GMP NEWS 2015

Two new USP General Chapters on extractables and leachables have become official on August 1, 2015 (USP 38-NF33, first supplement): <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems and  <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems. References to these new chapters have now been integrated in the drafts of General Chapters on Ophthalmic Products <771> and Injections <1> (PF 41(5)).

The "new" FDA Process Validation Guideline has been in force since January 2011. The revised Annex 15 has been valid since 1 October 2015. At a Conference in September 2015, which was co-sponsored by the FDA, Grace McNally, Senior FDA Official, reported about similarities and differences between the two documents from the perspective of the FDA.

Pharmeuropa 27.4 comprises a draft of Ph. Eur. Chapter 5.15. "Functionality-Related Characteristics of Excipients" - covering the critical quality attributes (CQAs) of excipients. Find out more about the Ph. Eur. Chapter 5.15 draft.

As a consequence of implementation of the Clinical Trial Regulation 536/2014 four new public consultations concerning good manufacturing practices and clinical trials for human medicinal products were opened August 28, 2015. It is expected that Annex 13 will be deleted from EudraLex Vol 4 when the new guidelines "Detailed Commission guidelines on GMP for IMPs for human use" become operational. Find out more about the current changes in EU regulations regarding IMPs.

The revised USP General Chapter <661> (Containers - Plastics) and new General Chapters <661.1> and <661.2>  will become official on May 1, 2016 (USP 39-NF34). Find out more about the USP General Chapters.

Related to the increasing complexity of Human Leucocyte Antigen Testing methodolgy in the field of transfusion and transplantation, the FDA published a guidance document "Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation".

The European Commission finally has published the new EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release".

The occurrence of foreign particles in the manufacture of active pharmaceutical ingredients is always undesirable. For the responsible QA departments it involves an increased effort as concerns the search for the root causes and for CAPA measures. A new APIC Guidance offers concrete recommendations for the GMP compliant handling of foreign particles in APIs, intermediates and raw materials.

The Warning Letters the FDA sent to active ingredient manufacturers last fiscal year, show similar patterns. Find out more about the frequent deficiencies found in the area of responsibility of quality assurance and in the handling of electronic data in production facilities for active pharmaceutical ingredients.