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2017 - The GMP Regulations Report

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TOP 5 GMP Downloads

1. Questionnaire for preparing GMP-inspections
More than 650 typical questions related to audits and inspections.

2. GDP Audit Questionnaire
More than 700 questions with reference to regulations.

3. GMP Fundamentals
A quick and comprehensive overview of the complex world of GMP.

4. Industry Guide to handle OOX Test Results
Every single step of the OOX process.

5. The New USP <1231>: Water for Pharmaceutical Purposes
A compact overview of the contents of the new version of USP <1231>.

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News about GMP/cGMP


WHO: Technical Report Series No.1010 published

With the publication of the 52nd Technical Report Series No. 1010 of the WHO, eleven Guidelines were adopted and recommended for use:


In the area of Quality Assurance – GMP:
  • WHO guidelines on good herbal processing practices for herbal medicines (Annex 1)
  • WHO good manufacturing practices for herbal medicines (revision) (Annex 2)
  • Guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems (revision) (Annex 8)
  • Guidance on good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions (Annex 9)
  • Stability testing of active pharmaceutical ingredients and finished pharmaceutical products (revision) (Annex 10)
And furthermore:
  • Considerations for requesting analysis of medicines samples (revision) (Annex 3)
  • WHO model certificate of analysis (revision) (Annex 4)
  • WHO guidance on testing of “suspect” falsified medicines (Annex 5)
  • Good pharmacopoeial practices: Chapter on compounding (Annex 6)
  • Good pharmacopoeial practices: Chapter on monographs on herbal medicines (Annex 7)
  • Collaborative procedure in the assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities (Annex 11).
Clicking here takes you directly to TRS 1010, that summarises and interprets all results of the 52nd WHO-Expert-Meeting of October 2017 in Geneva. The final guidelines are listed in form of annexes and will be published on the WHO website in form of single documents shortly.

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