GMP NEWS 2010

MHRA requires active Maintainance of API Manufacturing Sites

Through its inspection programme, the MHRA has encountered numerous examples of API manufacturing sites that are named on marketing authorisations but are not currently used and not fully maintained as approved suppliers. Please go here to read more.

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WHO Publishes Guidelines on the Use of Quality Risk Management

In August 2010, the WHO published a draft guideline on quality risk management (QRM). The document is astonishingly detailed and gives, among others, guidance on official inspections regarding QRM. Read more here.

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Outcome of EMA Workshop on Clinical Trials and Global Medicines Development

The European Medicines Agency (EMA) held an international workshop to discuss a way forward for a global framework of clinical trials. Read more.

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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.

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EMA Reflection Paper on the Use of Electronic Data in Clinical Trials published

The final Reflection Paper on expectations for electronic source data and data collection tools in clinical trials has been published. It outlines the current opinion of the EU GCP Inspectors Working Group. Read more.

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The New GAMP Good Practice Guide: How to Operate Computerised Systems in a GMP-Compliant Way

Alongside validation, the (GMP-compliant) operation of computerised systems is also becoming an increasingly higher priority. A new GAMP Good Practice Guide gives comprehensive support on this matter. Read more here.

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Clinical Trials in India - Current Developments

The number of clinical trials conducted in India is still increasing. According to a report created by the Federation of Indian Chambers of Commerce and Industry in co-operation with the consulting firm Ernst&Young, as many as 7% of all clinical phase III studies performed worldwide are already carried out in India. Our news highlights the reasons.

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WHO proposes new Sections for Guideline on Quality Assurance Topics

The World Health Organisation has proposed new sections for the WHO Good Manufacturing Practices (GMP) and has asked ECA to comment the new sections. Read more.

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Revision of USP <1235> Vaccines for Human Use - General Considerations

In the 2. supplement of USP33,  "General Informations" the USP published the revised chapter <1235> Vaccines for Human Use -General Considerations. Find more details.

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FDA Fosters the Development of Better Medical Devices

Jeff Shuren, Head of the Center for Devices and Radiological Health (CDRH), has announced on the FDA website that the FDA intends to further the development of improved medical devices. With the example of infusion pumps, Shuren explains… Read more here.

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FDA revises Guidance Document on Pre-Approval Inspections

The U.S. Food and Drug Administration has revised the Compliance Program Guidance Manual on Pre-Approval Inspections. The Guidance document has been completely reworked. Read more.

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New WHO Draft on the Manufacture of Sterile Medicinal Products

With the revision of the WHO Technical Report Series (TRS) No. 957 in June 2010, the WHO's expectations on the manufacture of sterile medicinal products were published as a draft for an Annex 6 "Good manufacturing practices for sterile pharmaceutical products". Read more here.

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New Toxicological Data on Isopropylbenzene Trigger its Categorisation as Class 2 Solvent

Due to new toxicity studies in rats and mice, the solvent Isopropylbenzene is meant to be categorised as Class 2 instead of Class 3. A corresponding ICH draft guideline has been published and released for commenting by the public. Here you will find the details.

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Inspection of Biological Drug Products

The FDA published 2010 the revised Compliance Program Guidance Manual – Chapter 45 Biological Drug Products: Inspection of Biological Drug Products (CBER). More details can be found here.

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FDA publishes Q&As on Drug Recalls

The FDA recently published a set on Q&As on recall procedures in the section Questions and Answers on Current Good Manufacturing Practices. Read more.

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EMA and US FDA seek potential Candidates for joint GMP Inspection Programme

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. Read more about the programme.

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Impurities and Setting Specifications - the EMA Publishes Harmonised Policies on Its Q&A Page

Impurities, like heavy metals, residual solvents and genotoxic substances, may have to be included in the drug substance specification depending on the point in time when they are formed or introduced into the synthesis process of an active pharmaceutical ingredient. On this issue, the EMA has described a harmonised policy on its Q&A page. Read more here.

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Specific Requirements on Plastic Packaging Materials for APIs and Solid Dosage Forms?

Which requirements do plastic packaging materials intended for packaging solid oral dosage forms and for packaging active pharmaceutical ingredients have to fulfil? The EMA's Q&A section provides important information.

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EudraCT Version 8.0 and new CTA Application Form will go into production soon

The EU Commission has announced that EudraCT Version 8.0 will go into production on 7 September 2010. Read more.

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