Author: Auditor

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

SOP for Equipment Troubleshooting in Aerosol Production

SOP for Equipment Troubleshooting in Aerosol Production Standard Operating Procedure for Equipment Troubleshooting in Aerosol Production 1) Purpose The purpose of this SOP is to provide guidelines for identifying, diagnosing, and resolving equipment issues in aerosol production. Effective troubleshooting ensures minimal downtime, maintains product quality, and promotes safety. 2) Scope This SOP applies to all…

Aerosols

SOP for Pharmacovigilance Case Processing

SOP for Pharmacovigilance Case Processing Guidelines for Processing Pharmacovigilance Cases 1) Purpose The purpose of this SOP is to define the procedures for processing pharmacovigilance cases to ensure timely and accurate reporting of adverse events and other safety information. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the case processing activities, including…

Pharmacovigilance

SOP for Formulation Development Quality by Design (QbD) Principles

SOP for Formulation Development Quality by Design (QbD) Principles Implementing Quality by Design (QbD) Principles in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for implementing Quality by Design (QbD) principles during the formulation development process, ensuring that product quality is built into the formulation design based on scientific…

Formulation Development

SOP for Maintenance of Tablet Presses

SOP for Maintenance of Tablet Presses Standard Operating Procedure for Maintenance of Tablet Presses 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of tablet presses in pharmaceutical manufacturing facilities to ensure efficient tablet production and product quality. 2) Scope This SOP applies to all tablet presses used…

Maintenance Dept.

SOP for Analytical Method Development Forced Degradation Studies

SOP for Analytical Method Development Forced Degradation Studies Conducting Forced Degradation Studies for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting forced degradation studies during the analytical method development process, aimed at evaluating method specificity and stability indicating capability. 2) Scope This SOP applies to all…

Analytical Method Development