EU-GMP Guide: New Introduction with Clarification of Status of Part III
As mentioned in a previous news, ICH Q9 and ICH Q10 will be adopted as Part III of the EU GMP Guide. In this regard, the EU Commission has revised the Introduction of the EU GMP Guide and clarified he status of the new Part III. Read more.
Following the adoption by the Council and the European Parliament, a new Regulation and a new directive on pharmacovigilance were published in the Official Journal of the EU. Read more.
In-depth analysis of the requirements on the new EU / PIC/S Site Master File
The new EU Site Master File document and the revision of the PIC/S document PE 008 on the creation of a Site Master File implies profound changes for the Site Master Files author. These changes affect every pharmaceutical manufacturer as a Site Master File is the basis for the inspection by a regulatory authority. You can find a detailed comparison between the new EU / PIC/S Site Master File document and the draft of the EC Commission here.
FDA takes action against non-compliant manufacturer
On January 18, 2011 the US FDA obtained permanent injunction against Deltex Pharmaceuticals Inc. FDA has announced just recently that it will take immediate actions if manufacturers fail to comply with cGMP requirements. Read more here.
The U.S. FDA launched a new website called FDA Basics for Industry. On these web pages a lot of information is provided about the FDA, its responsibilities, expectations and regulatory processes. Read more.
EMA publishes ICH Q9 and ICH Q 10 as Part 3 of the EU GMP Guide
The EMA announced the adoption of ICH Q9 and ICH Q10 as Part 3 of the EU GMP Guide. ICH Q9 was already published as Annex 20 but ICH Q 10 was not published as an Annex yet. Click here to read more.
EMA publishes two documents on the QP Declaration concerning GMP Compliance of the API
The European Medicines Agency (EMA) has published two new draft documents for a template for the QP's declaration concerning GMP compliance of the API used as starting material and verification of its supply chain called "The QP declaration template". Read more.
PIC/S SMF Guide Updated with Quality Management System Requirements
The PIC/S Committee has adopted the revision of the Explanatory Notes for Industry on the Preparation of a Site Master File The main purposes of the revision were the simplification of the document and the implementation of requirements in relation with Quality Management Systems (QMS). Read more.
The EDQM is strengthening its collaboration by signing Memorandums of Understanding (MoU) with the National Institute of Food and Drug Safety Evaluation (NIFDS), Korea Food and Drug Administration, and the Chinese National Institute of Food and Drug Control (NIFDC), respectively. Read more.
The final Chapter 4 ("Documentation") of the EU Guideline to GMP has now been published and will come into operation on 30 June 2011. Some important changes were included. Get a summary here.
New Best Practice Guides for the Submission and Processing of Variations published
The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h), has published the latest version of its Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure. Read more.
English Supervisory Authority MHRA Publishes Answers to FAQs on Risk Management
On its homepage, the English supervisory authority, MHRA, has published answers to frequently asked questions regarding the topic of quality risk management. Here you can read the answers.