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QA & QC

Cleaning Validation – Glossary of Terms

Cleaning Validation Glossary of Terms 1 Acceptable daily intake An amount of a substance administered or consumed on a daily basis that will not produce a pharmacological or toxic response 2 Analyte Substance for which an analysis is being performed 3 API Active pharmaceutical ingredient 4 Automated cleaning A cleaning …

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SOP on SOP

SOP on SOP Objective : To lay down a procedure for the preparation, approval and control of Standard Operating Procedures. Scope: This Standard Operating Procedure is applicable for the preparation and implementation of all Standard Operating Procedures to be followed at Pharmaceutical Company. Responsibility Staff of Initiator Department shall be …

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QUALITY SYSTEMS MODEL IN PHARMACEUTICAL INDUSTRY (Part – I)

QUALITY SYSTEMS MODEL The goal  is to describe a model for use in pharmaceutical manufacturing that can help manufacturers comply with the CGMP regulations. It should be noted that implementing an effective quality system in a manufacturing organization will require a significant investment of time and resources. However, we believe …

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CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS

CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS Quality should be built into the product, and testing alone cannot be relied on to ensure product quality. Several key concepts are critical for any discussion of modern quality systems. The following concepts are used throughout this guidance as they relate to …

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What are good documentation practices & how can they best be implemented?

What are good documentation practices & how can they best be implemented? Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from “good distribution practice” also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDP / GDocP standards …

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Drug Master Files (DMFs) and it submission

Drug Master Files (DMFs) and it submission Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They: Allow parties to reference material without disclosing DMF contents to those …

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QC SOPs List

QC SOPs List SNo. SOPs Title 1.0 SOP on entry & exit procedure in Quality Control Department 2.0 SOP on sampling of raw material. 3.0 SOP on intermediate and finished product analysis and approval 4.0 SOP on analysis of sample by contract laboratory 5.0 SOP on sampling procedure of packaging …

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Quality Assurances SOPs List

Quality Assurances SOPs List SNo. SOP Title 01 SOP on validation master plan 02 SOP on Function of quality assurance department 03 SOP on periodic physical observation of control sample 04 SOP on job responsibility of personnel working in quality assurance. 05 SOP on in-process sampling and analysis of oral …

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Pharmaguidances Whats App Groups

Pharmaguidances Whats App Groups Pharmaguidances   Pharma Post and Jabs     Pharma Vacancy Pharma Post and Jabs 2   Pharmaguideline   Pharmaguideline 2           MFR of SALBUTAMOL SULPHATE TABLET Pharmaceutical GuidanaceMr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical …

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Pharmaceutical Quality Assurance -Drug and Therapeutics Committee Training Course

Pharmaceutical Quality Assurance -Drug and Therapeutics Committee Training Course CONTENTS Pharmaceutical Quality Assurance Acknowledgment Purpose and Content Objectives Outline Key Definitions Introduction Determinants or Aspects of Medicine Quality Critical Elements of a Comprehensive Quality Assurance Program How Is Quality Assessed? How Is Quality Assured? Who Ensures Medicine Quality? Pharmaceutical Quality …

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