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TOP 5 GMP Downloads

1. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.


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More than 700 questions with reference to regulations for preparing and carrying out GDP audits.


3. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.


4. Technical Agreement
and Delimination of Pharmaceutical Responsibilities.


5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance


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News about GMP/cGMP


The U.S. Food and Drug Administration has announced that the USA is now a “listed country” with the European Commission (EC) so that U.S. companies need not obtain an export certificate form the FDA before shipping certain pharmaceutical products to Europe.


Japan has been added to the "list of third countries" as regards standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those of the EU.


Following consultation with relevant industry groups, TGA, the Australian Therapeutic Goods Administration, has announced the adoption of a number of EU/ICH guidelines in Australia, effective 1 June 2013.

These include, inter alia:

  • Guideline on plasma-derived medicinal products (EMA)
  • Guideline on active substance master file procedure (EMA)
  • Guideline on bioanalytical method validation (EMA)
  • Impurities: Guideline for residual solvents ICHQ3C(R5)

TGA: Newsroom


On 24 May 2013, the FDA has published a draft guidance for industry entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements”. The guidance describes the current thinking of the government authority on defining, establishing and documenting the responsibilities of all parties involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP).


The Chinese Authorities have recently released a few newslets, one concerning the “Written Confirmation for active substances exported to the EU”, an omnipresent topic.


China’s State Food and Drug Administration (SFDA) is now under new leadership and has changed its name to "The China Food and Drug Administration – CFDA".


As announced by Health Canada last week, Harper Government plans on strengthening drug safety with new standards, as Good Manufacturing Practices now apply to all active pharmaceutical ingredients


The WHO has published a proposal for revision of the Supplementary Guidelines on GMP: Validation, Appendix 7: Non-sterile Process Validation in April 2013. The revised document is expected for October 2013, after its presentation to the WHO Expert Committee on Specifications for Pharmaceutical Preparations.


The European Medicines Agency (EMA) has announced the first details of its planned reorganisation. Rooted firmly in the Agency’s overall public and animal health mission, the changes reflect a renewed focus on three key elements:

  • how to better support the scientific work of the EMA committees,
  • how to better share the data the Agency holds and
  • how to better meet the needs of its stakeholders and partners.

The EMA has published a draft guideline on similar biological medicinal products on May 2, 2013, which is now open for public consultation.


Australia has been added to the "list of third countries" as regards standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those of the EU. Following Switzerland, Australia is the second country to be adopted and listed by the European Commission.


EC: Commission implementing decision


The European Medicines Agency (EMA) has upgraded its EudraGMP database so that it now contains information on good distribution practice (GDP) in addition to good manufacturing practice (GMP). The new database is a key deliverable of the new European Falsified Medicines Directive and will make the supervision of manufacturing and distribution of medicines more robust by allowing all the actors in the supply chain to check information available on their suppliers.


India has recently published the revised draft guidelines for the issue of the “Written Confirmation” for APIs exported to the EU in accordance with Article 46(2)(b) of Directives No. 2001/83/EC.


This month the FDA has published the final version of the Guidance for Industry "Blood Establishment Computer System Validation in the User´s Facility". The FDA issued this guidance to assist blood establishments in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices.

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