Validation master plan

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Validation master plan:

Validation master plan Kathiriya Arun P Quality Assurance 10 MQ03


A Validation Master Plan (VMP) is a comprehensive document describing the applicable validation requirements for the facility, and providing a plan for meeting those requirements As per PICS; A Validation Master Plan is a document that summarises the firm's overall philosophy, intentions and approach to be used for establishing performance adequacy VALIDATION MASTER PLAN:


Minimize noncompliance costs Reduce rework Reduce rejected lots Avoid recalled lots Helps in new drug approval Satisfactory inspections Corporate image Financial gain Secure third-party contracts Corporate legal protection Scope:


Written for new or existing facilities WRITING A VALIDATION MASTER PLAN

Slide 5:

information New Facility Existing Facility Facility specifications Y Y Utilities specification Y Y HVAC specifications Y Y Major equipment list/specs. Y Y List of major SOPs Y y Descriptions of processes Y Y Personnel resumes Y Y Design review documents Y Y Major purchase orders Y Y Equipment manuals Y Y Review of audit citations N Y Review of past validation N Y Physical inspection of facility/equipment N Y

Why to Perform VMP?:

VMP is not a requirement of FDA ,but it has become almost an industry standard . IMPORTANCE: It sets the overall goals and limits Referred thought the project. To understand the scope of the validation and so avoid misconceptions. To define the scope of the project Why to Perform VMP?

Who Performs VMP?:

Validation Manager, Quality Assurance Department Member from Production Member from Engineering (Utilities) Member from Calibration Laboratory Member from Quality Control Laboratory Member from Maintenance Member from HVAC Department Member from Product Development Laboratory Who Performs VMP?

Qualification: :

in accordance with the job requirement and experience The resumes of validation team members are presented in a separate folder, including contract help. Qualification:

Which factors are considered in VMP?:

Contents of VMP: Introduction Methodology Qualification:DQ,IQ,OQ,PQ Personnel Schedule Preventative maintenance Change control Procedure Documentation Appendices Which factors are considered in VMP?

VMP content ::

Introduction : It include following details: A description of facility, premises,equipment,& its purpose Scope of validation Policies on regulatory bodies like GMP,cGMP,WHO. VMP content :


Methdology: Predetermined requirement to identifying the standards. Development of the acceptance criteria that are used to judge the validation It is also involve planning and execuation of documents such as protocols,records,reports, or other The std will involve three elements : Regulatory and guidance documents National standards Company standards Cont…


Qualification: Includes all the aspects of design,procurement,installation ,and comissioning process . It is important to ensure that the organization is consistent and cover all the aspect of validation process for specific project. The validation structure and organization is clear to any inspection authority. Design qualification providing documented evidence that the design of facility and equipment meet the requirements of the user specification &GMP. Cont….


Personnel: The CFR 21 states; “each person engaged in and each person responsible for supervising the manufacture processing,packaging,or holding of a drug product shall have the education,training,and experience.or a combination thereof ,to enable that person to perform the assigned functions” principles for personnel requirements. experience of personnel in house training reports, etc . Cont…


Schedules: Essential Prepared at early stage A good plan contains all necessary features which are to be considered during execution of plan and determines the control of the project. It ensures that the personnel involved in the VMP are not only aware of the engineering targets,but also the validation targets. Cont…

Cont …:

Preventive maintenance: This is the responsibility of site maintenance and operation dept. The activity should be performed during the design phase, and documentation required should be, included in requisition Cont …


Change control: This section of VMP should lay down requirements for a set of procedures for change control that cover; The project through design,construction,commissioning The ongoing change that will inevitably occur in both the process and the equipment and engineering aspects. Procedures: These cover engineering standards used in the project design,through to commissioning phases and the facilities standard procedures(SOPs) Cont…


Documentation: This section usually to identify the documentation that should be produced for the processing like; Engineering drawing Equipment supplier drawing and documents Factory acceptance document IQ documents OQ documents PQ documents Appendices: The appendices is mostly used VMP to hold the information of type of documents and formats that will be used in execution stage. Cont…

How VMP is prepared?:

Developing validation master plan: Documentation The VMP is used , managed,and enforced throughout the life of a process to ensure quality. The document the validation approach,specifies the responsibilities of each of the validation team member,and important effort at the beginning of a project The Description of following system are necessory to control validation activities as well as the ongoing operation of the system ,process,or equipment: Protocol and documentation prep Protocol execuation Documentation control Change control How VMP is prepared?

How VMP is prepared?:

Protocol: VMP includes the information into formal written protocols,which serve as guides for execuating appropriate validation activities. Protocol should be developed for IQ,OQ,PQ The information included in specific protocols are: Description of system Qualification objective Scope Responsibility and data collection procedures Test procedures,specific acceptance criteria Documentation procedures Summary and deviation report How VMP is prepared?

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Installation qualification IQ: It is perform to verify that the installed components are the ones specified,that they are properly identified,and so on,as stated in the construction documents in accordance with specific requirement of the user. IQ protocol includes: Spec ref,including purchase orders and contaracts nos Verification and calibration of critical installed components Verification of procedures Verification of major component Verification of control and monitoring devices Verification of utilities connections Lubricants Final drawing refrence manuals

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Operation qualification:OQ This involves the testing of various components of the system,process or equipment to document proper performance of these components. OQ Protocol includes: Verification of test equipment calibration Verification of controls and indicators Computer control system testing Verification of sequence of operation Verification of major components of operations Verification of alarms Power failure/recovery testing Functionality testing of distribution system valves etc System initial sampling

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Performance Qualification:PQ This involves challenging the system,process,or equipment to provide evidence of appropriate and variable operation PQ protocol includes: System sampling Equipment cold start tests System invasive tests Operating procedures: Procedures must be for prepared for all operations to be performed during the execuation of protocol Called as validation operating procedures,SOP’s,operating manuals Ensures that system process or equipment is operated consistently during validation and exactly as it should during normal operation conditions

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Change control procedure: Essentials for continous operation of the system,process,or equipment and provides a formal mechanism for monitoring changes during the continued operation of system The proposed changes that can affect the validated status of a system are reviewed by the validation team or responsible personnel and the proposed corrective action is approved Sufficient detailed documentation is necessary for each critical change to maintain control over the system with the passage of time.

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Various changes can be categorised as follow: Process equipment and system hardware change control Software change control Process change control Multiple changes Emergency changes Planned changes Repeatative changes Pending changes Cleaning validation:


Pharmaceutical master validation plan syed imtiaz haider Refrence:

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