Annex 16 – Authorised Person and Batch Release

Description

Annex 16: Authorised Person & Batch Release – eLearning Course

PIC/S GMP Compliance Training: Annex 16 eLearning Overview

This interactive eLearning module provides participants with a comprehensive understanding of PIC/S Annex 16 (PIC/S GMP Guide PE 009-17) regulations related to batch certification and release by the Authorised Person (AP).

Learners will gain insights into the roles, responsibilities, and Good Manufacturing Practice (GMP) expectations for batch release, as outlined in the current PIC/S PE 009-17 guidelines (PIC/S Version 17).

Certificate GMP Course for Annex 16: Authorised Person

• Upon successful completion of an online assessment, learners receive a Certificate of Completion (for GMP training records).
• This course can supplement onsite GMP compliance training and is best integrated into a blended, product-specific GMP training program.
• The online module is available 24/7 for up to 12 months per user license.

PIC/S Annex 16 Key Learning Topics

This GMP elearning course for Annex 16: Authorised Person & Batch Release course will help you to understand:

• The role of the Authorised Person (AP) as described in PIC/S PE 009-17 (which was added to the PIC/S GMP Guide Version 16 in 2022)
• Compliance Verification – Ensuring adherence to GMP, Marketing Authorisation, and national laws
• Batch Certification & Release Requirements – Key steps and regulatory expectations
• Batch Documentation & Compliance Control Records – Essential records for AP review
• Multi-Site Manufacturing & Certification Responsibilities
• Third-Party GMP Assessments & Audit Approvals
• AP Qualifications & Training – Education, experience, and skills required for the role

This course provides practical knowledge on batch certification and release for use, sale, or export [for pharmaceutical products] aligning with regulatory expectations across multiple jurisdictions.

Certificate GMP Course for Annex 16 Compliance

• Upon successful completion of an online assessment, learners receive a Certificate of Completion (for GMP training records).
• This course can supplement onsite GMP compliance training and is best integrated into a blended, product-specific GMP training program.
• The online module is available 24/7 for up to 12 months per user license.

Who Should Complete This Course?

This training is designed for Authorised Persons (APs) and other professionals involved in batch certification and release, including:
✅ Quality Managers & Associates
✅ Operations Managers
✅ Auditors & Inspectors
✅ Quality Risk Management (QRM) Personnel
✅ Logistics & Quality Testing Laboratory Personnel
✅ Pharmaceutical Business Owners & Industry Professionals

It is particularly useful for professionals in multi-site manufacturing operations and those working under regulatory authorities such as the EU, FDA, TGA, and other Competent Authorities.

Manufacturers and distributors of pharmaceutical products in Australia are encouraged to also complete the TGA Release for Supply training course in addition to this PIC/S Annex 16 course. Find that course and other GMP Compliance training courses by clicking here.

GMP Course Certificate

After the successful completion of each course, the trainee will have the option of printing or saving a personalised GMP training certificate that meets regulatory GMP requirements.

Also recommended: Pharmacovigilance training, Deviations Management, Complaints Management