Author: Auditor

SOP for Qualification of Contract Laboratories

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…

Quality Assurance

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 Maintenance of Personal Protective Equipment (PPE)

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…

Maintenance Dept.

SOP for Quality Agreements with Third Parties

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…

Quality Assurance

SOP for Maintenance of Safety Equipment

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…

Maintenance Dept.

Injectables: SOP for Personal Protective Equipment (PPE) Usage

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…

Injectables

SOP for Annual Product Quality Review (APQR)

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…

Quality Assurance

SOP for Replacement of Worn-out Parts

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…

Maintenance Dept.

SOP for Documentation of Stability Data for Gels

SOP for Documentation of Stability Data for Gels Standard Operating Procedure for Documentation of Stability Data for Gels 1) Purpose The purpose of this SOP is to establish procedures for documenting stability data of gels to ensure accurate recording, evaluation, and reporting of product stability over time. 2) Scope This SOP applies to the Quality…

Gels

Quality Assurance: SOP for Product Quality Review

SOP for Product Quality Review Standard Operating Procedure for Product Quality Review 1) Purpose This SOP outlines the procedures for conducting and documenting product quality reviews to evaluate the quality and compliance of marketed pharmaceutical products. 2) Scope This SOP applies to all pharmaceutical products marketed by the organization, including finished dosage forms, active pharmaceutical…

Quality Assurance