GMP NEWS 2019

PIC/S: Wie Inspektoren ein PQS bewerten sollten

PIC/S hat einen Entwurf zu einer sog. Recommendation (Empfehlung) zum risikobasierten Change Management innerhalb der PQS veröffentlicht.

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FDA continues to warn companies for illegally selling CBD products

The FDA recently issued 15 warning letters to companies for illegally selling products containing cannabidiol (CBD).

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ICH Q12 adopted

The new ICH Q12 Guideline for Post-Appproval Changes has been adopted in Singapore in November 2019. The document provides guidance on a framework to facilitate the management of post-approval CMC changes.

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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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Final Guideline on GCP for ATMPs published

The European Commission has now published the final Guideline GCP for ATMP as a further building block of its growing guidance package on  the requirements for Advanced Therapy Medicinal Products.

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Clinical Trials Regulation Questions & Answers Version 2.2

The European Commission (EC) published an updated Version 2.2 of the Questions & Answers relating to the Clinical Trials Regulation.

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FDA Warning Letter for receiving potentially unsafe drugs

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving potentially unsafe drugs from Chinese suppliers.

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Falsified Medicines: New EU Aide Memoire for GDP

The European Commission has published an aide memoire for Good Distribution Practices (GDP) inspection of wholesalers’ compliance with Commission Delegated Regulation (EU) 2016/161 for safety features.

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Cannabis Monograph in the Swiss Pharmacopoeia

Supplement 11.3 of the Swiss Pharmacopoeia (Ph. Helv.) includes a new monograph on Cannabis Flowers. 

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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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New Warning Letter - Quality Oversight in the Focus

Production and laboratory processes are for sure still a hot topic in inspections. But investigators are also focusing on the role of the Quality Unit and Quality Oversight.

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Nitrosamines in Elastomers?

An USP Stimuli article on Elastomeric Components for Inhalation Packaging / Delivery Systems has been published in Pharmacopeial Forum, proposing to test for nitrosamines in elastomeric components used for inhalation products.

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Batch Release without Determination of Identity and Strength and other GMP violations - A Look at FDA's Warning Letters over the Last Months

FDA's Warning Letters provide a valuable source of detailed information and can be helpful in preparing for an inspection, making a more detailed analysis worthwhile. Read more here about what FDA inspectors have discovered in recent months regarding frequent weaknesses at GMP-liable pharmaceutical manufacturers.

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Data Integrity for Analytical Instruments connected to a LIMS via a Middleware

The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 6: How can I handle analysis devices that are connected to a LIMS via a middleware? The manufacturer does not allow access to the original data in the automated analyser though.

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FDA works on regulatory pathways for CBD products

Cannabidiol (CBD) is currently marketed in a variety of product types, such as oil drops, infused pouches, capsules, syrups, teas and topical lotions and creams. Therefore, the FDA is working on the evaluation of regulatory policies related to cannabis and cannabis-derived ingredients.

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Another FDA Warning Letter for inadequate CAPAs

Deviations and CAPAs are still hotly debated topics in GMP inspections. This is shown once again by a recent FDA Warning Letter.

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General requirements for Plastics in Pharmaceutical Engineering

The main material used in plant engineering is stainless steel. The variant 316L is regarded as standard; material incompatibilities of steel with the product play almost no role. This is different for plastics. Beside the leach-out, ageing and surface finishing, other quality features are often specified. Now, what are the general requirements for plastics in pharmaceutical plant engineering?

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Data Integrity Violations detected by the FDA at US Company

Besides several Quality Unit related failures, a Warning Letter of the U.S. FDA mentions an enormous number of Data Integrity violations. Here you can read the remedations expected by the FDA.

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ISO Standard for the Production of Pharmaceutical Water

ISO 22519 is a new available international standard dealing with the pretreatment and the production of purified water (PW) and water for injection (WFI).

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Updated Ph. Eur. Chapter on plastic containers

A revision of Ph. Eur. chapter 3.2.2. Plastic containers and closures for pharmaceutical use has been published in Pharmeuropa.

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