21 CFR Part 211 Sec. 211.42: Key Design and Construction Standards for Pharmaceutical Manufacturing 

Explore the critical design and construction features outlined in 21 CFR Part 211 Sec. 211.42, ensuring compliance with CGMP for safe pharmaceutical manufacturing. Learn about cross-contamination prevention and operational area requirements. 

The regulation in 21 C.F.R. Part 211 Subpart C addresses design and construction features related to buildings and facilities for the manufacturing, processing, packing, and holding of drug products. This regulation also falls within the idealistic umbrella of Current Good Manufacturing Practice (CGMP) for Finished Pharmaceuticals administered by the Food and Drug Administration (FDA). The aim of the regulation is to ensure that proper operations are supported by appropriate design of the buildings, a sufficient amount of space, and defined operational zones to avoid cross contamination, and that the safety and quality of pharmaceutical products are secured. 

Proper Size, Construction and Location 

A drug product manufacturing facility must also contain any building(s) used in the manufacturing of the drug product, is of adequate size, construction, and location, as required by the regulation. This standard meets a few significant needs, like allowing for cleaning, upkeep, and right functions. Providing enough space allows manufacturers to organize their equipment (and materials) to reduce the possibility of mix-ups between different components, drug product container/closures, labeling, in process materials or final drug products. 

How to Avoid Cross-contamination and Cross-contamination 

The risk of contamination and mix-ups pose serious threats to pharmaceutical product quality and safety. In this regard, the regulation requires that the flow of components, drug product containers, closures, labeling, in-process materials, and drug products both into and out of the building(s) are carefully designed to preclude contamination. This need requires establishing suitable control systems and specified areas to keep the distinct materials separated and defined throughout the manufacturing cycle. 

Operational Areas Defined Exactly 

The regulation requires that the operations be performed in appropriately sized and precisely defined areas. These provided areas, or control systems, are crucial to ensuring that contamination and mix-ups do not take place during any of the procedures for pharmaceutical factors. The following processes need to be carried out in separate areas or with controlled systems to ensure product integrity. 

Components, drug product containers, closures, and labeling must be received, identified, quarantined, and withheld from use or distribution until they undergo quality control testing or examination. 

The items held before having to provide a disposition includes rejected starting materials, drug product containers and closures, and labeling.  

Following storage areas should be designed 

Released components, drug product containers, closures and labeling storage 

In-process material storage during Manufacturing and processing operations. such asOperations of Packaging and Labeling 

Storage in quarantine prior to the release of drug products 

Drug product storage after the release 

Control/Lab Operations 

Aseptic processing — includes some specific requirements, such as smoother surfaces that are easily cleanable, temperature controls, humidity controls, filtered air pressure, environment monitoring, and proper equipment maintenance. 

Dedicated Production Facilities for Penicillin 

Facilities that manufacture, process, and pack penicillin must also be physically separated from other facilities for drug products intended for human use, to further minimise the risk of drug contamination. Penicillin’s have specific risk factors during the manufacture and control steps, hence the requirement to prevent cross-contamination and allergic reactions of susceptible patients cannot be overemphasized. 

Conclusion

The standards described in 21 CFR Part 211 Sec. 211.42,include one of the most important designs and construction aspects of the buildings and facilities used within pharmaceuticals. Compliance with this regulation allows the pharmaceutical manufacturers to design the right type of building, provide enough space, prevent contamination and avoid the mix-ups. These steps in the end result in the safe and high quality of products going from raw materials to finished pharmaceutical products and help to maintain public health and maintain consumer confidence in the pharmaceutical industry. 

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