Group and the European Medicines Agency (EMA). At the end of May, special features for process validation (question 6.2) were added under the heading "GMP Flexibilites".

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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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ECA Validation Group launches new Website

The ECA's Validation Group has re-launched its website. With a cleaner design members and those interested can now find valuable information faster and easier.

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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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