Annex 16 – Authorised Person and Batch Release

Description

Annex 16 – Authorised Person and Batch Release

This interactive e-Learning module provides the participant with an understanding of the PIC/S GMP regulations in Annex 16 (PIC/S GMP Guide PE 009-16) relating to batch certification and release by the Authorised Person (AP).

Revision of PIC/S Guidelines (2022 publications)

• This new GMP education topic covers the PIC/S 2022 Guidelines detailed in Annex 16: Authorised Person and Batch Release.
• Learners completing this GMP course will learn about the roles and responsibilities of the Authorised Person (AP) as well as GMP expectations for batch certification and batch release procedures, which are detailed in the PIC/S 2022 guidelines (PIC/S Version 16).
• This online module is available 24/7 for up to 12 months (one user per licence).

Certificate GMP Course for PIC/S Annex 16

• Successful completion of an online assessment will provide a Certificate of Completion for this GMP education topic (for your personnel/GMP training files).
• This course can be used to supplement your onsite GMP compliance training program and is best when employed as part of a blended, product-specific GMP training program for pharmaceutical industry personnel.

Who should complete this PIC/S Annex 16 compliance course?

PharmOut’s PIC/S Version 16/Annex 16 training module is suitable for the person fulfilling any responsibilities related to batch certification and release (e.g. the Authorised Person and their qualified delegates) or related quality controls including transport of the batch.

• This fully-online training course is suitable for APs and other industry professionals working in various jurisdictions around the world and/or who have multi-site manufacturing operations.
• The training course for Authorised Persons/Batch Release processes is primarily focused on the newly released PIC/S guidelines for batch certification and release by the AP; but it includes examples of additional guidance from Competent Authorities such as the EU, the FDA, and the TGA relating to batch certification and batch release requirements.
• Australian manufacturers and distributors are also encouraged to take the TGA Release for Supply training course as well as this PIC/S Annex 16 course.

The course should be combined with intensive onsite training and product training, to meet the regulatory expectations for an Authorised Person (AP) and/or other quality management roles.

This Batch Certification & Release (Annex 16) training course is also suitable for:

• Quality Managers and Quality Associates
• Business Owners
• Operations Managers
• Auditors/inspectors
• Quality risk management (QRM) personnel
• Others

It may also be suitable for training logistics personnel, quality testing laboratory personnel, business owners, and other pharmaceutical manufacturing industry professionals with an interest in this aspect of manufacturing and quality control/quality risk management as part of the PQS.

This course on PIC/S ANNEX 16: Authorised Person and Batch Release covers GMP requirements for batch certification and batch release for use, sale, or export.

PICS Guidelines PDF 2022 (Version 16)

Many of our online GMP training courses include PIC/S PE009-16 GMP Guide updates (PIC/S GMP GUIDE PDF) 2022 (PIC/S Version 16).

The online Annex 16 Authorised Person & Batch Release training course includes information on:

• the role of the Authorised Person (AP) as described in the 2022 PIC/S Guidelines PDFs (Version 16) released in February 2022
• responsibilities for verification of compliance with GMP, the Marketing Authority, and national laws
• certification processes and batch release requirements
• which batch manufacturing documents and compliance control records should be checked by the Authorised Person who is certifying the batch for release for use, sale, or export
• the requirements for multi-site manufacturing in relation to certification and batch release responsibilities
• third-party GMP assessments and third-party audit approvals
• examples of the education, qualifications, experience and skills generally required for the role of Authorised Person (noting this can vary based on product type and other factors)

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