RT Journal Article
SR Electronic
T1 Contamination Control Strategy: Implementation Road Map
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 445
OP 453
DO 10.5731/pdajpst.2020.012385
VO 75
IS 5
A1 Walid El Azab
YR 2021
UL http://journal.pda.org/content/75/5/445.abstract
AB The article proposes an implementation road map of a contamination control strategy (CCS) in a facility. The CCS is the culmination of an exercise to identify activities designed to prevent microorganism, pyrogen, and particulate contamination in the product, the facility, and the supporting processes used to manufacture the product. Manufacturers can formulate their contamination control strategy based on information in the quality target product profile or in the critical quality attributes, in the facility, and in the processes used to manufacture and transport the product. The strategy implementation involves executing the strategic plan and managing the implementation by priority overtime should it be deployed. The evaluation of the efficiency and effectiveness of the contamination control strategy implemented is confirmed by analyzing and trending the various quality performance parameters related to contamination control. The strategy evaluation allows the manufacturer to identify a new strategic plan to support improvement goals or new measures and/or controls to achieve the desired result, minimizing the contamination risk.