GMP NEWS 2012

USP Chapter <62> Frequently Asked Questions

Recently, the USP published frequently asked questions relative to different General Chapters, amongst others to Chapter <62> Microbial Enumeration of Nonsterile Products: Tests for Specified Microorganisms. More details can be found here.

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APIs from China and India - will Import go down in 2013?

APIs produced in third countries in Asia (like China and India) can only be imported into the EU if the regulatory authority of the exporting country will issue a written confirmation of GMP Compliance. The MHRA has published concerns that some APIs might not be available if the authority in the third country will not issue the necessary written confirmation. Please read more.

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FDA Study Confirms Suitability of Plasma for Nucleic Acid Testing (NAT) of Blood Donations for Hepatitis C Virus

Scientists at the U.S. Food and Drug Administration (FDA) have confirmed that plasma specimens are well-suited for detecting the genetic material of hepatitis C virus (HCV) in potential blood donors who are infected with the virus. Read more.

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Revision of the Guidelines on Category Variations to the terms of Marketing Authorisations- EU Commission releases Public Consultation Paper

The detailed guidelines for the categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products are part of the "Variations Regulation" which is in force since the 1st January 2010. These guidelines which describe the categorisation of marketing authorisation variations are being significantly revised. Read more about the draft of the revised guidelines.

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EMA updates "Compilation of Community Procedures on Inspections and Exchange of Information"

In the light of recent events, the EMA has updated its "Compilation of Community Procedures on Inspections and Exchange of Information". Some documents concerning GDP have been added to this compilation of procedures which is not only interesting for inspectors. For more information read here.

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Audit Tools and Checklists for Good Distribution Practices

Warehouses and Distribution Facilities must be monitored very carefully. In order to assist the industry in meeting growing requirements, a new white paper and further documents have been published by Rx-360. Click here to read more.

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Revised Guideline Draft on Biosimilar Medicinal Products published

At the end of May, the EMA published a draft of the biosimilar guideline from 2006 for comment. This guideline describes the requirements on quality evidence for biosimilar medicinal products. Read more here about the updated instructions.

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News PIC/S Structure

In its latest press release, the Pharmaceutical Inspection Co-operation Scheme PIC/S highlighted the outcome of its last Committee Meeting. What are the main news? Read more.

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FDA starts Voluntary Audit Report Program for Medical Devices

On 5 June 2012, the FDA has begun a "voluntary program" for medical devices audits entitled "Medical Devices ISO 13485:2003 Voluntary Audit Report Submission Pilot Program" - based on ISO 13485:2003. The purpose is to extend FDA's inspection intervals. Read more.

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Two Third Party GMP Audits performed in Germany by API Compliance Institute

The API Compliance Institute recently performed Third Party GMP Audits at two API manufacturing sites in Germany. The Audits were initiated by a group of Qualified Persons and QA Managers from different pharmaceutical companies who are using the respective APIs to manufacture their medicinal products. Please read more here.

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FDA identifies 22 Chinese companies out of GMP compliance

The US FDA has published a list of 22 Chinese companies who fail to comply with the GMP regulations. All companies manufacture Heparin. Please read more here.

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Half-year Report 2012: FDA Medical Devices Warning Letter Statistics

We regularly analyse the Warning Letters issued by the FDA. The following information presents the current evolution of the Top 5 hit list - with regard to medical devices - for the first half of the fiscal year 2012 (from 1st October 2011 to 15 March 2012). Read more.

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Important Notice from the EDQM to CEP Holders - Warning of Fraudulent Invoices

In a press release from 21 May 2012, the EDQM warned CEPs holders (Certificates of Suitability) of fraudulent invoices. Read more in this News.

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EMA: Practical Guidance on Implementation of Pharmacovigilance Legislation published

The European Medicines Agency has published a set of questions and answers concerning the initial phases of the operation of the new pharmacovigilance legislation. Read more.

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New IMPD Guideline on the Requirements for Quality Documentation concerning Biological Investigational Medicinal Products in Clinical Trials

The new IMPD Guideline - which has been recently published by the EMA - describes the requirements for quality documentation concerning biotechnological investigational medicinal products and provides - among other things - statements about shelf-life extension. Get more here.

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New USP Chapter <1083> on Good Distribution Practices

In the USP Pharmacopeial Forum, you can find a new general chapter on "Good Distribution Practices - Supply Chain Integrity". The main issue focuses on measures to be taken against counterfeit medicines ("Best Practices to combat Counterfeit Drugs and Medical Devices") and actions to avoid theft during transportation ("Good Trucking Security Practices"). Read more in the News.

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GMP Requirements for Pharmaceutical Excipients: NSF International publishes new Draft Standard

The U.S. American Standard Organisation NSF International has published a draft document containing relevant provisions regarding GMP and GDP for pharmaceutical excipients. Read more here.

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FDA publishes Draft Guidance on Clinical Studies for Medical Devices

At the end of 2011, the FDA published two draft guidance documents on clinical studies for medical devices. More about the content and the pilot programme started in this context can be found here.

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FDA's new Guidance Documents for 2012

The  U.S. Food and Drug Administration FDA has issued its yearly list of planned draft and final guidance documents for 2012. There are about 50 such guidance documents planned. Read more.

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Current State of Harmonisation (EP/USP/JP)

According to a notice from the EDQM with regard to a meeting of the Pharmacopoeial Discussion Group (PDG) 28 of the 35 General Chapters and 41 of the 61 monographs on excipients are currently harmonised. You will find more about the latest status relative to the PDG working group in this news. The strategies for an efficient management of the different pharmacopoeial requirements (EP, USP, JP) are also the topic at an international Pharmacopoeia conference in Prague.

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