RT Journal Article
SR Electronic
T1 Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 91
OP 103
DO 10.5731/pdajpst.2016.007419
VO 72
IS 1
A1 Lynch, Rob
A1 Barabani, David
A1 Bellorado, Kathy
A1 Canisius, Peter
A1 Heathcote, Doug
A1 Johnson, Alan
A1 Wyman, Ned
A1 Parry, Derek Willison
YR 2018
UL http://journal.pda.org/content/72/1/91.abstract
AB 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, waste 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.