[Company Name] [Company Group, Division, Location] Prod Produc uctt Name Name:: [Pro [Produ duct ct Nam Name] e] Document Title: Validation Master Plan Docu Docume ment nt Numb Number er:: Docume Document nt Filen Filename ame::
[Doc [Docum umen entt Num Numbe ber] r] [Docum [Document ent Filena Filename] me]
CONTROLLED COPY/ MASTER COPY STAMP HERE
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Revision Level DRAFT 1.00
Revision Date DD/MM/Y Y DD/MM/Y Y
DCO/ECO Number YY-00000
Description of of Re Revision Draft
Revision Author Author Name
YY-00000
Initial Release
Author Name
COMPANY PROPRIETARY AND CONFIDENTIAL
[Company Name] [Company Group, Division, Location] [Product Name]
Validation Master Plan [Document Number] Rev x.xx DD/MM/YY
Table of Contents Table of Contents ............... ............................. ............................ ............................ ............................ ............................ ............................. ............................. ............................ .......................... ................. ........ ... 1 Tables and Figures.............. ............................ ............................ ............................ ............................ ............................ ............................. ............................. ............................ ...................... ............. .......... ....... 1 1.0 Purpose ............. ........................... ............................ ............................ ............................ ............................. ............................. ............................ ............................ ............................ ............................. ................... .... 2 2.0 Scope.............. ............................ ............................ ............................ ............................. ............................. ............................ ............................ ............................ ............................. ............................. .................... ...... 2 3.0 Definition Of Terms............. ............................ ............................. ............................ ............................ ............................ ............................ ............................. ............................. ......................... ............. 2 3.1 Contract Manufacture Manufacturerr.............. ............................ ............................ ............................. ............................. ............................ ............................ ........................ ............... .......... .......... ..... 3.2 Installati Installation on Qualificati Qualification on (IQ)............... ............................. ............................ ............................ ............................ ............................ ............................. ........................ ............. .... 3.3 Operational Qualificati Qualification on (OQ)............... ............................. ............................ ............................ ............................ ............................. ....................... ............. .......... .......... ....... 3.4 Performance Qualificati Qualification on............. ........................... ............................ ............................ ............................ ............................. ............................. ..................... ............ .......... ........ ...
2 2 2 2
4.0 References ............. ........................... ............................ ............................. ............................. ............................ ............................ ............................ ............................ ............................. ........................ ............. .... 2 5.0 Responsib Responsibilities ilities and Requirement Requirementss.............. ............................ ............................ ............................ ............................. ............................. ............................ ...................... ............. ......... .... 2 6.0 Validation Plan.............. ............................ ............................ ............................ ............................. ............................. ............................ ............................ ............................ ............................ .................... ...... 2 6.1 Component X Manufactur Manufacturing ing............. ............................ ............................. ............................ ............................ ............................ ....................... ............... ............ ............ ........ .. 2 6.1.1 Componen Components: ts:............. ............................ ............................. ............................ ............................ ............................ ............................. ............................. .......................... .............. 2 6.1.2 Qualificati Qualifications: ons:.............. ............................ ............................ ............................ ............................ ............................ ............................. ......................... ............... .......... ......... .... 3 6.2 Instruments/E Instruments/Equipment quipment ......... .................... ..................... ..................... ..................... .................... ..................... ..................... ..................... ..................... ............................. ................... 3 6.2.1 Off-the-s Off-the-shelf helf............. ........................... ............................ ............................. ............................. ............................ ............................ ............................ .................... ............ ........ .. 3 6.2.2 Custom.............. ............................ ............................. ............................. ............................ ............................ ............................ .......................... ................. .......... .......... ........... ........ .. 3 6.3 Soft Software ware 3 6.4 Facilities Systems............... ............................. ............................ ............................ ............................ ............................. ............................. ............................ ........................... .................. ..... 3 6.5 Supp Suppliers liers 3 6.6 Validation Testing and Standards for Product Handli ng, Storage and Distribution .............. ....................... ............... ........ .. 3 6.7 Product/Syst Product/System em Validation .............. ............................ ............................ ............................ ............................. ............................. ....................... .............. ........... ............ ............ ...... 3 7.0 Flowcharts ............. ........................... ............................ ............................. ............................. ............................ ............................ ............................ ............................ ............................. ........................ ............. .... 4
Tables and Figures
Table
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Figure
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[Document Filename]
COMPANY PROPRIETARY AND CONFIDENTIAL
Page 1 of 4
[Company Name] [Company Group, Division, Location] [Product Name]
1.0
Validation Master Plan [Document Number] Rev x.xx DD/MM/YY
Purpose The purpose of this document is to specify [Product Name] manufacturing process validation plans to ensure that the product meets its specifications and intended use.
2.0
Scope This document applies to all facilities, equipment and processes that are subject to the Food and Drug Administration Administration Quality System Regulations. Regulations. The scope of this document includes but is not limited to facilities, manufacturing equipment, analytical equipment, calibration, test equipment, computer related systems, processes and test methods used in the manufacture of [Product Name].
3.0 3.0
Defi Defini niti tion on Of Terms erms 3.1 3.1
Cont Contra ract ct Man Manuf ufac actu ture rer r A company that provides outsourced process development, manufacturing and packaging services for a fee.
3.2 3.2
Inst Instal alla lati tion on Qual Qualif ific icat atio ion n (IQ) (IQ) A method for establishing documented evidence in protocol and report form that process equipment and associated system installations adhere to design criteria and that the recommendations of the manufacturer are considered.
3.3 3.3
Oper Operat atio iona nall Qual Qualif ific icat atio ion n (OQ) (OQ) A method for establishing documented evidence in protocol and report form that operational parameters of equipment result in product that meets all predetermined specifications. specifications.
3.4 3.4
Perf Perfor orma manc nce e Qual Qualif ific icat atio ion n A method for establishing documented evidence in protocol and report form that a process will consistently produce acceptable product under normal operating conditions.
4.0
References 21 CFR part 820 Quality System Regulation, 820.75 Medical Device Quality Systems Manual, FDA 97.4179 FDA Process Validation Guidance
5.0
Respo Respons nsibi ibilit lities ies and Requi Requirem rement ents s The Quality and Engineering departments are responsible for the administration and management of the validation program, and serve as primary resources to determine validation requirements, and to write, review, and approve validation protocols.
6.0 6.0
Valid alidat atiion Plan 6.1 6.1
Comp Compon onen entt X Manu Manufa fact ctur urin ing g 6.1.1
Components Component 1 Component 2 Component 3
[Document Filename]
Components:
Source Contract Manufacturer (CM) Purchased from approved vendor CM to manufacture
COMPANY PROPRIETARY AND CONFIDENTIAL
Page 2 of 4
[Company Name] [Company Group, Division, Location] [Product Name]
6.1.2
Process Process 1 Process 2 Process 3 6.2 6.2
Validation Master Plan [Document Number] Rev x.xx DD/MM/YY
Qualifications:
Equipment Arbor Press Ultrasonic Welder Heat Sealer
IQ
O OQ Q
X
X X
PQ X X X
Performed By
Inst Instru rume ment nts/ s/Eq Equi uipm pmen entt 6.2.1
Off-the-shelf
Individual performance validations will not be conducted on off-the-shelf instruments, however a performance qualification will be performed on the entire test system. [Insert off-the-shelf equipment list here]
6.2.2
Custom
[Insert custom made equipment list here].
6.3
Software Software design and development will satisfy the requirements of [Insert requirements]. It will be validated [describe validation plans].
6.4 6.4
Facil acilit itiies Sys Systtems [Insert facilities requirements here].
6.5
Suppliers Suppliers will be qualified and managed in accordance with [Company Name] Supplier Control standard operating procedures.
6.6
Validatio Validation n Testing Testing and Stand Standards ards for for Product Product Handli Handling, ng, Storag Storage e and Distribu Distribution tion [Insert validation plans for packaging, shipping and handling].
6.7 6.7
Prod Produc uct/ t/Sy Syst stem em Vali Valida dati tion on [Insert product validation plans].
[Document Filename]
COMPANY PROPRIETARY AND CONFIDENTIAL
Page 3 of 4
[Company Name] [Company Group, Division, Location] [Product Name]
7.0
Validation Master Plan [Document Number] Rev x.xx DD/MM/YY
Flowcharts Table/Figure 1. Table/Figure 2. Table/Figure 3.
[Document Filename]
Table Name Figure Name Table Name
COMPANY PROPRIETARY AND CONFIDENTIAL
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