Author: Auditor

Injectables: SOP for Gowning Procedures in Cleanroom Environment

SOP for Gowning Procedures in Cleanroom Environment Standard Operating Procedure for Gowning Procedures in Cleanroom Environment 1) Purpose The purpose of this SOP is to define the procedures for gowning in a cleanroom environment to prevent contamination of pharmaceutical products and ensure compliance with cleanliness standards. 2) Scope This SOP applies to all personnel entering…

Injectables

SOP for Foreign Particulate Matter Testing in Gels

SOP for Foreign Particulate Matter Testing in Gels Standard Operating Procedure for Foreign Particulate Matter Testing in Gels 1) Purpose The purpose of this SOP is to establish procedures for detecting and quantifying foreign particulate matter in gels to ensure product safety and quality. 2) Scope This SOP applies to the Quality Control (QC) department…

Gels

SOP for Specific Gravity Testing in Gels

SOP for Specific Gravity Testing in Gels Standard Operating Procedure for Specific Gravity Testing in Gels 1) Purpose The purpose of this SOP is to define procedures for determining the specific gravity of gels to ensure consistency and quality. 2) Scope This SOP applies to the Quality Control (QC) department responsible for performing specific gravity…

Gels

SOP for Good Distribution Practices (GDP) Compliance

SOP for Good Distribution Practices (GDP) Compliance Standard Operating Procedure for Good Distribution Practices (GDP) Compliance 1) Purpose This SOP outlines the procedures for ensuring compliance with Good Distribution Practices (GDP) to maintain the integrity, quality, and safety of pharmaceutical products throughout the distribution chain. 2) Scope This SOP applies to all personnel involved in…

Quality Assurance

SOP for Maintenance of Drainage Systems

SOP for Maintenance of Drainage Systems Standard Operating Procedure for Maintenance of Drainage Systems 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of drainage systems to ensure effective wastewater management and compliance with environmental regulations in pharmaceutical manufacturing facilities. 2) Scope This SOP applies to all drainage…

Maintenance Dept.

SOP for Water Activity Testing in Gels

SOP for Water Activity Testing in Gels Standard Operating Procedure for Water Activity Testing in Gels 1) Purpose The purpose of this SOP is to establish procedures for measuring water activity in gels to assess product stability and quality. 2) Scope This SOP applies to the Quality Control (QC) department responsible for performing water activity…

Gels

SOP for Preservative Content Testing in Gels

SOP for Preservative Content Testing in Gels Standard Operating Procedure for Preservative Content Testing in Gels 1) Purpose The purpose of this SOP is to define procedures for testing preservative content in gels to ensure efficacy and compliance with regulatory requirements. 2) Scope This SOP applies to the Quality Control (QC) department responsible for performing…

Gels

SOP for Microbial Limits Testing for Gels

SOP for Microbial Limits Testing for Gels Standard Operating Procedure for Microbial Limits Testing for Gels 1) Purpose The purpose of this SOP is to establish procedures for conducting microbial limits testing on gels to ensure compliance with microbiological safety standards. 2) Scope This SOP applies to the Quality Control (QC) department responsible for performing…

Gels

SOP for Maintenance of Plumbing Systems

SOP for Maintenance of Plumbing Systems Standard Operating Procedure for Maintenance of Plumbing Systems 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of plumbing systems to ensure reliable water supply and drainage in pharmaceutical manufacturing facilities. 2) Scope This SOP applies to all plumbing systems within the…

Maintenance Dept.

SOP for Finished Product Testing for Gels

SOP for Finished Product Testing for Gels Standard Operating Procedure for Finished Product Testing for Gels 1) Purpose The purpose of this SOP is to define procedures for conducting finished product testing on gels to ensure they meet quality specifications before distribution to customers. 2) Scope This SOP applies to the Quality Control (QC) department…

Gels