FDA Approves OTC HIV Test for the First Time

The FDA has approved the first over the counter HIV Test to be performed at home. Read more here.


FDA publishes Q&A Guidance on Endotoxin and Pyrogen Testing

In June, the FDA has published a new Question and Answer Guidance for Endotoxin and Pyrogen Testing. It should reflect the current thinking of the agency on that topic. Read more here.


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.


Will there be an Authorisation Obligation for Critical Medical Devices?

Since the PIP scandal, the EU has been working on strengthening the planned revision of the Medical Devices Guidelines. The European Parliament has proposed different measures in a resolution to get rid of the "malfunctioning of the system at European and national levels". Read more here.


New Homepage of ECA's Rapid Microbiological Methods Working Group

The new Rapid Microbiological Working Group website is now online - providing additional information about RMM. More details can be found here.


ECA's Rapid Microbiological Methods Conference

The annual Rapid Microbiological Methods Conference of the ECA will take place on 11. and 12 December in Munich, Germany. Many speakers from authorities, industry and method development already confirmed their participation. Get the details.


Case Study of New Growth-based Rapid Microbiological Method (RMM) detects the Presence of Specific Organisms

In the March Edition of the American Pharmaceutical Review, Dr Michael Miller published a case study of a New Growth-based Rapid Microbiological Method (RMM) that Detects the Presence of Specific Organisms and provides an Estimation of Viable Cell Count. Read more.


Top 10 Deficiencies - Applications for Certificates of Suitability (CEP)

The EDQM has published a document about the most frequent deficiencies found in application dossiers for CEPs and gives recommendations on how to avoid such errors. Read more here about these "Top Ten Deficiencies".


Revised Guideline on the ASMF Procedure Coming into Force on 1st October 2012

The "Guideline on Active Substance Master File Procedure" describes the requirements for marketing authorisation holders regarding the ASMF procedure. The revision of this guideline which has been published recently will come into force at the beginning of this year's 4th quarter. Read more here about the coming changes for API manufacturers and the pharmaceutical industry.


Another Third Party GMP Audit performed in Germany by API Compliance Institute

The API Compliance Institute co-ordinates so called Third Party Audits. On behalf of one or several QPs, GMP audits are performed at API manufacturers. Some audits are made available for companies who were not involved in the initial sponsoring of the audit. These GMP audits are called shared audits. Please find more information about the latest Shared Audit.


Continuing Trend: Again, Numerous Warning Letters issued to European API Manufacturers

For some time now, the FDA has been strengthening its inspection activities at API facilities not only in the Far East but also in Europe. The analysis of the 8 Warning Letters which have already been issued for fiscal year 2012 confirms this trend. Read more here about what FDA investigators mostly have to object to in European facilities.


More GMP Inspections by EMA due to Increasing Quality Issues

In its annual report 2011, the European Medicines Agency (EMA) reported about the number of inspections performed in that year. Go here to read more.


How to set Specifications for Genotoxic, Metallic Impurities and Residual Solvents in APIs?

The EMA has recently extended its Questions and Answers collection with three statements regarding the setting of drug substance specifications for potentially genotoxic, metallic impurities, and solvent residues. More details here.


New Guide for Manufacturers of Stand Alone Software

On June 12, 2012 the Medical Products Agency (Swedish Authority) published an introduction to the so called MEDDEV 2.1/6 Guidelines. Click here to read more.


EU GMP Part 3: New Final Document on Written Confirmation

On 10 July 2012, the European Commission published the final Template for the 'written confirmation' for active substances. Please read more here


USP's Position to the Glass Particles Issue

In response to growing product recalls due to glass particles found in injectable medications, the USP will present the new Chapter <1660> in the July-August edition of the Pharmacopeial Forum (PF). This new chapter describes methods to test the inner surface of glass containers. Read more here.


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.


FDA issues Amendment to the Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products

The FDA has published a Draft Guidance for Industry: Amendment to “Guidance for Industry: "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products”. More details can be found here.


New Guidelines on Good Pharmacovigilance Practices released

The European Medicines Agencvy (EMA) has published two modules of guideline on good pharmacovigilance practices released for public consultation. Read more.


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.


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