The Ultimate Resource for Pharmaceutical SOPs and Best Practices
Standard Operating Procedure for Negative Control Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for maintaining negative control samples to ensure the validity of test results in the pharmaceutical manufacturing facility. Scope This SOP applies to all personnel involved in the maintenance and use of negative control samples within the…
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Standard Operating Procedure for Microbial Limit Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and procedures for determining the microbial load in pharmaceutical products, ensuring compliance with regulatory requirements and product safety standards. Scope This SOP applies to all personnel involved in microbial limit testing procedures within the…
Standard Operating Procedure for Media Fill Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and procedures for conducting media fill tests to assess the aseptic processing techniques in the pharmaceutical manufacturing facility. Scope This SOP applies to all personnel involved in conducting media fill tests within the pharmaceutical manufacturing…
Standard Operating Procedure for Disinfection and Sanitization Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the steps for effectively disinfecting and sanitizing laboratory surfaces and equipment to maintain a clean and sterile working environment. Scope This SOP applies to all personnel involved in laboratory operations and is applicable to all…
Standard Operating Procedure for Microbial Identification Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and protocols for the identification of microbial contaminants in products or environments within the pharmaceutical manufacturing facility. Scope This SOP applies to all personnel involved in microbial identification procedures, including microbiologists and quality assurance personnel. Responsibilities…
Standard Operating Procedure for Maintaining Positive Control Organisms Purpose The purpose of this Standard Operating Procedure (SOP) is to establish procedures for maintaining positive control organisms for testing purposes in the pharmaceutical manufacturing facility. Scope This SOP applies to all personnel involved in the maintenance and use of positive control organisms within the pharmaceutical manufacturing…
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Standard Operating Procedure for Equipment Calibration Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for calibrating microbiological testing equipment to ensure accuracy, reliability, and compliance with regulatory standards. Scope This SOP applies to all microbiological testing equipment used within the manufacturing facility. Responsibilities Quality Assurance (QA) Department: Responsible for…
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Standard Operating Procedure for Incubation Purpose The purpose of this Standard Operating Procedure (SOP) is to provide instructions for incubating microbial cultures under controlled conditions in the pharmaceutical manufacturing facility. Scope This SOP applies to all personnel involved in the incubation of microbial cultures within the pharmaceutical manufacturing facility. Responsibilities Quality Control (QC) Department: Responsible…
Standard Operating Procedure for Media Preparation Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for preparing microbiological growth media in a consistent and standardized manner to support microbial testing activities within the pharmaceutical manufacturing facility. Scope This SOP applies to all personnel involved in the preparation of microbiological growth…
Standard Operating Procedure for Sampling Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and procedures for collecting samples for microbiological testing in the pharmaceutical manufacturing facility. Scope This SOP applies to all personnel involved in the sampling process for microbiological testing within the pharmaceutical manufacturing facility. Responsibilities Quality Control (QC)…