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Sample ISO 9001 Quality Manual - American Society...

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Sample ISO 9001 Quality Manual - American Society...

Sample ISO 9001 Quality Manual Subject: Example quality manual for services Author: Graeme Payne Description: Example of a ISO-9001 quality manual.

http://asq.org/2010/06/iso-9000/sample-quality-manual-service.doc

Date added: August 18, 2016 - Views: 13

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Content 16-9: Writing a Quality Manual - WHO

16-9: Writing a Quality Manual. Structure and content Although there is considerable flexibility in how to prepare a quality manual, the content and structure should ...

http://www.who.int/ihr/training/laboratory_quality/cd_rom_optional_content_16-9_quality_manual.doc

Date added: August 18, 2016 - Views: 1

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Project Quality Management Plan Template - DARTNet

The Project Quality Management Plan documents the necessary information required to effectively manage project quality from project planning to delivery.

http://dartnet.info/media/toolkit/FAQ%20Res%203c%20CDC_UP_Quality_Management_Plan.doc

Date added: August 18, 2016 - Views: 3

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QUALITY MANAGEMENT SYSTEM MANUAL - Elsmar

Throughout this quality manual and in every operational procedure where the specific quality system process or activity is documented; and .

http://elsmar.com/pdf_files/Quality%20and%20Other%20Manuals/QUALITY%20MANAGEMENT%20SYSTEM%20MANUAL%20Single.doc

Date added: August 18, 2016 - Views: 3

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Quality Assurance Handbook: About Quality...

Quality Assurance Handbook: About Quality Assurance Author: Brian Kelly Last modified by: Brian Kelly Created Date: 5/27/2004 2:55:00 PM Company: UKOLN Other titles:

http://www.ukoln.ac.uk/qa-focus/documents/handbook/qa-handbook-qa.doc

Date added: August 19, 2016 - Views: 3

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Guidance on the GMP clearance of overseas medicine...

GMP Clearance for Overseas ... such as a Plant/Equipment File or a Quality Manual, ... the production and/or quality control of pharmaceutical manufacturing processes ...

http://www.tga.gov.au/sites/default/files/manuf-overseas-medicines-gmp-clearance-17.docx

Date added: August 18, 2016 - Views: 2

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SOP on Document Control and Management - pSMILE

Quality Manual, Standard Operating Procedures (SOPs) and forms, Quality Plans and Test Plans. Work instructions. Regulations, standards and other reference materials.

http://resources.psmile.org/resources/documents-and-records/Doc0.0-14%20Document%20Control%20and%20Management.doc

Date added: August 18, 2016 - Views: 1

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QUALITY POLICY - FP&M SETA

Quality Policy Policy QP/MC/001. Business Systems. ... This Quality Manual and its associated procedures establish and document the means by which we implement, ...

http://www.fpmseta.org.za/downloads/Generic_QMS_Template_Nov_2012.doc

Date added: August 18, 2016 - Views: 5

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Section 4 - Testmetric

Quality manual presentation. Control of the manual. Distribution list. ... Industries served include Pharmaceutical, Aerospace, Manufacturing, Educational and Utility ...

http://www.testmetric.com/images/Quality_Manual2.doc

Date added: August 18, 2016 - Views: 2

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SUPPLIER QUALITY EVALUATION QUESTIONNAIRE - Cefic

Yes No Active pharmaceutical ingredients? ... Yes No N/A 9.21 Does your carrier have a Quality Manual? ... Section E Extended Quality Questionnaire. Page 11 of 15

http://www.apic.cefic.org/pub/Supplier%20Questionnare%20-%20Section%20E%20%20Quality%20Q._modified.doc

Date added: August 18, 2016 - Views: 5

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Standard operating procedures (SOP) - Back Bone of...

o Make the long-form SOP a training document or manual to ... 6.G.Kieffer Robert “Procedures Improving Their Quality”, Pharmaceutical ... 8.Standard Operating ...

http://people.stfx.ca/tsmithpa/Chem361/Labs/SOP/Standard%20operating%20procedures.doc

Date added: August 18, 2016 - Views: 6

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Quality Assurance Plan - HUD/U.S.

QUALITY. ASSURANCE. PLAN. Project or System Name. U.S. Department of Housing and Urban Development. Month, Year Revision Sheet. Release No. Date Revision Description

http://portal.hud.gov/hudportal/documents/huddoc?id=DOC_15123.doc

Date added: August 18, 2016 - Views: 5

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Radiopharmaceutical Compounding Practices

American Pharmaceutical Association (APhA) Nuclear Pharmacy Compounding Practice Guidelines_5.2 TABLE OF CONTENTS. ... Quality Control 21. Compounded Reagent Kits 21.

http://nuclearpharmacy.uams.edu/Nuclear%20Pharmacy%20Compounding%20Practices%20Guidelines_5.2.doc

Date added: August 18, 2016 - Views: 2

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Good Manufacturing Practices (GMP’s) Policy -...

Good Manufacturing Practices (GMP’s) Policy. The purpose of this policy is to ensure compliance with current Good Manufacturing Practice (GMP) regulations for foods.

http://www.ssfpa.net/images/stories/fsi/Sample%20GMP%20documents/Other%20-%20Policies/GOOD%20GMP%20Policy.doc

Date added: August 18, 2016 - Views: 3

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Sample Procedure - ISO Quality Manual

ISO-Quality-Manual.com. Good luck on your certification! Tim and Quintin. Title: Sample Procedure Author: iso-quality-manual.com Last modified by: Quintin Shalla

http://iso-quality-manual.com/QSP%208.3.1%20Nonconforming%20Product%20-Sample.doc

Date added: August 18, 2016 - Views: 7

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No - U S Food and Drug Administration Home Page

Continually evolving to meet the current and emerging standards important to the Pharmaceutical ... in quality information management. Manual data handling is ...

http://www.fda.gov/ohrms/dockets/dockets/00d1538/00d-1538-lst0012.doc

Date added: August 18, 2016 - Views: 2

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ISO 9001 Quality Manual for Services - Worksmart...

Title: ISO 9001 Quality Manual for Services Author: Authorized User Last modified by: Mike McGarry Created Date: 1/29/2007 4:49:00 PM Other titles

http://www.worksmartinc.net/iso.doc

Date added: August 18, 2016 - Views: 8

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CEFIC

This template has been developed by APIC/CEFIC. ... Index of Quality Manual and / or Index of SOP’s covering ICH Q7 Chapters relevant to your operations.

http://apic.cefic.org/pub/Auditing/Auditing_Annex1_Questionnaire.docx

Date added: August 19, 2016 - Views: 1

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Quality Planning Procedure - CAPAtrak

Quality planning shall take place during product and/or process design and development. ... Quality Manual Electronic, maintained on company intranet.

http://www.capatrak.com/Files/Templ%20-%20Word%20-%20Procedure%20-%20QualityPlanning.doc

Date added: August 18, 2016 - Views: 2

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Guidance On Quality Systems For The Design And...

Title: Guidance On Quality Systems For The Design And Manufacture Of Medical Devices Author: GHTF Last modified by: Fletcher, Tim Created Date: 8/21/2012 3:25:00 AM

http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-8-guidance-on-quality-990629.doc

Date added: August 18, 2016 - Views: 6

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Section 1 Quality Manual - Hygiene Manual's

QUALITY POLICY. The quality manual defines the organisation and management requirements of Hygiene in relation to the company quality management system (QMS).

http://hygienemanuals.co.uk/manuals/quality/2000%20QM-1.doc

Date added: August 24, 2016 - Views: 1

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RECALL MANUAL - ssfpa.net

Recall Program and Procedures This Recall Manual outlines the requirements and steps to be taken in the event of a product recall and/or withdrawal.

http://www.ssfpa.net/images/stories/fsi/food_safety_docs/Generic%20GMPs/F%20Recall/Recall%20Manual/RECALL%20MANUAL.doc

Date added: August 18, 2016 - Views: 2

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行政院衛生署 - 衛生福利部食品藥物管理署

Name of Pharmaceutical Firm: (Chinese) ... 3.10 Has the original manufacturer provided the most up-to-date and valid version of quality manual, ...

http://www.fda.gov.tw/upload/133/Content/2013103011214320875.doc

Date added: August 20, 2016 - Views: 1

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SUPPLIER QUALITY EVALUATION QUESTIONNAIRE

Approximate number of employees in the Quality Unit ... Quality Policy / Manual. ... Do you supply to any other customer in the Pharmaceutical / Health care industry?

http://www.apic.cefic.org/pub/Supplier%20Questionnaire%20-%20Section%20A%20General%20Info.docx

Date added: August 20, 2016 - Views: 1

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Validation Plan Template - ISPE | GMP

Quality Assurance – Responsible for ... (including possible interim manual operations) ... Validation Plan Template Author: Bruce Lauderman Last modified by:

http://www.ispe.org/jett/vial-tray-loader-urs.doc

Date added: August 18, 2016 - Views: 9

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Quality Manual DS GMP 2007 Contents - ep.yimg.com

Quality Manual - 5 - Title: Quality Manual DS GMP 2007 Contents Author: Ame Quality Last modified by: Tang Created Date: 3/24/2008 12:36:00 AM Company: Ame Quality

https://sep.yimg.com/ty/cdn/yhst-66749609830114/QM01-1-00-Quality-Manual-DS-GMP-Contents.doc

Date added: September 24, 2016 - Views: 1

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Annex 2 - Auditing Guide - Apic - Cefic

Good Manufacturing Practice Guide for Active Pharmaceutical ... Is there a Quality Manual or equivalent documentation that describes in detail how the Quality ...

http://apic.cefic.org/pub/Auditing/Auditing_Annex2_AideMemoire.docx

Date added: August 19, 2016 - Views: 2

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Management Review Meeting Minutes template

Review the current Quality Objectives as outlined in the Quality Manual and modify goals accordingly. Complete the Objectives table on the next page.

http://www.oxebridge.com/downloads/MRMtemplate.doc

Date added: August 18, 2016 - Views: 13

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IPEC GDP for Excipients

IPEC Europe Good Distribution Practices Audit Guideline for Pharmaceutical Excipients. This document has been written to provide a tool for those auditing companies ...

http://ipec-europe.org/UPLOADS/IPEC_Europe_GDP_Audit_Guide__-_Revision_2011_final.doc

Date added: August 19, 2016 - Views: 2

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Model SOP - Quality Assurance/Quality Improvement...

AR 40-68 Clinical Quality Management provides the regulatory guidance for the development of Quality Assurance/Quality Improvement Program.

https://phc.amedd.army.mil/PHC%20Resource%20Library/PHC_Model_SOP_QA-QI%20_Final.docx

Date added: August 18, 2016 - Views: 2

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Analysis SOP - GLI Quality tool

QM Quality Manual. SOP Standard Operating Procedure . QA Quality Assurance Unit. DST Drug Susceptibility Testing. LJ Lowenstein-Jensen. MGIT Mycobacteria Growth ...

http://www.gliquality.org/sites/default/files/L2_templates/2.7_SOP%20Reporting_v2.doc

Date added: August 20, 2016 - Views: 2

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Good documentation Practices

Introduction: In a facility that uses . G. ood . M. anufacturing . P. ractices (GMP), numerous types of documentation exist and serve a variety of functions.

http://accounts.smccd.edu/kapp/bt415/sop/1000.01%20Good%20documentation%20Practices.doc

Date added: August 18, 2016 - Views: 4

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Quality Manual - Elsmar

Quality Manual. Page 20 of 21 Production process controls. Non conforming product. Identification and traceability. Preservation. Document control. Record control.

http://elsmar.com/pdf_files/Quality%20and%20Other%20Manuals/Quality%20Manual%20example.doc

Date added: August 18, 2016 - Views: 2

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2-1- Purpose - Medical Device, Risk Analysis, ...

2-1- Purpose. This document defines quality system policies and procedures for governing the design & manufacture of all Sobhan Chemotherapeutical Co. products.

http://www.elsmar.com/pdf_files/Quality%20and%20Other%20Manuals/Quality%20Manual%20En.doc

Date added: August 20, 2016 - Views: 1

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Standard Operating Procedure - PV Toolkit

Pharmaceutical companies. Patients or patient representatives. ... depending upon the seriousness of the event and the quality of the information. (WHO)

http://pvtoolkit.org/toolkit/readers/sop_spontaneous_reporting.doc

Date added: August 19, 2016 - Views: 2

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Guidance for Industry - Food and Drug...

Guidance for Industry. ... A. Responsibilities of the Quality ... A company can reference the equipment manufacturer instruction manual in its written procedures ...

http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0163-gdl0001.doc

Date added: August 18, 2016 - Views: 10

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IPEC GDP for Excipients

IPEC Good Distribution Practices Audit Questionnaire for Pharmaceutical Excipients. ... Is there a quality manual and written procedures describing all *GTDP related ...

http://ipec-europe.org/UPLOADS/IPEC_GDP_Audit_Guide_Final(1).doc

Date added: August 20, 2016 - Views: 1

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Control of the quality manual -...

Title: Control of the quality manual Author: Gill Chessum Last modified by: Hygiene Created Date: 10/29/2003 5:02:00 PM Company: Dell Computer Corporation

http://hygienemanuals.co.uk/manuals/quality/2000%20QM-2.doc

Date added: August 24, 2016 - Views: 1

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Table of Contents - ISPE

Table of Contents. I ... This item writing manual is to be used as a ... capable of fostering innovation and quality enhancements for the pharmaceutical and ...

http://www.ispe.org/certified-pharmaceutical-industry-professional/item-writing-manual.doc

Date added: August 20, 2016 - Views: 2

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FDA response:

For the most part there is a lot of quality information and direction in ... pharmaceutical wholesaler ... procedures in place for this manual paper ...

http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/110503/03N-0361-emc-000023-01.doc

Date added: August 19, 2016 - Views: 3

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Massachusetts Board of Pharmacy Ambulatory Best...

Best Practice Recommendations. To Promote Optimum Pharmaceutical Care. In the Commonwealth of Massachusetts. In 2000, in response to medication error rates and ...

http://www.mass.gov/eohhs/docs/dph/quality/boards/pharmacy/pharmacy-best-practice.doc

Date added: August 18, 2016 - Views: 2

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Checklist – Good Laboratory Practice Requirements...

Checklist – Good Laboratory Practice Requirements of the Michigan Regional ... The laboratory will utilize a comprehensive procedure manual. ... Quality Control ...

http://www.michigan.gov/documents/mdch/GLP_Checklist_359367_7.doc

Date added: August 18, 2016 - Views: 4

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Excipient Audit Guideline - IPEC Europe

Pharmaceutical Excipients. I. Purpose and Scope. In the pharmaceutical industry it is the responsibility of the drug product manufacturer to ensure the quality of all ...

http://ipec-europe.org/UPLOADS/IPEC_GMP_Audit-Systems_2008_Final_Printing_(3)(1).doc

Date added: August 18, 2016 - Views: 1

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Quality Agreement Template (exclusive APIs) -...

Quality Agreement Template. for. Exclusive Substances (Compliance Section only) Scope: APIs or intermediates exclusively made for one customer under a toll ...

http://www.apic.cefic.org/pub/Quality%20Agreement%20Guideline_final_December%202009_clean_appendix%20B.doc

Date added: August 18, 2016 - Views: 3

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Standard Operating Procedures and Policies (SOPs)

STANDARD OPERATING PROCEDURES AND POLICIES (SOPS) ... The purpose of the associated SOP Manual is to ensure accurate conduct of all Cell Therapy ... quality functions ...

http://c.ymcdn.com/sites/www.celltherapysociety.org/resource/resmgr/uploads/files/Resources/Lab%20Practices/Document%20Control%204.doc

Date added: August 18, 2016 - Views: 4

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SANITATION STANDARD OPERATING PROCEDURE (SSOP)

SANITATION STANDARD OPERATING PROCEDURE (SSOP) FOR. Our company. HACCP Coordinator: General Policy. The Plant Manager/ designated personnel is responsible for the ...

http://www.ssfpa.net/images/stories/fsi/Sample%20GMP%20documents/E%20-%20Sanitation%20&%20pest%20control/SSOP%20overview.doc

Date added: August 18, 2016 - Views: 5

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M.Pharm - Rajiv Gandhi University of Health...

M.Pharm-Drug Regulatory ... to have a thorough knowledge and understanding of the regulatory requirement of pharmaceutical ... GLP Quality Audit Manual, ...

http://www.rguhs.ac.in/Authoritysection/Notifications2013-14/MPharm/15_M.%20Ph%20Drugs%20Regulatory%20Affairs.doc

Date added: August 18, 2016 - Views: 1

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Auditing of Quality Systems of Medical Device...

Guidelines for Regulatory Auditing of Quality Systems . of Medical Device Manufacturers – ... such as the quality manual, ... Pharmaceutical Affairs Law. USA.

http://www.imdrf.org/docs/ghtf/final/sg4/technical-docs/ghtf-sg4-99-28-guidelines-auditing-device-manufacturer-quality-systems-part-one-990629.doc

Date added: August 18, 2016 - Views: 1

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Q10 - Ministry of Public Health

Quality Manual. 4. 2. MANAGEMENT RESPONSIBILITY 4. 2.1 . Management Commitment. 4. ... Diagram of the ICH Q10 Pharmaceutical Quality System Model. 17 Pharmaceutical ...

http://drug.fda.moph.go.th/zone_admin/files/Q10%20Step%204.doc

Date added: August 27, 2016 - Views: 1