Author: Auditor

SOP for Supplier Non-Conformance Handling

SOP for Supplier Non-Conformance Handling Supplier Non-Conformance Handling – Standard Operating Procedure 1) Purpose To establish guidelines for handling and resolving non-conformances related to materials or services supplied by vendors within the pharmaceutical purchase department. 2) Scope This SOP applies to handling non-conformances identified during supplier-related activities within the pharmaceutical purchase department. 3) Responsibilities Purchasing…

Purchase Departments

SOP for Odor Testing in Oral Liquids

SOP for Odor Testing in Oral Liquids Procedure for Odor Testing in Oral Liquids 1) Purpose The purpose of this SOP is to outline the procedure for testing the odor of oral liquid pharmaceutical products to ensure compliance with specifications and regulatory requirements. 2) Scope This SOP applies to all oral liquid pharmaceutical products requiring…

In-Process Control

SOP for Color and Clarity Testing in Oral Liquids

SOP for Color and Clarity Testing in Oral Liquids Procedure for Color and Clarity Testing in Oral Liquids 1) Purpose The purpose of this SOP is to outline the procedure for testing the color and clarity of oral liquid pharmaceutical products to ensure compliance with specifications and regulatory requirements. 2) Scope This SOP applies to…

In-Process Control

SOP for Equipment Qualification (IQ/OQ/PQ)

SOP for Equipment Qualification (IQ/OQ/PQ) Standard Operating Procedure for Equipment Qualification (IQ/OQ/PQ) 1) Purpose This SOP outlines the procedures for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of equipment to ensure that equipment is properly installed, operates as intended, and consistently produces results meeting predefined specifications. 2) Scope This SOP applies to…

Quality Assurance

SOP for Operation of Autoclaves

SOP for Operation of Autoclaves Standard Operating Procedure for Operation of Autoclaves 1) Purpose The purpose of this SOP is to outline the procedures for the safe and effective operation of autoclaves used for sterilizing equipment, media, and other materials in the manufacturing facility. 2) Scope This SOP applies to all personnel involved in the…

Injectables

SOP for Material Inspection and Acceptance

SOP for Material Inspection and Acceptance Material Inspection and Acceptance – Standard Operating Procedure 1) Purpose To establish guidelines for inspecting and accepting materials to ensure they meet quality standards and specifications within the pharmaceutical purchase department. 2) Scope This SOP applies to the inspection and acceptance of materials received by the pharmaceutical purchase department….

Purchase Departments

SOP for Specific Gravity Testing in Oral Liquids

SOP for Specific Gravity Testing in Oral Liquids Procedure for Specific Gravity Testing in Oral Liquids 1) Purpose The purpose of this SOP is to outline the procedure for testing the specific gravity of oral liquid pharmaceutical products to ensure compliance with specifications and regulatory requirements. 2) Scope This SOP applies to all oral liquid…

In-Process Control

Quality Assurance: SOP for Cleaning Validation

SOP for Cleaning Validation Standard Operating Procedure for Cleaning Validation 1) Purpose This SOP outlines the procedures for conducting cleaning validation studies to ensure that cleaning procedures effectively remove residues of products, cleaning agents, and microbial contaminants from equipment surfaces to prevent cross-contamination and ensure product quality and safety. 2) Scope This SOP applies to…

Quality Assurance

SOP for Viscosity Testing in Oral Liquids

SOP for Viscosity Testing in Oral Liquids Procedure for Viscosity Testing in Oral Liquids 1) Purpose The purpose of this SOP is to outline the procedure for testing the viscosity of oral liquid pharmaceutical products to ensure compliance with specifications and regulatory requirements. 2) Scope This SOP applies to all oral liquid pharmaceutical products requiring…

In-Process Control

SOP for Goods Receiving Process

SOP for Goods Receiving Process Goods Receiving Process – Standard Operating Procedure 1) Purpose To establish guidelines for the receipt and inspection of goods to ensure accuracy, completeness, and compliance with specifications within the pharmaceutical purchase department. 2) Scope This SOP applies to the goods receiving process for materials and supplies received by the pharmaceutical…

Purchase Departments