GMP NEWS 2012

Handling of Deviations and CAPA criticised by Inspectorates

Deviations and CAPA remain hot topics in inspections. The inspectorates' summaries of their observations show that things do not always work as desired. Read more.

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FDA publishes Draft Guidance on Stability Testing of Generics

In the near future, extensive stability data on the medicinal product and the API should be submitted for the application of generics in the USA. The FDA has recently published a draft guideline for comment. More details about the new requirements can be found here.

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Generic Drug Applications in the USA: Completeness Assessment of Drug Master Files for APIs by the FDA

The GDUFA (Generic Drug User Fee Act), the new fees regulation on generic drug applications, is valid in the USA as of 1 October 2012. One part of this legislative regulation is a completeness assessment of the Drug Master File, the generic drug application refers to. This has significant effect on the applicant. Go here for more information.

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GMP Matrix as Standard for Audits in many Companies

The European Compliance Academy developed a so-called Good Practice Guide some years ago. It is a juxtaposition containing the requirements laid down in the EU GMP Guide, FDA's cGMP Guide and ISO 9001. Read more here.

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Questions and Answers of the Japanese Regulatory Authorities regarding Computerized Systems

The Japanese Regulatory Authorities give answers to 46 questions concerning computerized systems. Now, there exists a translation into English. You can get further information here.

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What are the consequences if an API manufacturer has not been audited?

The Danish Medicines Agency offers some very helpful Question & Answer documents on their webpage. Please find the answer to this question here.

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US Government Report on Innovation in Pharmaceutical Development

The US President's Council of Advisors on Science and Technology (PCAST) has published a report to the President on propelling Innovation in Drug Discovery, Development and Evaluation. Read more.

 

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European Commission seeks Feedback on Paediatric Regulation

The European Commission has launched a public consultation on the experience gained with the paediatric regulation. Read more.

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Update of FDA Clinical Investigator Inspection List

FDA updates quarterly its Clinical Investigator Inspection List. The list contains names, addresses, and other information gathered from inspections of clinical investigators. Read more.

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Which Types of Third Party GMP Audits may be used - which not?

We are often consulted about the acceptance of GMP audits of API manufacturers. The point is that more and more organisations offer such audits. What is essential to pay attention to? More details can be found here.

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Chinese API Manufacturers revealed to have used gutter oil for the Manufacture of Antibiotics

Local Chinese authorities are currently investigating against a few renowned API manufacturers who are accused of having used waste oil from restaurants for the production of their antibiotics. China's largest API manufacturers are among the accused manufacturers. Read more.

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Qualified Person Association Database for Shared Audits "QPSHARE" comprises 284 API and Excipient Suppliers

In 2010 the European QP Association initiated the shared audits database "QPSHARE". With this database the Association wants to support European QPs in identifying suppliers other QPs are possibly interested in as well - and that way facilitates sharing audits. Read more.

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ISPE Guide bridges traditional Qualification and risk- and science-based Qualification

In last week's news we talked about an ISPE Mapping Document that illustrates relationships to other ISPE Guides on qualification. One of these ISPE Guides, the ISPE Good Practice Guide "Applied Risk Management for Commissioning and Qualification" is used as bridge in order to connect traditional qualification approaches according to ISPE Baseline Guide Volume 5 "Commissioning and Qualification" (C&Q) to a modern risk- and science-based qualification approach. Read more.

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FDA confirms Deadline for Application of QbD for Generic Drug Manufacturers!

The US FDA emphasised again, that the application of Quality by Design will be mandatory for manufacturers of generic drugs from January 2013 and will be demanded. In the meantime the second FDA case study has become available. Read more.

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FDA Dissolution Methods Database

FDA aids the pharmaceutical industry in developing generic drug products by providing a database on methods for active drug dissolution testing. The most important functions are described in the FDA document "Frequently Asked Questions". You can obtain more information in this news.

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Interesting Case Study on Quality by Design for Vaccines

The PDA has issued an interesing document with a case study on the application of Quality by Design in the manufacture of vaccines. This document was developed by a cooperation of five pharmaceutical companies. Read more.

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EMA explains EU Incident Management Plan for Human Medicines

The EMA has published the European Union regulatory network incident management plan for medicines for human use, explaining how the EMA, the European Commission and medicines regulatory authorities work together in the EU Member States. Read more.

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EMA recommends first Gene Therapy for Approval

With the recommendation of the authorisation of Glybera, the European Medicines Agency (EMA) recommends the approval of a gene therapy product for the European Union market for the first time. Read more here.

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The new EU GMP Chapter 1 in Pharmaceutical Development

The European Commission has published the final version of the revised Chapter 1 of the EU-GMP Guide, which will now be called "Pharmaceutical Quality System". The new Chapter 1 includes also refrence to IMPs and Pharmaceutical Development (read more).

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FDA Requirements on Bioequivalence Data for Generic Drug Products

In an FDA Guidance on bioequivalence data for ANDA authorisations, the FDA has defined the concept of "same drug product formulation" for manufacturers of generic drug products. Find out more.

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