Qualification of Systems and Equipments

1.0 Introduction

1.1 Principle

1.1.1 Systems and equipment should be suitably designed, located, installed, maintained and operated in accordance with their purpose

1.1.2 Critical systems should be qualified as they have the tendency to impact the product quality. Examples of such systems are air handling systems, steam systems, water purification systems and steam systems.

1.1.3 Gaining consistency from batch to batch is directly proportional to performance of the equipment therefore the critical equipment should be validated.

1.2 Scope

1.2.1 The guidelines given describe the general aspects for qualification of systems & equipment

1.2.2 Qualification is applicable to equipment & critical systems whose performance might have an impact on the product quality

1.3 General

1.3.1 Manufacturer should have qualification policy for systems & equipment

1.3.2 Equipment along with instruments which are used in quality control and production should be under qualification programme and policy

1.3.3 New systems and equipment should pass through every stage of qualification like design qualification, installation qualification, operational and performance qualification

1.3.4 In few cases all qualification stages are not required

1.3.5 Systems should be qualified prior to equipment and equipment should be qualified before using so that a documented evidence exists which indicates its appropriate usage.

1.3.6 Systems and equipment should undergo constant requalification and also requalification after change

1.3.7 Some stages of qualification for equipment should be done by third party or supplier

1.3.8 Documentation should be associated with qualification along with standard operating procedures, certificates, acceptance criteria and manuals

1.3.9 Qualification should be according to previously determined and approved qualification protocols

1.3.10 Results from qualification should be recorded and should be qualification reports

1.3.11 Period for qualification should be in accordance with criticality of systems and equipments

1.4 Design Qualification

1.4.1 Requirements from user should be taken when the specifications regarding system design and equipment are formulated

1.4.2 Supplier should be selected for system and equipment

1.5 Installation Qualification

1.5.1 Systems should be installed according installation plan and installation qualification protocol

1.5.2 During installation the requirements for maintenance, calibration and cleaning should be checked

1.5.3 Installation qualification includes the identification & verification of system elements, services, parts, controls, gauges and other components

1.5.4 Devices for measuring, controlling and indicating purposes should be calibrated against suitable national or international standards

1.5.5 Records for installation should be documented which indicates installation satisfaction and also the supplier and manufacture details. Equipment/ System name, installation date, serial number, model number, procedures, certificates and spare parts.

1.6 Operational Qualification

1.6.1 Systems and equipments should be operated in accordance with the operational qualification protocol.

1.6.2 Critical operating parameters should be identified and the studies on these critical variables should include upper and lower limits and circumstances for operation.

1.6.3 Operational qualification should include verifying the operations for system elements, parts, services, gauges, controls & other components.

1.6.4 Verification procedures should be documented indicating the satisfactory operation.

1.6.5 Standard operating procedures should be approved and finalized

1.6.6 Operators should be trained for operating the systems and equipments. Records for training should be maintained.

1.6.7 Systems and equipment should be released for using after operational qualification is completed. It is necessary that the cleaning, calibration, training and maintenance and other related tests are acceptable.

1.7 Performance Qualification

1.7.1 Systems and equipments should perform consistently according to the design specifications

1.7.2 Documented records should be present for verifying performance over a given time period. Manufacturers should be able to justify the time period when performance qualification is done.

1.8 Requalification

1.8.1 Requalification should be done according to a defined schedule. Requalification frequency should be on the basis of analysis of results obtained from calibration, verification and maintenance.

1.8.2 Requalification should be done periodically

1.8.3 If after requalification is done after changes then the extent of requalification should be justified according to the risk assessment of change.  

1.8.4 Requalification is often considered as an integral part of change control procedure

1.9 Qualification of in use systems & equipment

1.9.1 Data should be available regarding the performance of systems & equipment which have been used for some period without being subjected to installation or operational qualification.

1.9.2 Operating parameters & limits for calibration, critical variables, standard operating procedures, records, maintenance & preventive maintenance.

Qualification of systems and equipments, requalification, in use systems & equipment, design qualification, installation qualification, operational qualification, performance qualification