The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Trending and Data Analysis Standard Operating Procedure for Trending and Data Analysis 1) Purpose This SOP outlines the procedures for trending and analyzing data related to quality metrics, deviations, complaints, and other relevant parameters to identify trends, patterns, and potential areas for improvement within the organization. 2) Scope This SOP applies to all…
SOP for Cleaning Validation in Manufacturing Area Standard Operating Procedure for Cleaning Validation in Manufacturing Area 1) Purpose The purpose of this SOP is to define the procedures for cleaning validation in the pharmaceutical manufacturing area to ensure removal of residues and contaminants from equipment and surfaces. 2) Scope This SOP applies to all cleaning…
Read More “SOP for Cleaning Validation in Manufacturing Area” »
SOP for Maintenance of Emergency Exit Lights and Signs Standard Operating Procedure for Maintenance of Emergency Exit Lights and Signs 1) Purpose The purpose of this SOP is to establish the procedures for the maintenance and testing of emergency exit lights and signs to ensure their functionality and compliance with safety regulations in pharmaceutical manufacturing…
Read More “SOP for Maintenance of Emergency Exit Lights and Signs” »
SOP for Product and Process Improvement Standard Operating Procedure for Product and Process Improvement 1) Purpose This SOP outlines the procedures for identifying, evaluating, and implementing product and process improvements to enhance quality, efficiency, and compliance within the organization. 2) Scope This SOP applies to all pharmaceutical products and manufacturing processes within the organization, including…
SOP for Maintenance of Safety Showers and Eyewash Stations Standard Operating Procedure for Maintenance of Safety Showers and Eyewash Stations 1) Purpose The purpose of this SOP is to establish the procedures for the maintenance and testing of safety showers and eyewash stations to ensure their functionality and readiness for emergency use in pharmaceutical manufacturing…
Read More “SOP for Maintenance of Safety Showers and Eyewash Stations” »
SOP for Qualification of Contract Laboratories Standard Operating Procedure for Qualification of Contract Laboratories 1) Purpose This SOP outlines the procedures for qualifying contract laboratories that perform testing, analysis, or other services related to pharmaceutical products to ensure compliance with quality standards and regulatory requirements. 2) Scope This SOP applies to all contract laboratories engaged…
Read More “SOP for Qualification of Contract Laboratories” »
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…
Read More “SOP for Gowning Procedures in Cleanroom Environment” »
SOP for Maintenance of Personal Protective Equipment (PPE) Standard Operating Procedure for Maintenance of Personal Protective Equipment (PPE) 1) Purpose The purpose of this SOP is to establish the procedures for the maintenance and care of personal protective equipment (PPE) to ensure effectiveness and safety for personnel in pharmaceutical manufacturing facilities. 2) Scope This SOP…
Read More “SOP for Maintenance of Personal Protective Equipment (PPE)” »
SOP for Quality Agreements with Third Parties Standard Operating Procedure for Quality Agreements with Third Parties 1) Purpose This SOP outlines the procedures for establishing and maintaining quality agreements with third-party suppliers, contractors, and service providers to ensure compliance with quality standards and regulatory requirements. 2) Scope This SOP applies to all quality agreements established…
SOP for Maintenance of Safety Equipment Standard Operating Procedure for Maintenance of Safety Equipment 1) Purpose The purpose of this SOP is to establish the procedures for the maintenance of safety equipment to ensure a safe working environment for employees in pharmaceutical manufacturing facilities. 2) Scope This SOP applies to all safety equipment within pharmaceutical…