GMP NEWS 2011

New FDA Draft Guidance regarding Design Development of Medical Devices

Until 19 September 2011 you have the possibility to comment and maybe influence the new FDA Draft Guidance regarding Design Controls of Medical Devices. Read more here.

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Warning of Potential Contamination with Toxic Plasticizer

The recent discovery about the fraudulent replacement of vegetal oils as emulsifiers with toxic plasticizers in the products of two Taiwanese companies has led both the FDA and the IPEC Europe to publish warning notifications. Read more here about the incident.

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MPA Proposal: No GMP Certificate in Case of Violation of environmental Constraints

In a 46 page report, the Swedish Medical Products Agency (MPA) presents an initiative aiming to introduce environmental constraints into the EU GMP Guidelines. The reason for this is based on the near inexistence of environmental concerns in the countries where the manufacture of APIs is outsourced. Read more here about this initiative.

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New FDA Guidance on Dosage Delivery Devices (measuring Spoons, Droppers, etc.)

According to the FDA, wrong or insufficient labeling on dosage delivery devices for liquid drugs endangers the drug safety because this can lead to accidental overdoses. Read more in this News.

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Which kind of GMP Documentation is needed for an API Manufacturer who performs Sterilisation of an active Substance

The European Medicine Agency publishes answers to frequently asked questions after they are discussed and agreed to by the GMP/GDP Inspectors Working Group. In April 2011 the Agency published the following statement. Go here to read more.

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FDA publishes Analysis of 2010 Warning Letter Statistics regarding Medical Devices

The FDA Center for Devices and Radiological Health (CDRH) has recently published the Warning Letter Statistics for Medical Devices. Read more here.

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EU Commission publishes important new Draft Guideline on Good Distribution Practice of Medicinal Products for Human Use

The EU Commission has published a new Draft Guideline on Good Distribution Practice. This new takes into consideration the regulations of the Directive on Falsified Medicines and should replace the existing regulations which have been valid since 1994. What this implies for the pharmaceutical wholesale can be read here.

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New: ICH Guideline for ICH Q8, Q9 and Q10 implementation

There is still a lot of uncertainty about how the three guidelines should be used in combination. A new Points to Consider document is intended to provide clarification. Please find more information here.

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WHO publishes Notice of Concern regarding GMP Deviations about two Manufactures located in India

The WHO Notice of Concern are very similar to FDA Warning Letters. These letters will be issued  to a manufacturer, contract research organization or quality control laboratory, by the WHO Prequalification of Medicines Programme. Read more about the two new Notice of Concerns here

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Quality by Design for Generics - Case Studies

The Generic Pharmaceutical Association (GPhA, USA) has published two examples of development reports to show how generic manufacturers (ANDA application) can implement Quality by Design and document in front of the Agency (Office of Generic Drugs, FDA). Read more here.

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Excipact - the Certification Scheme for Pharmaceutical Excipients

The Certification Scheme for pharmaceutical excipients elaborated by IPEC Americas, IPEC Europe and three further European partner associations contains standards for Good Manufacturing and Distributing Practices as well as requirements for 3rd party audit organisations and their auditors qualification. Learn more about the programme here.

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Revision of the General Chapter NIR in PHARMEUROPA

The revised version of the General Chapter NIR-Spectroscopy in PHARMEUROPA particularly considers PAT concepts. You can read more in this News.

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The Falsified Medicines Directive published in the Official Journal of the European Union

On 1 July 2011 the Falsified Medicines Directive (2011/62EU) has been published in the Official Journal of the European Union. Now the countdown has started for the transposition of the Directive into national law by the EU Member States and for the adoption of Guidelines for APIs and pharmaceutical excipients by the EU Commission. Please read here more about the comprehensive legislation changes to come.

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FDA publishes Draft Guidance on Classification of Products as Drugs or Devices

In June, FDA published a new draft guidance which should help manufacturers to classify their products as drugs or devices. Read more here..

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New Guideline on EMA Certificates of Medicinal Products

The Regulatory and Procedural Guideline of the European Medicines Agency (EMA) on Certificates of Medicinal products - Instructions on how to fill the Application Form has been adopted. Read more.

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FDA publishes Draft Guidance for Industry on Processing/Reprocessing Medical Devices

In May, the FDA published a Draft Guidance for Industry and FDA Staff entitled "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". The document should … Read more here.

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Contract Manufacturers and Contract Laboratories do no longer need to be pre-approved by DMA

The Danish Medicines Agency (DMA) recently changed its practice to pre-approve contract manufacturers and contract laboratories acceptors. Read more.

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FDA's membership of PIC/S - why it is important

On 1 January 2011, FDA joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S) . Now, Dr Margaret A. Hamburg, Commissioner of the FDA, gave an interesting talk about the membership and its benefits. Read more.

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FDA plans on publishing further GMP and CMC Guidances for Combination Products

A drug and a device, a drug and a biological, a biological and a device, or maybe even all three can create a combination product. But what regulation is applicable for those products? Which new Guidance documents will be published soon? Please read more about this development in a very detailed article provided by the IPQ - one of the most important Journals in the GMP and regulatory environment. Read on here.

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Pfizer transfers first QbD Dossier within the FDA/EMA Project

On 1 April 2011 the FDA and the EMA started a pilot project (see our GMP News from 6 April 2011) for the evaluation of QbD authorisation applications. On 17 June the two authorities informed about the first dossier within the pilot programme which was issued by Pfizer. Read on here.

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