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FDA Sanitation Practices for Pharmaceuticals

Updated: Feb 16


In the realm of pharmaceutical manufacturing, safety and quality are of utmost importance. To maintain the integrity of drug products and protect public health, regulatory bodies such as the Food and Drug Administration (FDA) enforce stringent guidelines and regulations. One such crucial regulation is outlined in Title 21, Part 211, Subpart C, which focuses on ensuring proper sanitation practices in buildings and facilities involved in the manufacturing, processing, packing, and holding of pharmaceuticals.

In the realm of pharmaceutical manufacturing, safety and quality are of utmost importance. To maintain the integrity of drug products and protect public health, regulatory bodies such as the Food and Drug Administration (FDA) enforce stringent guidelines and regulations. One such crucial regulation is outlined in Title 21, Part 211, Subpart C, which focuses on ensuring proper sanitation practices in buildings and facilities involved in the manufacturing, processing, packing, and holding of pharmaceuticals.


Maintaining a Clean and Sanitary Environment: Section 211.56(a) of Subpart C emphasizes the need for pharmaceutical manufacturing buildings to be kept in a clean and sanitary condition. This requirement aims to prevent contamination and uphold product quality. Compliance with this regulation ensures that drug products are not compromised during production. Additionally, the regulation mandates that these facilities be free from infestation by rodents, birds, insects, and other vermin, except for laboratory animals. Timely and sanitary disposal of trash and organic waste matter is also an essential component of maintaining a hygienic environment.


Written Procedures for Sanitation: Subpart C further emphasizes the importance of establishing written procedures for sanitation. Section 211.56(b) states that these procedures should assign responsibility and provide comprehensive details regarding cleaning schedules, methods, equipment, and materials to be used for maintaining the cleanliness of buildings and facilities. Adhering to these written procedures ensures consistency and accuracy in cleaning practices, reducing the risk of cross-contamination and maintaining high levels of cleanliness.


Control of Rodents, Insects, and Fungicides: To protect against potential contamination, Section 211.56(c) requires the use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. However, it is crucial to note that these substances should only be used if registered and in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135). Compliance with this aspect of the regulation ensures that these control measures are employed safely and effectively without jeopardizing the integrity of equipment, components, drug product containers, closures, packaging, labeling materials, or the drug products themselves.


Inclusion of Contractors and Temporary Employees: It is essential to recognize that Subpart C extends its scope beyond full-time employees to include contractors and temporary employees. Section 211.56(d) emphasizes that sanitation procedures apply to work performed by these individuals as well. This provision ensures that all personnel involved in the ordinary course of operations are subject to the same sanitation standards, maintaining consistency and accountability throughout the manufacturing process.


Title 21, Part 211, Subpart C of the Food and Drug Administration's regulations plays a crucial role in ensuring the safety, integrity, and quality of finished pharmaceutical products. By emphasizing cleanliness, pest control, written procedures, and inclusivity of contractors and temporary employees, this regulation promotes a hygienic manufacturing environment and helps prevent contamination. Compliance with these guidelines demonstrates a commitment to maintaining the highest standards of pharmaceutical manufacturing, safeguarding public health, and instilling confidence in the quality of drug products.


Contact BioBoston Consulting now or visit our website to learn more about how we can support your regulatory activities.

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