Discussion Papers

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How Should Clinical Supply Chain Performance Be Measured?

While the objectives of supply chain metrics are applicable to multiple industries, the details of the metrics themselves may require customization, depending on the nature of the supply chain they are intended to manage. This is particularly relevant to clinical supply chain management wherein the very nature of the work includes unique but important elements that are worth measuring, for example accuracy of patient enrollment predictions.

Furthermore, although some individual clinical supply organizations have developed their own metrics, the investigational products community in general has not yet honed in on the most relevant KPIs, conducted benchmarking, or targeted a common set of metrics with associated performance standards.

Recognizing the potential benefit in doing this, the ISPE Investigational Products Community of Practice (CoP) has assembled a task team to address this need. The goal of the task team is to create a discussion paper/survey that establishes a framework for standardizing key performance indicators for the Clinical Material/Investigational Product Supply Chain.

Thus far the Investigational Products Task Team has assembled numerous potential measures, introduced them to the community in the January/February 2016 issue of Pharmaceutical Engineering® magazine, and obtained initial feedback at both the US and European 2015 and 2016 Annual Meetings and other clinical supply forums.

With this discussion paper/survey, we are encouraging the community of Clinical Supply Chain professionals to provide input on the importance and prioritization of the most relevant metrics, potential challenges, and solutions to overcome them, along with how each metric should best be captured for purposes of standardization.

The survey is now closed. 

The Investigational Products Task Team appreciates your participation and we look forward to reporting on the results.

Read the latest discussion papers on Process Validation and give us your feedback!

Let the authors know about process validation approaches that have worked for you and your company and lessons learned from proposed approaches. Your industry examples and direction could be used to create an ISPE Good Practice Guide.

Process Validation Lifecycle Implementation for Existing (“Legacy”) Products New

From the issuance of ICH Q8, Q9, and Q10 and the FDA Process Validation Guidance as well as subsequent guidance from various regulatory bodies, the ways of working in process validation have shifted dramatically to a lifecycle approach where decisions are based on product and process knowledge. The guidance that has been developed tends to be based upon new product introductions, but there are expectations for products which were validated and commercialized before this new guidance. This discussion paper examines some of the topics and challenges related to the implementation of current GMP process validation lifecycle concepts in the management of Quality Systems for existing products. This paper will discuss topics such as Current Validation Lifecycle expectations for legacy products, strategies for assessing and prioritizing requirements for legacy process/process validation remediation, expectations for revalidating a modified legacy process, and expectations for revalidating an unmodified legacy process based on existing PV “gaps”.

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

Determining the Number of Process Performance Qualification Batches Using Statistical Tools – Supplement to "Topic 1 – Stage 2 Process Validation" Discussion Paper

This discussion paper is presented as supplement to the original discussion paper that was issued in August 2012, “Topic 1 – Stage 2 Process Validation: Determining and Justifying the Number of Process performance Qualification Batches (Version 2)” proposing ideas for answering the question “How many process performance qualification batches (PV stage 2) are needed to demonstrate a high degree of assurance in the manufacturing process and that the control strategy is sufficiently robust to support commercial release of the product”. The purpose of this paper is to present four (4) statistical tools that may be applied to determine the number of PPQ batches. This paper discusses the statistical approaches, their limitations, assumptions, and also presents simulated examples. Considerable input has already been received, considered, and/or incorporated. The author team is interested in hearing about other approaches that could be used, and lessons from use of the proposed approaches described in the discussion paper and additional examples. The paper may be modified or expanded sometime in the future to reflect additional input.

Implementing Lifecycle Validation Practices at Contract Manufacturing Organizations

This paper discusses the nuances of lifecycle validation implementation at contract manufacturing organizations (CMOs). Much has already been written on the general implementation of best practices for lifecycle validation, including the elements of Quality by Design (QbD). CMOs have unique considerations for lifecycle validation implementation, however. These include differentiating responsibility for various stages of lifecycle validation for both the CMO and the customer, implementing quality systems that allow flexibility for various customer approaches, process knowledge-transfer mechanisms between the CMO and the customer, and generating a quality agreement that captures the elements of lifecycle validation.

Topic 1 – Stage 2 Process Validation: Determining and Justifying the Number of Process Performance Qualification Batches

This discussion paper proposes ideas for answering the question “How many process performance qualification batches (PV stage 2) are needed to demonstrate a high degree of assurance in the manufacturing process and that the control strategy is sufficiently robust to support commercial release of the product?” The purpose of this paper is to stimulate further discussion and suggest potential practical application.

Note: Version 1 of this document has been replaced to correct a statistical calculation error.

Topic 2 – Stage 3 Process Validation: Applying Continued Process Verification Expectations to New and Existing Products

This discussion paper proposes ideas for answering the questions How is Stage 3 monitoring and testing following PPQ determined, as part of the lifecycle approach to PV? What is the impact of the lifecycle approach to monitoring and testing of existing/legacy products? The purpose of this paper is to stimulate further discussion and suggest potential practical application.

Topic 3 – Lifecycle Approach to Biotech Process Validation

This discussion paper proposes ideas for answering the questions about the application of the lifecycle approach to PV to Biotech product manufacturing. The paper discusses unique elements of application to biotech products and similarities and differences as compared with utilizing the lifecycle approach to PV to validate other drug substance/API and drug product manufacturing. The purpose of this paper is to stimulate further discussion and suggest potential practical application.

Topic 4 – Evaluation of Impact of Statistical Tools on Process Performance Qualification (PPQ) Outcomes

This discussion paper uses segments of typical validation case studies (validation of key attributes such as: content uniformity, packaging key attributes and packaging critical defects) to apply various statistical tools and compare the outcomes of applying each tool pointing out the pros and cons of each application. General comment is also made on the statistical tools applied with some advantages, disadvantages and misuses briefly summarized.

 

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