Qualified Person (QP) Declaration in Clinical Trials. When developing a new drug, it is critical to ensure that it is safe and effective for use in humans. Clinical trials are…
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When it comes to conducting clinical studies in EU and UK, one of the critical steps is obtaining Qualified Person (QP) certification. QPs play a crucial role in ensuring the…
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As the global pharmaceutical industry continues to expand, sourcing reliable and high-quality suppliers is crucial for ensuring the availability and integrity of medicinal products. China has emerged as a major…
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In recent years, the Chinese pharmaceutical industry has experienced remarkable growth and has become a significant player on the global stage. As the industry expands, meeting international standards and regulations…
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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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