Search Results for: annex 15

PIC/s Annex 2A for ATMPs – GMP Regulation Updates
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PIC/s Annex 2A for ATMPs – GMP Regulation Updates

This article provides an introduction to the PIC/S Annex 2A updates in Version 15 in relation to Good Manufacturing Practice (GMP) requirements for Advanced Therapy Medical Products (ATMPs). PIC/s guidance on ATMPs and biological medicines: what changed in PIC/S Version 15? GMP requirements for the production of ATMPs (in Annex 2A) are now in a…

PIC/S Annex 2B Biological Products for Human Use
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PIC/S Annex 2B Biological Products for Human Use

GMP regulations (PIC/S guidelines) for Biologicals manufacturing were covered in the PE009-14 PIC/s (Annex 2: Manufacture of Biological Products for Human Use). However, PIC/S Annex 2 was changed in PIC/s Version 15 (now Version 16). The original PIC/S Annex 2 was divided into 2 separate Annexes, Annex 2A (ATMPs) and Annex 2B, covering Biological products….

Annex 2B – Manufacture of Biological Substances & Medicinal Products for Human Use

Annex 2B – Manufacture of Biological Substances & Medicinal Products for Human Use

Course duration: Allow 1.5 to 2 hours to complete this training course.

Note: This course currently covers GMP requirements in PIC/S Annex 2B which are applicable to the manufacture of biological substances and medicines as per PIC/S publications PE 009-15 & PE 009-16 (2022).

 

GMP eLearning – Top 5 Induction Programs
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GMP eLearning – Top 5 Induction Programs

What are the Top 5 GMP eLearning induction programs in the life sciences industry? If you manage Induction Programs for your new employees, it’s likely you need to get them up to speed within a rapid time frame. It’s often difficult to devote uninterrupted time to training new employees. Finding Managers with time available to…

GACP & GMP for Herbal Medicine Manufacturing
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GACP & GMP for Herbal Medicine Manufacturing

Introduction to compliance with GACP, GMP and Medicinal Cannabis Industry Regulations | Industry-specific courses (Medicinal Cannabis Industry Education Compliance Topics). PIC/S GMP Annex 07 for Herbal Medicine Manufacturing compliance requirements Are you needing to train your employees, contractors, warehouse personnel or suppliers in PIC/S GMP (Good Manufacturing Practice)?  If your team needs to understand the…

Blood, Tissues, Biologicals & ATMPs Regulations in Australia
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Blood, Tissues, Biologicals & ATMPs Regulations in Australia

Ensuring Safety and Integrity: The Significance of Blood, Tissues, Biologicals & ATMPs Regulations in Australia In Australia, medicinal products sourced from human blood or tissues represent a critical component of the healthcare system. Blood, blood components, tissue-derived products, biologicals and ATMPs are regulated by the Australian TGA (Therapeutic Goods Administration) under the Therapeutic Goods Act…

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