Qualification of Equipment / Instrument / Utilities SOP

By / Quality Assurance / QA, SOP /

SOP for Equipment Qualification in pharmaceutical industries | Equipment Qualification SOP |

  • Equipment Qualification SOP covers below points:
    • Equipment Qualification purpose
    • levels of Qualifications
    • User Requirement Specifications
    • Design qualification
    • Factory Acceptance Test
    • Site Acceptance Test
    • Installation Qualification
    • Operation Qualification
    • Performance Qualification
    • Re-Qualification
    • Removal/Retirement of equipment /instrument/utilities
    • Equipment Qualification protocol format
    • Equipment Qualification report format
1.0 OBJECTIVE :
  • This SOP describes the procedure for the Qualification activities of Equipment/Instrument/Utilities and the required documentation for execution of qualification activities.
2.0 SCOPE :
  • This procedure is applicable to all the Equipment/Instrument/Utilities used at Manufacturing site.
3.0 RESPONSIBILITY :
  • An expert team from different disciplines such as Production, Quality Control, Quality Assurance and Engineering shall be responsible to perform the qualification activities.
  • Head Q.A., Head Q.C., Head Production and Head Engineering shall be responsible for effective implementation of procedure.
4.0 ACCOUNTABILITY:
  • Q.A. Head
5.0 PROCEDURE :

5.1 The premises, the supporting utilities, the equipment and the processes have been designed in accordance with the requirements of Good Manufacturing Practices, Good Laboratory Practices, Good Engineering Practices and Good Documentation Practices.

5.2 Design Qualification, Installation Qualification, Operation Qualification & Performance Qualification shall be performed for new equipments/instruments. However Installation, Operation, Performance qualification shall also be performed when there is relocation of equipment, instrument, utilities or there is modification/ major spare part change.

5.3 The equipment / instrument qualification shall be carried out as per written authorized protocol. The protocol number shall be assigned as per respective procedure for Validation & Qualification document numbering system.

5.4 The equipment qualification(s) shall be performed using following levels of Qualifications.

5.5 User Requirement Specifications :

  • User department shall prepare URS and shall be reviewed by engineering department. QA department shall approve the URS.
  • The objectives of URS are, not limited to, as follows:
    • User Department shall be prepare URS before purchasing major machine (equipment, instrument, utility or component) with the help of engineering department.
    • Process requirements have been described.
    • Required / applicable features have been described.
    • Key process parameters have been described.
    • Technical requirements have been described.
    • Functional requirements have been described.
    • Utility requirements have been described.
    • Software requirement has been described.
    • Instrumentation & Calibration part have been described.
    • Safety features have been described.
    • Details about documentation required have been described.
    • The description meets the current Good Manufacturing Practices (cGMP) requirements.
  • The preparation of user requirement specification applies to following items:
    • New or refurbished premises, expansion.
    • Purchase of Utility Systems.
    • Purchase of processing equipment.
    • Custom built equipment.
    • Bespoke or user configured computer systems.
  • User requirement Specification is normally not required for:
    • In case similar/ analogous (where vendor, capacity & model are exactly same) equipment / instrument / system is to be procured, for which D.Q. is already performed & approved. Mention the URS number of the existing equipment and specify additional requirements, if any, on the existing equipment/ system/ utility.

5.6 Carry out all below mentioned qualification in sequence only.

5.7 Design qualification :

  • The purpose of Design Qualification is to evaluate the Vendor’s specifications vis-à-vis the user requirements & to ascertain that the proposed equipment /instrument/systems can deliver the intended applications with desired performance & quality indicators. This constitutes Design Qualification or D.Q.
  • User department shall prepare D.Q. protocol and report and shall be reviewed by department head, engineering head and quality assurance head. Head Quality shall approve the D.Q. protocol and report.
  • Design Qualification is subject to Q.A. approval & any changes subsequent to this stage require Q.A. review & approval. Any deficiency during the Design Qualification shall be addressed appropriately.
  • In case similar/ analogous (where vendor, capacity & model are exactly same) equipment / instrument / system is to be procured, for which D.Q. is already performed & approved, then a separate D.Q. may not be required. Only a position paper shall be prepared with justification for not performing D.Q.
  • Design Qualification shall be performed for following:
    • New or refurbished premises.
    • Purchase Utility Systems.
    • Purchase of processing equipment.
    • Custom built equipment.
    • Bespoke or user configured computer systems.
  • Design Qualification is not required for following:
    • Off-the-shelf laboratory instrument/equipment/system.
    • Relocation of equipment/instrument/system within locations.
  • Review of design drawing comparing with approved client definition drawings.
  • Verification that appropriate document e.g. engineering drawings and documents, spares list, planned preventive maintenance schedules, maintenance and operating manuals, etc. are available.
  • Reference to equipment and instrument descriptions e.g. supplier, model, capacity and material of construction.
  • Reference to instrument calibration details and schedules.

5.8 Factory Acceptance Test :

  • Factory Acceptance Test is to be carried out at vendor’s site, if required.
  • The Factory Acceptance Testing shall be aimed at verification of the equipment design parameters such as dimensions, construction features and finishes and the supportive documentation are in line with the approved Design Qualification prior to dispatch of the equipment from the vendor site.
  • FAT shall be performed as per FAT protocol. Protocol for FAT may be prepared at site or may be provided by the vendor.
  • The User Required Specifications (URS), Technical data, purchase order copy, design qualification report, equipment orientation room layout, G.I. Drawing, shall be referred, while performing the FAT.
  • Check for the machine dimensions, Material of Construction, Material of construction of bought out items, vibration and noise level, surface finish certificate, calibration certificate of critical instruments, if any.
  • Operate the machine and take the trial with or without material(s) for the verification of operational parameters, operational ranges, quality of the product output, etc.
  • Compile the observations as Factory Acceptance Test Report.
  • In case of major discrepancies observed during FAT, vendor shall be asked to rectify the observed deficiencies.
  • If the FAT report is satisfactory then vendor shall be allowed to dispatch the equipment / system from the premises.
  • Conduct FAT after getting information from vendor of machine.
  • Depute a team of Competent staff from User’s Department and Engineering Department.
  • Waive FAT whenever the same is not required but document the reason of waiving.

5.9 Site Acceptance Test:

  • Conduct SAT whenever required. This activity is not mandatory.

5.10 Installation Qualification:

  • The premises, supporting utilities and the equipment have been built and installed in compliance with their design specifications. This constitutes Installation Qualification.
  • The objectives of Installation Qualification are;
    • The system meets the Design Specifications / Qualifications.
    • The system is installed according to the manufacturer’s recommendations.
    • All instruments have been identified for calibration.
    • All testing Instruments have been identified for performing calibration.
    • All supporting utilities are property connected.
    • All required SOPs have been identified.
    • Requirement of the Safety, Security and Integrity of electronic records.
    • Requirement of password protection.
    • Requirement of Audit Trail.
    • Requirement of maintenance of Process Parameter History.
    • Requirement of Alarm Event, Log- In, Log-Out Reports.
    • Requirement of Document Retention.
    • Ensure that area/room is qualified before starting I.Q.
  • The system meets the current Good Manufacturing Practice requirements.
  • Engineering department shall prepare the I.Q. protocol and shall be reviewed by Head of user department and quality assurance. Head quality shall approve the I.Q. protocol and report.
  • The Installation Qualification activity shall encompass the following points :
    • Verification of availability of a valid Purchase order.
    • Verification that all the parts are delivered as per specification.
    • Verification on actual installation and whether the Equipment/system is complete with proper interface, associated equipments and civil structure.
    • Verification that required utilities like compressed air, electricity, lighting, plumbing, steam, vacuum, Liquid Petroleum gas, Nitrogen or other gas, Air Handling Unit are provided.
    • Verification of working ranges monitoring and recording instruments.
    • Verification of calibration status of the recording and monitoring instruments.
    • Verification of availability of machine related drawings, documents, manuals, etc.
    • Assignment of identification number to the equipment /system/area/facility.
    • Creation of log book, equipment usage log etc.
    • Inclusion of equipment/ system in preventive maintenance plan if applicable. Initially assign the schedule for preventive maintenance as per the supplier’s recommendation.
    • Identification of critical instruments, calibration at the site after installation and affixing of next calibration due label on the instrument.
    • Perform Passivation, cleaning and sanitization of the equipment. In case of system, facility or utility specify the special cleaning procedure performed in the I.Q. stage and specify the same.
    • Passivation : Passivation of stainless still is the non-electronic process of removing free iron from the surface or a part using a chemical solution as sodium hydroxide followed by nitric acid or citric acid etc.
    • Procedure: Chemical passivation is a two step process.
      • The first step is to remove any oil and grease compound that is on the surface, otherwise this oil and grease will create a localized site where product may get contaminated. Alkaline is used to dissolve away the oil and grease compounds. The surface itself is not affected by this process.
      • The second step is to remove any free iron or iron compound that is on the surface, otherwise this iron will create a localized site where corrosion can continue. Acid is used to dissolve away the iron and its compounds. The surface itself is not affected by this process.
        • Step First:
          • Thoroughly wash the surface of equipment with purified water twice.
          • Prepare a 5% Benefit solution (alkaline product, used to thoroughly clean equipment) 5 kg of sodium hydroxide plus 95 liter of purified water. Store/Circulate for 30 minutes so that oil and greases easily removed from the surface.
          • Rinse the system with water till pH is in between 7-8.
        • Step Second:
          • Use safety goggle and mask while preparing the solution.
          • Prepare a 20% solution of Pascal (This is a high concentration nitric acid ) use 1 liter Nitric acid (commercial grade) and 4 liters of purified water, mix well. Store/Circulate it for 1 hour so that oil and greases easily removed from the surface and alkali is neutralized.
          • Drain the system and rinse with purified water. Check the pH of water to ensure that all the acid is removed.
          • Reclean prior to production use.
    • Criteria for Passivation: This depends on a number of factors, but generally passivation is performed when:
      • New equipment has been installed.
      • Repairs (i.e. welding) have occurred.
      • Aggressive products (high salt/low pH) are processed through the equipment.
      • Equipment surfaces appear dull and dark.
    • Record the observations during the installation qualification in the protocol.
    • All the certificates related to I.Q. phase attached with I.Q. report.
    • Prepare the installation qualification report. Attach the observations during the installation qualification testing to the I.Q. report.
    • In case of any deviation from the technical specification, notify the supplier representative, concerned department Head and Q.A. Department through incident notification form. The deviation shall be handled as per the SOP for Deviation.
    • Operational qualification testing shall be initiated only after implementation of recommendations from the deviations, if any, and after approval of installation qualification report.
    • Installation qualification report should clearly indicate whether the I.Q. testing is completed satisfactorily and can be proceeded for Operational Qualification testing or not.
    • Supplier representative shall verify the functioning of the equipment/ system/utility after completion of installation testing and conduct a training program for all the users on operation.

5.11 Operation Qualification :

  • The premises, supporting utilities and the equipment operate in-accordance with their design specifications. This constitutes Operational Qualification.
  • The Operation Qualification shall be performed to ensure:
    • The system meets the current Good Manufacturing Practice.
    • All critical components have been calibrated.
    • The control panel has been verified for its specified functions.
    • All safety features have been verified.
    • Standard Operating Procedures have been verified.
    • The equipment / instruments / systems operation has been verified for its intended use.
    • Engineering department shall prepare the O.Q. protocol and shall be reviewed by Head of user department and quality assurance. Head quality shall approve the O.Q. protocol and report.
    • The Operation Qualification activity shall include the following activities :
      • Completion of the Prerequisite activities,
      • Enlisting of the Standard Test Instrument Details,
      • Calibration/Testing Of Instrument/Component,
      • Enlisting of Key Functionality,
      • Documentation of the SOP Training to the concerned personnel,
      • Documentation of the SOP verification,
      • Verification of the safety features,
      • Summary of the ‘ No Load ’  Trial,
      • Deficiency and Corrective Action Report,
      • Final Report,

5.12 Performance Qualification :

  • A specific process will consistently produce a product meeting its predetermined specifications and quality attributes. This constitutes Performance Qualification.
  • Performance qualification is not a must for equipment which is not used for processing of the product and that do not have any specific quality requirements for the output of the equipment.
  • System Owner shall prepare the performance qualification protocol after referring the User requirement specification.
  • Performance qualification protocol shall be reviewed and approved by the Head of the department, Quality Assurance and Head Quality.
  • Performance Qualification testing shall include the verification that the equipment/utility/ system can perform effectively and reproducibly based on approved process method and product specification.
  • Performance Qualification shall be carried out by performing processing of three consecutive batches on the equipment as per the process validation protocol or by the dummy products for which Quality attributes of finished product are predetermined in the performance qualification protocol of respective machines.
  • Based on results, conclusion shall be drawn. Qualification report shall be reviewed and approved for its routine use.
  • Qualification status shall be pasted on the equipment upon successful completion of complete qualification viz: D.Q., I.Q., O.Q. and P.Q. Specimen format of qualification status is attached as Annexure No. 01.

5.13 Re-Qualification :

  • Any aspect of, including significant changes to the Equipment/facility/utility/system which may affect the quality of the product, directly or indirectly, should be re-qualified and validated.
  • Re-qualification shall also be performed in case of change in location of the Equipment/facility/utility/system.
  • The extent of Re-qualification shall be assessed during change control evaluation.
  • The periodic re-qualification of Equipment/facility/utility/system shall be limited to check the physical aspects, utility connections & pipelines, safety features, compliance with the operating SOPs, status on the breakdown & preventive maintenance carried out on the equipment & review of the historical data.
  • Removal/Retirement of equipment /instrument/utilities:
    • Any instrument/equipment can be retired from service or removed from the designated area, due to following reasons.
      • Recurring breakdown, Equipment/Instrument beyond repairing.
      • Procurement of superior instrument/equipment. Procurement of superior instrument/equipment.
      • Stoppage of product specific machine.
    • Concerned user department shall send a request to Quality Assurance giving instrument details like name, make, model, serial number, reason for removal/retirement, alternate arrangement for performing the function of subjected equipment/instrument/utilities etc. as per Annexure No. 08.
    • Quality Assurance shall evaluate the details of the request in consultation with Head-Q.A., Head-Engineering and Head-Production and approve.
    • The instrument shall be retired/ removed after approval.
    • Master documents pertaining to retiring/removal of instrument/ equipment/utilities shall be discontinued and made obsolete, as applicable.
    • Take care that removal process does not contaminate the area.
  • Equipment Qualification Protocol Cum Report should be numbered as follows :
  • EQIP/VAL/ABC/YYY-ZZ
    • Where,
    • EQIP : Equipment
    • VAL: Validation
    • ABC: Equipment Name in abbreviated form
    • YYY: Serial Number of Report
    • ZZ: Revision Number
  • Instrument Qualification Protocol Cum Report should be numbered as follows :
  • INST/VAL/ABC/YYY-ZZ
    • Where,
    • INST : Instrument
    • VAL: Validation
    • ABC: Equipment Name in abbreviated form
    • YYY: Serial Number of Report
    • ZZ: Revision Number
  • Utilities Qualification Protocol Cum Report should be numbered as follows :
    • INST/VAL/ABC/YYY-ZZ
      • Where,
      • INST : Instrument
      • VAL: Validation
      • ABC: Equipment Name in abbreviated form
      • YYY: Serial Number of Report
      • ZZ: Revision Number
 6.0 ABBREVIATIONS:
AbbreviationExpanded form
SOPStandard Operating Procedure
Q.A.Quality Assurance
URSUser Requirement Specification
D.Q.Design Qualification
FATFactory Acceptance Test
SATSite Acceptance Test
I.Q.Installation Qualification
O.Q.Operation Qualification
P.Q.Performance Qualification

7.0 ANNEXURES:
Annexure No.Title
01Qualification Status Label
02Design Qualification Protocol Cum Report for …..
03Factory Acceptance Test Protocol Cum Report for …..
04Site Acceptance Test Protocol Cum Report for …..
05Installation Qualification Protocol Cum Report for …..
06Operational Qualification Protocol Cum Report for …..
07Performance Qualification Protocol Cum Report for …..
08Removal/Retirement Form of Equipment / Instrument / Utilities

8.0 SOP REFERENCES
  • GMP Guidelines 

END OF THE SOP

ANNEXURES :

Annex. No. 01 Qualification Status Label

Annex. No. 02 Design Qualification Protocol Cum Report for …..

Annex. No. 03 Factory Acceptance Test Protocol Cum Report for …..

Annex. No. 04 Site Acceptance Test Protocol Cum Report for …..

Annex. No. 05 Installation Qualification Protocol Cum Report for …..

Annex. No. 06 Operational Qualification Protocol Cum Report for …..

Annex. No. 07 Performance Qualification Protocol Cum Report for …..

Annex. No. 08 Removal/Retirement Form of Equipment / Instrument / Utilities