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Content 16-9: Writing a Quality Manual - WHO

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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: May 11, 2012 - Views: 75

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Quality Manual - WRAP

The MRF Name MS comprises three main parts, the Quality Manual (QM), the Quality Procedures (QPs - indexed in Appendix 1) and MRF Name process documents (instructions).

http://www2.wrap.org.uk/downloads/ISO_9001_Quality_Manual.ef8e4826.10122.doc

Date added: March 24, 2014 - Views: 64

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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: October 4, 2011 - Views: 1933

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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: November 16, 2011 - Views: 751

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Pro7.1-02 SOP Checklist - Quality Management

Requirements for laboratory director or designee review of the Quality Management System, Quality Manual, and other policies, processes, ...

http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/labStudyData.doc

Date added: September 29, 2011 - Views: 147

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Good documentation Practices

The German Government agency that must approve new pharmaceutical products ... Re evaluate the Quality Policy and the SOP so that ... Good documentation Practices.

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

Date added: November 14, 2015 - Views: 27

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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: May 2, 2013 - Views: 63

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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: January 31, 2016 - Views: 1

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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: November 10, 2011 - Views: 71

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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: July 3, 2012 - Views: 119

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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: December 7, 2013 - Views: 39

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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: September 2, 2011 - Views: 243

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Quality Assurance Plan Checklist - HUD/U.S.

This checklist is provided as part of the evaluation process for the Quality Assurance Plan. ... quality, and presentation. ... User’s Manual. Operations Manual.

http://portal.hud.gov/hudportal/documents/huddoc?id=DOC_15124.doc

Date added: December 10, 2011 - Views: 813

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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: November 26, 2011 - Views: 179

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Standard Operating Procedures and Shipping...

Title: Standard Operating Procedures and Shipping Guidelines for Medical and Pharmaceutical Products: Author: Andy Turner Last modified by: Susan E A Gurling

http://www.docs.csg.ed.ac.uk/Procurement/Suppliers/Medical_SOPS_CitySprint_Nov_06.doc

Date added: November 14, 2013 - Views: 105

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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: September 20, 2011 - Views: 785

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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: October 12, 2014 - Views: 39

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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: September 18, 2014 - Views: 1

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health.eac.int

INSPECTION MANUAL FOR GOOD ... inspectors when conducting inspection of pharmaceutical ... GMP is that part of quality assurance which ensures that ...

http://health.eac.int/draftgmpdocuments/EAC%20GMP%20Inspection%20Manual%20&%20Annexes/EAC%20GMP%20INSPECTION%20MANUAL.doc

Date added: August 2, 2014 - Views: 7

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Control of the quality manual - hygiiene.co.uk

... drinks and pharmaceutical industries throughout the United Kingdom. ... This Quality Manual describes the essential parts of the QMS as implemented within Hygiene.

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

Date added: December 29, 2015 - Views: 1

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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: April 4, 2014 - Views: 41

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February 19, 1997_DRAFT - New Jersey

State of the Art (SOTA) Manual . for Chemical and Pharmaceutical Processing. and Manufacturing Industries. July 1997. State of New Jersey. Department of Environmental ...

http://www.nj.gov/dep/aqpp/downloads/sota/sota5.doc

Date added: October 13, 2012 - Views: 10

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Operational Policy and Procedure Manual About the ...

This 3rd edition of the Operational Policy and Procedure Manual and subsequent revisions have been developed to reflect the vast changes mandated by OBRA regulations.

http://mail.scmcf.org/Policy%20&%20Procedures/Heaton%20Manual%20Policy%20and%20Procedure/Heaton%202009/PandP%20Word%20Files/OPPM%20Volume1/07-AboutManual/002-AboutManual.doc

Date added: November 1, 2013 - Views: 64

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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: September 23, 2011 - Views: 126

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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: October 13, 2014 - Views: 24

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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 8, 2013 - Views: 10

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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: September 1, 2013 - Views: 7

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Management Review Meeting Minutes template

This template is intended as a tool to prepare records of Management Review ... Review the current Quality Objectives as outlined in the Quality Manual and modify ...

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

Date added: June 18, 2012 - Views: 272

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Analysis SOP - GLI Quality

QM Quality Manager. SOP Standard Operating Procedure. ... Solving simple interference from the operation manual and / or user manual Lab techs Lab Manager

http://gliquality.org/sites/default/files/L2_templates/2.4_SOP%20equipment%20maintenance_v2.doc

Date added: February 28, 2015 - Views: 50

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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: October 1, 2011 - Views: 455

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EAC/TF-MED/GMP/PD/N1R0

INSPECTION MANUAL FOR GOOD ... and knowledge on pharmaceutical manufacturing including GMP ... or reasonably perceived to affect the quality or the result ...

http://mrh.eac.int/wp-content/uploads/2013/10/EAC-GMP-INSPECTION-MANUAL.doc

Date added: June 29, 2015 - Views: 7

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Purpose - Mount Sinai Hospital, Toronto

... pharmaceutical companies for clinical trials or any other reason, the police department, ... Quality Manual Policy QIMMI06004.09 Page . 1 . of . 1.

https://www.mountsinai.on.ca/education/staff-professionals/microbiology/microbiology-laboratory-manual/quality-manual/information-management/Handling%20request%20for%20laboratory%20results%20not%20by%20doc%20-%20Procedure%20QIMMI06004.doc

Date added: January 16, 2015 - Views: 1

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Dental Hygienist Online Renewal - Mass.Gov

Manufacturer Registration Renewal Manual. This document displays screen shots and describes what a Pharmaceutical or Medical Device Manufacturer should do to renew ...

http://www.mass.gov/eohhs/docs/dph/quality/healthcare/pharm-manufacturers-license-renewal.doc

Date added: October 2, 2012 - Views: 11

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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 19, 2013 - Views: 174

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“VALIDATION AND QUALIFICATION OF HEATING,...

Iyer S. Text book of guidelines on C GMP and quality of pharmaceutical . product, HVAC System 2003 : 1; ... Q .A manual Air handling System 2007 (3) : 55-56.

http://www.rguhs.ac.in/cdc/onlinecdc/uploads/04__29298.doc

Date added: November 14, 2012 - Views: 105

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行政院衛生署 - fda.gov.tw

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/TC/includes/GetFile.ashx?mID=133&id=45323&chk=83aee61b-7dc2-400c-899b-adc1ed2d2376

Date added: December 31, 2015 - Views: 1

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Pharmacy Policies and Procedures Manual

Pharmacy Policies and Procedures Manual – Month, Day, ... a pharmacist must use the pharmacist’s pharmaceutical ... assess the quality by examining its ...

https://pharmacists.ab.ca/sites/default/files/PoliciesProceduresManual.docx

Date added: September 15, 2014 - Views: 54

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ELEMENTS FOR THE CONTROL OF PHARMACEUTICAL...

ELEMENTS FOR THE CONTROL OF PHARMACEUTICAL PRODUCTS ... -Quantity used in quality ... Manufacturing records should be maintained in either manual hard ...

http://www.cicad.oas.org/Reduccion_Oferta/ENG/Resources/Pharmaceuticals/Fin_report_Feb_04.doc

Date added: February 24, 2012 - Views: 31

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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/00d1540/00d-1540-lst0012.doc

Date added: May 27, 2012 - Views: 84

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Quality Assurance Supplier Survey/Audit Form

Title: Quality Assurance Supplier Survey/Audit Form Author: Irene Last modified by: Greg Created Date: 5/17/2004 3:36:00 PM Company: Modern Industries Inc.

http://www.modinds.com/VR_Supplier/MII%20Supplier%20Survey%20Revision%205.doc

Date added: October 19, 2011 - Views: 430

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pharmainfo.net

Equipment manual. SOP of cleaning procedure. ... Quality Control Microbiology Laboratory: Cell culture and staining methods are used for detecting microbes.

http://pharmainfo.net/files/idownloads/sample%20cleaning%20validation%20protocol.doc

Date added: December 9, 2014 - Views: 54

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ISO 15189 - IAAC

It is directly linked to the ISO 15189:2003, the standard for quality ... The pharmaceutical industry ... The development of a preanalytical quality manual takes on ...

http://www.iaac.org.mx/Documents/Uncontrolled/Library/MedicalLabs/DocsLabsClinicos.doc

Date added: October 19, 2011 - Views: 463

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Scheme of Instruction and Evaluation for M -...

(Pharmaceutical Analysis and Quality Assurance) I – Semester. Subject Code Subject / Paper Theory / Practical Instruction Hours per week Evaluation Duration of ...

http://www.ssrcp.com/downloads/syllabus/M-Pharm-Pharm-Analysis.doc

Date added: May 3, 2013 - Views: 147

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FINAL_Article 57 Data Quality Control Methodology

Data Quality Control methodology for data submitted under ... (and bigger) pharmaceutical industries can generate the electronic product ... User Manual (http ...

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/04/WC500165467.doc

Date added: May 10, 2014 - Views: 6

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Pharmaceutical Compounding Calculations - KSU

MANUAL FOR. PHARMACEUTICAL TECHNOLOGY. Central Committee . ... A quality control procedure should be executed with each batch of capsules produced with the machine.

http://faculty.ksu.edu.sa/hisham/Documents/Students/Lab_Manuals/Lab/pharmaceutical%20technology%20training%20manual-2f.doc

Date added: October 5, 2011 - Views: 114

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CHAPTER 19

CHAPTER 28. COMMITTEE FUNCTIONS Committees in the Nursing Home. I. Continuous Quality Improvement Program - Medical Errors Committee. Consultant Pharmacist ...

http://file.cop.ufl.edu/ce/consultwb/2012Workbook/CHAPTER%2028.doc

Date added: February 28, 2014 - Views: 6

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Project Quality Management Plan Template -...

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: April 8, 2016 - Views: 1

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I

Only medication prescribed by a licensed prescriber and samples provided by pharmaceutical companies will ... (*From Michigan Department of Environmental Quality) ...

http://www.cmhcm.org/provider/manual%20forms/2-300-008%20Pharmaceutical%20Practices.doc

Date added: December 5, 2013 - Views: 1

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Process Handbook for Pharmaceutical Sciences...

1. 28. 1

http://www.pharmacy.vcu.edu/media/school-of-pharmacy/graduate/GradDocumentSpring2015.docx

Date added: August 6, 2015 - Views: 1