Supplier Qualification for Packaging Material

Recommendation

27-29 February 2024

GMP meets GCP - Live Online Training
Management, Supply and Quality Assurance of Clinical Trials

USP´s Packaging and Distribution Joint Subcommittee posted a proposal for the development of a new General Chapter <1xxx> Supplier Qualifications. The Joint Subcommittee will make recommendations to the General Chapters (GC) Packaging and Distribution Expert Committee who will be responsible for this new standard. The input deadline is 25 April 2021. The final proposal is expected to be published for comment in Pharmacopeial Forum (PF) 47(5) [September / October 2021].

Supplier qualification based on risk management and technical agreements

The various sources for packaging material include external, local, and global suppliers. External suppliers frequently also provide additional services such as assembly, analysis, packaging, warehousing, transportation, distribution, etc. This means that packaging components used in the final product have to be manufactured according to the appropriate (GMP-) standards. It also means that the processes in the supply chain for a material or service have to comply with relevant regulations and (GDP-) requirements (if applicable).

According to the USP pharmaceutical manufacturers should have processes in place to systematically evaluate packaging suppliers based on

• The risk to the quality of the material or service supplied,
• Compliance of the quality systems to relevant regulations and (GMP / GDP-) requirements, if applicable,
• The reliability of the supplier to avoid quality deviations and shortages of packaging components and / or materials,
• A supply contract or quality agreement.

The approach includes the identification and selection, evaluation and acceptance, performance monitoring, and disqualification of packaging material suppliers (e.g., primary, secondary, ancillary and shipping packaging), and service providers (e.g., logistic providers for warehousing and transportation, analytical services).

More information can be found in USP´s announcement for the new General Chapter  <1xxx> Supplier Qualifications.