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Are You Ready for EU GMP Annex 1?

  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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Welcome to PNR, Ray Collia!

We are very pleased to announce that GRGC, a specialist research, communications and business development consultancy, are working with us to support our growth. Ray Collia, one of GRGC’s co-founders,…

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PNR to be panelists – PHSS workshop June 13-14

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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Welcome to PNR, Di Morris!

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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UK clinical trials regulation overhauled

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?

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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Advanced Therapies 14-15 March in London

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! Annex 1 is almost here!

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 approved for the MIA (IMP) QP oversight license

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 GMP compliant?

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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