The Ultimate Resource for Pharmaceutical SOPs and Best Practices
Standard Operating Procedure for in-process Weight Variation Testing Purpose The purpose of this SOP is to outline the procedures for conducting weight variation testing during the tablet/ capsule manufacturing process to ensure uniformity and consistency of capsule/ tablet weight. Scope This SOP applies to all personnel involved in capsule/ tablet manufacturing, specifically those responsible…
Standard Operating Procedure for in-process Friability Testing Purpose The purpose of this SOP is to outline the procedures for conducting friability testing during the tablet manufacturing process to assess the durability and quality of tablets. Scope This SOP applies to all personnel involved in tablet manufacturing, specifically those responsible for friability testing. Responsibilities Quality Control…
Standard Operating Procedure for Moisture Content Determination in Manufacturing Purpose The purpose of this SOP is to outline the procedures for determining moisture content during the tablet manufacturing process to ensure product quality, stability, and compliance with regulatory requirements. Scope This SOP applies to all personnel involved in the tablet manufacturing process, particularly those…
Standard Operating Procedure for Incident Investigation and Reporting in Microbiology Lab Purpose The purpose of this Standard Operating Procedure (SOP) is to establish procedures for investigating and reporting microbial contamination incidents in the pharmaceutical manufacturing facility. Scope This SOP applies to all personnel involved in incident investigation and reporting, including microbiologists, quality assurance personnel, and…
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Standard Operating Procedure for Environmental Cleaning Validation Purpose The purpose of this Standard Operating Procedure (SOP) is to provide a protocol for validating the effectiveness of environmental cleaning procedures in the microbiology laboratory of the pharmaceutical manufacturing facility. Scope This SOP applies to all personnel involved in environmental cleaning validation activities, including laboratory technicians, microbiologists,…
Standard Operating Procedure for Microbiological Method Validation Purpose The purpose of this Standard Operating Procedure (SOP) is to provide instructions for validating microbiological testing methods in the pharmaceutical manufacturing facility. Scope This SOP applies to all personnel involved in the validation of microbiological testing methods, including microbiologists, laboratory technicians, and quality assurance personnel. Responsibilities Quality…
Standard Operating Procedure for Microbial Monitoring of Personnel Purpose The purpose of this Standard Operating Procedure (SOP) is to establish protocols for monitoring the microbial flora of personnel involved in manufacturing processes within the pharmaceutical facility. Scope This SOP applies to all personnel working in areas where microbial contamination poses a risk to product quality…
Standard Operating Procedure for Microbial Strain Verification Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for verifying the identity and purity of microbial strains used in testing within the pharmaceutical manufacturing facility. Scope This SOP applies to all personnel involved in the procurement, storage, handling, and testing of microbial strains…
Standard Operating Procedure for Laboratory Safety Purpose The purpose of this Standard Operating Procedure (SOP) is to establish procedures and guidelines for ensuring the safety of personnel working in the microbiology laboratory within the pharmaceutical manufacturing facility. Scope This SOP applies to all personnel working in the microbiology laboratory, including microbiologists, laboratory technicians, and support…
Standard Operating Procedure for Microscopic Examination Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and procedures for examining microbial cultures under a microscope in the pharmaceutical manufacturing facility. Scope This SOP applies to all personnel involved in microscopic examination procedures within the pharmaceutical manufacturing facility. Responsibilities Quality Control (QC) Department:…