Never ever a 483?

We can not promise that you will never get a 483
but we know that the GMP MANUAL includes all 
procedures and processes you need to be
GMP compliant.
Stay informed!

If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices


>>> simply register for our free GMP newsletter LOGFILE



GMP Subject Downloads


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


2. GMP Audit Checklist
for Pharmaceutical and API Manufacturers


3. Computer System Validation in the EU
a step-by-step guide to implementing a computer validation program


4. Risk Management
established methods of risk analysis
incl. ICH Q9


5. Preparing for the EU GMP Inspection
similarities - and subtle differences - between FDA and EU GMP inspections


Your benefits:

> no shipping costs
> no waiting period: if you choose payment by credit card you will receive an email with the download information immediately after payment.


>>> Click here to see all GMP Subject Downloads!


News about GMP/cGMP


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


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".


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


On 24 May 2013, the FDA has published a draft guidance for industry entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements”.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).


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.
Page 8/46    4   5   6   7   8   9   10   11   12   13