Qualification For Stability Chamber ( STABILITY DATA ACQUSITION SOFTWARE)

Qualification For Stability Chamber ( STABILITY DATA ACQUISITION SOFTWARE) Purpose The purpose of this Qualification Plan (QP) is to define the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Testing activities for the qualification of WALK IN CHAMBER, STABILITY DATA ACQUISITION SOFTWARE to be deployed at Quality Unit, for the users in the Quality Control/ … Read more

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 Manager. Quality Control  Approved By … Read more

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  UV germicidal lamp of Laminar … Read more

Prospective Process Validation

Prospective Process Validation I. INTRODUCTION Validation is an essential procedure that demonstrates that a manufacturing process operating under defined standard conditions is capable of consistently producing a product that meets the established product specifications. Process validation is establishing documented evidence that provides a high degree of assurance that a specific process  will consistently produce a product meeting … Read more

USER REQUIREMENT SPECIFICATION OF PRESSURE VESSEL

USER REQUIREMENT SPECIFICATION OF PRESSURE VESSEL S. No Table of Contents 1 General 2 Salient Features 3 Operational requirements 4 Utilities 5 Maintenance 6 Documentation 7 Training 8 Packaging 9 Deviations 10 Delivery  TECHNICAL S. No. Parameters Requirement Specifications 1 1.1. General Equipment No’s.  1.2 Description 1.3 Use 1.4 Field Identification     To be … Read more

Installation Qualification for Pass Box

Installation Qualification for Pass Box TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 Equipment Identification 5.0 Equipment location 6.0 Documentation 7.0 Pre-requisite of Installation Qualification 8.0 Installation Qualification Procedure 9.0 System Description 10.0 Procedure 10.1 Installation Check List 10.2 Inspection Check list 10.3 Leveling and Alignment 10.4 Material of Construction Check Points 10.5 … Read more

Operational Qualification for Pass Box

Operational Qualification for Pass Box TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 System Description 5.0 Pre-requisite of Operational Qualification 6.0 Operational Qualification Procedure 6.1 Training 6.2 Instrument Calibration 6.3 Key Functionality 6.4 Test Data Sheet 6.5 Safety Features Test 6.6 SOP Verification 7.0 Deviation and Corrective action 8.0 Change Control Proposal 9.0 … Read more

DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS)

DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS) TABLE OF CONTENT Objective Scope Responsibility Machine description Technical specification Technical specifications and make of sub-components/ bought out items. Details of Utilities Identification of components for calibration Material of construction of all components Safety features and alarms FAT procedure Change control procedure Qualification Document report approval Appendix … Read more

PERFORMANCE QUALIFICATION PROTOCOL

PERFORMANCE QUALIFICATION PROTOCOL TABLE OF CONTENTS 1.0       PROTOCOL APPROVAL 2.0       OBJECTIVE 3.0       SCOPE 4.0       RESPONSIBILITY 5.0       ACCOUNTABILITY 6.0       METHOD 7.0       RECORDING 8.0       ABBREVIATIONS 9.0       REFERENCES. 10.0     REVISION OF PROTOCOL   1.0     PROTOCOL APPROVAL: Protocol Prepared by: QA is responsible for the preparation of protocol for the Performance Qualification of the Nitrogen plant. NAME DESIGNATION SIGNATURE … Read more

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