GMP NEWS 2014

The deficiencies observed by FDA inspectors are written down in the so-called Form 483. Unlike Warning Letters, those aren't available online and have to be requested individually by post. Yet, FDA's evaluation of findings listed according to their frequency is pretty unknown. Read more here.

Which information is needed for compendial validation to include a method in the US American pharmacopeia USP/NF? In an article published in the Pharmacopeial Forum, the USP is proposing concrete requirements for compendial validation. More information can be found here.

The US FDA has recently introduced a new service on their webpage. A new "inspection dashboard" provides information and analysis about the inspections which have been performed by the FDA in the previous years. Read more in our GMP News.

Currently there are no harmonised approaches to technical and regulatory considerations for the lifecycle management of pharmaceutical products. Therefore, ICH has just published a Final Concept Paper for a new ICH Q12 Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle. The proposed ICH Guideline is intended to fill this gap. Please find more information in our GMP News.

Comments to the first draft on the revision of the current process validation guideline (for non-sterile processes) from April 2014 have now flowed into the second one. This is obvious at one point or another. Read more.

Compounding pharmacies in the US haven't been inspected by the FDA over the past years. For the first time, after a number of serious incidents which caused death, the FDA has tried to establish cGMP requirements for the manufacturers of outsourced drug compounding in an interim guidance for Industry. Read more details here.

The submission of documents relevant for authorisation to the Saudi Food and Drug Authority implies the consideration of certain requirements. A new Drug Master File Guidance provides information. Find out more.

The WHO has recently released the new version of its fundamental GMP Guide "Good Manufacturing Practices for Pharmaceutical Products: Main Principles" together with the Technical Report 986. Read more.

The European Commission has published the new EU GMP Chapter 8 on Complaints, Quality Defects and Product Recalls. The chapter has been revised completely and details additional requirements for recalling investigational medicinal products (IMPs). Read more.