Article archive

Training Presentation on 'ICH Q9: Quality Risk Management'

20/09/2015 10:10
Dear Friends!I made a training presentation on 'ICH Q9: Quality Risk Management'.I hope it is useful to all Pharmaceutical GMP professionals and Quality Auditors to understand basic principles of quality risk management and application of various risk assessment tools...

Training Presentation on 'ICH Q10: Pharmaceutical Quality System'

20/09/2015 09:54
Dear Friends!I made a training presentation on ICH Q10: Pharmaceutical Quality System.I hope it is useful to all Pharmaceutical GMP professionals to understand pharmaceutical quality system along with GMP for manufacturing of pharmaceutical products.ICH Q10: Pharmaceutical Quality...

Training presentation on 'How to conduct an effective internal quality audit'

20/09/2015 09:48
Dear Friends!I made a training presentation on 'How to conduct an effective internal quality audit'.I hope it is useful to all Pharmaceutical GMP professionals and Quality Auditors to understand auditing principles, requirements and management process (with reference to ISO 19011) along...

IPEC Federation Published Position Paper on Third Party Audit and Certification Programmes

20/09/2015 08:02
IPEC Federation PublishedPosition Paper on Third Party Audit and Certification Programmes Problem statement:Pharmaceutical manufacturers are facing increased regulatorydemands to ensure that the raw materials used in their medicines - includingexcipients - are safe, of high-quality, and...

WHO Draft on 'SUPPLEMENTARY GUIDELINES ON GMP FOR HVAC SYSTEMS FOR NON-STERILE PHARMACEUTICAL DOSAGE FORMS'

20/09/2015 07:55
WHO Draft Guidance on "Supplementary guidelines ongood manufacturing practices for heating, ventilation and air-conditioningsystems for non-sterile pharmaceutical dosage forms"·        BackgroundDuringthe consultation on data management, bioequivalence, GMP...

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

20/09/2015 07:49
This integrated version has been created for printing purposes only.Please refer to the individual question & answers as published in thepre-submission guidance for access to the hyperlinked information. Questions and answers are being updated continuously, and will bemarked by "NEW" or "Rev."...

Consultation on EU GMP Guidelines, revised Annex 17 on the Real Time Release Testing

20/09/2015 07:44
On15/09/2015, DG SANTE launches a consultation on the revision of Annex 17: RealTime Release Testing.Stakeholders - and other interested parties - are invited to comment on this consultation document.Commentsshould be sent at the latest by 11 December 2015 by e-mail to:...

New GMP Implementing Act published by EU

20/09/2015 07:41
The EU Commission haspublished a new public consultation on an Implementing Act on Principles and guidelineson good manufacturing practices for medicinal products for human use.The reason is that once Regulation(EU) No 536/2014 on clinical trials becomes applicable, manufacture and importof...

APIC revised the "How to do" Document on ICH Q7

20/09/2015 07:35
Shortlyafter the entry into force of the Good Manufacturing Guide for Active Pharmaceutical IngredientsICH Q7 in the year 2000 the Active Pharmaceutical Ingredients CommitteeAPIC wrote the "How to do" document which clarifies the requirementsof the guideline on the basis of experience gained from...

EDQM released new edition of Technical Guide for the Elaboration of Monographs

09/09/2015 23:29
At its 152nd sessionthe European Pharmacopoeia Commission approved thepublication of a new edition of the Technical Guide for the elaboration ofmonographs. This guide is an essential tool for the drafting of monographsbut also for the transposition of analytical techniques and parameters into...
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