To lay down the procedure for performance Qualification of the Equipments / Instruments/Systems.
1.0 PURPOSE
To lay down the procedure for performance Qualification of the Equipments / Instruments/Systems.
2.0 SCOPE
2.1 This procedure is applicable in All departments
3.0 RESPONSIBILITY
3.1 Validation – Coordinator
4.0 ACCOUNTABILITY
4.1 Manager-Quality Assurance
5.0 PROCEDURE
5.1 The PQ / analytical validation protocol will be as detailed as possible to with methodology to avoid later confusion over any aspect that was not previously documented.
5.2 The protocol consists of the following information in the respective cells of the format given in Annexure-I
|
Cell Number |
Information |
Font |
|
01 |
To write the equipment name / Analytical Validation name |
Upper case |
|
02 |
To write the equipment number / area where the analytical validation belong |
Sentence case |
|
03 |
To write the protocol number |
Upper case |
|
04 |
To write the effective date of the protocol |
DD/MM/YYYY |
|
05 |
To write the name of the Block |
Sentence case |
|
06 |
To write the name of the module |
Sentence case |
5.3 The contents of the Protocols shall be as follows
5.3.1 TABLE OF CONTENTS
5.3.1.1 Protocol Approval
Consists of the Name, Designation, Signature and date of the person(s) responsible for the Preparation, Checking and Approval of the Protocol.
5.3.1.2 Objective
The objective of the protocol shall be discussed in this section.
5.3.1.3 Scope / study site / system description
5.3.1.4 The scope / study site / system description of the subjected equipment shall be discussed in this section
5.3.1.5 Execution Team
Name, Designation and signatures of the Execution team responsible for the execution of the protocol
5.3.1.6 Methodology
The Instruments / study identified for Performance qualification / analytical validation shall have proper SOP’s / methods to conduct the study with materials an methods, data sheet and acceptance criteria .
5.3.1.7 Deficiencies and Corrective Action Report
a). Description of deficiency observed and date
b). Person responsible for corrective action and date assigned
c). Corrective actions taken /conducted with signature and date.
5.3.1.8 Summary and Evaluation of Results
a). Summary of document with relevant data
b). Analysis / Evaluation of data finished in the document.
5.3.1.9 Abbreviations
Expanded form of abbreviations used shall be defined.
5.3.1.10 Post approval
Consists of the Name, Designation, Signature and date of the person(s) responsible for the Preparation, Checking and Approval of the Protocol.
5.4 Analytical validation protocol shall be prepared as per annexure I and Performance Qualification protocol shall be prepared as per annexure II
END OF DOCUMENT
Analytical validation, qualification, performance, quality assurance
