Author: Auditor

SOP for Analytical Method Development Particle Size Method Development

SOP for Analytical Method Development Particle Size Method Development Developing Particle Size Methods for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for developing particle size methods during the analytical method development process, ensuring accurate measurement of particle size distribution in pharmaceutical formulations. 2) Scope This SOP applies…

Analytical Method Development

SOP for Formulation Development Raw Material Specification Development

SOP for Formulation Development Raw Material Specification Development Development of Raw Material Specifications in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for developing raw material specifications in formulation development, ensuring that raw materials used in pharmaceutical formulations meet predefined quality standards and regulatory requirements. 2) Scope This SOP…

Formulation Development

SOP for Pharmacovigilance Case Intake

SOP for Pharmacovigilance Case Intake Guidelines for Intake of Pharmacovigilance Cases 1) Purpose The purpose of this SOP is to establish standardized procedures for the intake of pharmacovigilance cases to ensure timely and accurate initial data capture for adverse event reports and other safety information. 2) Scope This SOP applies to all pharmacovigilance personnel involved…

Pharmacovigilance

SOP for Analytical Method Development Dissolution Method Development

SOP for Analytical Method Development Dissolution Method Development Developing Dissolution Methods for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for developing dissolution methods during the analytical method development process, ensuring accurate assessment of drug release from dosage forms. 2) Scope This SOP applies to all personnel involved…

Analytical Method Development

SOP for Batch Record Review in Aerosol Production

SOP for Batch Record Review in Aerosol Production Standard Operating Procedure for Batch Record Review in Aerosol Production 1) Purpose The purpose of this SOP is to establish a standardized process for reviewing batch records in aerosol production to ensure accuracy, compliance, and completeness. This review ensures that all production steps were performed according to…

Aerosols

SOP for Formulation Development Equipment Qualification

SOP for Formulation Development Equipment Qualification Qualification of Equipment in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for equipment qualification in formulation development, ensuring that equipment used in manufacturing processes is suitable for its intended purpose and meets regulatory requirements. 2) Scope This SOP applies to all formulation…

Formulation Development

SOP for Maintenance of Capsule Filling Machines

SOP for Maintenance of Capsule Filling Machines Standard Operating Procedure for Maintenance of Capsule Filling Machines 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of capsule filling machines in pharmaceutical manufacturing facilities to ensure efficient capsule filling processes and product quality. 2) Scope This SOP applies to…

Maintenance Dept.

SOP for External Audits by Regulatory Bodies

SOP for External Audits by Regulatory Bodies Standard Operating Procedure for External Audits by Regulatory Bodies 1) Purpose The purpose of this SOP is to establish procedures for preparing, conducting, and responding to external audits by regulatory bodies to ensure compliance with regulatory requirements and maintain certifications. 2) Scope This SOP applies to all personnel…

Injectables

SOP for Formulation Development Cleaning Validation

SOP for Formulation Development Cleaning Validation Validation of Cleaning Procedures in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for validating cleaning procedures in formulation development, ensuring that equipment and facilities are cleaned effectively to prevent cross-contamination and ensure product quality. 2) Scope This SOP applies to all formulation…

Formulation Development

SOP for Analytical Method Development Impurity Method Development

SOP for Analytical Method Development Impurity Method Development Developing Impurity Methods for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for developing impurity methods during the analytical method development process, ensuring accurate detection and quantification of impurities in pharmaceutical products. 2) Scope This SOP applies to all personnel…

Analytical Method Development