Transport Validation Protocol & its advantage for Pharma Products 2023

Transport validation in pharmaceutical plants is a critical process that ensures the safe and compliant transportation of raw materials, intermediate products, and finished pharmaceutical goods. It is a vital aspect of the overall quality management system within the pharmaceutical industry. The validation process involves verifying that the transportation methods and conditions maintain the integrity, safety, … Read more

What is GMP and cGMP in the Pharmaceutical industry?

In the world of pharmaceutical manufacturing, adherence to quality standards and regulatory compliance is paramount, So GMP and CGMP are the most important aspects. Two key pillars that govern this realm are Good Manufacturing Practice (GMP) and its enhanced counterpart, Current Good Manufacturing Practice (cGMP). In this article, we embark on a journey to uncover … Read more

GMP in pharmaceutical industry

GMP in the pharmaceutical world, maintaining quality standards is paramount. Good Manufacturing Practice stands as a cornerstone, ensuring the safety, efficacy, and integrity of medicinal products. This article delves into the intricate realm of GMP, exploring its significance, key principles, and the pivotal role it plays in the pharmaceutical industry. GMP is a comprehensive set … Read more

cGMP in pharmaceutical industry

In the sophisticated world of pharmaceutical manufacturing, ensuring product quality, safety, and efficacy is supreme. cGMP Current Good Manufacturing Practice stands as a guiding compass, steering pharmaceutical plants towards the pinnacle of manufacturing excellence. In this article, we unravel the unique and indispensable role played by Current Good Manufacturing Practices in the intricate tapestry of … Read more

GMP Audit Checklist

The GMP Audit Checklist is a comprehensive tool designed to facilitate meticulous self-assessment within the scope of Good Manufacturing Practice (GMP). As a cornerstone of excellence in the manufacturing industry, GMP sets forth stringent guidelines to ensure the production of safe and high-quality products while complying with regulatory standards. This GMP Audit Checklist serves as … Read more

Compressed Air Qualification

Explore the critical role of compressed air qualification in pharmaceutical industries. Discover how this vital process safeguards product integrity, meets regulatory standards, and prioritizes patient safety. Learn how compressed air qualification enhances operational efficiency, reduces costs, and upholds stringent quality assurance practices in pharmaceutical manufacturing. In the pharmaceutical industry, maintaining product integrity and ensuring patient … Read more

SOP for Execution of Preventive Maintenance EN-69

  EQUIPMENT HISTORY CARD Name of Equipment   :                                                                                                                            Equipment ID             : Make                           :                                                                                                                            Model                         : Serial  No.                   :                                                                                                                            Date of Installation                                  : Location                      : S. No. Date Description of Maintenance Spare Parts Details Breakdown hours Modification (if any) Done by (Sign/ Date) Checked by (Sign/ Date) Remarks Name Quantity … Read more

SOP For Cleaning, Operation & Calibration of Volumetric Air Sampler

S. No. Equipment Name Equipment ID Model Instrument Make 01 Air Sampler —————– —————– —————–                               SOP Version No. Change Control No. Reason For Revision Effective Date   CC-XX-YY     VOLUMETRIC AIR SAMPLER USAGE LOGBOOK Make: ______________________                                                  Instrument ID … Read more

DM Plant Regeneration Process EN-02

            SOP                 Standard Operating Procedure             RO                   Reverse Osmosis             HDPE              High Density Poly Ethylene             QC                   Quality Control             UV                  Ultra Violet ANNEXURES NO. TITLE OF ANNEXURE   FORMAT NO. Annexure-I Mixed Bed Regeneration Record EN-0XX/FYY-00 Annexure-II Mixed Bed Output Record EN-0XX/FYY-00         Not applicable                                                                 Revision No. Change Control No. Details … Read more