Process Validation Lifecycle for Packaging Oral Solid Dosage Forms
In August 2017, ISPE published the Discussion Paper “Overview of Packaging Validation for Drug Products,” which explores the different ways to implement packaging validation; however, it does not provide specific guidance on oral solid dosage forms packaging. This paper aims to address this gap using concepts based on the 2011 FDA Guidance, Process Validation: General Principles and Practices. Topics discussed in this Discussion Paper include managing risks in Stages 2 and 3 and using the statistical analysis of Stage 2.2 results as part of a comprehensive PPQ evaluation. Additionally, developing and implementing a Continued Process Verification plan is reviewed. The author team is interested in receiving feedback on the topics presented for applying the process validation lifecycle to oral solid dosage forms packaging, including lessons learned through regulatory agency feedback during review and inspection.
The paper may be modified or expanded sometime in the future to reflect additional input.
*The views expressed in this Discussion Paper by contributing authors represent their personal views and do not represent the official position of individual companies or regulatory authorities. This paper is not a regulatory guideline and the information in this paper does not reflect agreements among authors on content of process validation documentation.
1 Introduction
Packaging validation is the collection and evaluation of data to establish evidence that the packaging process is capable of consistently delivering packaged product that retains its suitability for its intended use. This paper presents concepts for implementing the process validation lifecycle approach to Oral Solid Dosage (OSD) forms packaging processes.
The ISPE Discussion Paper “Overview of Packaging Validation for Drug Products” [1] explores the different ways to implement packaging validation; however, it does not provide specific guidance on OSD forms packaging. This paper aims to address this gap using concepts based on the 2011 FDA Guidance, Process Validation: General Principles and Practices [2]. Covering Stages 2.2 and 3, this paper discusses risk assessments, developing sampling plans using Acceptance Quality Limit/Rejectable Quality Limit (AQL/RQL), and statistically determining an intra-batch sampling plan. Additionally, a review is provided of the Process Performance Qualification (PPQ) statistical analysis with suggestions for risk-based assessments to address results beyond specifications as part of a comprehensive evaluation. Developing and implementing a Continued Process Verification (CPV) plan is also presented.
2 Background and Scope
A packaging system is “the sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. A packaging system is equivalent to a container closure system.” [3, 4]