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…
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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….
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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…
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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…
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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…
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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….
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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…
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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…
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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…
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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…
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