The European Directorate for the Quality of Medicines & Healthcare (EDQM) has published new information about the CEP procedure and its related inspections. Please read more about he latest updates from EDQM.
The USP announced a revision of the general USP Chapter <1010> for the treatment and interpretation of analytical data in Pharmacopeial Forum. Find out more about the Revision of the General USP Chapter <1010>.
Especially globally operating pharma companies frequently face the question what differences there are between the US cGMP regulations (21 CFR 211) and the EU GMP Guide for Medicinal Products - and what parallels there are? You will find the answer in the completely revised FDA/EU GMP Matrix.
At the beginning of each year the FDA always publishes a list of the guidances it plans to publish during that year. It has done so again in 2015. The document is relatively comprehensive, containing five pages. Find out more about the Guidances the FDA plans on publishing in 2015.
Deficiencies with regard to CAPA (Corrective and Preventive Action) are regularly Top 1 in FDA's Warning Letter statistics. The FDA has just recently published presentations in form of webinars. One of them addressed the topic of CAPA.
The Warning Letter statistics for fiscal year 2013 with regard to manufacturers of medical device have been taken as a comparison by the FDA to comment on the current ranking of the 483 Forms issued. Read more here.
Starting with the 1 March 2015 the revised Chapter 3 (Premises and Equipment) and Chapter 5 (Production) of the EU GMP Guide Part I for Medicinal Products for Human and Veterinary Use will become effective. A table provides an overview of the changes by the number of the chapters. Find out more.
Reviewing data integrity is FDA's new inspection focus. Concerning this, new requirements in form of questions and answers have been added to FDA's Q&A webpage on Current Good Manufacturing Practices. Also the recent Warning Letters indicate a clear focus on the data integrity topic. More information can be found here in the News.
The EMA has published together with the FDA a new question & answer (Q&A) paper at the end of 2014. This document answers questions on detailed requirements in connection with the documents concerning regulatory submissions. Among others it contains the answer to the question "What level of detail should be considered for design of experiments (DOEs) in a regulatory submission?"
Starting with the 1 March 2015 the revised EU GMP Guide Part I, Chapter 8 (Complaints, Quality Defects and Product Recall) becomes effective. Until then the version with the validity date 1 February 2006 is still valid. A matrix provides a compact overview of the changes. Find out more.
In January the MHRA, UK, published a Guideline on data integrity in the GMP environment. Now, a data governance system for data in the GMP manufacture and analytical laboratories is required in addition to the existing quality systems. More information can be found here in the News.
The new EU Directive 2011/62/EU and its delegated acts keep on changing the pharmaceutical supply chain. The directive introduced numerous Delegated Acts with different time schedules and had some impact on revisions of several chapters of the EU-GMP Guidelines. Read more about the current status.
The EMA has published a new question & answer-(Q&A) paper together with the FDA at the end of 2014. This document answers questions on detailed requirements in connection with the documents concerning regulatory submissions. Read the answers to the topic risk analysis here.
Again and again, Warning Letters keep on reprimanding GMP-violations of the handling of electronic data. In some cases, the FDA urgently recommends the support of an external consultant. Read more here about what FDA's expectations regarding consultants are.
According to a position paper of the CMDh, package leaflets and outer packaging of medicinal products can be tagged with QR codes in the future. This will apply to both prescription and over-the-counter medicinal products. Read more here in the News.
At the beginning of February 2015, the European Medicines Agency (EMA) published a Concept Paper on the revision of Annex 1. Annex 1 of the EU GMP Guide is the Guideline for Europe which describes the requirements on the manufacture of sterile dosage forms. Read more.
The EU has re-published the recently revised Chapters 3 and 5 and has made modifications regarding the coming into effect of the introduction of the toxicological evaluation of products in multipurpose facilities. Read on.