Annex 1 “Manufacture of Sterile Medicinal Products” was first published in 1971, providing specific guidance on the minimum controls required to ensure sterility of medicinal products during manufacture. In…
Learn More
With Annex 1 implementation date fast approaching we are really pleased to announce that Di Morris and Pam Turner are discussion panellists in the PHSS Sterile product manufacturing conference & Aseptic Processing workshop 2023….
Learn More
We are delighted to welcome Di Morris to PNR Pharma as Qualified Person / QA Compliance Advisor. Di has worked in the pharmaceutical industry for over 40 years including in the areas…
Learn More
Please see this post from the Medicines and Healthcare products Regulatory Agency We’re working with support from partners to make it faster and easier to gain approval and to run…
Learn More
Is your vendor management programme compliant? PNR Pharma has the expertise to conduct API and finished product audits for all product types, including sterile and ATMPs to determine compliance with GB…
Learn More
PNR Pharma will be exhibiting at “Advanced Therapies 2023” London, Excel 14-15 March. Pam Turner and Sarah Coram will be happy to answer your questions on EU/ UK clinical trials, commercialisation and commercial supplies….
Learn More
Time is running out! Are you ready for the new PICs/EU GMP Annex 1, the Manufacture of Sterile Medicinal Products, to comply with the requirements of Eudralex Volume 4 and…
Learn More
PNR Pharma currently has IMP, MIA and WDA licences authorised by the HPRA. Allowing the QP certification of both clinical and commercial supplies within the EU. As part of the…
Learn More
Is your manufacturer in compliance with current GMP? PNR can assist with remediation of deficiencies identified in an audit and bridge gaps in your site’s Quality Management System. We can…
Learn More
See this post from the EMA: Just published: Q&A on the interoperability of biosimilar medicines in the European Union. This Q&A responds to questions raised by the publication of a…
Learn MoreWe will email you to start the conversation