Contamination in Pharma manufacturing facilities is an integral topic of interest and significant concern for manufacturers and regulatory bodies. While Pharma manufacturers are responsible for implementing contamination control strategies, regulatory bodies are responsible for establishing such guidelines.
In this regard, the role of regulatory bodies is crucial because pharma manufacturers are responsible for following guidelines laid down by regulatory bodies. If regulatory bodies fail to establish an effective contamination control strategy, all efforts of both these bodies and pharma manufacturers will result in vain.
What is contamination control?
Contamination control is the processes, steps, or controls that prevent, minimize, or reduce contamination in pharma manufacturing processes. Since there are a number of stages and processes involved, there are various types of controls to prevent contamination.
Contamination control is implemented for every part or component directly or indirectly involved in pharmaceutical manufacturing processes. For example, the building in which Pharma manufacturing is being carried out must also be part of the contamination control strategy.
Regulatory guidelines
As mentioned above, contamination control strategies are defined by various regulatory bodies that must be adhered to by Pharma manufacturers that intend to market or sell their products in their jurisdiction. Compliance to these guidelines is closely monitored by the regulatory bodies during routine inspection, and deviation from the guidelines, could result in warning, and even can result in shut down of operations.
This article will focus on the Unites States FDA, and some common regulatory guidelines related to contamination control are mentioned below.
21 CFR 211.42
It is the United States FDA regulation for finish pharmaceuticals. It's sub part c “buildings and facilities". Provides guidance to contamination control in their section (b) and c.
This regulations emphasis on adequate space for orderly placement of equipment and material to prevent mix-ups and contamination. Its part [c], emphasis on separate or defined areas or space for operations to prevent contamination or mix-ups
21 CFR 211.46
It is the United States FDA regulations for ", building and facilities", and provides guidance related to ventilation, air filtration air heating and cooling.
It's a part (b) mentions prevention techniques for contamination in production area, by having a proper design of material flow through the buildings.
Additionally it's part b States requirement for controlling dirt microorganism humidity and temperature, which are an important contributor in contamination in an area.
21 CFR 211.63
It is the United States FDA, regulation for GMP "equipment". Selection of equipment design, size and location shall provide basic qualities of machine involved in Pharma processes for cleaning and maintenance.
21 CFR 211.65
It is the United States FDA regulation for GMP finished pharmaceuticals. It's a part (a) provides guidance related to part of equipment surface that contacts Pharma product during manufacturing process, and it shall not be reactive, additive or absorptive to alter the product characteristics.
21 CFR 211.67
It is the United States regulation for equipment cleaning and maintenance. It emphasizes on cleaning of equipment and utensils at regular interval to prevent contamination
21 CFR 211.113
It is the United States the regulation for control in microbial contamination. It's part b, emphasizes on written procedure to prevent microbial contamination of sterile drug products
Types of contamination in Pharma industry
There are various types of contamination which are described below.
Physical contamination
Physical contaminants are the types that have a physical existence, i.e., having a particular size, shape, or area. These are generated by any object interacting with the process or area in which product...
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