Remove Article Remove Documentation Remove Pharmaceutical Manufacturing
article thumbnail

PDA releases contamination control strategy report

European Pharmaceutical Review

The Parenteral Drug Association (PDA)’s long-awaited Technical Report 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing is now available. Key features of the PDA TR 90 report The document addresses the evolution of contamination control principles towards a holistic approach.

article thumbnail

Revised Annex 1 now effective

European Pharmaceutical Review

The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision?

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

How should cleaning validation sampling locations be chosen?

European Pharmaceutical Review

A recent paper outlines a process that can be used to select and document worst-case sampling locations to validate cleaning processes. To overcome these concerns, Pluta presents the process and documentation activities undertaken by one company.

article thumbnail

How ready are you? Preparing for the impact of EU GMP Annex 1 on primary packaging

European Pharmaceutical Review

Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety.

article thumbnail

Top 5 takeaways from international hybrid and virtual meeting guidance for pharma

pharmaphorum

But the new Joint Guidance on Virtual and Hybrid International Medical Congresses, from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) is here to plug that gap.

article thumbnail

Validation master plan (VMP) – when and how to create one?

GMPSOP

If you are in the pharmaceutical business, regulatory authorities mandate that you develop, implement, and periodically review a validation master plan for qualifying your systems, processes, cleaning method, testing methodologies, equipment, facilities, etc. – General guidance for validation document format. 12 or 24 months).

article thumbnail

Global manufacturing capacity for active pharmaceutical ingredients remains concentrated

Quality Matters

Insights from USP’s Medicine Supply Map demonstrate that geographic concentration of pharmaceutical manufacturing anywhere in the world – including within the United States – increases the risk for drug shortages. Promoting geographic diversity of the manufacturing base of U.S.