Guidance for Sterile Pharmaceutical Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice

Regulatory Guidelines to control endotoxin in sterile pharmaceuticals

21 CFR 211.63 states that “Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.”

21 CFR 211.65(a) states that “Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.”

21 CFR 211.67(a) states that “Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identify, strength, quality, or purity of the drug product beyond the official or other established requirements.”

21 CFR 211.94(c) states that “Pharmaceutical Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove endotoxin. pyrogenic  properties to assure that they are suitable for their intended use.”

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21 CFR 211.167(a) states that “For each batch of drug product purporting to be sterile and/or pyrogen/ endotoxin, free, there shall be appropriate laboratory testing to determine conformance to such requirements. The test procedures shall be in writing and shall be followed.”
Endotoxin contamination of an injectable product can occur as a result of poor CGMP controls. Certain patient populations (e.g., neonates), those receiving other injections concomitantly, or those administered a parenteral in atypically large volumes or doses can be at greater risk for pyrogenic reaction than anticipated by the established limits based on body weight of a normal healthy adult . Such clinical concerns reinforce the importance of exercising appropriate CGMP controls to prevent generation of endotoxins. Drug product components, containers, closures, storage time limitations, and manufacturing equipment are among the areas to address in establishing endotoxin control.
Adequate cleaning, drying, and storage of equipment will control bioburden and prevent contribution of endotoxin load. Equipment should be designed to be easily assembled and disassembled, cleaned, sanitized, and/or sterilized. If adequate procedures are not employed, endotoxins can be contributed by both upstream and downstream processing equipment.
Sterilizing-grade filters and moist heat sterilization have not been shown to be effective in removing endotoxin. Endotoxin on equipment surfaces can be inactivated by high-temperature dry heat, or removed from equipment surfaces by cleaning procedures. Some clean-in-place procedures employ initial rinses with appropriate high purity water and/or a cleaning agent (e.g., acid, base, surfactant), followed by final rinses with heated WFI. Equipment should be dried following cleaning, unless the equipment proceeds immediately to the sterilization step.

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This Guidance is published by US FDA on September 2004
We also recommend our readers to visit US FDA’S website for undated guidances on sterile drug products

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