Pharma GMP News of the Week: 18-June-2022
Period: June 12, 2022 to June 18, 2022
MDCG published Position Paper “Notice to manufacturers to ensure timely compliance with MDR requirements”
Date of notice: June 13, 2022
Source: https://ec.europa.eu/health/system/files/2022-06/mdcg_2022-11_en_0.pdf
US FDA published a draft guideline “QUALITY RISK MANAGEMENT Q9(R1)” on its website that currently is under public consultation
Document issued on: June 14, 2022
In the pharmaceutical sector, quality risk management (QRM) is a valuable and very essential element to carve an effective quality management system. The principles of QRM and its framework is clearly defined in the ICH Q9. ICH provides an official ICH training material that supports this guideline in enhancing the application of effective QRM by industry and regulators.
Source: https://www.fda.gov/media/159218/download
EDQM announced “Pharmeuropa Bio & Scientific Notes now accessible without registration”
Document issued on: June 14, 2022
EDQM started a free online journal for Pharmeuropa Bio & Scientific Notes, that can be used without prior registration as of 13 June 2022.
Source: https://www.edqm.eu/en/-/pharmeuropa-bio-scientific-notes-now-accessible-without-registration
US FDA published a draft guideline “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies” on its website
Document issued on: June 15, 2022
The objective of this guideline is to provide a standards recognition program for regenerative medicine therapies (SRP-RMT) at CBER to identify and recognize VCS to help in developing and assisting RMT products regulated by CBER as appropriate.