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Quality Manual Template - General - Wadsworth...

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Quality Manual Template - General - Wadsworth...

The quality manual references these documented procedures. Where applicable, work instructions are referenced in the documented procedures and the quality manual.

http://www.wadsworth.org/labcert/elapcert/forms/QM_general_072211.doc

Date added: April 19, 2012 - Views: 526

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2-1- Purpose - Medical device

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

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

Date added: October 23, 2012 - Views: 39

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Sample ISO 9001 Quality Manual

Example of a ISO-9001 quality manual. Designed for a service organization that is part of a larger organization which is NOT registered. Within the manual an in ...

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

Date added: October 4, 2011 - Views: 1601

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Document Index - Quality Engineering, Validation...

Quality Documents for the Pharmaceutical Manufacturing. Templates. Title: Quality Manual Template. Abstract:

http://www.qualityleader.com/Document%20Index%20with%20index-%20beta1.doc

Date added: October 18, 2011 - Views: 452

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Sample Procedure - ISO Quality Manual

ISO-Quality-Manual.com Quality System Procedure. QSP 8.3.1. ... Thank you for downloading this sample procedure applicable to control of a non-conforming product.

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

Date added: September 20, 2011 - Views: 739

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Internal Quality Audits - Wadsworth...

To ensure that the procedures in the quality manual, related to quality systems, and the lab’s method manual, ... _a__ Internal quality control procedures ...

http://www.wadsworth.org/labcert/elapcert/forms/InternalAuditSOP_012413.doc

Date added: March 24, 2013 - Views: 230

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Content 16-9: Writing a Quality Manual

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: 55

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SOP on Document Control and Management - pSMILE

The following types of documents are controlled by the document control procedure: Quality Manual, Standard Operating Procedures (SOPs) and forms, ...

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

Date added: February 1, 2012 - Views: 96

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DOC Good documentation Practices - SMCCD

... numerous types of documentation exist ... The German Government agency that must approve new pharmaceutical ... Re evaluate the Quality Policy and the ...

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

Date added: October 14, 2011 - Views: 326

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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: 209

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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: 21

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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: 17

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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: October 11, 2011 - Views: 232

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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: April 2, 2013 - Views: 45

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SCADA User Requirements Specification Template -...

This User Requirements Specification ... Guide available through the International Society for Pharmaceutical ... favoring a high level of manual process ...

http://ispe.org/jett/scada-urs.doc

Date added: November 18, 2014 - Views: 25

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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: 72

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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 ... (Please refer to ISO 13485 ... 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: 34

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MSL936001A Maintain quality system and continuous...

1.Develop and maintain quality framework within ... supervisor with a pharmaceutical company had participated in the production of a company wide quality manual.

http://training.gov.au/TrainingComponentFiles/MSL09/MSL936001A_R1.docm

Date added: August 2, 2013 - Views: 25

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Guidance for Industry

Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations. DRAFT GUIDANCE. This draft guidance document is being distributed for ...

http://www.gmpua.com/World/FDA/QualitySystemsApproach/6452dft.doc

Date added: November 6, 2011 - Views: 62

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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: 44

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Project Quality Management Plan Template

Title: Project Quality Management Plan Template Subject: Author: Daniel Vitek MBA, PMP - Consultant to CDC NCPHI Keywords: CDC Unified Process, CDC UP, CDCUP

http://www2.cdc.gov/cdcup/library/templates/CDC_UP_Quality_Management_Plan_Template.doc

Date added: September 18, 2011 - Views: 473

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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: 56

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4 - NSF International

4 Quality Management System Introduction. The principles outlined provide a comprehensive basis for the quality management system used in the ... pharmaceutical users

http://standards.nsf.org/apps/group_public/download.php/8184/GMP_Quality_System_Standard_5-4-2010%20IS.doc

Date added: February 27, 2014 - Views: 44

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USER REQUIREMENTS TEMPLATE - International Society...

This document describes the user requirements for a water system designed to produce USP quality water in ... of pharmaceutical ... Manual and automatic ...

http://www.ispe.org/jett/validation-plan-template.doc

Date added: April 25, 2012 - Views: 137

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GHTF SG3 Quality Management System - Medical...

Several medical device quality management system regulations have their ... software (e.g. engine control software, driver's manual), ... pharmaceutical manufacturers ...

http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n17-guidance-on-quality-management-system-081211.doc

Date added: January 22, 2013 - Views: 44

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pharmainfo.net

CLEANING VALIDATION PROTOCOL TEMPLATE. ... Equipment manual. ... with the product Labelling machine Non-critical Doesn’t affect quality and purity ...

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

Date added: December 9, 2014 - Views: 16

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Q10 - Ministry of Public Health

Pharmaceutical Quality System. Q10. ... A Quality Manual or equivalent documentation approach should be established and should contain the description of the ...

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

Date added: December 16, 2014 - Views: 8

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Comparison of paragraphs, as found in IPEC Draft...

4.2.2 Quality Manual. The organization shall establish and maintain a quality manual that includes or references: d) ... Where critical to pharmaceutical quality, ...

http://pqg.org/download-files/GDP%20Annex%20to%20ISO%209001%20draft%2020091222%20for%20review.doc

Date added: November 1, 2011 - Views: 34

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Work Instruction Template - NASA

QM Quality Manual. WI Work Instruction. Process Flow Diagram {A process flow diagram is a high-level depiction of the processes described in this WI.

http://www.nasa.gov/centers/ivv/doc/171736main_T2003.doc

Date added: October 5, 2011 - Views: 1553

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Comparison of paragraphs, as found in IPEC Draft...

The quality manual should define the ... For more details see the Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients 2006 and ...

http://pqg.org/download-files/ExcipCert-2-IPEC-PQG%20ExcipientsGMPStandard20091116.doc

Date added: October 31, 2011 - Views: 44

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standards.nsf.org

A Quality Manual or equivalent documentation approach should be established and should ... The pharmaceutical quality system should assure that the desired ...

http://standards.nsf.org/apps/group_public/download.php/7600/Quality%20System%20Comparison%20-%20Completed.doc

Date added: June 1, 2012 - Views: 5

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PHARMACEUTICAL CGMPS FOR THE 21ST CENTURY

pharmaceutical CGMPs for the 21st century ... It is crucial that pharmaceutical quality standards or requirements be ... FDA Staff Manual Guide -Quality System ...

http://www.mgdservices.com/pharmaceutical%20CGMPs%20for%20the%2021st%20century.doc

Date added: October 31, 2011 - Views: 64

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Pharmaceutical Compounding Calculations - KSU

MANUAL FOR. PHARMACEUTICAL TECHNOLOGY. ... A quality control procedure should be executed with each batch of capsules ... Pharmaceutical Compounding Calculations Author:

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

Date added: October 5, 2011 - Views: 100

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Quality Management Plan - Home - Centers for...

Quality Management Plan Version X.Xii<Project Name / Acronym> For instructions on using this template, please see Notes to Aut. hor/Template Instructions on page. 10.

http://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/XLC/Downloads/QualityMgmtPlan.docx

Date added: June 15, 2013 - Views: 146

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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: February 10, 2012 - Views: 68

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Dana-Farber/Harvard Cancer Center

Clinical Trials. Audit Manual. July 2009. Prepared by the DF/HCC Quality Assurance Office for Clinical Trials. ... pharmaceutical industry or other sponsors.

http://www.dfhcc.harvard.edu/fileadmin/DFHCC_Admin/Clinical_Trials/QACT/Policies_and_Procedures/Audit_Manual_July_2009.doc

Date added: October 20, 2011 - Views: 149

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

Pharmaceutical . companies have found ways to improve quality and costs ... o Make the long-form SOP a training document or manual to supplement the shorter sub-job ...

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

Date added: July 3, 2012 - Views: 89

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For ENAS use only - ESMA

A copy of the laboratory's Quality Manual A copy of the laboratory's ... pharmaceutical testing . ... N. Compliance with ISO/IEC 17025 and ENAS Accreditation ...

http://www.esma.gov.ae/en-us/Services/Lists/ESMAServiceForms/Attachments/4/TESTCalibrating%20lab.doc

Date added: November 5, 2014 - Views: 12

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www.gesundheit.bfh.ch

2003 Lecture « e-Quality Manual », Specialisation Course « Quality Assurance ... 1987-2003 Expert of pharmaceutical federal intermediate examinations in the fields ...

http://www.gesundheit.bfh.ch/fileadmin/wgs_upload/users/jzh1/130124CV_hjenzer.doc

Date added: April 9, 2014 - Views: 1

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Pharmaceutical Engineering Guide for New and...

Water quality criteria for pharmaceutical manufacturing and product development are driven by the product characteristics, ... (with automatic or manual controls) ...

http://www.socalwatertreatment.com/pdfs/ISPE%20baseline%20guide%20volume%204.docx

Date added: March 1, 2014 - Views: 55

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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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mrh.eac.int

This document acts as a model quality manual for EAC NMRAs in documenting their quality management system as per ... inspection of pharmaceutical manufacturing ...

http://mrh.eac.int/wp-content/uploads/2013/10/EAC-TF-MED-QMS-PD-N3R0-EAC-QMS-Model-Manual-edited-accepted-changes.doc

Date added: June 6, 2014 - 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: November 26, 2011 - Views: 146

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Quality Assurance for the Biosciences Orientation...

Quality Assurance for the Biosciences Orientation Manual

http://www.bio-link.org/home/sites/files/quality_assurance_orientation_1.docx

Date added: July 25, 2014 - 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: 10

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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: 28

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DoD 4140 - DoD Shelf-Life Program

... DoD Manual 4140.26-M, ... Any pharmaceutical that is found to have been exposed to T/H conditions outside the ... and the DoD QSL. C. Quality Status ...

https://www.shelflife.hq.dla.mil/Policy_4140_27/DoD_4140_27-M-PUBLIC.doc

Date added: October 8, 2011 - Views: 238

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Compounding Initial Draft – 9-18-06

Pharmaceutical Compounding ... Quality control pertains to the policies ... and all pharmacies should have a policy and procedure manual to ensure the safety and ...

http://www.nm-pharmacy.com/COP_/Extern_Articles/Compound.doc

Date added: February 4, 2012 - Views: 41

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gmp-gcp- quality-control.pharmaceuticalconferences...

... manual, PubChem compound ID ... pharmaceutical analysis or regular quality control are also possible with E-BABE. E-BABE was built understanding the needs of ...

http://gmp-gcp-quality-control.pharmaceuticalconferences.com/abstract-template.doc

Date added: June 29, 2015 - Views: 1