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In this environment, the distribution and transport of medicines and active ingredients (APIs) for human use are key supply chain activities that must be controlled in order to maintain the quality and integrity of the medicines, as set forth in the European regulations, 2011/62/EU and related Guides 2013/C 343/01 and 2015/C 95/01, as well as current FDA initiatives and expectations.
How to identify all the actors involved in the supply chain?
What controls should be established along the supply chain?
Who should have a GDP certificate for the distribution or transport of medicines?
What is a GDP certificate and who can issue it?
How responsibilities along the supply chain should be defined?
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.
Blog From repeatable rigour and experienced expertise, to highly ethical and transparent practices Alasdair Leckie, VP Audit Services, Rephine As in any other area of life …
Pharmaoffer, the ‘Amazon’ of API suppliers, will link its customers to Rephine’s vast library of live, off-the-shelf GMP audit reports of manufacturers around the world …
Article Live online event to be held on April 17th-18th 2023 and will feature deep domain expertise within the scope of Quality Assurance. Stevenage, Hertfordshire, 27th …
Article The strategic alliance will offer global pharmaceutical companies a streamlined, software-based solution to enhance quality assurance across their global supply chains San Francisco, February 28, …
Blog EUROPEAN COMMISSION PROPOSAL AMENDING MDR & IVDR TRANSITIONAL PROVISIONS (2023) On February 16 2023, the European Parliament finally voted on the EU Commission Proposal about …
Article Specialist GMP auditors will provide three speakers at the event, focusing on Good Manufacturing Practice, Quality Management Digitization, and GMP & Quality Data Integrity. …
Blog An appeal to the European health authority for leeway on the August 2023 compliance date has been rejected, putting the onus back on drug manufacturers …
Article Summary EU GMP Annex 1 requirements for Manufacture of Sterile Medicinal Products were revised in August 2022, starting the clock for compliance by August 2023. …
Article Pharma Manufacturing Transitions to Biotech and Personalized Therapies Drives Quality Process Innovation Article by Dr. Eduard Cayón, Rephine Published by Pharmaceutical Outsourcing The past decade …
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