Tag Archives: Aberdeenshire

List of SOPs of Environment, Occupational Health and Safety (EOHS)

List of SOPs of Environment, Occupational Health, and Safety (EOHS) S. No. SOP Title 1. Operating procedure for Effluent treatment plant 2. Procedure  for analysis of treated effluent 3. Procedure for operation and calibration of Tds meter in ETP laboratory 4. Calibration and Operating procedure for pH meter 5. Operating …

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Warehouse (Stores)

Warehouse (Stores) Warehousing is a complex and dynamic field that plays a critical role in maintaining the integrity and safety of products. Adhering to regulatory standards, and implementing best practices, Warehouses or stores can contribute to the overall efficiency of the supply chain. The Importance of Warehousing: Warehouses or stores …

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HR SOPs (Human Resources)

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HR SOPs (Human Resources) S. No. SOP Title 1 Medical Examination 2 Personnel clothing and  Hygiene 3 First Aid Procedures 4 Accident management Procedures 5 Preparation of Job responsibilities 6 Training of  Personnel s 7 Scrap Management and Disposal 8 Cleaning and Sanitation of General Area 9 Cleaning and Classification …

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SOP LIST (Quality Assurance)

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SOP LIST (Quality Assurance) S. No. SOP Title 1.        Preparation, Approval, and Control of Standard Operating Procedures 2.        Vendor Approval 3. Change Control 4. Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products. 5. Preparation, Approval and Control of Specifications and Standard Test Procedures …

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SOP on Sampling of Raw Material

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SOP on Sampling of Raw Material Objective: To lay down the procedure for the sampling of raw material. Scope: This procedure is applicable for the sampling of raw material. Responsibility: Chemist or above Accountability: Head – Quality Control Procedure: Sampling of Raw Materials: Raw material sampling shall be initiated after …

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List of SOPs Quality Control

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List of SOPs Quality Control Sr. No. SOP Title 1. SOP on entry & exit procedure in Quality Control Department 2. SOP on sampling of raw material. 3. SOP on intermediate and finished product analysis and approval 4. SOP on analysis of sample by contract laboratory 5. SOP on sampling …

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Design Qualification of Gelatin Colour Mixer

Design Qualification of Gelatin Colour Mixer OBJECTIVE: To design, engineer and supply the Gelatin Colour Mixer and to provide assurance that the machine is manufactured and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in …

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SOP for operation of Strip Packing Machine

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SOP for operation of Strip Packing Machine Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of Strip Packing Machine. Scope This SOP is applicable for the operation of Strip Packing Machine used to pack the Tablets and Capsules into Strips in the formulation plant. Responsibility Production …

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Installation Qualification of Gelatin Storage Vessel

Installation Qualification of Gelatin Storage Vessel PURPOSE: To describe the Installation Qualification of Gelatin Storage Vessel its accessories and to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification. Aid verification of the installation as per equipment general arrangement …

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SOP for operation of de-dusting and polishing machine

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SOP for operation of de-dusting and polishing machine Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of de-dusting and polishing machine. Scope This SOP is applicable for operation of de-dusting and polishing machine used to polish the Filled Capsules in Capsule Filling Area to the formulation …

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SOP on operation of Paste Kettle

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SOP on operation of Paste Kettle Standard Operating Procedure (SOP) Objective To lay down the procedure for operation of Paste Kettle Scope This SOP is applicable for operation of Paste Kettle in the formulation plant. Responsibility Production Operator/ Technician – For operation of the equipment. Production Officer/ Executive – To …

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SOP FOR STABILITY STUDY IN PHARMA INDUSTRY

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SOP FOR STABILITY STUDY IN PHARMA INDUSTRY OBJECTIVE: To lay down the procedure for collection, storage and analysis of stability of  samples. SCOPE: This SOP shall be applicable for stability study of samples in Quality Control Department in Pharma Industry. RESPONSIBILITY: Officers/Executive-Quality Control shall be responsible for follow that procedure. …

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Tablets In Pharma Industry

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Tablets In Pharma Industry NOTE- The provisions of this monograph do not necessarily apply to tablets intended for use other than by oral administration such as Vaginal preparations or Or mucosal preparations, and to lozenges, oral pastes and oral gums. Introduction Tablets are solid dosage forms each containing a unit …

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CAPSULES IN PHARMA INDUSTRY

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CAPSULES IN PHARMA INDUSTRY Capsules are solid dosage forms in which the drug substance is enclosed within either a hard or soft soluble shell. Generally, the shells are formed from gelatin. The capsule may be regarded as “container” drug delivery system, which provides a tasteless/odorless dosage form without the need …

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Total Organic Carbon in Water in Pharma Industry

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Total Organic Carbon in Water in Pharma Industry This method for determining total organic carbon (TOC) indirectly measures the total· amount of organic substances present in water for pharmaceutical use in Pharma Industry. The molecules of organic matter in water are oxidised to produce carbon dioxide which is then measured …

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Disintegration Test in Pharma Industry

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Disintegration Test in Pharma Industry This test determines whether dosage forms such as tablets, capsules, boluses pessaries, and suppositories disintegrate within a prescribed time when placed in a liquid medium under the prescribed experimental conditions. For the purpose of this test, disintegration does not imply complete solution of the dosage …

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Checklist for QC Audit in Pharma Industry

Checklist for Laboratory in Pharma Industry Laboratories should be audited regularly and at least once per year. Auditing is an independent activity and separate from self-inspection. Auditing activities could include reviewing SOPs, worksheets, laboratory notebooks, balance calibration records, working control data, pipette calibration records, equipment monitoring logs and other related …

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Effectiveness of Antimicrobial Preservatives in Pharma industry

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Effectiveness of Antimicrobial Preservatives in Pharma industry The efficacy of antimicrobial preservation of a pharmaceutical preparation on its own or, if necessary, with the addition of a suitable preservative has to be ascertained during the development of the product. The primary purpose of adding antimicrobial preservatives in Pharma industry to …

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Equipment in Pharma company as per USFDA

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Equipment in Pharma company as per USFDA Equipment design, size, and location (§ 211.63) in Pharma company Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its …

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