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QA & QC

SOP FOR STABILITY STUDY IN PHARMA INDUSTRY

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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Total Organic Carbon in Water in Pharma Industry

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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Effectiveness of Antimicrobial Preservatives in Pharma industry

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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Document Management System in Quality Assurance Department in Pharma Industry

Document Management System in Quality Assurance Department Standard Operating Procedure (SOP) Objective: To lay down a procedure for Management of Documents in Quality Assurance Department in Pharma Industry Scope: Applicable for Document Management system in Quality Assurance department. Responsibility: Quality Assurance Department Accountability: Head- QA shall be accountable for compliance …

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Management Review

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 …

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SOP on Standard Operating Procedures In Pharma Industry

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

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SOP For Line Clearance

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 …

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Indian pharmacopoeia 2007

Pharmaceutical GuidanaceMr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco …

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BUBBLE POINT TEST

BUBBLE POINT TEST Introduction Membrane filters have been used successfully for many years to remove yeast, bacteria and particulate from fluid streams. The ultimate integrity test for a sterilizing grade membrane filter is the bacterial challenge. Unfortunately, this is a destructive test; the filter cannot be used afterwards to filter …

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Analytical Method Validation protocol

Analytical Method Validation protocol                                                                                             …

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