VMP

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Validation Master Plan

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Validation Master Plan and Process deviation Mr. Nitin Kadam

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2 /31 List of contents….. 1. VALIDATION MASTER PLAN (VMP) Introduction Definition Purpose Principle VMP scopes VMP Rationale. List of Products / Processes / Systems to be Validated Planning & Scheduling 2. Process deviation References Questions

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3 /31 WHAT IS VALIDATION ?

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4 /31 Good presentation SOP Tell them what you are going to say. Say it Tell them what you said .

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5 /31 Good validation SOP Tell them what you are going to do. (VMP) Do it( IQ/OQ/PQ) Tell them what you did.( FR)

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6 /31 Validation master plan (VMP) (documents intent and pathway) Qualification (IQ/OQ/PQ) (confirms design intent) Process validation (PV) (assures process consistency/ reproducibility) Final reports (FR) (summarizes test results Vs acceptance criteria) Compliance Programme (ensures continuing state of validation by calibration, change control, revalidation, preventive maintenance) Validation Umbrella…

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7 /31 Validation Master Plan (VMP)

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8 /31 It is long before said that “failing to plan means planning to fail” thus the chance of success of a project depends on the quality of your plan. this also true in case pharmaceutical industry as we need to plan properly so that we can execute that to get success. Thus planning for validation is necessary and it is the vital part of validation activity. VMP is the blueprint for a successful validation project which defines your approach to validation , the applicable references , and the requirements of your GMP system. VMP will also describe the approach to training , the procedures for deviation management , and change control , and establish the responsibilities for your validation project as a whole. The VMP provide a complete overview of the GMP compliant approach to validation project, and sequence and schedule of activities.

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DEFINITION :- It is the document that summarizes the firms overall philosophy, intentions and approach to be used for establishing performance adequacy . It also define the approach to activities like FAT (factory acceptance test) SAT (site acceptance test.) The role of VMP is to help an organization “get its arms around” a project specific validation effort by setting the scope by which all subsequent documents shall be bounded.

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10 /31 PURPOSE OF VMP :- The VMP should present an overview of entire validation operation, its organizational structure, its content and planning. List of items to be validated and planning schedule. VMP helps management to understand what is validation and its necessity. It helps all members of the validation team to know their tasks and responsibilities. It helps GMP inspectors to understand firms approach to validation

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11 /31 Validation in general requires a meticulous preparation and careful planning of the various steps in the process . In addition, all work involved should be carried out in a structured way according to formally authorized standardized working and administrative procedures. PRINCIPLE OF VALIDATION:-

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12 /31 Validation is characterized by….. Multidisciplinary approach. Time constraints Costs

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13 /31 VMP is a document that has never been mandatory, but one of the first documents a regulator will ask to view. This is an extremely important document , mainly because in constructing it many serious, commitments and decisions have to be made. The purpose of VMP in a prospective or concurrent validation effort is to explain the validation rationale associated with the installation, start up, and use of new production line. VMP RATIONALE:-

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14 /31 Introduction Scope Facility description Commissioning Qualification Process validation Computer system validation List of required protocols and procedures List of SOPs. Equipment and utility system descriptions. Additional cGMP programs References. Subjects covered in VMP :-

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15 /31 Additional cGMP programs :- Document or change control SOPs Calibration Preventive maintenance Revalidation Operator training.

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16 /31 VMP and FDA :- Prior to NDA submission a brief description of the validation procedures including the VMP can be submitted for review Early regulatory feed back can be obtained Helps to avoid answering questions during approval cycle Helps to avoid delay in product lunch date .

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17 /31 Presubmission meeting with FDA to review VMP Allows companies to work with the FDA in an advisory Vs an enforcement mode . Helps to take some anxiety out of validation process and improves its chances of success

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18 /31 Before distributing a product made using a change, an applicant shall demonstrate through appropriate validation… the lack of adverse effect of the change on the identity, strength, quality, purity, or potency of the product.. Whether the change is major or minor, a VMP will provide the FDA the basic components of the organizational validation philosophy and intentions to comply with applicable regulations .

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19 /31 To identify the timing and level of anticipated resource needs To document the corporations validation philosophy and individual elements. To show the FDA the preapproved intent to bring on a new product line in full compliance The creation of a VMP at the beginning of project serves many purposes…

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20 /31 The VMP is meant to document the major equipment and utility systems associated with the production process, assess the impact on the quality of the resulting product and determine the validation requirements. Thus VMP acts as a resource and task planning tool. Conclusion…

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21 /31 List of , Products, Processes & Systems to be Validated

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22 /31 1.1. Facility Description 1.2. Description of Building 1.3. Equipment Description 1.4 HVAC description 1.5. Utilities Description 1.6. HVAC System Validation Program Overview 1.7. HVAC System Validation 1.8. Calibration Program Summary 1.9. Preventive Maintenance 1.10. Key Standard Operating Procedures 1.11 Validation of building 1.12. Validation of Utility Systems 1.13. Process Building Description a Dry Production: Building A 1.14. Process Description Liquid and Semisolid Production 1.15. Process Description for Parenterals Production Facility 1.16. Qualification of Process Equipment 1.17. Validation of Support Process 1.18 QA/Control laboratory validation 1.19. CGMP Procedures & Programs

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23 /31 Process deviation ?

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24 /31 Using invalidated process for manufacturing. Reasons for process deviation….. Remember….. It would be more cost effective to spend time for developing a validated process rather than trying to fix it after problems has occurred.

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25 /31 Document clearly what occurred and when it occurred. Interview personnel as soon as possible and document the interview. Collect any additional data Describe a sequence of events of when and what happened, review batch records , and corroborate events through data and records Documents any and all remedial actions that they may have been taken. List all possible causes for the event After investigating, eliminate causes that do not fit the data Establish a cause or most probable cause based upon the data List corrective actions that need to be implemented Steps to check process deviation…..

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26 /31 Deviation Impact Process deviations (Deviations from the specification) Product complaints Process conditions deviation (e.g. Unapproved vendors,etc) Adverse events Environmental excursions (e.g. water, gases, etc deviations) Product complaints, Stability problems, etc. Go for statistical quality control to counter it.

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27 /31 Spend time at early stage for validation Go for full scale manufacturing using SOPs. If any deviation still seen report it thoroughly and take necessary steps. If deviations are due to natural calamities consider it as uncontrollable validation failure. Conclusion…

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28 /31 References :- Leon Lachman , Herbert A. Lieberman, Joseph L. Kanig “The Theory and Practice of Industrial Pharmacy”, 3rd edition:805-855 James Swarbrick , James C. Boylan , Encyclopedia of Pharmaceutical Technology, Vol.13:207-231 www. Wikipedia, free encyclopedia-change control . www.emea.eu.int/ http://www.picscheme.org www.valicareGmBh.com/validation.htm . www.askaboutvalidation.com www.pharmpedia.com

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29 /31 www.labcomplains.com www.GMP-ONLINE-CONSULTANCY.COM Ludwig Huber and Rory Budihandojo, Qualification of Network Components and Validation of Networked Systems, Part II, Pharmaceutical Technology Nov., 2001,pg. 46. Annex 15 to the EU Guide to Good Manufacturing Practice Michael Schousboe , “Computer Validation Master Planning, Validation Strategies" Pharmaceutical Technology, Nov 1, 2005

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“ Good things happen only when planned , but bad things happen on their own”

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