GMP NEWS 2011

Medical Devices Warning Letter Statistics 2011

The ECA provides the FDA Warning Letters Analysis on a regular basis. This news describes the development of the 2002 to 2011 Warning Letters Top Five list with regard to medical devices. The number of Warning Letters issued by the Center for Devices and Radiological Health (CDRH) is…. read more.

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International Information Sharing is Impacting FDA Inspection and Enforcement Decision-Making

As International Pharmaceutical Quality (IPQ) reports in its September issue, the growing information sharing around the globe has an increasing impact on the US Food & Drug Administration's (FDA)  inspection decision-making and activities. Read more.

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First ECA/EQPA Conference in the U.S. a great Success

From 7-9 June 2011, the first joint conference of the European Compliance Academy and European QP Association was held in Bethesda, Maryland on European GMPs and the duties and responsibilities of the Qualified Persons according to the European regulations. Find out more.

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FDA Inspectional Observations on Hygiene, Cleaning and Sanitation

The overview about FDA deficiency reports (Form 483) still shows a large number of objections with regard to hygiene, cleaning and disinfection. Concerned are the classic medicinal products manufacture as well as the areas biologicals and medical devices. Read more.

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GHTF publishes Guidance on Globally Harmonised Identification of Medical Devices

On 16 September 2011, the Global Harmonisation Task Force (GHTF) published the final version of a guidance entitled "Unique Device Identification (UDI) System for Medical Devices".  What the purpose of this document is you can read here.

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FDA Draft Guidance regarding Media Fills for PET Drugs

Most PET drugs are designed for parenteral administration and are produced by aseptic processing. The FDA has published a draft guidance for manufacturers regarding the points to consider for media fill. Read more here.

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FDA defines 25 SOP provisions required by CFR

The latest edition of the Federal Register shows a very good summary of SOPs required by 21 CFR Part 211. Read more.

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FDA publishes List of Guidance Documents for Medical Devices

In early October the FDA published a list in the Federal Register presenting documents regarding the regulation of medical devices which are to be considered for development  in the fiscal year 2012 (October 2011- September 2012). Read more here.

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CHMP adopts Guideline on Quality Aspects on the Isolation of Candidate Influenza Vaccine Viruses

On July, CHMP adopted the Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture as a guidance for the use of cells to isolate the viruses, the needed conditions and the passage of the viruses. More can be found here.

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EU Commission publishes a New Document about Duplicate Marketing Authorisation Applications

In certain cases, it may be economically and practically interesting to possess several authorisations for one and the same medicinal product. The conditions for such an exceptional situation are explained in a document published by the EU Commission. Read more here.

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FDA strives for more Transparency regarding GMP Compliance and Enforcement Data

The US Food and Drug Administration (FDA) has issued a report in which it proposes to make Compliance and Enforcement Information more accessible and user-friendly. The proposals are part of FDA's current efforts to make its operation and decision making more transparent. Read more.

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FDA Q&As on pathogenic Contamination of animal-derived Drug Ingredients

The Food and Drug Administration (FDA) published some new Q&A on contamination of animal based drug ingredients. Read more here.

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Summary of FDA 483 Inspectional Observations

The U.S. Food and Drug Administration FDA is frequently publishing summaries of its inspection observations listed documented on an FDA Form 483. Read more.

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Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005-2010 Revision Cycle

Scott Suttion and Radhakrishna Tirumalai issued a review of the published activities of the Microbiology and Sterility Assurance Expert Committee (MSA EC) of the United States Pharmacopeial Convention (USP) Council of Experts for the 2005–2010 revision cycle. Read more here.

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Technical Report - Assistance for Biotechnology Cleaning Validation

Since the Nineties, cleaning validation has been a topic in the area of GMP. Most guidelines cover the topic of cleaning validation only in a general way. The PDA's Technical Report No. 49 focuses on biotechnologically-manufactured products. This document consists of 68 pages, divided into 16 chapters. Read more here.

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EMA Reflection Paper provides Concrete Information about Risk based Quality Management

The "Reflection paper on risk based quality management in clinical trials" recently published by the EMA contains a table (Annex 1) which presents the points to consider for the risk identification, examples of how to control them and eventually mitigation and/or acceptance solutions. This gives interesting insights into EMA's specific positions about risk control. Read more here.

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Extension of the Variations Regulation to Purely National Authorisations coming: new Consultation Paper published by the EU Commission

An implementing regulation is necessary to extend the scope of the Variation Regulation (EC) No 1234/2008. In the run-up of this Regulation, the EU Commission has published a Public Consultation Paper to be commented with respect to special questions on variations procedures for purely national marketing authorisations. Read more here

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New FDA Requirements regarding Tablet Splitting

The FDA has published a new Draft Guidance providing extensive requirements regarding consistent and significant criteria for the splitting of tablets. Read more here. 

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EMA's Current Positions on Transfer of a Marketing Authorisation

After pharmaceutical companies have been bought over, sold or merged, questions are raised about the procedure for the transfer of existing marketing authorisations to the new legal entity and the right change management. There are clear rules which have been recently updated and published on the EMA Q&A webpage. Read more here.

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FDA's Current Position about Melamine Contamination in Pharmaceutical Excipients

A few years ago, the highly toxic substance melamine was discovered as illegal extender in pet food and milk products from China. As a result of a potential hazard for the patients' health, the FDA published a "Guidance for Industry" document on melamine contamination in pharmaceutical components. The current position of the FDA regarding the melamine analysis issue has been recently published. Read more here.

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