Pharmaceutical Quality Systems

Question 1

What do you know about PICs?

Answer 1

The Pharmaceutical Inspection Cooperation Scheme

Aim is to harmonise inspection procedures by developing common standards

Training, Seminars, Guidance Documents (Aide Memoirs)

Question 2

How long do you retain documents for commercial and IMP’s?

Answer 2

Commercial- 1 yr after the expiration of the product or 5 years from certification- whichever is longer

IMP’s - 5 years after the completion of the last clinical trial in which the batch was used.

Question 3

What do EDQM do?

Answer 3

EPh
Biological Standards
Reference Standards
CEP

Question 4

Give an overview of the EP / BP?

Answer 4

Primary source of official quality standards for medicines and their excipients. The standards provide scientific basis for QC of a product throughout its life cycle

Question 5

Tell me about ICH

Answer 5

International Council for Harmonisation

Rationalise and harmonise regulatory requirements

ICH Guidelines- Quality, Safety, Efficiency and Multidisciplinary