In the Pharmacopeial Forum 42(4) [Jun-Jul 2016] a stimuli article on the effect of primary packaging on the drug stability of solid dosage forms has been published . Read more about The Effect of Primary Packaging on the Physical Degradation of Metformin, Lisinopril, and Simvastatin Solid Doses During Patient Use When Stored at Different Temperature and Humidity Conditions.
The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to current guidance on first-in-human clinical trials.
As a part of their Technical Report Series with guidance documents comprising recommendations for biological products, the The World Health Organization (WHO) now published "Annex 2 - WHO good manufacturing practices for biological products".
WHO's guideline for clinical research organisations performing in vivo bioequivalence studies has been extensively revised and recently published. Read more in the News about which requirements are now binding for CROs with regard to the QM system and electronic data management.
The ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process in June 2016 and now enters the consultation period (Step 3). This new ICH Guideline is proposed to provide guidance on general principles on planning/designing Multi-Regional Clinical Trials (MRCTs). Read more about the ICH E17 General Principles for planning and design of multi-regional Clinical Trials.
The US FDA implemented the updated Guidance for Industry Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components.
The EMA published the final "Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus" after the completion of the accepted comments of the public consultation.
The European Directorate for the Quality of Medicines & Healthcare (EDQM) published a survey to gather information from relevant stakeholders for elaboration of a chapter on microbiological control of tissues.
In January and March 2015, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) published a "GMP Data Integrity Definitions and Guidance for Industry". The agency has recently published a new version of the Guidance. Please find here a short overview of the new features in the "GxP Data Integrity Definitions and Guidance for Industry: Draft version for consultation".
The World Health Organization (WHO) recently published a draft document on analytical method Validation for comment. Read more about the draft "Guidelines on Validation - Appendix 4 Analytical Method Validation".
What needs to be considered if an API is produced in the time period of a valid written confirmation but imported after this confirmation has expired? This is answered in a revised Q&A Document of the EU Commission.
In Pharmeuropa 28.3 revisions of two Ph. Eur. general chapters on containers (3.2.9 and 3.2.3) have been published for comment. Deadline for comment is September 30, 2016. Read more about the drafts for 3.2.9 "Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders" and 3.2.3 "Sterile plastic containers for human blood and blood components".
The ECA Foundation's Rapid Microbiological Methods (RMM) Working Group was originally established in June 2006 at the Paul-Ehrlich-Institut (PEI) - the German Federal Agency for Vaccines and Biomedicines. Now the Foundation announced a new orientation for its RMM Working Group.
EudraGMDP is the European Database for GMP and GDP Compliance information. The database receives a lot of attention from industry because of the GMP and GDP Non-Compliance Reports. Now, the database has been changed without notice and has caused some confusion. Read more about the updated EudraGMDP Database.
One and a half year after its publication, the ICH Q3D guideline still raises many questions. The EMA has recently published a guideline draft aiming at clarifying the practical implementation of ICH Q3D. Read more here about what is expected in a marketing authorisation application or in an application for a CEP with regard to risk assessment and the control of elemental impurities in APIs and medicinal products.