Handling of Spillage of Materials

Spillage of Materials Objective :To lay down a procedure for Handling of Spillage of Materials to prevent contamination in surrounding areas and to avoid environmental hazards by any hazardous material. Scope : This Standard Operating Procedure is applicable in the facility for the handling of spillage of Material in the pharma industry. Responsibility Concerned Department … Read more

SOP for Drain Point Sanitization

SOP for Drain Point Sanitization Objective :  To lay down a procedure for Drain point sanitization. Scope : This SOP is applicable for cleaning and sanitization of drain points available in all sections of formulation plants of pharma industries. Responsibility Operator/Technician – To perform the procedure. Production personnel (Officers & above) to ensure the procedure … Read more

SOP on testing and approval / rejection of packaging material

Testing and approval/rejection of packaging material Objective: To lay down a procedure for testing and approval/rejection of packaging materials. Scope:                              This sop is applicable for testing and approval/rejection packaging materials Responsibility: QC –Chemist or above shall be responsible for testing of packaging materials QC-Executive / Nominee shall be responsible for reviewing of worksheet. Accountability: Head … Read more

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

WATER FOR PHARMACEUTICAL INDUSTRY

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 … 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