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TOP 5 GMP Downloads

1. GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals


2. Quality Agreement
Standard draft to adapt and extend


3. Premises
Official requirements | material flow | room classes | and much more...


4. GMP Audit Checklist
for Pharmaceutical and API Manufacturers


5. Documenting Process Validation
A Drugmaker‘s Guide – step-by-step manual based on real-world examination experience


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News about GMP/cGMP


The TGA has announced the launch of the Medical Device Single Audit Program (MDSAP) from January 2014, together with Brazil's ANVISA, Health Canada, and the US Food and Drug Administration FDA, to develop a global approach to auditing and monitoring the safe manufacturing of medical devices.


In the past nine months, the US regulator has expanded its inspection team in India from 12 to 19, and opened two more offices in Hyderabad and Mumbai, in addition to its first office in New Delhi. With 135 FDA-approved manufacturing units in India and rising compliance problems this comes as no surprise.


The European Medicines Agency (EMA) has announced details of its new organisational structure with the intention to better support its health mission and its role as part of the European medicines regulatory system.


On October 2, 2013, the EMA’s Management Board agreed to publish the agendas and minutes of all its scientific committees. This is part of the EMA’s approach to increasing transparency and opening up its operations.


The Japanese Ministry of Health (MHLW) and the PMDA have started entering information on good manufacturing practice (GMP) compliance related to Japanese manufacturers, upon the manufacturer's request, into the EudraGMDP database. This is the first time that information from a non-European regulator has started to be added to EudraGMDP. The initiative is expected to speed up regulatory processes and save time for importers, manufacturers and regulatory authorities.


The FDA is announcing the availability of a draft guidance for industry entitled ANDA Submissions—Refuse-to-Receive Standards.” This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) The guidance describes what should be included in these submissions and highlights serious deficiencies that may cause FDA to refuse to receive an ANDA.


With the beginning of this month, the FDA has published the following two updated lists of GMP guidelines:


After more than a year delay, IPEC India is expected to be created by the end of the year. IPEC-Americas’ vice chair confirmed that the registration process is moving forward. Due to difficulties concerning the naming of the organization the formation could not be realized in 2012.

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