GMP News - Quality Assurance

19.06.13

WHO Guideline on Quality Risk Management finalised

With the new Technical Report (TRS 981) the WHO has published a comprehensive paper on the development of a QRM system. Read more.

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12.06.13

ACAA with Israel: what the QP needs to know

The ACAA between the EU and Israel entered into force on 19 January 2013. It is a framework agreement that recognizes Israeli industrial standards as equivalent to European standards and is similar to a Mutual Recognition Agreement (MRAs). Read more.

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05.06.13

New FDA Guidance on Contracts

The U.S. Food and Drug Administration FDA has published the long awaited draft Guidance for Industry "Contract Manufacturing Arrangements for Drugs: Quality Agreements". Read more.

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05.06.13

EMA: new Expectations for QPs

The European Medicines Agency has published a new set of Question and Answers on their website. A whole set of Q&As is dealing with API supplies and the auditing of the respective sites. Read more.

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05.06.13

MHRA Contingency Plan for API Import

The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has published a Contingency Plan for exceptional waivers intended to apply where it is necessary to ensure the availability of medicinal products. Read more.

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05.06.13

Brazil's GMP Guideline Available in English

In a globalised world, it is interesting to consider pharmaceutical markets outside the classical regions Europe, USA and Japan like, for example, South America. Read more.

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29.05.13

Half-year Report 2013: FDA Medical Devices Warning Letter Statistics - 2 New Deficiency Group in the Top 5

On behalf of the Eurpean Compliance Academy the team of Concept Heidelberg regularly analyses 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 fiscal year 2013 (from 1st October 2012 to 31 March 2013). The number of Warning Letters (107) issued by the Center for Devices and Radiological Health (CDRH) and the respective "District Offices" in the first half of fiscal year 2013 is considerably higher. Read more here.

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22.05.13

EMA issues Draft Guideline on Similar Biological Medicinal Products for public consultation

EMA's new draft  "Guideline on Similar Biological Medicinal Products" is open for comments until end of October 2013. More details about the guideline and its scope can be found here.

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15.05.13

GMP Guideline Manager Version 15.0 released

The European Compliance Academy's (ECA) GMP Guideline Manager CD is a very useful tool, providing all relevant guidelines on a single CD. It is distributed to all members of the ECA. This year the CD was issued in its 15th edition. Read more.

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08.05.13

Is there going to be "GMP Rating"?

Janet Woodcock from the FDA has published a very interesting report in the Nature Publishing Group. As leader of the CDER, she has one of the most important positions within the FDA. Read more here.

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17.04.13

Written Confirmations: Time is running out - new EU Progress Report

The EU Commission has published a progress report giving an overview on 20 major countries and their status of preparation for adhering to the new rules. It seems there are still quite a few challenges. Read more.

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17.04.13

Change Control: New SUPAC Guidance published

FDA has published a new draft Guidance for Industry: SUPAC - Manufacturing Equipment Addendum. The guidance document is being distributed for comment purposes. Read more.

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10.04.13

FDA publishes GMP Requirements for "Combination Products"

As of 22 July 2013, cGMP requirements on combination products will apply in the USA as 21 CFR Part 4. But what are combination products? These are composed of medical products, medicinal products, and ... Read more here.

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10.04.13

Sample Documentation on EU Site Master File published

The introduction of the EU Site Master File (Part III of the EU GMP Guide) has significantly changed the requirements on the creation of a company description. The very precise instructions have all disappeared. New requirements have been added. A sample documentation shows how to take into account the new requirements in a SMF. Read more here.

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04.04.13

Written Confirmations - How is the EU pharmaceutical Industry dealing with that?

To find out how pharmaceutical companies in the EU are seeing the challenges with the Written Confirmations, the European QP Association conducted a brief survey amongst its members beginning of this year. Almost 300 QPs gave answers to the questions. Read more.

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