GMP NEWS 2015

In December the EDQM published the comments concerning revised texts of chapter 5.1.10. Guidelines for using the Test for Bacterial Endotoxins. Find out more about the scope and the added specific points in the Test for Bacterial Endotoxins Guideline.

According to a current publication of EMA, QR codes can be put in the future on package leaflets and outter packaging. Now, this also applies to centrally authorised medicinal products. Find out more about the EMA Principles for QR Codes.

The pharma sector must comply with IDMP standards in the EU region starting July 2016. This provides regulators with the means of easily comparing product data across regions and with different manufacturers.

The "new" FDA's process validation guideline has been effective since January 2011. One of the considerable changes made to the original validation guideline from 1987 was to put a significantly greater emphasis on statistics in the context of process validation. So far, relatively few inspection deficiencies had been observed by the FDA with regard to statistics. At a conference in September 2015 co-sponsored by the FDA, Grace McNally - Senior FDA official - reported about current "findings" which also address statistical problematics.

The USP has described the future requirements for the integrity of pharmaceutical packaging in the Pharmacopeial Forum 40(5). The New and revised chapters will become official on August 1, 2016 (USP 39-NF34 1S)  in form of 4 general chapters. Find out more about the new USP Chapters on the Integrity of Pharmaceutical Packaging.

After the long-awaited Chapter <1790> on visual inspection of injections was first published in the PF 41(1) as a draft the USP has now submitted a revised draft in the PF41 (6). Read more about the revised draft of the USP Chapter <1790>.

One of the main reasons for the revision of the EU GDP Guideline in November 2013 was securing the so-called supply chain from falsified medicinal products. A current case shows how important this new regulation is. Read more here about the robbery of medicinal products in a distribution warehouse.

Data Integrity as a topic has become one of the main focuses of the regulatory authorities. Mid-September, the WHO published a draft guidance for comment on this topic too. Read more about the WHO Draft Guidance on Good Data and Record Management.

A draft of a new Ph. Eur. chapter  "Co-Processed Excipients" has been published in Pharmeuropa 27.4 with deadline for comments on December 31, 2015. Find out more about the proposed requirements for co-processed excipients.