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Quality Assurance

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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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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Question ans Answer on Cleaning validation in Pharmaceutical Industry

Question 1. What Is Cleaning Validation? Answer:   To evaluate the capability of cleaning procedure  in removing the drug residue and microbiological bio burden on equipment within established acceptance criteria, through the validation of cleaning procedures. To establish sufficient documented evidence to assure that, cleaning procedures can repeatedly and reproducibly remove …

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Code to Code Transfer of Materials and Additional Testing of Materials / Products

Code to Code Transfer of Materials Objective (procedure) To lay down a procedure for code transfer of same material from one code to another and to carry out additional testing of APIs, Excipients and Drug Products to comply with other specifications or Pharmacopoeia. Scope This standard operating procedure is applicable …

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CALIBRATION MASTER PLAN

CALIBRATION MASTER PLAN     TABLE OF CONTENTS  SECTION TITLE                                                                      1.0  Calibration Master Plan Approval 2.0 …

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SOP on In-process sampling of semi-finished product

SOP on In-process sampling of semi-finished product Objective: To lay down procedure for in-process sampling of semi finished drug product. Scope: This procedure is applicable to the in-process sampling of semi-finished drug product  in formulation plant of Pharmaceutical company. Responsibility: IPQA personnel are responsible for collecting in-process semi finished product …

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SOP on execution of exhibit batches

SOP on execution of exhibit batches  Objective To lay down a procedure for execution of exhibit batches. Scope This SOP is applicable for execution of exhibit batches to formulation plant of Pharmaceutical company. Responsibility Officer/above of production and quality assurance department shall be responsible. Accountability Head of Department shall be …

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