Author: Auditor

SOP for Extrusion-Spheronization in Granules Production

SOP for Extrusion-Spheronization in Granules Production Standard Operating Procedure for Extrusion-Spheronization in Granules Production 1) Purpose The purpose of this SOP is to provide guidelines for the extrusion-spheronization process in granules production within the pharmaceutical industry, ensuring the formation of spherical granules with controlled particle size and uniformity. 2) Scope This SOP applies to all…

Powder & Granules

SOP for Stability Testing Equipment

SOP for Stability Testing Equipment Standard Operating Procedure for Stability Testing Equipment 1) Purpose The purpose of this SOP is to establish procedures for the operation and maintenance of stability testing equipment used to assess the stability of dental dosage forms over time, ensuring product quality and shelf-life determination. 2) Scope This SOP applies to…

Dental Dosage Forms

SOP for Batch Record Review and Approval

SOP for Batch Record Review and Approval Standard Operating Procedure for Batch Record Review and Approval in Vaginal Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to define the procedure for reviewing and approving batch records to ensure compliance with established specifications and GMP requirements for vaginal dosage forms. 2) Scope This…

Vaginal Dosage Forms

SOP for Automatic Gel Filling Machine

SOP for Automatic Gel Filling Machine Standard Operating Procedure for Automatic Gel Filling Machine in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized procedure for the operation, cleaning, and maintenance of the automatic gel filling machine to ensure accurate and sterile filling of gels for ocular dosage…

Ocular (Eye) Dosage Forms

SOP for Sampling Procedures for Quality Control

SOP for Sampling Procedures for Quality Control Standard Operating Procedure for Sampling Procedures for Quality Control 1) Purpose The purpose of this SOP is to establish procedures for the sampling of raw materials, intermediate products, and finished products during the manufacturing of dental dosage forms to ensure compliance with quality specifications and regulatory requirements. 2)…

Dental Dosage Forms

SOP for Milling Process in Granules Production

SOP for Milling Process in Granules Production Standard Operating Procedure for Milling Process in Granules Production 1) Purpose The purpose of this SOP is to provide guidelines for the milling process in granules production within the pharmaceutical industry, ensuring uniform particle size reduction and maintaining product quality. 2) Scope This SOP applies to all personnel…

Powder & Granules

SOP for Batch Record Preparation

SOP for Batch Record Preparation Standard Operating Procedure for Batch Record Preparation in Vaginal Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to define the procedure for preparing batch records accurately and comprehensively to ensure consistent manufacturing of vaginal dosage forms. 2) Scope This SOP applies to the preparation of batch records…

Vaginal Dosage Forms

SOP for Syringe Sealing System

SOP for Syringe Sealing System Standard Operating Procedure for Syringe Sealing System in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized procedure for the operation, cleaning, and maintenance of the syringe sealing system to ensure proper sealing of syringes containing ocular dosage forms. 2) Scope This SOP…

Ocular (Eye) Dosage Forms

SOP for Handling and Storage of Finished Products

SOP for Handling and Storage of Finished Products Standard Operating Procedure for Handling and Storage of Finished Products 1) Purpose The purpose of this SOP is to establish procedures for the proper handling, packaging, labeling, and storage of finished products after manufacturing dental dosage forms to ensure product integrity, traceability, and compliance with regulatory requirements….

Dental Dosage Forms

SOP for Drying Process in Granules Production

SOP for Drying Process in Granules Production Standard Operating Procedure for Drying Process in Granules Production 1) Purpose The purpose of this SOP is to provide guidelines for the drying process in granules production within the pharmaceutical industry, ensuring uniform drying of granules while maintaining product quality and compliance with regulatory standards. 2) Scope This…

Powder & Granules