The pharmaceutical regulatory landscape is currently changing more rapidly than at any time since the first requirements were introduced in the late 1960s/early 1970s.
The PQG aims to influence regulatory bodies, particularly the MHRA, on new standards, concept papers and other documents that shape the environment we operate in.
We aim to use the joint knowledge of our Members to provide insight and advice on practical considerations that only we can provide from experience in our respective fields of expertise. This could lead to alternative wording that may result in the final draft adding maximum value to our industry and also ensuring the intent of the document is maintained in implementation.
PQG have a unique relationship with the regulators whereby they value and appreciate contribution from our membership in the spirit of collaboration.
Using Member Knowledge
PQG members collectively have significant knowledge regarding the many facets of practical pharmaceutical quality assurance and the PQG committee is keen to harness this knowledge to the benefit of both the industry and the patients we serve. Therefore, we seek to identify and publicise new proposals from regulators and collate feedback to influence the final document.
Please look out for e-mails from PQG about consultations and take an active role in responding. If you become aware of a regulatory document that you believe we should comment on, then please send the details to the advocacy e-mail address.
Current documents that PQG are collating comments on:
20110411 – EMA consultation on “The QP declaration template” Click here to view the document
This is a Template for the Qualified Person’s declaration concerning GMP compliance of the active substance used as starting material and verification of its supply chain “The QP declaration template”
Password protected pages
If you click on the lower tabs from this page (on the left), you may see that the result gives a “password protected page”. This means that the subject is currently being prepared for consultation and will be available for comment in a week or so. Please look again soon.