To describe the procedure for preparation of qualification protocols, and reports and provide the guidelines for execution of qualification activity and related documentation.


This SOP shall be applicable for the qualification of all newly procured and upgraded systems/ equipment/utilities at Relax Pharmaceutical Pvt. Ltd Unit-I, Paonta Sahib (H.P.).



Qualification: Documented evidence that premises, systems or equipment are able to achieve the predetermined specifications when properly installed, and/or work correctly and lead to the expected results.

User Requirement Specification (URS): The set of owner, user and engineering requirements necessary and sufficient to create a feasible design meeting the intended purpose of the system. 

Risk assessment (RA): is a systematic process of identifying hazards and evaluating any associated risks within a workplace and Equipment/Instrument and Facility, then implementing reasonable control measures to remove or reduce them. 

Design Qualification (DQ):  The documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose. 

Installation Qualification (IQ): The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations. 

Operational Qualification (OQ): The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.

Performance Qualification (PQ): The documented verification that systems and equipment can perform effectively and reproducibly based on the approved process method and product specification.

Requalification: Repeated qualification of a previously qualified system, to ensure continued compliance with established requirements.

Qualification protocol: A document describing the activities to be performed during qualification, including the acceptance criteria.

Qualification report: A document in which the records, results and evaluation of qualification are documented and summarized. It should also contain a conclusion of the outcome of the qualification.


URS   :     User Requirement Specification

RA     :     Risk Assessment

DQ     :     Design Qualification

IQ       :     Installation Qualification

OQ     :     Operational Qualification

PQ     :     Performance Qualification

RQ     :     Re-qualification



All Qualification Protocol/Report and its documents shall be prepared as per the procedure mentioned in this SOP.

Only Controlled copies of documents/protocol shall be made available at the time of Qualification activity.

Previous qualification activity shall be documented & completed while performing the next activity of qualification.

Equipment Qualification Approach:

The universal “V model” approach shall be followed for all the qualification activities.

The model is as follows:


The left arm of the “V” deals with defining the requirement and design of the equipment.

The right arm of the “V” ensures that for each item in the left arm, there is a corresponding activity that verifies the same in the equipments.

These include:

The installation is as per the design specification in the URS (this activity is called IQ).

The Operation is as per the function and design specification in the URS (this activity is called OQ).

The performance is as per the overall performance requirements specified in the URS (this activity is called PQ).

FAT & / or SAT may be done based on the risk assessment or criticality of the equipment; it is not mandatory and hence, is shown with dotted lines.

Qualification activity shall consider stages from the initial development of the user requirement specification through to the end of the use of the equipment, facility, utility, or system.

The introduction of any new equipment or system shall follow the quality risk management approach for qualification activity.

The impact of equipment or system shall be assessed during risk assessment to determine the equipment or system that requires qualification and the equipment, which do not have this requirement.

Based on the impact assessment, the equipment or system shall be categorized as “Direct Impact”, “Indirect Impact” or “No Impact”.

An equipment or system shall be defined as Direct Impact if it meets any of the following criteria.

It has direct contact with the product which is impacting product quality attributes. E.g. Air quality, MOC, etc.

To provide or produce an in-process material or an ingredient /excipient or solvent, which forms a part of final product formulation e.g. purified water.

It is used in the cleaning and sterilization of critical equipment. E.g. autoclave, CIP system

It preserves the product status of raw material / In-process material /Product/QC samples e. g Nitrogen.

Produces data, which is used to accept/reject in-process material or product e.g. electronic batch recording system, critical process parameter chart recorder.

It is a process control system that may affect product quality and for which alternative independent verification is not available e.g. PLC, or SCADA.

An equipment or system shall be defined as “Indirect Impact” if it meets any of the following criteria:

Indirect impact equipment /systems will be those parts that are connected to direct impact or are playing role in direct impact systems/equipment e.g. Carton packing machine, Sticker labeling machine, etc.

An equipment or system shall be defined as having “No impact” and has no impact on product quality e.g. lifting and positioning device, Conveyor belt, Shipper coding machine, etc.

Appropriate qualification practices shall be applied to “Direct Impact” equipment or system, and “Indirect Impact” equipment shall undergo enhanced commissioning.

While the “No Impact” equipment shall be installed and commissioned according to “Good Engineering Practices”.

Table – 1

Equipment Categories Need for Qualification activity Approach for Qualification Activity
Direct Impact Yes URS, DQ , FAT/SAT (if applicable) , IQ , OQ ,PQ
Indirect Impact Yes URS, DQ,  FAT/SAT (if applicable),

EQ (IQ &OQ, PQ or IQ, OQ and PQ) as applicable

No Impact No Good Engineering Practice


All equipment and system are categorized and enlisted as direct impact, Indirect Impact, and No impact on the basis of the Impact Assessment Exercise and attached as Attachment-XI ‘Categorization of equipment and system”.

“Direct Impact” and Indirect Impact” equipment shall be subjected to periodic re-qualification/ validation as per the defined schedule in VMP.

User Requirement Specifications (URS):

User requirement specification (URS) shall be prepared by the user department in coordination with engineering based on previous performance and practical experience.

The following points shall be considered for the preparation of URS but not limited to:

  • Objective
  • Scope
  • Responsibility
  • Equipment / System description
  • User requirement specification
  • Equipment / System performance
  • Material of construction
  • Required documents
  • Utility available on site
  • Safety Design Features
  • Location and Environment
  • Support required from the supplier
  • Attachment(s)
  • Abbreviation(s)
  • Review and Comments
  • Approval

Approved URS shall be submitted to the Quality Assurance department for issuing an ‘UNCONTROLLED COPY’ to the Engineering/User department for identification of the vendor in coordination with the Purchase Department.

Based on the URS, the proposals given by the vendors are reviewed and the vendor who meets the specification is selected and referred to the purchasing department for procurement.

Design Qualification (DQ):

The DQ is aimed to specify that the equipment, system, or facility is designed in accordance with the requirements of the user and Good Manufacturing Practice (GMP).

Design qualification document shall be prepared, reviewed, and approved by Manufacturer.

For feasibility, DQ document is reviewed and approved by User, Engineering, and QA departments.

If Design qualification is not provided by the manufacturer then the DQ document shall be prepared by the engineering department in coordination with the user department based on User Requirement Specifications and technical specifications provided by the manufacturer.

The Design qualification document shall include the following details but not limited to:

  • Pre-approval
  • Objective
  • Scope
  • Overview
  • Qualification Team and Responsibility
  • Pre-requisites
  • Equipment /System description
  • Equipment /System/Technical Specification
  • Review/evaluation of vendor design against user requirements
  • Deficiency sheet
  • Review Inclusive of follow-up action (if any)
  • Abbreviation(s)
  • Recommendation/Conclusion
  • Post-approval

The DQ document must cover –

  • All the necessary diagrams,
  • Layout,
  • Location Suitability desired special feature of components,
  • Equipment and their specification,
  • Desired material for construction,
  • Location of the control panel,
  • Electrical requirement and utility requirements

After sign-off, any change in DQ of equipment that may have a direct or indirect impact on the Quality, Safety, and Efficacy of the product shall be evaluated and incorporated through the change control procedure SOP.

Factory Acceptance Test (Optional):

For major and tailor-made (specially designed) equipment, Factory Acceptance Test (FAT) may be carried out by
User/QA and Project/Engineering department through FAT document which shall be provided by the vendor.

The necessity of FAT shall be evaluated by User, Project/Engineering, and QA Departments.

The Factory Acceptance Test shall be performed in the supplier document and shall include the following (but not limited to):

Visual inspection of components: This includes the verification of dimension, motor, blower specification, MOC, Valves (Size/No and safety requirements (alarm/Interlocks)

Critical operational requirement: this includes the verification of critical operations based on URS

Proof of functionality, by either a conventional function test or by simulation

Verification of documents (availability and quality)

Overall Review/Inspection

Any modification with respect to the approved design, and requirements shall be identified, and the same is explained to the vendor and documented as minutes of the meeting duly signed by the User, QA Project/Engineering, and Vendor.

Any modification from the approved DQ, identified during FAT shall be incorporated through
Change Control and Considered during Installation Qualification.

The minutes of the meeting shall be annexed to the change control procedure.

The FAT document shall be filed in the Quality Assurance department.

Site Acceptance Test (Optional)

Site acceptance test shall be performed by the User department, Engineering, and QA at the site after the recipient of equipment/system in presence of the vendor to ensure that the equipment/system is in a good state, no components are damaged, and meeting the designed as per URS.

SAT involves the inspection of equipment Major or sub-components in packed or unpacked condition, and alignment checks of various components, systems, and subsystems. Master document –Maintenance /user manual, Qualification document (If applicable), calibration certificate.

SAT also includes verification of supporting utilities, pendants availability and adequacy, etc. at the site.

Site acceptance test done as per checklist attached as Attachment –

Installation Qualification:

Installation qualification documents of equipment shall be prepared by the engineering department in coordination with the user department and Quality assurance.

IQ is carried out to ensure that the premises supporting utilities and equipment have been built and installed in compliance with their approved design specification (DQ) and manufacturer’s manual and recommendations.

Installation qualification documents shall include the following details (but not limited to):

  • Pre-Approval
  • Objective
  • Scope
  • Equipment description & Identification
  • Qualification team & responsibility
  • List of reference documents & drawings
  • Pre-requisites
  • Checklist for Inspection of Equipment on receipt
  • List of Spare parts received
  • Location suitability
  • Physical verification of area
  • Verification of major component
  • Verification of Installation
  • Identification of equipment / Instrument for calibration and preventive maintenance
  • Material of construction
  • Utilities / Services connection checks
  • Cleaning & Passivation
  • Manufacturer Certificates
  • Identification of product contact surfaces
  • Deficiency sheet
  • Attachment(s)
  • Abbreviation(s)
  • Summary and Conclusion
  • Post Approval

Wherever IQ documents are compiled by the vendor the document submitted by the vendor is evaluated and any parameters, if not included in the document submitted by the vendor shall be
carried out and details shall be documented.

Any non-compliance observed during Installation qualification shall be recorded.

Operational Qualification:

After successful completion of IQ. OQ shall be performed to verify that the equipment, instrument, utility, and system, operate in accordance with design specification, manufacturer recommendation, and cGMP requirements.

Operational qualification documents of equipment shall be prepared by the User department in
coordination with the engineering department and Quality Assurance.

OQ of equipment shall be prepared based on the design qualification and manufacturer’s manual and recommendation.

Operational Testing is to be done, whenever possible to challenge the system, to the limits of anticipated operating conditions.

Typically OQ shall be done “without load”.

However, if the equipment cannot be run without load, then load trials may be taken.

OQ must also verify the performance of the equipment’s components, as applicable, such as motors, blowers, sensors, functioning of interlocks, safety features, etc.

The Operation qualification document shall include the following details (but not limited to):

  • Pre- Approval
  • Objective
  • Scope
  • Qualification team and Responsibilities
  • Equipment operating principle
  • Pre-requisites for operational qualification
  • Methodology for operation qualification
  • Calibration review of critical instrument like sensor, probes, gauges, recorders, air flow rates,
  • Directions, pressure, temperatures etc. And referred standard test instrument.
  • Filter integrity and efficacy test
  • Operational verification of Equipment i.e. operational testing as per process & system
  • Requirement and challenging
  • Verification of draft SOP, s & Training
  • Critical parameters of DQ verified in OQ.
  • Testing of safety features & interlocks
  • Power failure verification
  • Validation of PLC
  • Training to personnel for Maintenance and Operation
  • Deficiency sheet
  • Abbreviation(s)
  • Attachment(s)
  • Summary and conclusion
  • Post Approval

Wherever OQ documents are compiled by the vendor, the document submitted by the vendor is evaluated, accepted, and approved by Quality assurance.

Any parameters, if not included in the document submitted by the vendor shall be carried out and details are documented.

Any non-compliance observed during operational qualification shall be recorded.

Operational qualification is normally performed after IQ but depending on the complexity of the equipment, it may be performed as a combined Installation /Operational qualification (IOQ).

The completion of a successful OQ should be allowed the finalization of standard operating and cleaning procedures, Operator training, and preventive maintenance requirement.

Performance Qualification:

Performance qualification is the final stage of qualification, which demonstrates how the equipment/system will perform when challenged under simulated or actual production conditions.

A series of tests are designed to demonstrate that the equipment/system is capable to perform consistently and meet required specifications under routine production operations.

Studies on the critical variables shall be included a condition or a set of conditions encompassing upper and lower processing or operating limits and circumstances, commonly referred to as “worst case” conditions

Performance qualification documents of equipment and system shall be prepared by QA (Validation) in coordination with the user department & Engineering department.

Performance Qualification of equipment shall be prepared based on the user’s requirement and design qualification/technical specification, provided by the manufacturer.

The Performance qualification document shall include the following details (but it’s not limited to):

  • Pre- Approval
  • Objective
  • Scope
  • Qualification team and Responsibilities
  • Pre-requisites for performance qualification
  • Methodology for performance qualification
  • Performance verification Tests
  • Deficiency sheet
  • Abbreviation(s)
  • Attachment(s)
  • Summary and Conclusion
  • Recommendation
  • Post Approval

PQ shall normally be the successful completion of IQ and OQ.

However, it may in some cases be appropriate to perform it in conjunction with OQ or process validation.

Any significant changes to the approved DQ/IQ/OQ/PQ documents during execution, e.g. acceptance criteria, operating parameters, etc., should be documented as a deviation and be scientifically justified.

Conditional approval to proceed to the next qualification stage can be given where certain acceptance criteria or deviations have not been fully addressed and there is a documented assessment that there is no significant impact on the next activity.

Qualification activities wherein locations need to be identified for placement of data logger or sensors, then schematic layouts to depict the position of sensors or location identification shall be specified in the Qualification/validation protocol for better clarity.

In some cases when the equipment operational ranges or any other additional checks are not validated during performance qualification then it shall be part of process validation (PV).

Any non-compliance observed during performance qualification shall be recorded.

After Completion of qualification of new equipment/ system shall be released for routine activity after approval as per Attachment No.

Requalification of Equipments and System:

The extent of requalification after the change shall be justified based on the risk assessment of the change.

Requalification after the change shall be considered as part of the change control procedure.

Re-qualification shall be carried out for one or more of the following reasons, (but not limited to):

Modification in the equipment which directly or indirectly affects the quality of the products being processed on the equipment

Relocation of the equipment

Any other change as deemed necessary for requalification through the change management system.

Equipment Upgradation

Note: Re-qualification shall not be required for portable equipment (Like Vibro sifter, Multi mill, Metal detector, Vibro deduster, Stirrer, Check weigher )

However, procedures for operating of this equipment shall be available that shall contain extensive checks on the equipment prior to its operation and operation of any equipment must be verified prior to use

During equipment qualification and re-qualification activity following shall be considered:

Acceptance criteria shall be adequately defined to enable configurations to be attained.

The approach taken towards qualification /validation activity (e.g. selection of product, test, and batch sizes for OQ/PQ) shall be based on rational /risk assessment.

“Challenge test scripts” (additional protocols ) used during qualification/validation shall be Referenced in the qualification documents

Pre-approved before starting activities

Descriptive & clear so as to avoid ambiguity.

The re-qualification document shall include all essential qualification details as per initial Installation, Operational, and Performance qualification content.

The re-qualification documents shall be prepared separately (RIQ, ROQ, and RPQ or a common requalification document (RQ) shall be prepared for equipment or system after change.

Re-qualification document shall be prepared as per the Attachment and the content of the document shall be as per type document i.e. RIQ, ROQ, RPQ and RQ, etc.

Periodic re-qualification of equipment:

Periodic re-qualification of “Direct Impact” and Indirect Impact” equipment shall be carried out as per the schedule defined in the VMP.

For Direct impact Equipment: 3 years ± 3 months

For Indirect impact Equipment: 5 years ± 3 months

Periodic re-qualification documents shall be prepared by QA in coordination with engineering and the User.

The periodic re-qualification documents shall include the following details:

  • Pre-Approval
  • Objective
  • Scope
  • Qualification team and Responsibilities
  • Equipment Description
  • Reference Documents
  • Pre-requisites for equipment re-qualification (Review of change control, Document Verification, Physical verification of equipment, PM detail verification, Breakdown details verification, Calibration verification)
  • Installation Verification
  • Operational Verification
  • Performance Evaluation
  • Details of non-conformance
  • Summary and Conclusion
  • Recommendation (S)
  • Abbreviation(s)
  • Attachment(s)
  • Post-approval

Dismantling of Equipments:

For Dismantling of the Equipment/system the request shall be raised as per the Attachment- (Equipment/Instrument/Utility retirement form)

Dismantling verification document shall be prepared by the User department in coordination with Engineering and QA for equipment whenever equipment has to be transferred or removed from its qualified location.

The dismantling document shall be prepared as per the Attachment-.

Dismantling verification of equipment shall be done whenever equipment has to be transferred or removed from the qualified location.

Dismantling verification document shall include the following details (but not limited to):

  • Pre- Approval
  • Objective
  • Scope
  • Verification team and Responsibilities
  • Methodology for dismantling verification
  • Equipment description
  • Dismantling procedure (Equipment verification, Document verification, Instrument calibration verification, Checks and tests to be performed before dismantling, Dismantling checks)
  • Deficiency sheet
  • Abbreviation(s)
  • Attachment(s)
  • Summary and Conclusion
  • Post Approval

Assessment, Evaluation and Interpretation of data:

Assessment: During and after qualification study, study data shall be assess from concern department

Evaluation: After the collection of different test data report, all data shall be evaluated on the basis of comparison with the acceptance criteria mentioned in the approved document or protocol

Interpretation (Summary & Conclusion):

If the qualification tests results found satisfactory or meeting the acceptance criteria than the summary the test result and draw the conclusion shall be clearly state that the equipment/ system has qualified and it will be released to concern department for further or routine usage or its intended usage.

In case any of the result not meeting the acceptance criteria than it will lead to non-conformance to the qualification of the respective equipment/system.

If any non-complies found than the conclusion of the report shall be clear state that the equipment/system not complying with the acceptance criteria of the approved document or protocol hence the equipment/ system not qualified for it intended usage and it will proceed for further investigations for the failure.

Recommendation of approved report shall be prepared on Attachment-  and issued to the concerned department as per the SOP No. QA-048 for operation and verification purpose.

Procedure for reviewing of results

QA validation team member shall review the calibration certificate and test report results of equipment’s/instruments which provided by external party contracted for qualification activities.

After reviewing the results, QA person shall affix the QA reviewed stamp with signature and date to all document used during qualification studies.

General Instructions – Equipment Qualification:

Equipment Qualification/Re-qualification planner shall be prepared as per Attachment- and updated annually.

The entire body content of the qualification document or protocol shall be as per type of document and in “appropriate font and size (as per Document and Data Control SOP)”.

Equipment/ System/ Area under qualification/re-qualification shall be labeled with “UNDER QUALIFICATION” status label till completion of the qualification/ re-qualification activity.

Qualification document numbering system maintained as per SOP

The entire Qualification/Re-qualification schedule shall be reviewed annually and prepared new schedule for next year.


ISPE, Volume 5, Commission & Qualification.

Good manufacturing practices: guidelines on validation Annex 3 (trs1019)

EU GMP Annex 15: Qualification and Validation

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