Annex 19 – Reference and Retention Samples (PIC/S Annex 19)

Description

PIC/s Annex 19 – Reference and Retention Samples

EU and PIC/S updates to Annex 19 (Reference and Retention Sample requirements) went into force on 24 September 2026.

PIC/S Annex 19 – Reference and Retention Samples (PIC/S PE009-18)

Annex 19 of the PIC/S GMP Guide (PIC/S ‘Version 18’) sets out GMP guidance for the taking and holding of reference and retention samples. It is harmonised with Annex 19 of the European Commission’s EudraLex Volume 4 – EU Guidelines for Good Manufacturing Practice (GMP).

This interactive PIC/S Annex 19 e-Learning module will provide you and/or your team members with an understanding of the GMP regulations relating to reference and retention samples. Completing this course will help learners understand the latest requirements for reference and retention samples including samples of starting materials, intermediates (where stability permits), packaging materials/labels, and finished products. It is applicable to both the EC (EU) GMP guidelines and PIC/S guidelines for retaining, storing and documenting samples from different stages of production.

Note: PIC/S Annex 19 is not a standalone guidance publication. Sample requirements are also listed in other parts of the GMP Guide and in certain Annexes. Other legal requirements may apply, for example, to certain products such as biological products, Radiopharmaceutical products, and Investigational Medicinal Products (IMPs).

Learning objectives for EU & PIC/S Annex 19 (Online GMP Training)

Completing this PIC/S Annex 19 GMP compliance eLearning course will help learners to:

• Understand why sampling is an important part of the Pharmaceutical Quality System (PQS)
• Key principles of reference and retention samples
• Describe the differences between reference samples vs retention samples
• Recognise the GMP requirements for retaining samples for the required duration of storage time periods applicable to different sample types
• Understand the requirements for parallel imported and distributed products (EC/EU requirements)
• Understand the requirements for when a manufacturing facility closes down

PIC/S Annex 19 GMP Training Certificate (Course Certificate)

After successful completion of each course, learners will have the option of saving and/or printing a personalised GMP Training Course Certificate of Completion that meets regulatory GMP requirements.

One learner per licence. You can combine this course with other eLearning courses by clicking on one of the ‘bundle’ tabs on this page for discounted bundles of online GMP training courses. For training of over 20 personnel, send us a message on the contact us page with the subject line of ‘Training Enquiry’.

PharmOut also offers onsite training for teams of 10 or more personnel. Visit https://www.pharmout.net/training/ for information.

Course duration: Allow 1.5 to 2 hours to complete this course.