GMP News - Quality Assurance

14.08.12

FDA issued 8 Warning Letters to Companies because of Missing Establishment Registration

Within 5 months, the FDA has issued 8 Warning Letters to companies who failed to comply with the obligation to register production establishments. Read more here.

11.07.12

FDA - S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

The US Food & Drug Administration (FDA) published two Guidances for Industry with regard to Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. Find more details here.

04.07.12

MHRA publishes GMP Deficiency Data Review April 2011 - March 2012

In April, the Medicines and Healthcare products Regulatory Agency (MHRA), UK, issued a review of the main GMP deficiencies for the period from April 2011 to March 2012. More details can be found here.

13.06.12

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.

13.06.12

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.

06.06.12

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.

06.06.12

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.

05.06.12

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.

16.05.12

Foundation of a new French Health Regulation Authority

The existing French health authority has been re-organised. The AFSSAPS has been replaced by the ANSM (Agence nationale de sécurité du médicament et des produits de santé). Read on.

09.05.12

FDA Update

The FDA has published a presentation on ongoing activities of the FDA. Read more.

11.04.12

FDA: Ensuring the Safety of Vaccines in the United States

The FDA published two documents on vaccines safety and the reporting of vaccine adverse events in the United States. More details can be found here.

14.03.12

PIC/S asks Inspectors to have a look at Job Cuts

In a new Recommendation on for Risk-Based Inspection Planning in the GMP Environment, the PIC/S asks Inspectors to have a look at job cuts. Read more.

07.03.12

EMA Reflection Paper on Sourcing Biological Starting Materials

According a new Reflection Paper, the European Medicines Agency (EMA) wants companies to trace their heparin supplies back to the slaughterhouse. Read more.

07.03.12

New Chinese GMP rules published in English

The Chinese Ministry of Health has published revised GMP rules for drugs in the beginning of 2011. March 1, 2011 was specified as date for the entry into force. Now, an English translation is available. Read more about the main differences between the Chinese GMP rules and EU GMP Guideline Part I.

29.02.12

FDA Draft Guidance: How to qualify Heparin Suppliers

The U.S. Food and Drug Administration (FDA) recently published a draft Guidance on Monitoring Crude Heparin for Quality. Read more.

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GMP News - Quality Assurance

FDA issued 8 Warning Letters to Companies because of Missing Establishment Registration

FDA - S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

MHRA publishes GMP Deficiency Data Review April 2011 - March 2012

News PIC/S Structure

FDA starts Voluntary Audit Report Program for Medical Devices

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

EMA: Practical Guidance on Implementation of Pharmacovigilance Legislation published

FDA's new Guidance Documents for 2012

Foundation of a new French Health Regulation Authority

FDA Update

FDA: Ensuring the Safety of Vaccines in the United States

PIC/S asks Inspectors to have a look at Job Cuts

EMA Reflection Paper on Sourcing Biological Starting Materials

New Chinese GMP rules published in English

FDA Draft Guidance: How to qualify Heparin Suppliers

Recommended Event

Analytical Instrument Qualification Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory

GMP News - Quality Assurance

FDA issued 8 Warning Letters to Companies because of Missing Establishment Registration

FDA - S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

MHRA publishes GMP Deficiency Data Review April 2011 - March 2012

News PIC/S Structure

FDA starts Voluntary Audit Report Program for Medical Devices

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

EMA: Practical Guidance on Implementation of Pharmacovigilance Legislation published

FDA's new Guidance Documents for 2012

Foundation of a new French Health Regulation Authority

FDA Update

FDA: Ensuring the Safety of Vaccines in the United States

PIC/S asks Inspectors to have a look at Job Cuts

EMA Reflection Paper on Sourcing Biological Starting Materials

New Chinese GMP rules published in English

FDA Draft Guidance: How to qualify Heparin Suppliers

Recommended Event

Analytical Instrument Qualification Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory

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