Injection -Line clearance SOP

Injection -Line clearance SOP Objective: To lay down the procedure for line clearance of manufacturing and warehouse areas.  Scope: This SOP is applicable for line clearance of production (Injection), and warehouse activities held at the Formulation plant. Responsibility: The operator/Supervisor shall be responsible for proper cleaning of equipment / area. Warehouse/ Production Chemist/ Officer shall … Read more

Betamethasone Neomycin EYE /EAR DROPS

Betamethasone Neomycin EYE /EAR DROPS PURPOSE:  This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form. SCOPE:                                                                                                                                                     This procedure is performed and is applied during the manufacturing of dosage form. RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Assistant Manufacturing Chemist to follow and adhere to … Read more

Magnehelic Gauge

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 … Read more

Quality Trends

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 … Read more

Management of sterile area after power resume

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 … Read more

In-process Checks For Primary Packaging

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 … Read more

Compressed air validation in Pharmaceutical Industries

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 … Read more

Guideline for CAPA (Corrective and Preventive Action) handling procedure

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 … Read more

Smoke Study in Clean Rooms of Pharmaceuticals

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 … Read more

Pharma CAPA 

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 … Read more