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Equipment Qualification Procedure and Protocol

Equipment Qualification is the final series of inspections and tests to ensure that critical requirements necessary for related product quality are satisfied and that documents and procedures necessary to properly operate and maintain the system are in place.

Equipment Qualification Procedure

1.0   Objective :

    • To lay down the procedure for preparation of Qualification documents, execution of Qualification activities, Review and Compilation of data, Assessment and Interpretation of Qualification & validation activity results.

2.0   Scope :

    • The standard operating procedure applicable for preparation of qualification and re-qualification documents for all equipment & system and execution of qualification activities performed at pharmaceuticals plant.

3.0   Procedure – Equipment Qualification :

    • Equipment Qualification Approach :

    • The universal “V model” approach shall be followed for all the qualification activities.
    • The model is as follows:

Equipment Qualification Approach

    • 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 left arm, there is a corresponding activity which 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 activities 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 initial development of the user requirement specification through to the end of use of the equipment, facility, utility or system.
    • 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 those equipment or system that requires qualification and those equipments, which do not have this requirement.
    • Based on the impact assessment, the equipment or system shall be categorized as “Direct Impact”, “Indirect Impact” and “No Impact”.

  • An equipments 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 cleaning and sterilization of critical equipments. E.g. Vertical autoclave, CIP system
    • It preserves 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, SCADA or DCS

  • 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 which 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 “No impact” having 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

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 Impact Assessment Exercise and attached as Annexure-VI ‘Categorization of equipment and system”.
    • “Direct Impact” and Indirect Impact” equipment shall be subjected to periodic re-qualification/ validation as per defined schedule in VMP.

  •  User Requirement specifications (URS):

    • User requirement specification (URS) shall be prepared by the user department in co-ordination 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 Quality Assurance department for issuing an ‘UNCONTROLLED COPY’ to Engineering/Project department for identification of vendor in co-ordination with Purchase Department.
    • If required a PDF version also provided to Engineering department for necessary action with purchase department and vendor.
    • Based on the URS, the proposals given by the vendors are reviewed and the vendor who meets the specification is selected and referred to purchase department for the 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 department.
    • If Design qualification is not provided by manufacturer then DQ document shall be prepared by engineering department in coordination with user department based on User Requirement Specifications and technical specifications provided by 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 of construction ,
      • Location of control panel,
      • Electrical requirement and utility requirement
    • After sign off, any change in DQ of equipment which may have direct or indirect impact on Quality, Safety and Efficacy of product shall be evaluated and incorporated through change control procedure SOP.

  • Factory Acceptance Test (Optional):

    • For major and tailor made equipment, Factory Acceptance Test (FAT) may be carried out by
      User/QA and Project/Engineering department through FAT document which shall be provided by vendor.
    • The necessity of FAT shall be evaluated by User, Project/Engineering, and QA Department.
    • The Factory acceptance Test shall be performed in 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 operation 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 approved design, requirements shall be identified, and the same is explained to vendor and documented as minutes of meeting duly signed by 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 meeting shall be annexed to the change control procedure.
    • The FAT document shall be filed in Quality Assurance department.

  • Site Acceptance Test (Optional)

    • Site acceptance test shall be performed by User department, Engineering and QA at site after the recipient of equipment / system in presence of vendor to ensure that the equipment/system is in good state, no components are damaged and meeting the designed as per URS.
    • SAT involves inspection of equipment Major or sub components in packed or unpacked condition, 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 site.
    • Site acceptance test done as per checklist attached as Annexure No. VII

  • Installation Qualification:

    • Installation qualification document of equipment shall be prepared by engineering department in coordination with 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 vendor the document submitted by vendor is evaluated
      and Any parameters, if not included in the document submitted by 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, operates in accordance with design specification, manufacturer recommendation and cGMP requirements.
    • Operational qualification document of equipment shall be prepared by User department In
      coordination with 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 feature & 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 vendor, the document submitted by vendor is evaluated, accepted and approved by Quality assurance.
    • Any parameters, if not included in the document submitted by vendor shall be carried out and details are documented.
    • Any non compliance observed during operational qualification shall be recorded.
    • Operational qualification 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 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 that 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 are 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 document of equipment and system shall be prepared by QA (Validation) in coordination with user department & Engineering department.
    • Performance Qualification of equipment shall be prepared based on user’s requirement and design qualification/technical specification, provided by 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 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 deviation 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 needs to be identified for placement of data logger or sensors, then schematic layouts to depicts the position of sensors or location identification shall be specified in 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 the 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 Annexure No. XIII

  • Requalification of Equipment’s and System:

    • The extent of requalification after the change shall be justified based on risk assessment of the change.
    • Requalification after change shall be considered as part of the change control procedure.
    • Re-qualification shall be carried out for one or more of the following reason, (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 change management system.
      • Equipment Up gradation
    • Note: Re-qualification shall not be required for portable equipment (Like Vibro sifter, Multimill, Metal detector, Vibro deduster, Stirrer, Checkweigher )
    • However procedures for operating of these 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 are 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 common requalification document (RQ) shall be prepared for equipment or system after change.
    • Re-qualification document shall be prepared as per Annexure no.-II and content of document shall be as per type document i.e. RIQ, ROQ, RPQ and RQ etc.

    • Periodic re-qualification of equipment’s :

    • Periodic re-qualification of “Direct Impact” and Indirect Impact” equipment’s shall be carried out as per schedule defined in the VMP.
      • For Direct impact Equipment: 3 years ± 3 month
      • For Indirect impact Equipment: 5 years ± 3 months
    • Periodic re-qualification documents shall be prepared by QA in co-ordination with engineering and 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 Annexure- III (Equipment/Instrument/Utility retirement form)
    • Dismantling verification document shall be prepared by User department in coordination with Engineering and QA for equipment’s whenever equipment’s has to be transferred or removed from its qualified location.
    • The dismantling document shall be prepared as per the Annexure-II.
    • Dismantling verification of equipment’s 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

  • Approval of Equipment Qualification Documents:

    • Equipment Qualification documents shall be prepared and approved as under:
Pre-Approval
Documents Prepared By Reviewed By Approved By
DQ Engineering Head- User,

Head- Engineering

Quality Assurance

 Head- Quality Assurance

Head Operation
IQ Engineering Head- User,

Head- Engineering

Quality Assurance

 Head- Quality Assurance

Head Operation
OQ User Head- User,

Head- Engineering

Quality Assurance

 Head- Quality Assurance

Head Operation
PQ Quality

Assurance

 Head- User,

Head- Engineering

Quality Assurance

 Head- Quality Assurance

Head Operation
Common equipment, Qualification, Common  RQ and PRQ Quality

Assurance

 Head- User,

Head- Engineering

Quality Assurance

 Head- Quality Assurance

Head Operation
Post approval
DQ/ IQ/ OQ/

PQ/EQ/REQ/PRQ

 User,

Engineering,

Quality

Assurance

 Head- User

Head-Engineering

Quality Assurance

 Head-Quality Assurance

Head-Operation
URS

 

 User Head-User

Head- Engineering

Quality Assurance

 Head-Quality Assurance

Head –Operation
Miscellaneous

study protocol and

report

 User Head-User

Head- Engineering

Quality Assurance

 Head-Quality Assurance

Head –Operation

 

  • 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 Annexure No. X 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 equipments/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 Annexure No. –I and updated annually.
    • Qualification documents shall be prepared as per specimen format attached as Annexure No.-II and other miscellaneous study document shall be prepared as per Annexure No. XIV.
    • 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 SOP on SOP)”.
    • At the time of periodic revision/intermittent revision of protocol, all the supplements attached to protocol shall merge in the actual protocol.
    • The copy of the Master/ approved/ controlled documents (e.g. executed BMR/ validation reports) that need to be attached as a supportive documents with the qualification document shall be stamped with “Reference Copy” (Red colour). The stamp shall be applied at the Right bottom of each page.
    • Equipment/ System/ Area under qualification/re-qualification shall be labeled with “UNDER QUALIFICATION” status label till completion of the qualification/ re-qualification activity.
    • The traceability matrix shall be prepared as per the Annexure No.-V.
    • Qualification document numbering system maintained as per Annexure No. XII
    • The entire Qualification/Re-qualification schedule shall be reviewed annually and prepared new schedule for next year.

4.0   Annexures – Equipment Qualification:

Annexure-I : Equipment Qualification/Requalification schedule
Annexure-II : Format for preparation of qualification documents  (specimen copy)
Annexure III : Equipment / Instrument/Utilities Retirement Form
Annexure-IV : Equipment Qualification Document Numbering System
Annexure-V : Traceability Matrix
Annexure-VI : Categorization of equipment and system
Annexure-VII : Site acceptance test format
Annexure-VIII : Time Based activity schedule
Annexure -IX : Miscellaneous study protocol numbering log
Annexure -X : Recommendation  format
Annexure -XI : Addendum to Validation document format.
Annexure -XII : Qualification document numbering log
Annexure -XIII : Release of Equipment
Annexure -XIV : Format for preparation of Miscellaneous validation/ qualification study documents

5.0   Reference (S)

    • Validation Master Plan (VMP)
    • ICH, (CDER and CBER), Q9 Quality risk management, Guidance for industry, June 2006
    • EU guidelines for GMP for Medicinal products for human and veterinary use, Annex 15:Qualification and Validation

Annexure-I : Equipment Qualification/Requalification schedule

Document No.:                Department:               Section:                                   Effective Date:

Sr. No. Name of Equipment Equipment

ID. No.

 Initial Quali-fication Date Qualification/

Re-qualification

Done On

 Periodic Re-qualification

due on

 Re -Qual.

Completion  Date

 Next Re-Qual.

Due on

 Checked By

(Sign. / Date)

 Remarks

Note: @ denote initial Qualification date, $ denote Re-qualification date, * denote Periodic re-qualification date

Prepared By: Checked By: Approved By:
Sign.  Date
Name

Annexure-II : Format for preparation of qualification documents

QUALIFICATION DOCUMENT OF —————————-

DEPARTMENT :
LOCATION :
NAME OF THE EQUIPMENT :
EQUIPMENT  I. D. :
MAKE :
MODEL / TYPE :
EFFECTIVE DATE (POST APPROVAL) :

 

Document No. & Rev. No. Effective Date (Pre-approval) Reason for revision

TABLE OF CONTENTS

Sr. No. Content Page No.
1.         
2.     
3.     
4.     
5.     
6.     
7.     
8.     
9.     
10.   
11.   
12.   

Annexure-III : Equipment / Instrument/Utilities Retirement Form

EQUIPMENT / INSTRUMENT / SYSTEM DETAILS :
Date :

Name of the instrument/equipment/system :

Instrument/ equipment ID    :                                                          Make       :

Model                                     :                                                                   Sr. No     :

Area of installation               :

Reason for Retirement/Removal: (Attach additional sheet if required) …………………

Prepared by:                                                                                                  Dept. Head:

(Sign/date)                                                                                                      (Sign/date)
QA Comments
Remarks: (Attach additional sheet if required)…………………………………………………………………………….

QA Manager

(Sign/date)
Approval
Remarks: (Attach additional sheet if required) ………………………………………………

 QA Head   

(Sign/date)

Annexure-IV : Equipment Qualification Document Numbering System

Sr. No

 Name of Document

Document Numbering System
1. User’s Requirement specification
2. Design Qualification
3. Installation Qualification                      
4. Operational Qualification               .
5. Performance Qualification
6. Common qualification document
7. Periodic Re-qualification
8. Miscellaneous validation/Qualification/Study protocol
9. Miscellaneous validation/Qualification/Study report
10. Dismantling Verification document

Annexure-V : Traceability Matrix

Equipment Name: Equipment ID No.: Location:
Make: Model: Sr. No.:

Sr. No.

 URS No. DQ FAT SAT IQ OQ PQ

Remarks

Annexure-VI : Categorization of equipment and system

  • Production Equipment:

    • Equipment having “Direct Impact “on the product Quality:
Sr. No Equipment Name Sr. No Equipment Name
1. Sifter 2. Multimill
3. RMG 4. FBD
5. Tray Dryer 6. Compression Machine and line equipment
7. Blender Bin 8. Capsule filling machine and line equipment
9. Coating machine 10. Alu-Alu Packing Machine
11. Blister Packing Machine 12. Storage Vessel
13. Strip Packing Machine 14. Basket Filter
15. Manufacturing Vessel 16. In line Homogenizer
17. Sugar Dissolving Vessel 18. Bottle Washing Machine
19. Filter press 20. 2 D Vision and printing system
21. Filling & Sealing Machine 22. Inspection belt (manual)
23. Stirrer

    • Equipment having “Indirect Impact “on the Product Quality:

Sr. No Equipment Name Sr. No Equipment Name
1. Jacketed Vessel or Paste kettle or Solution preparation tank 2. Jet Cleaning Machine
3. Check weigher 4. Carton packing machine
5. Optical Inspection Machine(Manual) 6. IR Dryer
7. Dedusting booth 8. Sticker labeling machine
9. Camera Inspection Machine

    •  Equipment having “No Impact “on the Product Quality :

Sr. No Equipment Name Sr. No Equipment Name
1. Lifting and Positioning device 2. Conveyor belt
3. Turn table 4. BOPP Taping Machine
5. SS Pressure Vessel 6. Strip de-foiling machine
7. Stacker and lifter

  • Utility Equipment And System:

    • Equipment/system having “Direct Impact “on the Product Quality:
Sr. No Equipment Name Sr. No Equipment Name
1. Air Handling Unit (Classified areas) 2. AHU cum Dehumidifier
3. Dehumidifier unit 4. Purified water generation, storage and distribution system
5. Compressed air system 6. Nitrogen system

    •  Equipment/System having “Indirect Impact “on the product

Sr. No Equipment Name  Sr. No Equipment Name
1. Dry Scrubber 2. Wet scrubber
3. Filter cleaning machine 4. Dust Extraction Unit

    •  Equipment/System having “No Impact “on the Product Quality:

Sr. No Equipment Name Sr. No Equipment Name
1. Boiler 2. Chiller
3. D.G Set 4. Hot water generator
5. Cooling tower 6. Storage tanks (other than water system)
7. Vacuum system 8. Ventilation supply
9. Ventilation exhaust 10. Dust collector
11. Air conditioners 12. ETP Plant
13. Electrical system

Annexure-VII : Site acceptance test format

Checklist / Report of SAT
 Page No.      :
Machine Name   :

Capacity             :

Date                    :

 Model No.      :

Make               :
Sr.

No.

Job Description

 Status  Observation if any Remarks
1. Dimension as per drawing. OK/Not OK
2. MOC Certificate of product. OK/Not OK
3. Surface finish certificates if applicable. Available/ Not Available
4. Motors, Gearbox or other parts should be of Standard make. OK/Not OK
5. Service manuals along with control Drawings are provided. Available/ Not Available
6. Others OK/Not OK
Comments if any:

Annexure-VIII : Time Based activity schedule

Document No. :                      Department:                      Effective Date                               

Sr. No.

 Validation for Area Frequency Last done date Scheduled on Done date Next

Due on

 updated By

(Sign./Date)

 Checked By

(Sign./Date)

Remarks

Annexure-IX : Miscellaneous study protocol numbering log

Sr. No. Protocol Name Protocol No. and Effective date Updated by

(Sign./Date)

 Checked by

(Sign./Date)

 Report No. & Effective date Updated by

(Sign./Date)

 Checked by

(Sign./Date)

 Remark

Annexure-X : Recommendation Format

Recommendation for…………………………………..

Ref.  Protocol No. & Revision No. .:                                              Effective Date:                     

Report No. & Revision No. :                                                           Effective date:

Batch size:

Recommendation:____________________________________

Approval:
Functional Area Name Signature/ Date
Prepared By (QA)    
Reviewed By (QA)    
Reviewed By (User Department )    
Approved By (Head QA)    

Annexure-XI : Addendum to Validation document format

Addendum to ……. .…….

Addendum No. :                                                                                                  Effective Date

Initial Document Name:

Initial Document No:

Effective Date of Initial Document:                                    

Description of Supplement:

Approval:
Functional Area Name Signature/ Date
Prepared By(User Department)    
Reviewed By (QA)    
Reviewed By (User Department )    
Approved By (Head QA)    

Annexure-XII : Qualification document numbering log

Sr. No. Equipment Name Equipment ID URS No. DQ No. IQ No. OQ No. PQ No. Updated by

(Sign./Date)

 Checked by

(Sign./Date)

 Remark
                     
                     
                     

Annexure-XIII : Release of Equipment

 Release of Equipment/System for Routine Activity

 This is to certify that

 Name of the Equipment/System:                                                 Equipment ID:                     

Make:                                                                                                       Model :

Has been Installed, Commissioned and Qualified in …………area having room ID …… and same has proven satisfactory.

Thereby, the Equipment/ System is handover to user department on

Date …………..

Recommendation:………………………………………………………

Approval:
Functional Area Name Signature/ Date
Quality Assurance    
User Department    
Engineering    
Approved By (Head Operation)    
Approved By (Head QA)    

Annexure-XIV : Format for preparation of Miscellaneous validation/ qualification study documents

VALIDATION /QUALIFICATION STUDY DOCUMENT OF  —————————-

  :  
  :  
  :  
  :  

 

Document No. & Rev. No. Effective Date Reason for revision
     

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Janki Singh

Mrs. Janki Singh is the professional pharmaceuticals Blogger. She has already posted more than #1000 articles on varrious topics at different blogging plateforms. Contact : guideline.sop@gmail.com