The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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…
SOP for Personal Protective Equipment (PPE) Usage Standard Operating Procedure for Personal Protective Equipment (PPE) Usage 1) Purpose The purpose of this SOP is to establish procedures for the selection, use, and maintenance of personal protective equipment (PPE) to ensure the safety and health of personnel working in pharmaceutical manufacturing areas. 2) Scope This SOP…
Read More “Injectables: SOP for Personal Protective Equipment (PPE) Usage” »
SOP for Annual Product Quality Review (APQR) Standard Operating Procedure for Annual Product Quality Review (APQR) 1) Purpose This SOP outlines the procedures for conducting annual product quality reviews (APQRs) to evaluate the quality and performance of pharmaceutical products. 2) Scope This SOP applies to all pharmaceutical products marketed by the organization, including finished dosage…
SOP for Replacement of Worn-out Parts Standard Operating Procedure for Replacement of Worn-out Parts 1) Purpose The purpose of this SOP is to establish the procedures for the timely and proper replacement of worn-out parts in pharmaceutical manufacturing equipment to ensure continuous operation and product quality. 2) Scope This SOP applies to all pharmaceutical manufacturing…