The document details control strategies that include manufacturing, quality and contamination control and stresses that they’re interconnected and a robust strategy should blend all three, considering both facility design and daily operations. The control strategies are focused on, “product quality, efficacy, and patient safety.”
The document points out that manufacturing control strategies must be tailored to the main characteristics of the product and process, such as the product type and dose form, as well as the manufacturing processing method. Automation and equipment to be used is also part of manufacturing control, specifically the level of automation and how users will interact with the process. Risk assessment is a critical aspect to manufacturing control.
As with the manufacturing control strategy, the document notes that quality control must be tailored to the process specifics, such as product, process and critical quality attributes (CQAs) in manufacturing. The document notes that quality control strategies are not to be designed to support bad designs or practices, and that there is a need for an approach that it methodical. As with manufacturing control, product quality, efficacy and patient safety are paramount.
The document notes that, “A Contamination control strategy should include a strategy for environmental control of product manufacturing environments...” It goes on to point out that contamination control strategies will vary based on the manufacturing process.
The document goes into deeper details of considerations for setting a contamination control strategy, focusing on a “holistic view” of the following:
Once these have been established with appropriate justification, the document explains that management must identify and assess areas of contamination risk. The risk management stage may be one of the toughest, but it’s necessary. Because contamination in Grade A and B areas likely originates from contamination in less controlled Grade C and D areas, the document observes that a successful control strategy should identify and mitigate risks associated with the perimeter of the facility and the flow of raw materials, equipment and personnel into the processing area.
The PHSS monograph serves as a guide to designing an effective control strategy in the manufacture of sterile pharmaceutical/drug products. To document is available for purchase at the Pharmaceutical & Healthcare Sciences Society website.
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