This interactive eLearning course provides an in-depth understanding of PIC/S Annex 2A regulations for Advanced Therapy Medicinal Products (ATMPs), as outlined in PIC/S Version 17 (PE 009-17).
When was PIC/S Annex 2 split into Annex 2A for ATMPs and Annex 2B for Biological products?
Major updates to PIC/S Annex 2 (Biologicals) guidelines were implemented when the PIC/S PE 009-15 Annexes were updated.
PIC/S Annex 2 was divided into 2 separate Annexes (2A and 2B) as of PIC/S Version 15, effective 1 May 2021.
The current PIC/S version (PIC/S PE 009-17) retains these two individual Annexes (Annex 2A and 2B) due to the growth in both ATMPs (2A) and biological products (2B) in the pharmaceutical manufacturing industry.
The updated Annex 2 (2A GMP guidelines for ATMP manufacturing) came into effect on 1 May 2021 in many countries.
This online GMP compliance training will help researchers, quality teams and industry manufacturing professionals to understand the updated GMP compliance requirements for producing ATMPs, including cell-based medicines, gene therapies, and tissue-engineered products.
Successful completion of the Final Assessment awards a Certificate of Completion (for GMP training records).
The course takes approximately 4โ5 hours to complete and is available 24/7 for 12 months per user license.
It is recommended as part of a blended GMP training program alongside product-specific and onsite training.
Who Should Take This Course?
This training is designed for professionals involved in ATMP manufacturing and quality assurance, including:
โ Operations Managers & Quality Management Personnel
โ Responsible Persons & Batch Certification Teams
โ Hospital Medical Teams (Doctors, Nurses, Pharmacists)
โ Research & Laboratory Professionals
โ Regulatory Compliance & Auditing Personnel
โ Life Science & Biopharmaceutical Industry Professionals
Key Learning Topics
This Annex 2A ATMP GMP course covers:
๐ PIC/S Annex 2A GMP Requirementsfor ATMPs (Advanced Therapeutic Medicinal Products) โ which has been in effect as of 1 May 2021
๐ Pharmaceutical Quality System (PQS) for ATMPs โ Essential controls & compliance
๐ Risk Management in ATMP Manufacturing โ Recalls, emergency handling & testing
๐ Types of ATMPs & Quality Control Requirements โ Including xenogeneic & gene therapy products
๐ Cross-Contamination Prevention โ Best practices for ATMP facilities
๐ Sampling & Testing Procedures โ Regulatory expectations & sample retention periods
๐ Viral Vector Manufacturing & Outsourcing โ Vendor qualification & quality control
๐ Manufacturing Facility & Equipment Requirements โ Including closed-system operations
ATMP Manufacturers Training Resources
ATMPs represent one of the fastest-growing segments in the pharmaceutical industry, with an estimated annual growth rate (CAGR) of 13.2%. Due to the complexity of gene therapies, cell-based medicines, and tissue-engineered products, updated GMP regulations ensure compliance, safety, and efficacy.
With the major revisions in PIC/S Version 15, this course helps manufacturers stay compliant with Annex 2A and understand its impact on process flows, regulatory oversight, and risk-based quality management.
Note: Annex 2A (ATMPs) and Annex 2B (Biological Medicines) are now separate. The Annex 2B training course (Biological Pharmaceuticals) is available as a separate module and will be published next month.
Information on the new Annex 2A and 2B guidelines:
Purchase and complete the Annex 2A ATMPs GMP compliance training course
Note: This online GMP compliance training course covers Annex 2A (ATMPs).
Allow an average of 4 to 5 hours to complete this course, including the Final Assessment to gain your Annex 2A ATMP Manufacturing Training Course Certificate of Completion.
ATMP represents “advanced therapy medicinal products” and includes medicines used in gene therapies. Examples include xenogeneic and somatic cell-based therapies, tissue engineering, donor-matched cell-based medicines, DNA editing/genome editing, medicines delivered via plasmids/viral vectors, and various other medicines currently used to treat rare diseases and/or complex medical conditions, including tissue damage, organ failure, hereditary disorders/congenital diseases, infections, and tumours.
