Tag Archives: Western Isles

Management Review Objective To have a systematic approach for quality review as per Quality Management System (QMS) with a objective to monitor product quality, validated status of products and related processes, identify improvements required in manufacturing process and systems and take care of quality risks throughout product life-cycle. Scope This …

SOP on SOP (Standard Operating Procedures) In Pharma Industry Objective: To lay down a procedure for the preparation, review, approval, distribution, control & revision of Standard Operating Procedure In the Pharma Industry. Scope: This procedure is applicable to all sops of the formulation plant of the Pharma Industry. Responsibility: Personnel …

SOP For line clearance Objective: To lay down the procedure for line clearance of manufacturing and warehouse area. This is to ensure that the start up of any production/ process is free from previous material/ contaminants.  Scope: This SOP is applicable for line clearance of production (oral), production (Injection), and …

PREVENTIVE MAINTENANCE OF PRODUCTION EQUIPMENT OBJECTIVE; To define the procedure for preventive maintenance of production equipment. SCOPE: This procedure is applicable for preventive maintenance of production equipment. RESPONSIBILITY: This procedure is applicable for preventive maintenance of production equipment. RESPONSIBILITY: Mechanical Engineer ACCOUNTABILITY: Engineer Head ATTACHMENTS: Attachment I – Preventive maintenance …

Indian Pharmacopoeia Commission (IPC) In the healthcare system, Indian Pharmacopoeia Commission (IPC) plays an important role particularly in matters related to the quality standards, safety and rational use of medicines in the country. IPC was set up on 01st January, 2009 as an autonomous Institution under the Ministry of Health …

SOP for Procedure of shutdown and startup of Facility Objective To lay down the procedure of shutdown and start-up after shutdown of Facility. Scope This SOP is applicable for procedure of shutdown and start up after shutdown of Facility in the formulation plant. Responsibility All personnel working in respective areas. …

SCALE UP AND POSTAPPROVAL CHANGES (SUPAC) GUIDANCE FOR INDUSTRY: A REGULATORY NOTE – PHARMA INTRODUCTION Technology transfer of a pharmaceutical product from research to the production floor with simultaneous increase in production outputs is commonly known as scale-up. In simple terms, the process of increasing batch size is termed as …

SOP for PLASTICS AS PACKAGING MATERIAL Plastics in packaging have proved useful for a number of reasons, including the ease with which they can be formed, their high quality, and the freedom of design to which they can be changed. Plastic containers are extremely resistant to breakage and thus offer …

SOP and Guideline for Hold-Time Studies of Tablets These guidelines focus primarily on aspects that should be considered in the design of the hold-time studies during the manufacture of non-sterile solid dosage forms. Many of the principles described here also apply to other dosage forms such as liquids, creams, and …

SOP for Hold Time Studies Protocol of Ornidazole Tablets 500 mg Process Step – Blending/ Lubrication About 500 gms material from blended mass is kept under simulating conditions. The material is subjected to analysis for Assay of Ornidazole,Total & single impurity  and LOD at 0 day, after 7th day & after 15th …