GMP library generates statements on compliance of API suppliers

Published: 18-May-2020 Featured companies: Rephine
Regulatory

Rephine's GMP audit reports are personalised, detailed, and comprehensive and recognised and accepted by QPs and regulatory authorities around the world

Rephine's GMP library allows customers to receive an immediate independent statement on the GMP compliance of their API suppliers, and fulfil all necessary regulatory requirements. Rephine estimates that it has established the largest library of currently valid third-party audit reports and it now covers more than 4000 APIs

How does this process work?

Rephine has a library of GMP audit reports of suppliers that can be provided to their customers or potential customers. These audit reports are comprehensive and satisfy all QPs and regulatory authorities. All Rephine GMP audits are conducted by fully qualified and highly experienced consultants. All GMP audit reports are personalised, detailed, and comprehensive that are recognised and accepted by QPs and regulatory authorities around the world.

Click here to view the available audit reports in Rephine's library.

Contact Rephine at enquiries@rephine.com

Featured companies

See more

You may also like

Regulatory

How to comply with regulatory expectations to access compliance data for the entire pharmaceutical supply chain

Read more
The pharmaceutical supply chain must work and must be known, is not a novel idea. Anyone involved in this industry’s quality processes knows that mastering 100% of its supply chain has been unachievable in the current state-of-the-art… until now!

Trending Articles

  1. Overcoming CMC challenges in cell and gene therapy: part II Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
  2. Overcoming CMC challenges in cell and gene therapy: part I Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
  3. Momentum in the US cannabidiol market gains retailers' attention Walmart and other big-name stores in talks with food and drinks makers in preparation for the day CBD-enriched products are allowed on the shelves
  4. Ametek Mocon achieves accreditation for analytical testing laboratory Ametek Mocon, provider of instruments and services for testing, measuring and analysing a variety of gases, has achieved ISO/IEC 17025 accreditation for its Minneapolis analytical testing laboratory
  5. Chemistry, manufacturing and control (CMC) as key drivers for drug discovery success Embracing collaborative strategies not only accelerates drug development programmes but also fosters science-based milestone decisions, mitigates risks and prepares for successful market entry from the early stages of development, reports Frederick Duynslaeger, Senior CMC Writer at Ardena

Relevant companies

See more

Upcoming event

Cleanroom Conference UK

22–23 May 2024 | Exhibition | Birmingham, UK See all

You may also like

Regulatory

How to comply with regulatory expectations to access compliance data for the entire pharmaceutical supply chain

The pharmaceutical supply chain must work and must be known, is not a novel idea. Anyone involved in this industry’s quality processes knows that mastering 100% of its supply chain has been unachievable in the current state-of-the-art… until now!
Regulatory

Five reasons why it is necessary to digitise supplier compliance information in pharma

Regulatory bodies have increased awareness about falsified drugs and subsequently worked out requirements to prevent falsified drugs entering the legal pharmaceutical supply chain.
Regulatory

Quality Risk Management explained

Rephine’s Roger Smith, Consultant and Auditor, explains in this new white paper
Regulatory

Rephine shares mantras for preparing a GMP audit in the COVID Era

Rephine’s Alessandro Manni, Consultant and Auditor, explains
Regulatory

White paper: Core Auditing Behaviours

Rephine's Roger Smith, Consultant and Auditor, explains
Regulatory

Understanding investigations, root causes and implementing an effective CAPA system

Rephine's white paper is available to download now
Regulatory

Rephine extends its presence in India and Turkey

Rephine announces the formation of subsidiaries and offices in both India and Turkey bringing its 23 years of experience in quality compliance and regulatory affairs to local customers
Subscribe now