Pharmaceutical Facility

by

Pharmaceutical Facility Management A pharmaceutical facility is a GMP-compliant manufacturing, testing, packaging, warehousing, and distribution environment designed to ensure that pharmaceutical products are consistently produced and controlled according to predefined quality standards. The facility must be designed, constructed, qualified, operated, maintained, and monitored to prevent contamination, mix-ups, cross-contamination, and errors while ensuring compliance with regulatory … Read more

Utilities in Pharmaceutical

by

Utilities in the Pharmaceutical Industry Utilities are the essential support systems that enable pharmaceutical manufacturing, testing, packaging, and storage operations. Although utilities are not always part of the finished product, they directly impact product quality, patient safety, process reliability, and regulatory compliance. Therefore, pharmaceutical utilities must be designed, qualified, operated, monitored, maintained, and periodically reviewed … Read more

Key Quality Systems in the Pharmaceutical Industry 

by

Key Quality Systems in the Pharmaceutical Industry  A Pharmaceutical Quality Management System (PQMS) is a comprehensive framework designed to ensure that pharmaceutical products are consistently manufactured, tested, stored, and distributed to meet predefined quality, safety, efficacy, and regulatory requirements. It is based on the principles of ICH Q10 Pharmaceutical Quality System, WHO GMP, EU GMP, … Read more

SOP for Procedure for Assigning New Product Retest Date

by

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

by

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

by

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

by

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

by

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

by

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

DESIGN QUALIFICATION (DQ) FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM

by

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