Guidance on GMP & GDP: Q&A

The EMA has updated this Q&A relating to key GMP and GDP topics. Updates relate to two questions, which are questions 2 and 5:

EU GMP Guide Part 1 CH 5 Q2

 

This indicates that it is possible to use multiple batch numbers in packaging of medicinal products

 

Q5 relates to the requirements for batch numbers appearing on the packaging of medicinal products subject to parallel trade.

 

See: https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Good Distribution Practice - new guidance

The MHRA has issued a new blog post about Good Distribution Practice (GDP), dated January 2021. The blog emphasises that qualification and re-qualification of suppliers and customers is one of GDPs highest risk areas.

It states that the MHRA expects organisations to have qualification and re-qualification procedures implemented as part of a quality management system. Online resources provide a certain degree of confidence for conducting independent checks on licence details, such as company name, company number, site name, site address, authorised licensable activities, authorised categories of products to be handled on site and contact information.

 

The blog notes that inspectors often see stakeholders relying on this information available in the public domain to establish the legitimacy of a business partner. MHRA expects companies to adopt practices that incorporate independent checks as part of procedures.

It says that when verifying your business partners, it is crucial that you consider your sources of information and who else may potentially have the same access.

 

See: https://mhrainspectorate.blog.gov.uk/2020/12/21/qualifications-of-suppliers-and-customers-online-reliable-or-fake-news/ 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

PHSS Storage of Blood Products – Temperature Monitoring and Mapping Guide

The UK science society, the PHSS, have published a free guide titled ‘Storage of Blood Products – Temperature Monitoring and Mapping Guide’.

The scope of the guide reads: “This document provides guidelines for the temperature monitoring and mapping requirements for the storage and distribution of blood components, products, reagents and test kits in blood establishments and hospital blood banks and gives some examples of what to do in the event of a temperature excursion outside of specification.”

The document does not refer to plasma products. 

To access go to: PHSS

Posted by Tim Sandle