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QA & QC

DISINFECTANT VALIDATION

DISINFECTANT VALIDATION TABLE OF CONTENTS  Section No Topics Page No 1.0 Protocol Approval 2.0 Objective 3.0 Acceptance Criteria 4.0 Responsibilities 5.0 Validation Methodologies 6.0 Evaluation of test Result 7.0 Re-validation Frequency 8.0 Documentation 9.0 Conclusion PROTOCOL APPROVAL   Name /  Designation  Signature  Date  Prepared By Microbiologist      Checked By  Microbiology …

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PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM

PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM INDEX PART –I                                                                                                 Page no. Objective Brief Description Purpose Procedure Acceptance criteria PART –II Data generation for viable count PART –III Summary Recommendation Attachments PART-I  1.0          OBJECTIVE The objective of this study is to determine the efficacy of  …

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Unit Dose Sampling Procedure for Blend Uniformity

Unit Dose Sampling Procedure for Blend Uniformity OBJECTIVE To lay down the procedure for collecting unit dose blend samples for evaluation of blend uniformity so as to ensure accurate and consistent sampling. RESPONSIBILITY : Officer – Quality Assurance to collect the samples. Head of Quality Assurance to ensure compliance. PROCEDURE: …

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Worst case identification for cleaning validation

Worst case identification for cleaning validation OBJECTIVE: Objective of this SOP is to provide the procedure to be followed during worst case identification for cleaning validation. It also includes updating of API solubility – potency matrix, calculation of acceptable residue levels during cleaning validation. SCOPE: This SOP covers the worst …

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VALIDATION MASTER PLAN

VALIDATION MASTER PLAN CONTENTS SR. NO. CONTENTS PAGE NO. 1 APPROVAL 2 INTRODUCTION 3 VALIDATION POLICY 4 OBJECTIVE 5 SCOPE 6 VALIDATION RESPONSIBILITIES 6.1 Validation Team Constitution 7 FACILITY DESCRIPTIONS AND DESIGN 7.1 General Description and Design Concept 7.2 Description of Products 7.3 Description of Process 7.4 Description of Equipments …

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Management Review

Management Review OBJECTIVE: To have a systematic approach for Management Review through meetings to review Quality Management System (QMS) with an objective to monitor product quality, products status and processes, identify improvements required in system, process and resources, review of quality risks throughout product life-cycle and to review if the …

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Temperature Mapping

OBJECTIVE: To lay down a procedure for temperature mapping in control rooms to determine the hot and cold spots.  SCOPE: This SOP is applicable for Control areas of  Pharmaceutical company. RESPONSIBILITY: Officer and above of respective department shall be responsible for follow the procedure.. Engineering department shall be responsible for …

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Types of liquid column chromatography ( HPLC),HPLC Separation and HPLC Silica gel

Types of liquid column chromatography ( HPLC),HPLC Separation and HPLC Silica gel Type of liquid column chromatography can be  to classify  on the based the nature of the stationary phase and the separation process, Can be classify  three type Adsorption chromatography Ion-exchange chromatography Size exclusion chromatography Adsorption chromatography In adsorption chromatography the stationary …

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SOP for environmental  monitoring of air

SOP for environmental  monitoring of air OBJECTIVE  :To lay down a procedure for environmental  monitoring of air. SCOPE  :This SOP shall provide the procedure for monitoring the viable air borne count . RESPONSIBILITY :Microbiologist ACCOUNTABILITY Manager QC/QA PROCEDURE  The microbial environmental conditions  shall be monitored as per defined frequency and …

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Deviation Handling and Quality Risk Management (Part – I)

Deviation Handling and Quality Risk Management Purpose The aim  is to contribute to the understanding of a quality risk management approach in the handling of deviations from a practical perspective as per WHO expectations.  The intent is to support effective and timely implementation of tools related to deviation management encountered …

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