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

Description

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

This eLearning course covers PIC/S GMP requirements for the Manufacture of Biological Substances and Medicinal Products for Human Use (Annex 2B) in PIC/S Version 16.

• This interactive module covers the GMP regulations relating to Annex 2B (biologicals/biological medicines).
• This section of the former PIC/S Annex 2 (now 2B) covers the manufacture of biological substances and medicinal products for human use.
• This module is suitable for all manufacturing, engineering, warehouse, and quality personnel involved in the production of biological medicinal products.

History of Annex 2 (Biologicals) and ATMPs – changes to PIC/S Annexes

• Note: PIC/S Version 15 (PE 009-15) was the first PIC/S version to separate out ATMPs from other biological products.
• The original Annex 2 was split into 2 separate parts, Annex 2A (for ATMPs) & Annex 2B (this module) for biological substances and medicines for human use.
• Read more about the split of Annex 2 into two separate guidelines.

This online GMP training module is based on the latest PIC/S guidance in Annex 2B (Biological substances/biological medicines) as described in PIC/S Version 16 (PE 009-16) effective as of February 2022.

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This online training presentation for Annex 2B (biological substances/medicines) aims to help learners better understand:

• the different methods by which biological medicinal products may be manufactured and the differing levels and types of regulatory controls
• principles of biological manufacturing
• personnel requirements for manufacturing and/or administering biological substances and medicines
• requirements for premises and equipment for biological substances and medicines for human use
• general requirements for animal quarters and care relating to biological medicines
• importance of documentation
• production requirements and the importance of Quality Control

This course covers Annex 2B (Biologicals) based on PIC/S GMP Guidance.

If you’re manufacturing Advanced Therapy Medicinal Products (ATMPs), purchase the PIC/S Version 16 – Annex 2A (ATMP) course by clicking here.

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GMP Training Course Certification for Annex 2 (soon to be Annex 2B) for Biological Medicines

After successful completion of each online GMP training course (including the Final Assessment, all available online with 24/7 access for 12 months from purchase), you can print, save, and forward a personalised training certificate that meets regulatory GMP requirements.

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Annex 2 was converted into two separate Annexes (2A and 2B) in PIC/S Version 15

• PIC/S Version 15 (PE 009-15) Annex 2 for biological medicines was significantly modified compared to Version 14 in terms of GMP requirements.
• This online course covers PIC/S Version 16 GMP for biological medicines (Annex 2B)
  • Note the latest guidance from PIC/S is in Version 16 (PE 009-16)
  • Annex 2A and 2B guidance did not change between PIC/S Versions 15 & 16
  • This Annex 2B training course also covers PIC/S Version 15 which is currently referred to by the TGA
• Looking for GMP guidelines for Annex 2A – ATMPs manufacturing? Click here for Annex 2A.

Annex 2A (covering ATMP GMP requirements) is a separate GMP training course and must be purchased and completed separately.

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Updates to PIC/S Annex 2B   

Read more about Annex 2A and 2B updates/modifications first occurring in PIC/S Version 15 (now Version 16).

What changes occurred relating to GMP requirements for biological substances and biological medicines & ATMPs?

Read more about the PIC/S updates to Annex 2 and the new guidelines in our summary article/blog on the topic of GMP for biological medicines and related products.

Why were updates to Annex 2 needed for ATMPs and biological medicines GMP guidelines?

• When it came to changing Annex 2 requirements (in PIC/S 009-15), PIC/S acknowledged that ATMPs & biological medicines were each rapidly evolving, and independent, sectors of healthcare and pharmaceutical manufacturing
• Each type of substance/medicine had unique requirements for source materials and for production processes
• ATMPs were not covered adequately in the original PIC/S Annex 2 guidelines (pre-Version 15) which became Annex 2B with generally minor modifications
• Weaknesses of the earlier PIC/S versions of GMP guidance for ATMPs and Biologicals:
  • Did not provide adequate, product-relevant guidelines for producing compliant medicines of the varying nature of these types of medicines, particularly for ATMPs
  • Previous PIC/S guidelines (through PE 009-14) were open to broad interpretations by ATMP manufacturers
  • Guidance subject to broad interpretations inherently increases risks of non-compliance with product safety, quality and efficacy requirements and thereby increases risks to patients

Scroll up and add this product to your cart to take the PIC/S Annex 2B Biologicals (PIC/S GMP compliance training course by PharmOut).

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