Author: Site Editor Publish Time: 2026-10-19 Origin: Site
September 23, 2026 | Pharmaceutical Regulatory Update
On September 23, 2026, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced the revision of its Guide to Good Manufacturing Practice for Medicinal Products, introducing the updated Annex 19, Reference and Retention Samples, under document PE 009-18. The revised guide took effect on September 24, 2026, in alignment with the corresponding revision of EU GMP Annex 19.
The update primarily concerns Section 9, which addresses reference and retention samples for parallel-imported, parallel-distributed, and parallel-traded medicinal products. It clarifies sample management requirements for repackaging operations, including packaging material retention, finished product samples, and the conditional use of photographic or digital samples.
For pharmaceutical manufacturers and quality professionals, the revision reinforces the importance of representative samples, batch traceability, and data integrity throughout the product lifecycle.
The revised Annex 19 provides more specific requirements for sample management during the repackaging of parallel-traded medicinal products.
Physical samples of packaging materials used during repackaging—including labels, cartons, patient information leaflets, and other package inserts—must be retained for the shelf life of the repackaged finished product.
This requirement helps preserve evidence of the packaging configuration and labeling used for products released to the market, supporting subsequent quality investigations and traceability.
A retention sample must be taken for each repackaging operation and must represent the finished product as released to the market. The sample must be retained for at least one year after the expiry date of the repackaged product.
The revised requirements also clarify that a separate reference sample for analytical testing is not required for these specific repackaged products under Section 9.
These provisions address the risks associated with repackaging, including potential product mix-ups and discrepancies in labeling or packaging configuration. They also help ensure that an appropriate physical record of the marketed presentation remains available for future investigation.
One notable aspect of the revision is the explicit provision for photographic or digital retention samples under defined circumstances.
A photographic or digital sample may be used only when the inability to retain a physical sample of the repackaged finished product is duly justified and prior authorization has been obtained from the competent authority.
The digital sample must support a full visual examination equivalent to that of a physical retention sample. It must capture the relevant product presentation and packaging information, including the batch number, expiry date, and applicable safety features.
Digital records must also remain traceable to the relevant batch and repackaging documentation. Electronic storage systems must comply with the applicable requirements of GMP Annex 11, supporting data integrity and the continued reliability of records throughout the required retention period.
Digital retention samples should therefore not be regarded as a general substitute for physical samples. Their use is conditional on a justified need, prior regulatory authorization, and compliance with the relevant technical and data integrity requirements.
The revision primarily addresses sample retention for parallel-imported, parallel-distributed, and parallel-traded medicinal products undergoing repackaging.
The applicability of Section 9 remains subject to local legislation covering these activities. The revision should not be interpreted as a comprehensive change to retention and reference sample requirements for all medicinal products or all manufacturing operations.
Pharmaceutical companies should assess the requirements in the context of the applicable national legislation, product category, packaging process, and regulatory commitments. Particular attention should be given to distinguishing the requirements for repackaged parallel-trade products from the general sample management requirements applicable to other products.
For companies operating across multiple markets, differences in local implementation should also be considered when establishing global quality procedures.
The revised Annex 19 provides a timely opportunity for pharmaceutical manufacturers, quality assurance (QA) teams, and quality control (QC) functions to review their existing sample management systems.
Review sample retention procedures. Confirm that packaging material samples and finished product retention samples are collected, identified, and retained for the required periods for applicable repackaging operations.
Verify sample representativeness. Ensure that retained finished product samples accurately reflect the final marketed presentation, including relevant packaging components and labeling.
Strengthen batch traceability. Maintain clear links between original product batches, repackaging operations, final packaging configurations, and associated quality records.
Assess digital record controls. Where digital retention samples are permitted and authorized, verify that the storage system, access controls, record integrity, retrieval capabilities, and retention arrangements meet applicable GMP requirements.
Update quality documentation. Review relevant standard operating procedures (SOPs), batch packaging records, retention schedules, and training materials to ensure alignment with applicable regulatory requirements.
These actions can help quality teams demonstrate that sample management processes remain effective and that appropriate evidence is available to support investigations and regulatory inspections.
The PIC/S Annex 19 revision highlights three continuing priorities in international pharmaceutical quality management: sample representativeness, end-to-end traceability, and data integrity.
Effective sample management is not simply a matter of retaining materials for a specified period. Retained samples must provide meaningful evidence of the product as released to the market, while the associated records must enable investigators and inspectors to reconstruct relevant packaging and batch histories.
For pharmaceutical companies serving international markets, regulatory compliance requires more than updating a single procedure. It requires a coordinated quality system that connects packaging operations, sample retention, documentation, electronic records, and batch traceability.
Companies should therefore monitor developments from PIC/S and EU GMP, evaluate their applicability to specific products and markets, and incorporate relevant changes into their quality management systems.
As international GMP standards continue to evolve, maintaining representative samples and reliable records will remain essential to pharmaceutical quality assurance, effective investigations, and sustained regulatory compliance.
