In May the European Commission published the Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials. It addresses the specific documentation requirements with regard to biological, chemical andpharmaceutical quality of IMPs containing biological / biotechnology derived substances. Get the details.
In reviewing FDA's Warning Letters from the calendar year 2011, it has been found that 10 Warning Letters contained complaints about GMP/FDA compliant handling of OOS results. As a matter of fact, the handling of OOS results remains one of the most critical aspects during an FDA inspection. The most important citations from the Warning Letters can be found in this News.
The MHRA has published a presentation on its website about the expectations of the authority regarding the handling of OOS results in pharmaceutical laboratories. Among other things, the website provides 20 questions and answers on the OOS topic. At ECA's OOS Forum in Prague in June, Di Morris from the MHRA will present the correct handling of OOS results in the microbiological laboratory. Find out more.
Pharmacopoeias are defining normative standards to be followed by the pharmaceutical industry. Actually some of the most important general chapters are being revised or updated and some texts will be established as completely new chapters. In addition harmonisation is another important issue. Please read more here.
Many members of the European Compliance Academy (ECA) have recognised that there is a paradigm shift in Process Validation. Therefore, the new ECA Process Validation Working Group has defined its first project: A Good Practice Guide with the goal to provide assistance relative to the new Process Validation requirements and specifically to "what to do" and "how to do it". Read more.
We already informed about the availability of the new EMA Draft Guideline on Process Validation in one of our previous newsletters. Today we publish a detailed and comprehensive analysis of the document's content, the new requirements and the differences to the FDA Guide on Process Validation. Read more here.
One year after the publication of the Draft Consensus Guideline ICH Q11 "Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)", the finalised document has been released. Read more here about the new guideline.
The method transfer is a documented process which establishes the evidence that a laboratory is qualified to use an analytical method which has been elaborated in another laboratory. Hereby the evidence must be brought that the laboratory has the knowledge and the ability to perform the analytical method as intended. The USP 35 now includes a new General Chapter <1224>. Read more here in the News.
Bulk products used in the manufacturing of medicinal products are subject to the same GMP regulations as APIs and finished products regarding storage and transport. The respective guidelines only provide unclear information about the data required for the application dossiers. The EMA has now closed this loophole with the publication of a Questions and Answers document. Read more.
The USP has put new standards online and for free in the Medicines Compendium. In doing so, the USP wants to contribute to improve the quality of starting materials and medicinal products worldwide. This includes monographs for APIs and medicinal products, General Chapters and even data on the validation of the analytical methods used. Read more in this News.
The European Medicines Agency (EMA) has published the final reflection paper concerning ethical and good clinical practice (GCP) aspects of clinical trials conducted outside of the European Union (EU)/European Economic Area (EEA). Read more.
In April, the European Medicines Agency published a new document on regulatory procedural advice on similar biological medicines. This guidance should provide help for the applicants to submit applications, which are in conformity with the legal and regulatory requirements. More details can be found here.
Medical device manufacturers "fear" FDA inspections as well. Companies which have never had an FDA inspection often don't know how such an inspection is performed. They can find support in an FDA Manual published last year.
EMA's eSubmission Gateway was released on 23 April 2012. This portal for the internet-based transmission of documents related to the authorisation for centralised procedures is now available for all applicants. Read more here.
GAMP is going to update the Laboratory Good Practice Guide. The main objective of the second edition is to align it with the principles in GAMP 5. One outcome of the new edition is that the seven categories have been discontinued and replaced by the GAMP 5 software categories. The new Laboratory GPG "Risk-Based Approach to GxP Compliant Laboratory Computerised Systems" has gone to press and is scheduled for publication in June. Read more in the news.
In addition to the Anti-Counterfeiting Directive 2011/62/EU, an importation certificate must be delivered by the regulatory authority to import APIs from Third Countries into the EU. The EU Commission has recently published such a document for comment. Read more here.
The post approval change management protocol is an important document for every marketing authorisation holder which must be approved by the regulatory authority. The EMA has recently published a Questions and Answers document to clarify some principles of this protocol. Read more here.