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Showing posts with label GUIDELINES UPDATES. Show all posts
Showing posts with label GUIDELINES UPDATES. Show all posts
Wednesday, 29 March 2017
Friday, 1 July 2016
USFDA released technical conformance guide on QUALITY METRICS yesterday.
Update: USFDA released technical conformance guide on QUALITY METRICS yesterday.
Find the copy in following link
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Manufacturing/UCM508464.pdf
Friday, 27 May 2016
WHO Revised Supplementary Draft HVAC Guide
May 26, 2016
The World Health Organization (WHO) recently issued a guideline for commenting which describes the requirements for HVAC systems used for the manufacture of non-sterile dosage forms. As most guidelines on this topic address the requirements for sterile forms, the previous version (TRS 961, Annex 1) from 2011 was gladly accepted by industry. Mentioned are non-sterile dosage forms as tablets, capsules, liquids or ointments, but also for the final steps in the manufacture of APIs. The WHO guideline means to provide guidance specifically for the areas design, installation, qualification and maintenance of ventilation systems. For the manufacture of highly potent materials the WHO refers to their Guideline TRS 961, Annex 3.
The biggest changes comprise:
The chapter "Premises" was moved to the front to emphasize its importance. The chapter now further comprises some sample layouts The section "Commissioning, Qualification and Validation" was revised to match it with the WHO Guideline TRS 937, Annex 4(Supplementary guidelines on good manufacturing practices: validation) The part "Maintenance" was removed from the part "Commissioning, Qualification and Validation" and is now a separte chapterIn addition a number of comments were added, graphs revised, and the overall readability was improved
Due to the many references and the numerous and improved illustrations the document is a good source for the (exemplary) requirements in the manufacture of solid and non-sterile dosage forms.
To find out more please visit the WHO website where you will find the draft document SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES FOR HEATING, VENTILATION AND AIR-CONDITIONING SYSTEMS FOR NON-STERILE PHARMACEUTICAL DOSAGE FORMS. The deadline for comments is the 12 July 2016. The results are expected to be discussed during the 51st WHO expert committee meeting in October.
Guideline Link :
Sunday, 17 April 2016
USFDA has published draft guidance on - Data Integrity and Compliance With cGMP.
Publishing date - 14 April 2016
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