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

USD $35.00

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).


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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.

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.

PICS Annex 2B biological-medicine-GMP-requirements-PICsAnnex2B

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.

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

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

Annex 2B biologicals biological-medicines-Annex-2B-Annex 2-GMP

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).