GMP NEWS 2018

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.

After an FDA inspection with relevant results, the FDA usually expects a response within 15 days. What happens, however, if there is no response to the FDA inspection results?