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FDA Guidance for Industry Update - Process Validation

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FDA Guidance for Industry Update - Process Validation

The changing face of Validation; are IQ, OQ and PQ really dead and buried?really dead and buried? In November 2008, the FDA released a draft version of its long-awaited update to its Process Validation Guidance for Industry.

http://www.pharmout.net/downloads/white_paper_fda_process_validation_guidance_update.pdf

Date added: November 23, 2012 - Views: 101

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Validation: an introduction to IQ , OQ and PQ .

Validation: an introduction to IQ, OQ and PQ. This seminar teaches the basics of validation. It is designed for people who have no experience in validation.

http://www.vcillc.com/training/Class.Outline-Validation.an.introduction.to.IQ.OQ.and.PQ.pdf

Date added: March 2, 2012 - Views: 309

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Validation: an introduction to IQ, OQ and PQ.

Validation: an introduction to IQ, OQ and PQ. This seminar teaches the basics of validation. The participants will learn how to write practical protocols

http://www.vcillc.com/sites/vcillc.com/files/pdf/Class.Outline-Validation.an.introduction.to.IQ.OQ.and.PQ.pdf

Date added: January 10, 2014 - Views: 11

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Validation of Equipment and Computer Systems in Laboratories

O Steps/approaches for validation and testing, e.g., DQ, IQ, OQ, PQ O Criteria and examples for risk assessment O Release procedure, e.g., who has to approve O Discontinuance O Content of validation report O Documentation and archiving. 7 Design Qualification -

http://www.chem.agilent.com/Library/eseminars/Public/Validation%20of%20Equipment%20and%20Computer%20Systems%20in%20Laboratories.pdf

Date added: September 13, 2011 - Views: 44

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IQ, OQ, PQ Qualification Seminar Presentation

For Immediate Release April 2, 2013 For More Information, Contact Rich Yeaton 603.421.2748 or email [email protected] IQ, OQ, PQ Qualification Seminar Presentation

http://www.eastcoastvalidation.com/news/ECVS-PR-4-2-13.pdf

Date added: June 5, 2013 - Views: 18

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Pharmaceutical Cleanroom Commissioning, Certification, and ...

1 JENOPTIK Group. Thai FDAj Presentation 08.04.05 Pharmaceutical Cleanroom Commissioning, Certification, and Validation DQ, IQ, OQ, and PQ Pharmaceutical Cleanroom

http://www.gmpua.com/CleanRoom/Design/CleanroomQualification.pdf

Date added: December 18, 2011 - Views: 277

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FDA Guidance for Industry Update - Process Validation

For many companies, core validation activities have been IQ, OQ, PQ and 3 process validation batches. The FDA is keen to move firms away from this thinking. Indeed the guidance states: “Focusing exclusively on qualification efforts without also understanding the

http://www.pharmout.net/downloads/white_paper_fda_process_validation_guidance_final.pdf

Date added: November 9, 2012 - Views: 29

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IQ, OQ, PQ - Pharma Edge Centre

www.pharmaedge.co.in Change Control….. • DQ : Evaluate changed parameters • IQ : Install the changes during IQ –Determine which are the existing OQ and PQ

http://www.pharmaedge.co.in/yahoo_site_admin/assets/docs/Pharma_Edge_IQ_OQ_PQ.36210038.pdf

Date added: June 9, 2013 - Views: 52

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Commissioning & Validation Services - O'Brien & Gere

Commissioning & Validation Services VidTNAl A iO Master Plan development Equipment qualification (IQ/OQ/PQ) Critical utility qualification (IQ/OQ/PQ)

http://www.obg.com/resource-files/CommissioningValidationServices.pdf

Date added: June 1, 2012 - Views: 5

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METTLER TOLEDO Validation What does IQ mean to you?

What does IQ mean to you? METTLER TOLEDO Validation What do you associate with DQ, OQ and PQ? If you automatically associated these acronyms with production

http://us.mt.com/dam/mt_ext_files/Editorial/Generic/2/Validation_Product_Brochure_Editorial-Generic_1111064218320_files/brochurevalidatione.pdf

Date added: March 26, 2012 - Views: 8

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Process Validation 101 - DIGICOM Electronics

Process Validation 101 by Anne Bynon, MSBE and Fariba Hurry, MS 3 What is a PQ? The PQ demonstrates that the process consistently produces acceptable product.

http://www.digicom.org/Electronics-Manufacturing-Services-EMS-Process-Validation-101.pdf

Date added: October 26, 2012 - Views: 35

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General Principles of Software Validation; Final Guidance for ...

Validation; Final Guidance for Industry and FDA Staff Document issued on: January 11, ... (IQ), operational qualification (OQ) and performance qualification (PQ). ... While IQ/OQ/PQ terminology has served its purpose well and is one of many legitimate ways to

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126955.pdf&keyword=iq-oq-pq-Software-validation

Date added: February 14, 2014 - Views: 1

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IQ/OQ/PQ - CfPA

IQ/OQ/PQ 10±11 March 2014 · Amsterdam, The Netherlands | Offering# 1403-203 The Center for Professional Advancement 2014 COURSE OUTLINE www.cfpa.com

http://www.cfpa.com/pdf/2014/1808,F,1403-203.pdf

Date added: October 25, 2013 - Views: 22

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GMP - Cefic

equipment (DQ, IQ, OQ, PQ) and partially qualified / unqualified equipment. Through many years of use, ... details of an Installation Qualification for established equipment nor the detailed ... Qualification Report Validation Master Report (or equivalent reports)

http://apic.cefic.org/pub/Qualification_existing_equipment_final.pdf

Date added: February 1, 2012 - Views: 150

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Process Validation for Medical Devices - Ombu Enterprises

IQ, OQ, PQ • Write a validation protocol • Conduct the protocol and collect the data • Analyze the data • Improve the process, as warranted, based on the data and analysis • Prepare a report • Keep the documentation as a quality record.

http://www.ombuenterprises.com/LibraryPDFs/Process_Validation_for_Medical_Devices.pdf

Date added: August 18, 2011 - Views: 60

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Validation Standard Operating Procedures - Moko Apt

CONTENTS Section VAL 100.00 100.10 Introduction to Validation Section VAL 200.00 200.10 Fundamentals of Validation SOPs 200.20 Validation Master Plan and Guideline for DQ, IQ, OQ, and PQ

http://moko31.files.wordpress.com/2008/12/validation-standard-operating-procedures.pdf

Date added: February 11, 2012 - Views: 241

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ABC LABORATORIES - Elsmar

IQ/OQ/PQ Protocol March 23, 2004 Page 1 of 42 ABC LABORATORIES Lunaire Environmental Chamber Model # CEO932W-4 Serial # 25647-07 Equipment IQ/OQ/PQ Protocol EQP-NOV-04-001 ... The validation status must be re-evaluated at least every three years.

http://elsmar.com/pdf_files/IQ_OQ_PQ_protocol_sample.pdf

Date added: April 27, 2012 - Views: 44

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Qualification, calibration and maintenance of stability chambers

Qualification 1. Qualification of stability chambers 1.1 General aspects 1.2 URS, analysis of local conditions 1.3 Qualification: DQ, IQ, OQ, PQ 1.4 periodic Re-Qualification

http://apps.who.int/prequal/trainingresources/pq_pres/workshop_GhanaDecember2009/presentations/1-4_Stability-Maintainance.pdf

Date added: December 30, 2011 - Views: 58

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Glossary of Validation Acronyms - Norman Noble

IQ/OQ. PQ. Process Qualification – Documented evidence that a process will provide predictable results. This is often a challenge of a given range of process parameters. PPQ. Product Performance Qualification ... Manufacturing Software Validation – Documented evidence that the process specific

http://www.nnoble.com/Services/Quality/ProcessValChart.pdf

Date added: May 17, 2013 - Views: 7

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Validation for - Mack

Validation for Devices Global Requirements Are Intensifying for Molded Components p. 12 cover.indd 1 7/20/10 9:09 AM. A successfully validated process is ... The IQ/OQ/PQ procedures are outlined below. It’s important to note that the use of

http://www.mack.com/resource/MoldingTechnologies_Medical%20Molding_July10.pdf

Date added: April 27, 2012 - Views: 8

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IQ OQ PQ in place? - Minerva Biolabs

Validation tools for testing PCR thermal cyclers according to legal requirements IQ OQ PQ in place? Traditional Thermal Cycler Validation Kit qPCR Thermal Cycler

http://www.minerva-biolabs.com/download/flyer/FL25-1EN_Validierung.pdf

Date added: November 5, 2013 - Views: 1

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IQ OQ PQ in place

as precise as diagnostics should beTM Products for the control of microbials in cell cultures, water and for human health in place? IQ OQ PQ Traditional Thermal

http://www.dnagdansk.com/media/ProductSpecyficFiles/PCR%20cycler%20validation%20kits_1.pdf

Date added: August 29, 2014 - Views: 1

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(Please use this code when registering) 520 IQ/OQ/PQ

Course Offering # 1409-501 Priority Code: (Please use this code when registering) IQ/OQ/PQ September 30–October 1, 2014 • New Brunswick, NJ Registration Form

http://www.cfpa.com/PDF/2014/1808,D,1409-501.pdf

Date added: April 26, 2014 - Views: 1

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Qualifications (IQ/OQ/PQ)

Qualifications (IQ/OQ/PQ) An innovative, multi-platform, harmonized analytical instrumentation qualification service for the makes and models of chemical analysis systems we service.

http://theoverbrookgroup.com/wp-content/uploads/2013/09/OSS_Qualifications-data-sheet.pdf

Date added: December 6, 2013 - Views: 10

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Thermo Scientific Validation Services for Laboratory Equipment

Improved Productivity Our factory-developed IQ, OQ, PQ protocols allow you to start the review process before the equipment arrives, increasing product uptime.

http://labequipmentparts.com/support/documents/BRSERVALID1010.pdf

Date added: October 26, 2012 - Views: 19

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A Comparison of the FDA’s Draft Process Validation Guidance ...

process validation guidance. A Comparison of the FDA’s Draft Process Validation Guidance and . ASTM E2500. by Robert E. Chew, PE. T. he. ... IQ, OQ, and PQ,” the following is suggested with . respect to documents typically produced during an ASTM

http://www.commissioningagents.com/clientuploads/directory/Documents/09mj-chew.pdf

Date added: October 7, 2011 - Views: 234

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IQ/OQ (INSTALLATION QUALIFICATION/OPERATION QUALIFICATION)

IQ/OQ (INSTALLATION QUALIFICATION/OPERATION QUALIFICATION) ... • PQ Assistance IQ/OQ services are available for many of STERIS’s products currently in production. The STERIS IQ/OQ is a fundamental element of any comprehensive validation program for newly installed or relocated equipment,

http://www.sterislifesciences.com/~/media/Files/LifeSciences_com/PDF/Services/IQ%20OQ%20validation.ashx

Date added: August 11, 2014 - Views: 1

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MicroBio MB1 IQ/OQ/PQ - Cantium Scientific

MicroBio MB1 IQ/OQ/PQ Installation, Operational and Performance Qualification Protocol and Report for the MicroBio MB1 Bioaerosol Sampler Document No:

http://www.cantiumscientific.com/downloads/P0001W004.pdf

Date added: April 10, 2012 - Views: 15

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PlantWeb University SIS 203 - Verification and validation

Hint Pay special attention to … The difference between verification and validation How to "decompose" the SIS into subsystems How validation models like IQ-OQ-PQ can help

http://www2.emersonprocess.com/siteadmincenter/PM%20Central%20Web%20Documents/SIS_203-Verification_and_validation.pdf

Date added: February 4, 2013 - Views: 6

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Validation Strategies for Equipment from Multiple Vendors

Dial +44 20 7162 0187 Chairperson John Vis for e-Seminar Audio. Page 5. Validation Master Plan. URS PQ Build FS DS OQ IQ • Scope, e.g., for all regulated environments

http://www.chem.agilent.com/Library/eseminars/Public/Validation%20Strategies%20for%20Equipment%20from%20Multiple%20Vendors.pdf

Date added: May 14, 2012 - Views: 8

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A WHO guide to good manufacturing practice (GMP) requirements

84 Good manufacturing requirements -- Part 2: Validation. F. Gas Systems (IQ/OQ/PQ) 1. Compressed air a. Sterile b. Non-sterile c. Instrument air d. Industrial air ... Validation of Manufacturing Processes for Drug Substances: An FDA Perspective. Volume 1, Number 4, ...

http://whqlibdoc.who.int/hq/1997/WHO_VSQ_97.02.pdf

Date added: December 19, 2011 - Views: 245

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Validation Tutorial - North Carolina State University

Installation Qualification (IQ) Operational Qualification (OQ) ... validation plan usually involves just a PQ section. Process Validation. Just as equipment validation, major changes after the initial validation will result in the need for subsequent revalidation.

http://www.ncsu.edu/project/actionagenda/coprotein/media/Validation_Tutorial.pdf

Date added: October 26, 2013 - Views: 1

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V VAALLIIDDAATTIIOONN GGUUIIDDEE - Packworld USA

The validation system employs IQ, OQ and PQ as described above and combines these with process trials at preset operating settings. Replicates are undertaken and data collected and analyzed to determine the consistency between trial runs and conformance

http://packworldusa.com/pdf/Packworld_Validation_Guide.pdf

Date added: April 17, 2012 - Views: 1

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Complete and Efficient Process Validation - FINAL

IQ/OQ/PQ reports for equipment −Validation of critical process utilities −EIRs– last three years – look for validation issues −Change Control procedures and policies. Preparing for Validation – Quality Agreements

http://www.bptc.com/sites/default/files/presentations/complete.pdf

Date added: October 14, 2012 - Views: 13

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Guidelines for Validation &Qualification, including Change ...

1 Guidelines for Validation & Qualification, including Change Control, for Hospital Transfusion Laboratories British Committee for Standards in Haematology

http://www.bcshguidelines.com/documents/Guidelines_for_validation_bcsh_13082010.pdf

Date added: February 13, 2012 - Views: 123

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DISSOLUTION TEST SYSTEM VALIDATION LOGBOOK

Performance Qualification of the DISTEK Dissolution Test System Unit. ... I agree that the IQ, the OQ and the PQ procedures in this document, assembled by DISTEK, ... Validation Tools. from DISTEK available which should be used for the qualifications.

http://www.diessechem.com/download.php?file=1296231549-IQOQDIss_Copy.pdf

Date added: June 9, 2013 - Views: 9

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SOP 7-5-2-A Validation of Product and Processes and VMP

Validation is responsibility of the Quality Control Department. ... As a direct result of our IQ-OQ-PQ program, preventive maintenance schedule for all equipment and systems that have an impact on quality of the product has been established.

http://www.pharmcoaaper.com/pages/Quality_Systems/sops_selected/sop_7_5_2_a_validation_of_product_and_processes_and_vmp.pdf

Date added: June 13, 2013 - Views: 29

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VALIDATION AND QUALIFICATION

• Type of Validation (IQ, OQ or PQ) • Purpose of the Validation ... C. Establish testing conditions (Step-by-step directions for validation.) C.1. Installation Qualification 1. Identify Equipment 2. Check SN and add to Bio Med Surveillance program

http://c.ymcdn.com/sites/www.celltherapysociety.org/resource/resmgr/files/PDF/Meetings/ISCT_2009/Presentations/Tuesday/BallroomA/Caballero_0730.pdf

Date added: October 12, 2013 - Views: 18

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Validation Iq Oq Pq Documents

State of California Validation iq oq pq documents Gedling validation iq oq pq documents restart, Derby. essa stone malaga Guernsey, Salisbury. Validation iq oq pq documents Wakefield marcela

http://telexfere.com/manual-pdf/Validation_Iq_Oq_Pq_Documents.pdf

Date added: August 29, 2014 - Views: 1

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V1 Validation Protocols & On-Site Validation Services 29 03 11

Validation Protocols & On-Site Validation Services Rely on a comprehensive and ready to use validation. ... Plan and perform IQ, OQ and PQ (suitability of the test methodology) with ease. They follow international guidelines such as EP/USP and GMP.

http://labface.com/suppliers/pdf/milliporevalidationpdf.pdf

Date added: May 6, 2013 - Views: 92

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The λ Validation Model - Infosys

Qualification (OQ) and Performance Qualification (PQ) and both the arms converge at the Build and Unit Testing phases at the V-Point. ... Figure 2: λ Validation Model URS FS DD IQ OQ PQ IT ST A T B • Project Plan • Validation Plan • Requirements Gathering • Requirements Analysis

http://www.infosys.com/industries/life-sciences/white-papers/Documents/regulatory-application-development.pdf

Date added: September 12, 2012 - Views: 6

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IQ/OQ Protocol - ExpotechUSA

IQ/OQ Protocol Installation ... It is written to assist the end-user in validation of predetermined specifications. ... Performance Qualification Once the washer has been checked for proper installation and operation, its performance may

http://www.expotechusa.com/Catalogs/Labconco/PDF/IQ10587.pdf

Date added: February 14, 2012 - Views: 130

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Verification

36 Prerequisites Before starting any verification process—whether it's FAT, SAT, IQ, OQ, PQ or some other activity—make sure all prerequisites have been fulfilled

http://www.learnaboutgmp.com/FileStorage/Objects/118/HVAC-Sample.pdf

Date added: July 16, 2014 - Views: 1

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Validation & Documentation

Validation & Documentation What do I need to do? Wayne Goddard Quality Control Professional Manager . ... IQ) – Operational Qualification (OQ) – Performance Qualification (PQ)

http://www.tutelamedical.com/wp-content/uploads/2013/07/Temperature-Storage-Validation-Wayne-Goddard.pdf

Date added: August 8, 2013 - Views: 1

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Quality Management systems - Process Validation Guidance

• Create validation protocols • Perform IQ, OQ, PQ and document results • Determine continuous process controls • Prepare final report and secure management approval • Control the process continuously Maintaining a state of validation:

http://www.aami.org/QSConnect/qsfda/pv.guidance.pdf

Date added: June 18, 2013 - Views: 1

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IQ/OQ Protocol - ExpotechUSA

IQ/OQ Protocol Installation ... Performance Qualification ... The performance validation should be designed to meet the specifications and accuracy required of the application. In general this requires establishing acceptance criteria, ...

http://www.expotechusa.com/Catalogs/Labconco/PDF/IQ_OQ-Delta.pdf

Date added: April 10, 2012 - Views: 15

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GAMP Automated Manufacturing Practices - ISPE

IQ OQ PQ Validation Report. 10/7/2004 [email protected] GAMP Objectives Achieve Compliance by building upon existing industry good practices in an ... GAMP4 Validation of Automated Systems Calibration Management Validation of Process Control Systems

http://www.ispe.org/san-francisco/good-automated-manufacturing-practices-gamp.pdf

Date added: May 25, 2012 - Views: 87

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Process Validation of Solid Oral Dosage Forms, Part I General ...

IQ/OQ Phase PQ Phase Change Control Calibrations Validation Training Time. Prospective Process Validation Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Protocol Approval PQ Protocol Execution Data Analysis Validation Report and Conclusions

http://www.ikev.org/haber/bozzonejune1.pdf

Date added: December 21, 2011 - Views: 261

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Validation of a low-temperature, low-pressure, vaporized hydrog

After performing IQ, OQ, and PQ procedures the instrumentation necessary for a fully independent, calibrated ... sterilization cycle of a STERRAD® 100S validation process is presented; the temperature, a non-critical parameter, is also depicted.

http://www.wfhss.com/html/educ/lectures/efhss2004_validation_sterrad100s_en.pdf

Date added: December 20, 2011 - Views: 24

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REQUIREMENTS FOR COMPUTER SYSTEM REQUIREMENTS, VALIDATION ...

reports, including the validation plan for a system, the IQ, OQ and PQ validation protocols, protocol reports and the Validation Final Report as required by VAL002 or VAL003. 2. SCOPE This procedure applies to all computer system validation plans, protocols (IQ, OQ, or PQ),

http://www.complianceonline.com/images/supportpages/501056/sample_VAL004%20Req%20for%20val%20plans%20%20protocols%207%20Mar%2006.pdf

Date added: May 25, 2012 - Views: 48