OBJECTIVE:

• To define the standard procedure for the qualification of equipment, instruments, and systems to ensure they are fit for intended use and consistently operate within established limits as per EU GMP / WHO TRS requirements.

 SCOPE:

• All new equipment, instruments, utilities, and systems used in production, quality control, and support areas. Requalification after relocation, modification, or defined intervals.

RESPONSIBILITIES:

• User Department:
• • • Drafts User Requirement Specification (URS).
    • Provides operational input during qualification.
    • Ensures equipment is operated only after qualification approval.

• Engineering Department:
  • Provides technical specifications.
  • Ensures proper installation, utilities, and safety features.
  • Maintains equipment history files.
• Quality Assurance (QA):
  • Reviews and approves URS, protocols, and reports.
  • Ensures qualification activities are risk-based and GMP compliant.
  • Issues final certification of qualification.
• Validation/Qualification Team:
  • Executes qualification studies.
  • Documents raw data, test results, and deviations.
• Head Quality Assurance:
  • Ensures adequate resources.
  • Ensures SOP compliance across departments.

DEFINATIONS:

• Qualification: Documented evidence that equipment/instruments/utilities consistently operate within defined limits and are fit for intended use.
•  User Requirement Specification (URS): A document detailing intended use, performance needs, capacity, operating parameters, critical quality attributes, and GMP requirements.

• Design Qualification (DQ): Verification that the proposed design meets URS and GMP requirements.
•  Factory Acceptance Test (FAT): Verification at supplier site ensuring URS and design criteria is met prior to dispatch.
•  Installation Qualification (IQ): Verification that equipment is installed as per design, properly identified, calibrated, and documented.
•  Operational Qualification (OQ): Verification that equipment operates as intended within acceptance criteria under simulated conditions.
•  Performance Qualification (PQ): Verification that equipment performs consistently under actual operating conditions to produce product of the required quality.
•  Requalification (RQ): Repeat of qualification to demonstrate continued performance after change, relocation, or at defined frequency.

• Continuous Verification: Ongoing assurance of equipment performance through calibration, preventive maintenance, deviations review, and data trending.

• Risk Assessment (RA): A systematic process of identifying potential failures, assessing their impact, and deciding qualification extent based on risk.

• Change Control: A formal, documented system for evaluating, approving, and implementing changes to equipment, systems, processes, or documentation to ensure they do not adversely affect product quality, regulatory compliance, or validated/qualified state.

PROCEDURE:

Qualification Planning and Risk Assessment:

• A Validation Master Plan (VMP) or project-specific plan shall define qualification strategy.
• Risk assessment shall be conducted to determine the extent of testing.
• All qualification activities shall be initiated, tracked, and controlled through the Change Control system when triggered by modification, relocation, or upgrade.

User Requirement Specification (URS)

• URS shall be Prepared by the User Department in consultation with Engineering and QA.

• URS shall be reviewed and approved by cross-functional team. Must include:
  • Functionality, capacity, utilities, safety features.
  • Critical process parameters and critical quality attributes.7
  • Regulatory and cGMP requirements.

• URS shall be Prepared once for new equipment; revised if equipment undergoes major change.

Design Qualification (DQ):

• Design Qualification shall be Conducted before procurement or installation.
• User department shall ensure design meets URS and GMP along with Engineering and Quality Assurance.
• The supplier shall provide DQ documents or in-house DQ documents shall be used.
• Final DQ documents shall be reviewed and approved by QA.
• DQ documents shall prepare once per equipment/Instrument/system. It shall repeat if major redesign occurs.

Factory Acceptance Test (FAT)

• FAT shall be performed to ensure that all the design criteria and process requirements as laid down in the URS/ Purchase order and design qualification document has been addressed by the vendor.
• Factory Acceptance Test shall be conducted at manufacturers/supplier’s site by inspection team comprising of representative from Project/ User / Engineering department / Quality Assurance.
• The team for FAT may comprise of one or more persons from mentioned departments.
• The inspection team shall finally give the clearance for dispatch of the equipment / instrument/ system.
• Factory Acceptance test shall be performed as per Format or vendor provided protocol which shall be reviewed and approved by inspection team comprises of different functions.
• Test results of FAT can be included with justification by execution team members at site to avoid repetition during Installation and operational qualification supported with test documents, specification and vendor internal test reports.

Installation Qualification (IQ):

• Before conducting Installation Qualification, the Design Qualification (DQ) shall be completed. IQ is performed to verify that the equipment/instrument and its components are installed as per approved specifications and requirements.
• The equipment/instrument and all associated components shall be installed in accordance with the specifications defined in the DQ.
• Each equipment/instrument shall be uniquely identified with an identification number, and its current location shall be documented in line with the approved facility design specifications.
• The approved operating manuals, technical manuals, and other relevant documentation shall be available at the site of installation.
• All test and measuring instruments/devices used for qualification activities shall be calibrated as per established calibration procedures and records shall be maintained.
• Safety features of the equipment/instrument shall be verified to ensure their presence and functionality.
• IQ shall be performed as per the approved protocol provided in Format
• For newly procured equipment/instruments, the qualification shall be executed using the supplier’s approved protocol (where available) and shall be reviewed and approved by the Quality Assurance (QA) department.
• Frequency: After initial installation, and repeated if equipment is relocated or undergoes major modification.

Operational Qualification (OQ):

• Operational Qualification (OQ) shall be performed only after successful completion of Installation Qualification (IQ).
• The purpose of OQ is to verify and demonstrate that all components of the equipment/system function as intended, operating within the defined parameters and specified tolerances.
• Standard Operating Procedures (SOPs) required for the correct operation of the equipment/system shall be developed and approved prior to execution.
• The qualification shall be performed using either the supplier-provided or in-house protocol, which must be reviewed and approved by Quality Assurance (QA). Alternatively, the approved protocol attached in Format may be followed.
• Frequency: Once for new equipment; repeated if major controls or software are changed under Change Control.

Performance Qualification (PQ):

• Performance Qualification (PQ) represents the final stage of the qualification lifecycle.
• It is conducted to demonstrate that the equipment/instrument/system performs reliably when subjected to simulated or actual production and operational conditions.
• The PQ phase consists of a defined series of tests designed to confirm that the equipment/instrument/system can consistently operate as intended and is capable of producing output that meets the predetermined quality requirements.
• This stage shall be initiated only after successful completion and approval of both Installation Qualification (IQ) and Operational Qualification (OQ).
• PQ shall be performed for all critical equipment, instruments, and systems. The qualification shall be executed in accordance with the approved protocol provided in Format.

• Frequency: Once for new equipment; repeated if product or process changes impact equipment performance.

Re-Qualification (RQ)

• Re-Qualification (RQ) provides documented evidence that the equipment, instrument, or system continues to perform as intended and remains in compliance with the original qualification status established under IQ and OQ.
• Any modification to the equipment/instrument/system shall be implemented only after a satisfactory review and formal approval of a documented change proposal in accordance with the Change Control procedure. As part of this review, the requirement for partial or full re-qualification shall be evaluated.
• Minor changes, or those with no direct impact on in-process or finished product quality, shall be managed under the established Preventive Maintenance (PM) program and associated documentation system.
• Re-Qualification shall be conducted in accordance with the approved protocol provided in Format.

• Triggers for RQ:
  • Every 5 years (time-based).
  • Relocation to new site.
  • Major modification or upgrade.
  • Regulatory requirement or significant deviation.

Continuous Verification:

• Ensures equipment remains in a state of control between requalification cycles. It includes:
  • • Calibration: As per calibration SOP/schedule.
    • Preventive Maintenance (PM): As per Engineering PM plan.
    • Deviation & CAPA Review: As per the trend.
    • Data Trending: Critical parameters trended and reviewed during Annual Product Quality Review (PQR).
    • Deviations observed in routine monitoring may trigger requalification under Change Control.

Documentation and Approval

• Each qualification stage (URS, DQ, FAT, IQ, OQ, PQ, RQ) must include:
  • • • Protocol with predefined acceptance criteria.
      • Execution records and raw data.
      • Summary report with deviations and conclusions
      • QA approval and closure.
• QA shall finally certify the qualification and approve it.

Protocol cum Report Numbering System:

• All qualification protocol cum reports shall follow a standardized numbering format to ensure traceability and control.
• The numbering format shall be as follows:
• • • PR: protocol cum Report
    • XQ: Stage of Qualification (US, DQ, IQ, OQ, PQ, RQ)
    • DEPT: Department Code (e.g., PD, QA, QC, EG, WH, EH, IT, HR,)
    • YY: Last two digits of the calendar year
    • NNN: Sequential running serial number (starting from 001 each year)
    • Example: PR/IQ/EG/25/007: Installation Qualification protocol cum Report, Engineering Department, year 2025, 7th protocol cum Report issued.

REFERENCES:

• EU GMP – Annex 15: Qualification and Validation.
• EU GMP Part I, Chapter 1: Pharmaceutical Quality System.
• ICH Q9 – Quality Risk Management.
• WHO TRS 1019, Annex 3 – Qualification of Equipment.

RECORDS:

REVISION HISTORY.