Overview of Packaging Validation for Drug Products

Numerous guidances are available from regulatory and industry sources concerning process validation; however, very few provide information regarding the packaging process. This paper begins a discussion on the varied ways to implement packaging validation. Focusing on the primary, secondary and tertiary packaging of drug products, it offers available tools and demonstrates, through limited examples, their use in a packaging validation regime. This paper incorporates common validation approaches into the packaging process by offering suggestions for risk mitigation, determining product matrixes and sampling plans, as well as strategies for developing a packaging ongoing process verification program. The author team is interested in receiving feedback, and information about other approaches, including lessons learned.

The paper may be modified or expanded sometime in the future to reflect additional input.

Authors: Richard Chandler (Unither Pharmaceuticals, USA), Paul Corbishley (AstraZeneca, UK), Walter Harper (Eli Lilly, USA), Matthew McMenamin (GlaxoSmithKline, USA), Dilip Somayajula (Co-Lead) (Boehringer Ingelheim, USA), Erica Stolz (Lead) (Clarke Solutions, USA)

1 Introduction

The ISPE Process Validation Team recognized a potential gap in the knowledge of process validation of packaging processes. In response, the committee enlisted a cross-functional team to 1) seek guidance from similar, well-established industry standards or practices (e.g., International Medical Device Regulators Forum or IMDRF) and 2) formally solicit feedback on packaging process validation from drug manufacturing industry leaders and peers by way of an ISPE discussion paper. This paper looks at recognized process validation definitions, theories, and tools and how they transcend manufacturing and packaging of all dosage forms.

2 Scope

The scope of this paper is the application of process validation methods and tools as they pertain specifically to the drug product packaging process. Packaging processes examined in this paper include primary, secondary, and tertiary packaging operations.

This paper provides some example case studies taken from the experiences of panel members. The case studies are not intended to be authoritative but to encourage thought and discussion. Readers are asked to provide their insights and/or questions about the packaging validation process.

The following topics are not included in the scope of this paper. For most of these topics, published regulatory and/or international industry standards are available.

  • Product package design process (e.g., package materials selection, package design or package design validation) [1, 2]
  • Filling of sterile injectable products [3, 4]
  • System Qualification e.g., Commissioning and Qualification (C&Q) [5], Verification
  • Packaging of medical devices [6]
  • Package serialization e.g., in accordance with the United States Drug Supply Chain Security Act [7]

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