Description

PICS Annex 2 (Version 14) – Manufacture of Biological Medicinal Products for Human Use (GMP for biological medicines – Annex 2B)

Version 14 – Annex 2 in PE 009-14 – Manufacture of Biological Medicinal Products for Human Use

This interactive module covers the GMP regulations relating to the manufacture of biological 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.

Note: PIC/s Version 15 (PE 009-15) now separates Annex 2A (for ATMPs) and Annex 2B (for other biological medicines) into separate Annexes.
Read more.

The objectives of this Annex 2 (being updated to Annex 2B) biological medicines training module are for learners to better understand:

• the different methods by which biological medicinal products may be manufactured and the differing levels and types of regulatory controls
• the principles of biological manufacturing
• the personnel requirements
• the requirements for premises and equipment
• the requirements for animal quarters and care
• the importance of documentation
• production requirements and the importance of Quality Control

If you’re manufacturing Advanced Therapy Medicinal Products (ATMPs), purchase the PIC/s Version 15 – Annex 2A (ATMP) course by clicking here.

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.

Because Annex 2 was updated in PIC/s Version 15:

This Annex 2 course is currently being modified to cover the new GMP guidelines in Version 15 (covered in Annex 2B for biological medicines).

• PIC/s Version 15 (PE 009-15), Annex 2 was significantly modified with updates to GMP requirements.
• This course covers PIC/s Version 14 GMP for biological medicines (Annex 2)
• For GMP guidelines for ATMPs manufacturing, click here
• This Annex 2 GMP training course (biological medicines) is in process of being updated to Annex 2B
• The new Annex 2B course will cover the updated GMP requirements for biological medicines manufacturing as listed in the PIC/s Version 15 Annex 2B guidelines (PE 009-15).
• The new course (Annex 2B) will automatically replace this original/existing course upon publication, which is scheduled for late August 2021/early September 2021
• In other words, you will have the NEW version of GMP training for Annex 2B (biological medicines) as soon as it is published, automatically

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

Are you looking for the updates to Annex 2?

If your regulatory authority is auditing your GMP compliance for ATMPs or biological medicines using PIC/s Version 15, then read more about Annex 2A and 2B updates/modifications in PIC/s V15.

You can purchase this existing course on Annex 2 (V14) and know that it will be automatically updated to Annex 2B by early September, and you’ll still have 12 months’ 24/7 access to the online GMP training course for biological medicines manufacturing.

You can also purchase the ATMP GMP requirements training course based on PIC/s Version 15 (click here) if applicable to your industry, job role, and product lines.

What changed in the field of biological medicines and ATMP manufacturing requirements?

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.

Recommended reading (resources)

Article excerpt:

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

• PIC/s acknowledges that ATMPs and biological medicines are each a rapidly evolving sector of healthcare
• Each type had unique requirements for source materials and production and ATMPs were not covered adequately in the original PIC/s Annex 2 guidelines (pre-Version 15)
  • Prior versions of Good Manufacturing Practice (GMP) guidelines did not provide adequate, product-relevant guidelines for producing compliant medicines of this nature, particularly for ATMPs
• PE 009-14 guidelines were also open to broad interpretations by ATMP manufacturers, which could increase non-compliance and increase product risk/patient risks
• Continue reading