Publications by authors named "Derek Willison-Parry"

5 Publications

  • Page 1 of 1

Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program.

PDA J Pharm Sci Technol 2020 Mar-Apr;74(2):249-263. Epub 2019 Nov 15.

Takeda, Cambridge, MA.

For manufacturers of both sterile and nonsterile pharmaceuticals, there is an expectation that the manufacturing process is performed in a manner that prevents extraneous contamination so that the products are provided in a safe, integral, pure, and unadulterated form. As part of that process, cleaning and disinfection are an absolute necessity. Although cleaning and disinfection support control of microbial contamination through preventive and corrective action, specific compendia methods do not currently exist. The intent of this paper is to provide a general guidance on how to perform disinfectant efficacy validation and implementation. This includes how to make sure the concepts are understood, how to interpret facility data and utilize it to demonstrate control awareness for your facilities, and how to leverage the data to reduce redundancies in validation or verification. This paper represents the thoughts and best practices of the authoring team and their respective companies and provides an efficient way to qualify disinfectants without impacting the quality of the study. If you choose to follow the recommendations in this paper, you must ensure that the appropriate rationale is sound and the scientific data is documented. It is the belief of the authoring team that only then will this approach meet regulatory requirements.
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http://dx.doi.org/10.5731/pdajpst.2018.009662DOI Listing
January 2021

Microbiological Control for Affinity Capture Chromatography Processing: An Industry Perspective.

PDA J Pharm Sci Technol 2018 Mar-Apr;72(2):213-221. Epub 2018 Feb 14.

BPOG

The purpose of this paper is to provide a summary of a BPOG-led industry survey of the microbiological control aspects of affinity chromatography processing in the biopharmaceutical industry. The document provides a summary of historical microbiological control concerns, coupled with industry-derived best practices, for material, equipment, and storage controls required to mitigate the potential for microbial ingress and contamination of chromatography resin and equipment. These best practice guidelines, which are derived from the members of the BPOG Bioburden Working Group, are intended to assist biopharmaceutical manufacturers to enhance microbial control and monitoring strategies for chromatography systems.
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http://dx.doi.org/10.5731/pdajpst.2017.008045DOI Listing
March 2019

Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities.

PDA J Pharm Sci Technol 2018 Jan-Feb;72(1):91-103. Epub 2017 Oct 12.

GSK

In multi-product biopharma facilities, the protection from product contamination due to the manufacture of multiple products simultaneously is paramount to assure product quality. To that end, the use of traditional changeover methods (elastomer change-out, full sampling, etc.) have been widely used within the industry and have been accepted by regulatory agencies. However, with the endorsement of Quality Risk Management (1), the use of risk-based approaches may be applied to assess and continuously improve established changeover processes. All processes, including changeover, can be improved with investment (money/resources), parallel activities, equipment design improvements, and standardization. However, processes can also be improved by eliminating waste. For product changeover, is any activity not needed for the new process or that does not provide added assurance of the quality of the subsequent product. The application of a risk-based approach to changeover aligns with the principles of Quality Risk Management. Through the use of risk assessments, the appropriate changeover controls can be identified and controlled to assure product quality is maintained. Likewise, the use of risk assessments and risk-based approaches may be used to improve operational efficiency, reduce waste, and permit concurrent manufacturing of products.
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http://dx.doi.org/10.5731/pdajpst.2016.007419DOI Listing
April 2019

Risk Management in Biologics Technology Transfer.

PDA J Pharm Sci Technol 2016 11/12;70(6):596-599. Epub 2016 Jun 20.

Technology transfer of biological products is a complex process that is important for product commercialization. To achieve a successful technology transfer, the risks that arise from changes throughout the project must be managed. Iterative risk analysis and mitigation tools can be used to both evaluate and reduce risk. The technology transfer stage gate model is used as an example tool to help manage risks derived from both designed process change and unplanned changes that arise due to unforeseen circumstances. The strategy of risk assessment for a change can be tailored to the type of change. In addition, a cross-functional team and centralized documentation helps maximize risk management efficiency to achieve a successful technology transfer.
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http://dx.doi.org/10.5731/pdajpst.2016.006718DOI Listing
May 2018
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