Rephine HQ, UK
+44 1763 853135
Barcelona, Spain +34 934 178065
However, the FDA’s ‘risk-based-approach’ initiative and, later, the guidelines that emerged from that initiative: ICH Q8, Q9, Q10, Process Analytical Technology (PAT)… brought the requirement for the application of GxP principles (GLP, GMP, GCP) to the entire Lifecycle of a pharmaceutical product in a much higher level.
Concepts such as Quality by Design (QbD) are applied since the initial stages of development. The application of solid scientific criteria for the evaluation of results and data or the design of experiments, contribute to the knowledge and understanding of the product and the process, which is the key for obtaining and demonstrating the necessary control on the process and its design and the consistent quality of the product.
During the development phases of drugs, products used in clinical trials must be manufactured with quality standards equivalent to those applied in commercial drugs, adapting some requirements to the development phases. The labelling and secondary packaging of clinical trial medication is an essential part of the process to ensure that volunteers or designated patients take assigned medication..
We provide extensive GMP consulting and regulatory services to help keep our clients ahead of the needs and expectations of regulators.
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, …
EUROPEAN COMMISSION PROPOSAL AMENDING MDR & IVDR TRANSITIONAL PROVISIONS (2023) On February 16 2023, the European Parliament finally voted on the EU Commission Proposal about …
Specialist GMP auditors will provide three speakers at the event, focusing on Good Manufacturing Practice, Quality Management Digitization, and GMP & Quality Data Integrity. …
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 …
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. …
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 …
Bringing rigour to global supply chains as the reinvention of medicine continues by: Dr. Eduard Cayon, VP Audit Services, Rephine New waves of innovation in …
About this Ebook In August, the revised EU GMP Annex 1 requirements, related to the Manufacture of Sterile Medicinal Products, were issued, starting the clock for …
Telephone:
Rephine HQ, UK
+44 1763 853135
Barcelona, Spain +34 934 178065
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