SOP for Procedure for Assigning New Product Retest Date 1.0 Objective To establish a procedure for assigning or extending the retest date of products based on stability data, ensuring product quality, safety, and compliance with regulatory requirements. 2.0 Scope This SOP is applicable to all finished products manufactured for which retest date assignment or extension … Read more
SOP for Procedure for Operation and Cleaning of Vacuum Cleaner 1.0 Objective To lay down a procedure for the proper operation and cleaning of the vacuum cleaner to ensure effective cleaning and prevent cross-contamination in pharmaceutical areas. 2.0 Scope This SOP is applicable to all vacuum cleaners used in production, warehouse, and Quality Control areas. 3.0 … Read more
SOP for Cleaning, Calibration and Verification of Volumetric Glassware for Accuracy 1.0 Objective To lay down the procedure for Cleaning ,calibration and verification of volumetric glassware to ensure accuracy and reliability of analytical results. 2.0 Scope This SOP is applicable to the Quality Control Department for calibration of volumetric glassware. 3.0 Responsibility Analytical Chemist shall be … Read more
SOP for Calibration of UV Cabinet 1. Purpose To establish a procedure for calibration and performance verification of the UV cabinet to ensure effective UV radiation for microbial control and compliance with GMP requirements. 2. Scope This SOP applies to all UV cabinets used in the microbiology laboratory and other controlled areas for sterilization/disinfection purposes. 3. … Read more
SOP for Loan License Product Manufacturing 1. Purpose To define the procedure for manufacturing, control, and release of products under a loan license arrangement, ensuring compliance with applicable GMP guidelines and regulatory requirements. 2. Scope This SOP applies to all products manufactured at the site under a loan license agreement for third-party (contract giver) companies. 3. … Read more
DESIGN QUALIFICATION (DQ) WFI STORAGE & DISTRIBUTION SYSTEM 1. INTRODUCTION The Water for Injection (WFI) Storage and Distribution System is designed to store and distribute WFI for manufacturing and cleaning applications. WFI is generated from the Multi Column Distillation Plant (MCDP) and stored in a 1500 L jacketed storage tank, followed by distribution through a recirculating … Read more
DQ) FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM 1.0 INTRODUCTION The Purified Water (PW) Storage and Distribution System is designed to store and distribute purified water for manufacturing and washing applications. Purified water is generated from the PW Generation System and stored in a 3000 L storage tank . It is then distributed to various … Read more
DQ FOR PURE STEAM DISTRIBUTION SYSTEM (PSDS) Pure Steam is a critical utility used in pharmaceutical and biotechnology industries for sterilization and sanitization processes. It is generated from purified water or Water for Injection (WFI) and is free from contaminants such as pyrogens, chemicals, and microorganisms. Pure Steam is primarily used where direct contact with product-contact … Read more
DESIGN QUALIFICATION (DQ) FOR NITROGEN GAS DISTRIBUTION SYSTEM (NGDS) 1.0 INTRODUCTION : The Nitrogen Gas Distribution System (NGDS) is designed to supply nitrogen gas from the source/header line to various user points within the facility Design Qualification (DQ) ensures that the system design complies with: User Requirement Specifications (URS) Applicable cGMP guidelines Industry standards for pharmaceutical utilities … Read more
DESIGN QUALIFICATION (DQ) OF PURIFIED WATER GENERATION SYSTEM 1.0 INTRODUCTION : Design Qualification (DQ) is a documented verification that the proposed design of the Purified Water Generation System complies with the User Requirement Specification (URS), cGMP guidelines, and applicable regulatory standards. This document demonstrates that the system designed ,suitable for producing purified water meeting pharmacopoeial standards … Read more