QP Declaration in Clinical Trials

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…

Learn More

Streamlining QP Certification for Clinical Studies in EU and UK

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…

Learn More

Expanding Your Supplier List: Considerations for Adding a Chinese Pharmaceutical Company

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…

Learn More

The Challenges of GMP Audits in Chinese Pharmaceutical Companies

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…

Learn More

EU GMP Annex 1: The Cost of Non-Compliance

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…

Learn More

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…

Learn More

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…

Learn More

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…

Learn More

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…

Learn More

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…

Learn More

More Posts

Let us tell you more

We will email you to start the conversation