GMP News

The US Food & Drug Administration (FDA) has issued a Warning Letter to a US company recommending to have a look at FDA's Guidance on Contract Manufacturing Arrangements.

Several revised Ph. Eur. packaging chapters have been recently adopted by the Ph. Eur. Commission. These general chapters will appear in Ph. Eur. 9.6. Read more about the revised chapters on plasticized PVC materials and glass containers.

In June 2017, the FDA opened a docket intended for public comments on the topic of continuous manufacturing. The FDA seems mainly interested in receiving comments on the C-SOPS document which was already published in 2016. This document contains recommendations of a group of U.S. university and industrial representatives regarding continuous production.

The GMP/GDP IWG at EMA is currently discussing actions required after an inspection concludes that a manufacturing site does not comply with GMP, and how to make risk based decisions to avoid drug shortages.

The European Commission published its final Bisphenol A (BPA) Regulation. The Regulation lowers the BPA limit from currently 0.6 mg/kg to 0.05 mg/kg. This limit also applies for varnishes and coatings. Read more about the final Commission Regulation (EU) 2018/213.

During the last year, the notifications on mechanical defects and reported suspicions of counterfeits increased. Distributors should also be interested in these figures.

The European GDP Association evaluated the current implementation status of the EU-GDP guidelines in a survey. The response was interesting.

The coming into force of the new FDA guidance on process validation in 2011 led to a shift in paradigm. Validation is a three-stage life cycle now and also includes commercial production in stage three. What does that mean for implementing the FDA proces validation guidance though? 

On 27 November, 2017, the EMA's Committee on Herbal Medicinal Products (HMPC) published the HMPC meeting report about their 79. meeting held from 20-21 November, 2017. Learn more about the key issues discussed during the EMA HMPC meeting.

Microbiological testing of topical drug products to prove compliance with the specifications prior to release and correct labelling is mandatory for products applied to the skin. Find out, what GMP violations regarding the manufacturing, testing and labelling FDA inspectors found during an inspection.

The guideline VDI 6022 Part 1 underwent substantial revisions and now contains many new obligations for manufacturers, planners, constructors, operators and supervisors of HVAC systems and air conditioners.

With the authorities' increasing attention to data governance and data integrity the ECA's Data Integrity Task Force's just released version 2.0 of its Data Integrity Guide provides an ideal tool for implementing data integrity in practice.