Tag: Media preparation

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…

Read More “Sop for Maintaining Positive Control Organisms” »

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…

Read More “Microbiology Testing: SOP for Equipment Calibration” »

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…

Read More “SOP for Microbial Culture Incubation” »

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…

Read More “SOP for Media Preparation ” »

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)…

Read More “SOP for Sampling for Microbiological Testing” »

Standard Operating Procedure for Environmental Monitoring Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines and procedures for monitoring the microbial environment within the manufacturing facility of the pharmaceutical company. Scope This SOP applies to all areas within the manufacturing facility where pharmaceutical products are handled, processed, or stored. Responsibilities Quality…

Read More “Microbiology Testing: SOP for Environmental Monitoring ” »

Standard Operating Procedure for Sterility Testing Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a protocol for conducting sterility tests on pharmaceutical products to ensure compliance with regulatory requirements and product safety standards. Scope This SOP applies to all personnel involved in the sterility testing of pharmaceutical products within the manufacturing…

Read More “Microbiology Testing: SOP for Sterility Testing ” »

Standard Operating Procedure for Microbial Contamination Control Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines and procedures for preventing microbial contamination in the manufacturing environment of the pharmaceutical company. Scope This SOP applies to all areas within the manufacturing facility where pharmaceutical products are handled, processed, or stored. Responsibilities Quality…

Read More “SOP for Microbial Contamination Control ” »