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…
Management of sterile area after power resumes In the fast-paced and technology-driven world of healthcare, maintaining sterility in critical areas is paramount. The disruption of power supply in healthcare facilities can pose significant challenges, potentially compromising the integrity of sterile environments. When power is restored, a well-thought-out plan is essential to ensure that sterile areas…
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…
Compressed air validation in Pharmaceutical Industries Compressed air is air under pressure above atmospheric pressure. Useful for many household and industrial purposes. Compressed air is an important source of energy and is used in a variety of industrial applications. When properly processed, compressed air is considered safe and clean compared to other energy sources. The…
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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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Smoke Study in Clean Rooms of Pharmaceuticals Clean rooms play a pivotal role in the pharmaceutical industry, providing controlled environments where critical processes are conducted to ensure product quality, safety, and efficacy. A smoke study is a fundamental test performed in clean rooms to evaluate the effectiveness of airflow patterns, ventilation, and containment systems. The…
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,…
HPLC Method Validation: Ensuring Reliable and Accurate Pharmaceutical Analysis High-Performance Liquid Chromatography (HPLC) is a powerful analytical technique widely used in the pharmaceutical industry for drug analysis, quality control, and research purposes. The reliability and accuracy of HPLC results are crucial to ensuring the safety and efficacy of pharmaceutical products. Method validation is an essential…
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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…