Quality Assurance
PROCESS VALIDATION To define a procedure for validation of process to demonstrate its effectiveness and reproducibility including the preparation of protocols and report. It also outlines the personnel responsibilities and other qualification documents required for performing the validation activities. SCOPE: This SOP is applicable for execution of process validation activity. RESPONSIBILITY & ACCOUNTABILITY: RESPONSIBILITY: Quality…
HANDLING OF DATA INTEGRITY PURPOSE: To lay down a procedure for the management of data generated through electronic and paper-based systems which should be Attributable, Legible, Contemporaneous, Original, and Accurate throughout the data lifecycle to ensure Data integrity. SCOPE: Data integrity management as described in the SOP applies to all manual, electronic, and paper-based data…
WATER FOR PHARMACEUTICAL INDUSTRY Water plays an important role in the pharmaceutical industry, serving as an essential component in the development and production of various products. Different types of water are used for different dosage forms such as water for injection, sterile water for injection and purified water. However, if microbiological purification and validation of…
Magnehelic Gauge The Magnehelic Gauge is renowned for its reliability and versatility, making it an exceptional device. It has consistently demonstrated its capability to deliver precise and instantaneous pressure readings in a wide range of environments, including industrial settings, laboratories, and HVAC systems. This blog aims to delve into the intricate mechanisms, diverse applications, and…
Quality Trends The notion of quality has transformed from a fixed standard to a flexible and responsive influence. In the current swiftly evolving environment, quality is no longer merely a target to achieve, but an ongoing process of enhancement. In this article, we will delve into the emerging facets of quality management that are revolutionizing…
In-process Checks For Primary Packaging (Blister / Strip Packing) Record the temperature and relative humidity of the Packaging area. Tablets and Capsules: The following defect /Issue to be sorted out before strip/blister sealing Broken Tablets Laminated Tablets Chipped Tablets Discoloured Tablets With Black particles Tablets With foreign particle Tablets Distorted Tablets Foil shifting: Foil shifting…
Guideline for CAPA (Corrective and Preventive Action) handling procedure PURPOSE To define the procedure for handling of Corrective and Preventive Action. SCOPE This guideline is applicable for all Corrective and Preventive Action that are recommended if any, but not limited to the following documents: Incident / Deviation – Investigation Change control Laboratory deviations Repeat…
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Pharma CAPA Pharma CAPA – Corrective and Preventive Actions (CAPA) are fundamental to the pharmaceutical industry’s commitment to ensuring product quality, safety, and compliance with regulatory requirements. CAPA is a systematic approach used to identify, investigate, and resolve deviations, non-conformities, and potential issues that may arise during the manufacturing or distribution of pharmaceutical products. The…
Medicine and Drug Manufacturing in Pharmaceuticals: Ensuring Quality, Safety, and Accessibility The pharmaceutical industry plays a critical role in global healthcare by manufacturing medicines and drugs that improve and save countless lives. Medicine and drug manufacturing in pharmaceuticals is a complex and highly regulated process that involves research, development, production, and quality control. The quality,…
Unraveling the Power of Corrective and Preventive Actions (CAPA): Enhancing Quality and Driving Continuous Improvement Corrective and Preventive Actions (CAPA) is a fundamental component of a robust Quality Management System (QMS). CAPA processes enable organizations to identify, investigate, and resolve quality issues, as well as implement preventive measures to prevent their recurrence. In this comprehensive…