1.1 The purpose of this SOP is to define the procedure for the Preparation, Review, and Approval of the Validation Master Plan and Qualification Document.
2.0 SCOPE
2.1 This SOP is applicable for the Preparation, Review, and Approval of the Validation Master Plan and Qualification Document
3.0 RESPONSIBILITY:
3.1 Quality Assurance department shall be responsible for the preparation and updating of the validation master plan and qualification document.
3.2 Engineering and functional head or designee shall be responsible for reviewing of validation master plan and qualification document.
3.3 Quality/head quality shall be responsible for approval/authorization of Validation Master Plan and qualification document.
3.4 Head-Quality Assurance is responsible for the implementation/compliance of this procedure.
4.0 DISTRIBUTION
4.1 Quality Assurance
4.2 Quality Control
4.3 Production
4.4 Warehouse
4.5 Engineering
4.6 Information Technology
4.7 Environmental, Health & Safety
5.0 DEFINITION(S) & ABBREVIATION(S)
5.1 Definitions
5.1.1 Validation: Validation is the documented evidence that provides a high degree of assurance that the process, utility, and material that produces the product are at pre-determined specifications and quality attributes.
5.1.2 Prospective Validation: Validation is carried out during the development stage by means of a risk analysis of the production process, which is broken down into individual steps, these are then evaluated on the basis of past experience to determine whether they may lead to critical situations.
5.1.3 Concurrent Validation: Validation carried out during routine production of products intended for sale.
5.1.4 Retrospective Validation: Involves the examination of past experience of production on the assumption that composition, procedure, and equipment remain unchanged.
5.1.5 Re-Validation: Repeated validation of an approved process (or a part thereof) to ensure continued compliance with established requirements.
5.1.6 Validation Protocol: A validation protocol is a written plan stating how validation will be conducted, including test parameters, product characteristics, and production equipment, and decision points on what constitutes acceptable test results.
5.1.7 Validation Report: A validation report is a written report on the validation activities, the validation data, and the conclusions drawn.
5.1.8 Qualification: The planning, execution, and recording of tests of equipment and systems that form part of the validated process, to demonstrate that it will perform as intended.
5.1.9 User Requirement Specification (URS): A requirement specification that describes what the equipment or system is supposed to do, thus containing at least a set of criteria or conditions that have to be met.
5.1.10 Design Qualification (DQ): Documented evidence that the premises, supporting utilities, equipment and processes have been designed in accordance with the User Requirement specifications of cGMP.
5.1.11 Installation Qualification (IQ): IQ is the documentary evidence to verify that the equipment has been built and installed in compliance with the design specifications.
5.1.12 Operational Qualification (OQ): OQ is the documentary evidence to verify that the equipment operates in accordance with its design specifications in its normal operating range and performs as intended throughout all anticipated operating ranges.
5.1.13 Performance Qualification (PQ): PQ is the documentary evidence to verify that the equipment or system performs consistently and gives reproducibility within defined specifications and parameters for a prolonged period.
5.1.14 Re-qualification: Re-qualification is done to ensure that changes in the process and/or in the process environment whether intentional or unintentional, do not adversely affect process characteristics and product quality
5.2 Abbreviations
5.2.1 VMP : Validation Master Plan
5.2.2 URS : User Requirement Specification
5.2.3 FAT : Factory Acceptance Test
5.2.4 SAT : Site Acceptance Test
5.2.5 DQ : Design Qualification
5.2.6 IQ : Installation Qualification
5.2.7 OQ : Operational Qualification
5.2.8 PQ : Performance Qualification
5.2.9 GMP : Good Manufacturing Practice
5.2.10 cGMP : Current Good Manufacturing Practice
5.2.11 HVAC : Heating, Ventilation, and Air Conditioning
5.2.12 PIC/S : Pharmaceuticals Inspection and Convention / Co-operation Scheme
6.0 PROCEDURE
6.1 Equipment qualifications involve the following
6.1.1 User Requirement Specification (URS)
6.1.2 Design Qualification (DQ)
6.1.3 Installation Qualification (IQ)
6.1.4 Operational Qualification (OQ)
6.1.5 Performance Qualification (PQ)
6.1.6 Re-Qualification
6.2 User Requirement Specification (URS):
6.2.1 URS shall be prepared by the user department head in consultation with the validation team members as per Format No. .....
6.2.2 URS shall contain limited but not limited to objective, scope, process or product requirement, operational requirement, GMP requirement, safety requirement, documentation requirement, service required from the manufacturers, references (if any), documents to be attached, abbreviations, summary, conclusion and signing off.
6.2.3 A copy of URS shall be sent to different equipment manufacturers for the availability of required equipment and technical specifications of the equipment.
6.3 Design Qualification (DQ):
6.3.1 In Design Qualification the User Requirement Specification should be finalized based on the technical specification of the selected supplier and URS.
6.3.2 The DQ protocol and report shall contain but are not limited to objective, scope, Responsibility, User requirement specifications, Machine Description, Technical specification, Details of utilities, technical specification of the sub-component, safety requirements, utility requirements, material of construction of product contact parts and non-contact parts, P& ID diagram for reference & approval, equipment orientation with room layout, Brief process description, Safety features and alarm, Change control procedure, abbreviation, conclusion, design qualification report approval and signing off.
6.3.3 After the approval of DQ report, a copy of DQ along with the purchase order shall be sent to the selected equipment manufacturer for designing of the equipment.
6.4 Installation Qualification (IQ):
6.4.1 Installation Qualification shall include the documentation of maintenance requirement for each installed item and the collection and collation of supplier operating and working instructions, maintenance and cleaning requirements, these shall be the minimum documentation for a satisfactory installation qualification.
6.4.2 It shall require a format and systemic check of all installed equipment components against the equipment manufacturer's specifications and additional criteria identified by the user as part of the purchase specification.
6.4.3 Equipment shall be checked with respect to general requirements, critical variables and safety features.
6.4.4 It shall contain the identification of critical component / instrument, verification of manufacturer's calibration certificates of all measuring devices of the equipment and test certificates for material of construction.
6.4.5 All Stainless Steel Material of Construction (MOC) of the equipment for product contact parts and product Non-Contact parts shall be verified using Molybdenum test kit.
6.4.6 Any deviations observed during Installation Qualification shall be captured and justified by the validation team in the individual IQ report.
6.4.7 Change control (if any) should be approved and shall be captured in the IQ report.
6.4.8 The IQ protocol and report shall contain but are not limited to objective, scope, Approval, Specification of system/equipment, description of equipment, general requirements, pre-installation checks, installation checks, identification of critical components for calibration, verification of safety features, references (if any), abbreviations, documents to be attached, any changes made against the formally agreed parameters, conclusion, installation certification statement and installation qualification signing off.
6.4.9 After completion of the Installation Qualification tests and IQ report is signed off, Operational Qualification test shall be initiated.
6.5 Operational Qualification (OQ):
6.5.1 The equipment shall be verified with respect to its operational requirements, critical variables and safety features.
6.5.2 The critical variables such as speed, Voltage, Current drawn etc. shall be verified for three consecutive readings during operational confirmation.
6.5.3 All critical components of the equipment shall be calibrated by the approved external agency.
6.5.4 The details of the instrument used for verifications, such as instrument name, identification number, and calibration status shall be recorded in the qualification report. A copy of the calibration certificate of the instruments used for verification shall be enclosed to the operational qualification report.
6.5.5 The SOP's for equipment, Operation, Cleaning, and Preventive Maintenance shall be prepared and training for all concerned personnel shall be imparted.
6.5.6 The Preventive Maintenance Plan and Calibration plan shall be updated to include the new equipments / system for routine preventive maintenance and calibration activity.
6.5.7 Any deviations observed during the Operational Qualification shall be captured and justified by the validation team in the individual OQ report.
6.5.8 Change control (if any) should be approved and shall be captured in the OQ report.
6.5.9 The OQ protocol and report shall contain but not limit to objective, scope, site of study, validation team members, description of equipment, general requirements, calibration details, pre-operational checks, operational checks, safety parameter checks, standard operating procedure details, training details, references (if any), abbreviations, documents to be attached, any changes made against the formally agreed parameters, conclusion, operational certification statement and operational qualification signing off.
6.5.10 After completion of the Operational Qualification tests and OQ report is signed off, Performance Qualification test shall be initiated.
6.6 Performance Qualification (PQ):
6.6.1 During Performance qualification the working of the system as a whole should be checked with respect to output, quality, and any specific requirement as per design qualification.
6.6.2 In PQ simulated products/ products shall be used to conduct the performance qualification. Studies on the critical variables shall include a condition or a set of conditions encompassing upper and lower processing or operating limits and circumstances commonly referred to as “worst case” conditions.
6.6.3 Three consecutive batches/runs shall be carried out for satisfactory completion of performance qualification.
6.6.4 Any deviations observed during the Performance Qualification shall be captured and justified by the validation team in the individual PQ report.
6.6.5 Change control (if any) should be approved and shall be captured in the PQ report.
6.6.6 The PQ protocol and report shall contain but are not be limited to objective, scope, site of study, validation team members, description of equipment, SOP to be followed, pre-performance checks, performance checks, abbreviation, document to be attached, any change made against the formally agreed parameters, conclusion, performance certification statement and performance qualification signing off.
6.6.7 After completion of the Performance Qualification test and PQ report is signed off the equipment shall be released for its intended use and affix the Validation label Format No....
6.7 Re-Qualification: Re-qualification is whenever of two types:
6.7.1 Re-qualification after the change:
6.7.1.1 Equipment should be subjected to re-qualification when ever major changes are made or equipment is relocated.
6.7.1.2 Re-qualification after changes should be performed when these changes could have an effect on the quality of the product or the product characteristics.
Examples of major changes which require re-qualification are:
6.7.1.2.1 Change in RPM of Blender.
6.7.1.2.2 Change in Speed of Agitator.
6.7.1.3 The extent of re-qualification will depend on the nature and significance of the changes. This will be decided by the validation team.
6.7.1.4 The re-qualification need not to be performed for the minor changes in the equipment/area.
6.7.1.5 All changes in the equipment should be recorded in the machine History Card.
6.7.1.6 If any fixed equipment is shifted from one area to another area, critical parameters should be checked during re-qualification. For the relocation of portable equipment, re-qualification is not required.
6.7.1.7 During the transfer of equipment from one unit to another unit, re-qualification of IQ, OQ, and PQ should be conducted based on critical parameters. A copy or original qualification should be attached as a reference.
6.7.1.8 Any change in equipment leading to re-qualification should go through a change control procedure with proper justification for change.
6.7.2 Periodic Re-qualification:
6.7.2.1 Based on the extent of validation required, the data available for a reasonable period (sufficient to prove consistency) may be reviewed and equipment put in use with ongoing validation in progress. Additional checks and control may be incorporated during the period. This process of interim use needs to be approved by Head QA.
6.7.2.2 Equipment should be subjected to re-qualification in accordance with a defined schedule available at the unit and recorded.
6.7.2.3 Frequency of periodic Re-qualification should be decided based on critical monitoring parameters and it should not exceed 5 years.
6.7.2.4 Manual documents shall be prepared by the user department in the format as detailed in Format No. ..... Issuance and retrieval of the document shall be as per SOP NO. .....
6.7.3 The numbering system for Manual:
6.7.3.1 This is an alphanumeric number Consisting of 8 characters:
6.7.3.2 For example: XX/ZZ/RR -
Where,
XX : Represent the title of the document TM (Training Manual),QM (Quality Manual)
etc .
/ : Separator.
ZZ : Indicate the version number of the document starting from 01 and continuing serially
in increments of one unit.
RR : Indicate the Revision number of the document starting from 00 and continuing
serially in increments of one unit.
6.8 Validation Master Plan shall give an overview of the entire validation operations, its organizational structure, content and planning.
6.9 Validation Master Plan shall be a summary document, which is brief and clear.
6.10 Validation Master Plan shall be prepared for an existing facility, when an existing facility undergoes renovation or for a new facility.
6.11 VMP shall identify the layout of the operations, the associated utilities and systems, the equipment, and the processes to be validated along with the information as to extent of the qualification and validation, required documentation, SOPs, acceptance criteria and responsibilities.
6.12 Validation Master Plan shall be prepared in the format as detailed in Format No. ..... and supporting qualification documents shall be prepared in the format as detailed in Format No.........
6.13 Validation Master Plan shall consists of following:
6.13.1 It contains details of document preparation, review and approval. Each section shall have the information as mentioned below:
6.13.1.1 Prepared By: This column shall bear the signature of the person who has prepared the VMP along with the date. The concerned person or Quality Assurance shall prepare the VMP.
6.13.1.2 Checked By: This column shall bear the signatures of the persons who have checked/reviewed the VMP along with the date. The Department of Production and Engineering or their designees (Quality Assurance) shall review the VMP.
6.13.1.3 Approved By: This column shall bear the signatures of the persons who have approved the VMP along with the date. Plant Head/ and GM-Quality shall approve the VMP.
6.13.2 Table of contents: This page contains list of sections of the Validation Master Plan and the page number on which they start.
6.13.3 Introduction: This section contains preliminary explanatory matter to extend the understanding of VMP.
6.13.4 Objective: This section describes about the intent of the Validation Master Plan and seeks to attain by implementation of validation Master Plan.
6.13.5 Scope: This section describes the extent to which Validation Master Plan is applicable.
6.13.6 Validation Responsibility: This section describes about people / team responsible for listed activities based on the type of validation /qualification activities undertaken.
6.13.7 Manufacturing facility description: This section describes about manufacturing facility.
6.13.8 Functional description of the utilities: This section describes about AHU, Design criteria for AHU System of Manufacturing, water system and compressed air system, dust extractor system etc.
6.13.9 Process / product description and requirements: This section describes about Process / Product Description, Production, Engineering, Quality Assurance and Quality Control.
6.13.10 Qualification / validation overview: This section describes about the firm’s overall approach and intention of all the validation activities to be performed.
6.13.11 Validation requirements: This section describes Validation requirements about to facility, Equipment/Instrument/Utilities Qualification, HVAC, Water and compressed air system to be performed.
6.13.12 Process validation: This section describes about the Process validation activities to be performed.
6.13.13 Cleaning validation (CV): This section describes about the Cleaning validation activities to be performed.
6.13.14 Analytical Method validation (AMV): This section describes about the Analytical Method validation activities to be performed.
6.13.15 Computerized systems validation: This section describes about the computerized systems validation activities to be performed.
6.13.16 Sanitizing/disinfecting agent validation: This section describes about the sanitizing /disinfecting agent validation activities to be performed.
6.13.17 Revalidation and requalification (RQ): This section describes the frequency of periodic assessment, revalidation criteria, and procedures to be followed for revalidation.
6.13.18 Documentation: This section describes about the documents related to the validation activity.
6.13.19 Additional programmes: This section describes about the change control, Calibration and Preventive Maintenance, deviation, Training, and Annual Product Quality Review related document.
6.13.20 Validation planning & scheduling: This section describes about the validation planning & scheduling.
6.13.21 Revision control: This section described the Revision control.
6.14 Numbering system:
6.14.1 The numbering system for Validation Master Plan:
6.14.1.1 This is an alphanumeric number Consisting of 9 characters:
6.14.1.2 For example: VMP/ZZ/RR –
Where,
VMP: Represent the title of the document Validation Master Plan.
/ : Separator.
ZZ: Indicate the version number of the document starting from 01 and continuing
serially in increments of one unit.
RR: Indicate the Revision number of the document starting from 00 and continuing
serially in increments of one unit.
6.14.2 The numbering system for Qualification:
6.14.2.1 This is an alphanumeric number that shall be as per SOP No...
6.15 Review and Revision of Validation Master Plan:
6.15.1 The Validation Master Plan shall be reviewed every two years or whenever there is a modification, expansion, version, or addition in the existing facility. The same shall be captured through change control.
6.15.2 All the changes made shall be entered in brief in the ‘Revision History’ and attached at the end of the VMP. ‘Revision History’ shall indicate all the changes associated with each of the versions.
6.15.3 If there are no changes during the review, ‘Revision History’ shall be revised mentioning ‘Review did - No changes required’ under the column changes made and approved in the same way as VMP.
6.16 Revalidation of the validated equipment/system/utilities shall be carried out by the supplement qualification protocol.
7.0 REFERENCE(S) & FORMAT(S)
7.1 References
7.1.1 PIC/S – Guidelines PI 0066-3.
7.1.2 WHO GMP Annex-4; Supplementary guidelines on good manufacturing practices: Validation
7.2 Formats
7.2.1 Format- I: Validation Team Members List
7.2.2 Format- II: Validation Master Plans & Manual
7.2.3 Format-III : Qualification documents
7.2.4 Format-IV: Label Format for Validation
END OF DOCUMENTS
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