Posted on: 28th March 2018
The Multi-Product Facility workstream have two closely related papers published in the PDA which together will allow companies to reduce the time they take in changing over from one product to another. Both papers use a quality risk management approach to systematically identify the best way to manage the changeover processes and can offer substantially value when fully realised.
The first paper, titled “Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities” looks at how the endorsement of Quality Risk Management will allow the use of risk-based approaches to continually assess and improve established changeover processes and therefore reduce product changeover waste, which is any activity not needed in the process to ensure the quality of subsequent products.
The second paper published by the workstream in the PDA is, “Elastomer Change Out – Justification for Changing the Removal of Elastomers to Prevent Cross-Contamination in a Multi-Product Facility.” The paper surveyed six member companies and looked at the use of elastomers in over 10 manufacturing sites. It outlines that using a risk-based approach to outline the rationale for reducing elastomer change-out at the biopharmaceutical change over.