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The guideline also states that where the manufacturer of a nonsterile API either intends or claims that it is suitable for use for further processing to produce a sterile drug product, water used in the nal isolation and puri cation steps for such API should be monitored and controlled for total microbial counts, objectionable microorganisms, and endotoxins (Q7A Section 43) The guideline recommends cleaning of equipment assigned for continuous production or campaign production of successive batches of the same intermediate or API at appropriate intervals to prevent buildup and carryover of objectionable levels of microorganisms (Q7A Sections 52 and 85) Under the laboratory controls section of the guideline, ICH recommends that if the API has a speci cation for microbiological purity, appropriate action limits for total microbial counts, objectionable organisms, and endotoxins should be established and met (Q7A Section 111).
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Appropriate microbiological speci cation tests should be conducted on each batch of intermediate or API where microbial quality is speci ed (Q7A Section 112) The guidelines specify that equipment cleaning/sanitation studies should address microbiological and endotoxin contamination for those processes where there is a need to reduce total microbiological count or endotoxins in the API, where a nonsterile API is used to manufacture sterile products (Q7A Section 127) For APIs manufactured by cell culture, fermentation techniques, raw materials used such as media, and buffer components may have potential for microbiological contamination For example, in such cases, depending on the intended use of the API or intermediate, control of bioburden, viral contamination, and/or endotoxins during manufacturing and monitoring of the process at appropriate stages may be necessary (Q7A Section 181).
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Tools must be selected that suit the target environment. Do not use Perl if your target server will not have Perl. Any of the following tools can be used to automate common chores. However, it is important to follow some guidelines and rules in the process.
When the quality of the API can be affected by microbial contamination, manipulations using open vessels should be performed in a biosafety cabinet or similarly controlled environment (Q7A Section 183) 6323 GMPs for Bulk Pharmaceutical Excipients.
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