The new GMP Annex 1 standards will enter into force on 25 August 2023 (except for Chapter 8.123, which is postponed until 25 August 2024), and all organisations involved in…
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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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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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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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When planning clinical project timelines, the certification of batches by the QP can be a rate limiting step causing hold-ups and frustration within the clinical supplies team. Being able to interact with and…
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Season’s Greetings from the PNR Pharma team. Wishing you all the best for the holidays and looking forward to further supporting our clients through 2023
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Post from the HPRA: We have published recordings from our recent #IVDR webinar for manufacturers, importers, distributors, health institutions, authorised representatives and performance study sponsors working to implement the new Regulation. Five…
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