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Document Index - Quality Engineering, Validation and ...

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Document Index - Quality Engineering, Validation and ...

Quality Documents for the Pharmaceutical Manufacturing. Templates. Title: Quality Manual Template. Abstract: ISO standards and FDA require that a manufacturing entity has a Quality Manual in place. This is required before a INDA or PMA is submitted.

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

Date added: October 18, 2011 - Views: 353

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Guidelines for Good Wholesaling and Distribution Practices ...

The Quality Manual must be established, documented and maintained. ... In this environment it equates to quality pharmaceutical products delivered to the correct customers, under the correct storage and transportation conditions.

http://www.mccza.com/genericDocuments/4.02_SA_Guide_to_GWP_v2_Mar12_for_comment.doc

Date added: May 21, 2012 - Views: 99

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ANSI/NSF 4 B 2000 - NSF International: Welcome

NSF Draft Standard for. Pharmaceutical Excipients – Good Manufacturing Practices (GMP) for Pharmaceutical Excipients. 1 General. 1.1 Introduction. The principles outlined in this Standard provide a comprehensive basis for the quality management system used in the manufacture of pharmaceutical ...

http://standards.nsf.org/apps/group_public/download.php/16070/363i1r1e.doc

Date added: May 19, 2012 - Views: 37

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2-1- Purpose - Elsmar

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: 10

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Section 4 - Testmetric

Quality manual presentation. Control of the manual. Distribution list. Control list. Organization. 2.1 Business background. ... Industries served include Pharmaceutical, Aerospace, Manufacturing, Educational and Utility Field. The Facility is located as follow: Testmetric . 605C Cité des Jeunes ...

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

Date added: May 2, 2013 - Views: 18

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Quality Assurance Plan Checklist - HUD/U.S.

The Quality Assurance Plan (QAP) presents a framework for activities, which when followed, will ensure delivery of quality products and services. ... User’s Manual. Operations Manual. Maintenance Manual. Validation, Verification, and Testing Plan (final)

http://www.hud.gov/offices/cio/sdm/devlife/tempchecks/qapchecklist.doc

Date added: September 18, 2011 - Views: 598

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IPEC GDP for Excipients

IPEC Good Distribution Practices Audit Questionnaire for Pharmaceutical Excipients. This document has been written to provide a tool for those auditing companies involved in the supply chain of pharmaceutical excipients.

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

Date added: October 14, 2011 - Views: 28

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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 starting materials and other components contained in or used in the manufacture of the final product dosage form.

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

Date added: November 3, 2011 - Views: 30

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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 manufacture of pharmaceutical excipients.

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: 9

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行政院衛生署 - FDA

Name of Pharmaceutical Firm: (Chinese) Address of Pharmaceutical Firm: (Chinese) ... 3.10 Has the original manufacturer provided the most up-to-date and valid version of quality manual, document list, and quality system procedures in this application?

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

Date added: December 7, 2013 - Views: 7

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

4.2.2 Quality Manual. ... Where critical to pharmaceutical quality, the organization shall establish an appropriate monitoring programme to show the consistent operation of the excipient handling process.

http://www.pqg.org/pharma/wp-content/uploads/2010/07/GDP-Annex-to-ISO-9001-draft-20091222-for-review.doc

Date added: August 10, 2013 - Views: 4

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Pharmaceutical Engineering Guide for New and Renovated Facilities

Water quality criteria for pharmaceutical manufacturing and product development are driven by the product characteristics, ... (with automatic or manual controls) or another water treatment unit operation. ADVANTAGES: Simple design and maintenance. Flexible in water flow production.

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

Date added: March 1, 2014 - Views: 16

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Operational Policy and Procedure Manual About the Manual

The manual is a how-to reference that focuses primarily on policies and procedures that govern the day-to-day practices of ... Administrative Services Pharmaceutical Services. ... Care Plans Quality Assessment and Assurance. Committees Resident Assessment (MDS) Dental Services Resident Rights.

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: 10

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Compliance Policy Guide - Food and Drug Administration

electronic records, and product quality, apply to pharmaceutical manufacturers, repackagers, relabelers, distributors, retailers, or others who participate in feasibility studies and pilot programs (collectively "a study" or "studies") using Radiofrequency Identification ...

http://www.fda.gov/downloads/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/UCM246448.doc

Date added: May 11, 2012 - Views: 24

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SUPPLIER QUALITY EVALUATION QUESTIONNAIRE - objectives

Yes No Active pharmaceutical ingredients? Yes No Technical products? Yes No Packaging material? Yes No ... Yes No N/A 9.21 Does your carrier have a Quality Manual? Yes No N/A 9.22 To which norm is this quality system related? 9.23 ...

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

Date added: February 10, 2012 - Views: 24

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February 19, 1997_DRAFT - The Official Web Site for The State ...

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

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

Date added: October 13, 2012 - Views: 3

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

The quality manual should define the organisation’s validation policy, ... Where critical to pharmaceutical quality, the organization shall establish an appropriate monitoring programme to show the consistent operation of the excipient manufacturing process.

http://www.pqg.org/pharma/wp-content/uploads/2010/07/ExcipCert-2-IPEC-PQG%20ExcipientsGMPStandard20091116.doc

Date added: August 15, 2013 - Views: 4

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SCADA User Requirements Specification Template

... and quality assurance Testing Testing strategies, ... favoring a high level of manual process interaction by operating personnel, ... NDA New Drug Application A process prescribed by the US FDA for introducing a new pharmaceutical product or product form to the US marketplace.

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

Date added: February 23, 2012 - Views: 267

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Quality Manual - NHS Joint Research

Quality Manual. The collection, storage and use of tissue in research in accordance with Newcastle University’s research sector Human Tissue Act Licence (No. 12534)

http://www.newcastlejro.org.uk/wp-content/uploads/2012/04/Quality-Manual_Mhairi_E02.docx

Date added: March 7, 2014 - Views: 1

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Auditing of Quality Systems of Medical Device Manufacturers ...

Title: Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements Subject: GHTF Last modified by: Mason, Jenny Created Date

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: 10

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For ENAS use only - هيئة الإمارات ...

4 B - pharmaceutical testing . Part 5 - About your quality system All new applicants . ... Yes No Quality Manual reference/other comment 1. Is a copy of the Quality Manual supplied with this application? If "No" give reason 2.

http://www.esma.gov.ae/SiteCollectionDocuments/ENAS/Application.doc

Date added: March 14, 2012 - Views: 9

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Dental Hygienist Online Renewal - Massachusetts

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

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

Date added: October 2, 2012 - Views: 3

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Supplier Approval

The Quality Manager shall review supplier performance and present reports at Management Review Meetings and maintain records. Procedure OP 4.4.1 Management Review. 4.0 Persons Responsible: Group Director. Finance Director. Quality Manager. Clerical Assistants.

http://home.btconnect.com/Briarcare/QMS/Quality%20Procedures/156%20OP%20Manual%20Section%204.9.1supplier%20approval%20%20review%20-%20rev2.doc

Date added: November 11, 2011 - Views: 12

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Pharmacy Services NC II - PANGASIWAAN SA EDUKASYONG TEKNIKAL ...

Preparing and packaging pharmaceutical products in dose administration containers 34-38. ... Maintain quality of own performance 9 hours CORE COMPETENCIES (235 hours) ... Company policy and procedures manual.

http://www.tesda.gov.ph/inc/files/Pharmacy%20Services%20NC%20II.doc

Date added: January 29, 2012 - Views: 40

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PHARMACEUTICAL CGMPS FOR THE 21ST CENTURY —

This quality systems model, now incorporated into the FDA Staff Manual Guide, Quality Systems Framework for Internal Activities, ... It is crucial that pharmaceutical quality standards or requirements be harmonized internationally to the fullest extent possible.

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

Date added: October 31, 2011 - Views: 38

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State of the Art (SOTA) - New Jersey

Air Quality Permitting Program State of the Art (SOTA) Manual . Table of Contents. ... Manual for Chemical and Pharmaceutical Processing and Manufacturing Industries. 3.6: State of the Art (SOTA) Manual for Degreasers and Other Solvent Based Metal Surface Cleaners.

http://www.nj.gov/dep/aqpp/downloads/sota/sota0.doc

Date added: February 28, 2013 - Views: 2

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Auditing Guide - objectives

Is there a Quality Manual or equivalent documentation that describes in detail how the Quality System is implemented? ... Production of highly toxic, non-pharmaceutical products, for example pesticides excluded from pharmaceutical production facilities? 4.5.

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

Date added: September 15, 2013 - Views: 8

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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 External Examination

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

Date added: May 3, 2013 - Views: 76

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GUIDANCE DOCUMENT: - » SAMSIG 2013 Annual Meeting

... Good Manufacturing Principles asserted to by Pharmaceutical Medicine Manufacturers as prescribed by the Medicines Control Council. The MCC is committed to ensure that all medicines that are registered are of the required quality, ... of the Quality Manual. Assessment of the Validation ...

http://mccza.com/genericDocuments/4.09_Inspections_involving_GMP_inspectors.doc

Date added: October 20, 2011 - Views: 78

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21CFR Part 11: FDA Compliance Program Guidance Manual Program ...

Sterility testing methods should be based on current editions of USP, and for the Sterility Analytical Manual. ... Guide to Inspections of Pharmaceutical Quality Control Laboratories. Guide to Inspections of High Purity Water Systems.

http://www.lesman.com/21cfr_11/7356-002.doc

Date added: November 9, 2011 - Views: 44

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Guidance for Industry - Food and Drug Administration

Any manual or mechanical manipulation of the sterilized drug, components, ... Guide To Inspections of Microbiological Pharmaceutical Quality Control Laboratories, 1993. Guide To Inspections of Sterile Drug Substance Manufacturers, 1994. Pyrogens: Still a Danger; ...

http://www.fda.gov/ohrms/dockets/ac/02/briefing/3900B1_06_Sterile%20Drug%20Products.doc

Date added: October 23, 2011 - Views: 109

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eGov Screen Shots for Setup Utility - Massachusetts

User Manual for Licensees. This document displays screen shots and describes what a licensee should do to create an account and login using the Massachusetts Department of Public Health Online Licensing site.

http://www.mass.gov/eohhs/docs/dph/quality/healthcare/pharm-manufacturers-licensing-account-creation.doc

Date added: May 18, 2013 - Views: 2

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SCHEME OF INSTRUCTION AND EVALUATION FOR - Webs

QA manual by D.H.Shah. Basic test for pharmaceutical substances WHO 1988. Elements in biotechnology by P. K. Gupta. ... 11. Quality control tests for pharmaceutical containers. 12. Quality control testing of pharmaceutical containers. 13.

http://memberfiles.freewebs.com/56/49/68654956/documents/PHARM.ANALYSIS.doc

Date added: September 18, 2013 - Views: 29

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USER REQUIREMENTS TEMPLATE - International Society for ...

Both the material feed system and the tablet press will be located in a designated operating area within a finished pharmaceutical manufacturing facility and must be constructed and ... to the press settings to maintain product quality ... operating in the manual compression force mode ...

http://www.ispe.org/index.php/ci_id/3420/la_id/1.htm

Date added: May 7, 2013 - Views: 4

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Accreditation Application - Accredited Labs

... 7F” section C). It is preferable that the Attachments and Quality Manual be submitted as “text searchable” documents. ... Pharmaceutical Testing Fields of Testing (FoT) Technology sub-type/ Detector List In-House Laboratory Method Number (e.g., ...

http://www.aihaaccreditedlabs.org/programfees-guidelines-forms/Documents/LAP%20LLC_Checklist_Accreditation_Application_R10%20%28effective%20June%2021%2c%202013%29%20FINAL.doc

Date added: July 10, 2013 - Views: 14

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Pharmaceutical Compounding Calculations - KSU

TRAINING MANUAL FOR PHARMACEUTICAL TECHNOLOGY ... Training should be rotated in the different production lines, quality control, quality assurance, raw material handling and marketing departments. JUSTIFICATION: ...

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

Date added: October 5, 2011 - Views: 69

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Glossary Pharmaceutical - سایت دارويی دکتر ...

Added to Pharmaceutical Glossary. Quality Control [QC] ... The process of exercising or evaluating a system or system component by manual or automated means to verify that it satisfies specified requirements or to identify differences between expected and actual results.

http://www.drannabi.com/pharmacy/s.d/Glossary%20Pharmaceutical.doc

Date added: October 19, 2011 - Views: 20

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Pharmaceutical Sector Scan - Medicines Transparency

Pharmaceutical Sector Scan. Part of Component 1 of MeTA Baseline Assessments Part II ... National medicines formulary manual exists. ... Results of quality testing during the procurement process are publicly available Yes &

http://www.medicinestransparency.org/fileadmin/uploads/Documents/Resources_MSH/Toolkits/Pharma_Scan/Data_Collection_Tables.DOC

Date added: May 10, 2012 - Views: 4

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Pharmacy Operations Manual - Massachusetts General Hospital

Quality. QUA-001 Pharmacy Policy Manual. QUA-002 Documentation Control Procedures. QUA-003 Pharmacy Quality Assurance Program. ... 3.1.8 Pharmaceutical Company Representatives. 3.2 Handling and Storage. 3.2.1 Packing Slips. 3.2.2 Receipt of Damaged Items.

http://www2.massgeneral.org/pharmacy/QUA-004%20POM%20Table%20of%20Contents.doc

Date added: July 31, 2012 - Views: 70

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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 EAC QMS requirements. ... Processes for the service provision (inspection and licensing of pharmaceuticals outlet, inspection of pharmaceutical manufacturing plants, ...

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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For ENAS use only

4 B: Scope of application: for Pharmaceutical testing only. Raw material / Finished products Active ingredients Types of medicine Uncertainty of Measurement (where applicable) ... Yes No Quality Manual reference/other comment 1.

http://www.esma.gov.ae/SiteCollectionDocuments/ENAS/ACF10-01.doc

Date added: June 17, 2013 - Views: 2

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Questionnaire on structures and processes of country ...

Important note: To improve the comparability of results across different survey instruments investigating national pharmaceutical policies, the National Pharmaceutical Sector Form used in the first edition of the survey methodology has been replaced with an abridged version of the WHO ...

http://www.haiweb.org/medicineprices/manual/medpricesAttachements/surveyDocs/Annex1.doc

Date added: January 31, 2012 - Views: 11

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For PNAC Use only - Pakistan National Accreditation Council ...

*Please also mention Active Pharmaceutical Ingredient (API) in case of Pharmaceutical Testing 4C. List the major items of equipment currently used for the types of test listed in part 4 ... Yes No Quality Manual reference/other comment 1.

http://www.pnac.org.pk/INFOPACK/labsinfopack/F-0101%20Application%20for%20Labs%20Rev%2005.doc

Date added: July 18, 2013 - Views: 1

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MSL936001A Maintain quality system and continuous improvement ...

MSL936001A Maintain quality system and continuous improvement processes within work/functional areaDate this document was generated: ... The laboratory 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: 3

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Auditing Guidelines

Quality Elements. Sub-Elements. ... Double check is performed for manual critical data entries (e.g. weights, batch-no's.). The system records the identity of operators entering, ... Properties of the active pharmaceutical ingredient.

http://asq.org/conferences/customer-supplier-symposium/2008/presentations/123-GMp-checklist.doc

Date added: October 1, 2011 - Views: 79

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AN AUDIT OF PHARMACY PROCUREMENT - PDIG - Procurement and ...

An Audit Tool. Pharmaceutical procurement is an integral part of medicines management. This document sets out standards for the service and provides a framework for auditing local practice.

http://pdig.bravoindia.com/downloads/audit_document_ds_Version_dec_03.doc

Date added: November 2, 2011 - Views: 23

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Guidance for Industry - ISO портал

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

http://www.iso.staratel.com/GMP/FDA/QualitySystemsApproach/6452dft.doc

Date added: July 27, 2013 - Views: 3

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HVAC Design for Pharmaceutical Facilities Course No: M05-006 ...

HVAC Design for . Pharmaceutical Facilities . In pharmaceutical manufacturing, how space conditions impact the product being made is of primary importance.

http://www.mafna.com/ShowNewsLetter.ashx?letterID=9

Date added: August 16, 2013 - Views: 8

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Pharmaceutical Sector Scan - Medicines Transparency

Pharmaceutical Sector Scan Part of Component 1 of the MeTA ... published a working draft of a manual to collect and analyse the prices people pay for a selection of important ... Registration Medicines Trade: Manufacturing Medicines Trade: Quality Assurance ...

http://www.medicinestransparency.org/fileadmin/uploads/Documents/Resources_MSH/Toolkits/Pharma_Scan/Supporting_Sources_and_Comments.doc

Date added: May 16, 2012 - Views: 3

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M.Pharm - RGUHS

Pharmaceutical Quality Assurance by Manohar A. Potdhar, 2nd edition, Nirali Prakashan. ... GLP Quality Audit Manual, Milton A. Anderson, Third Edition, Informa Healthcare. Laboratory Auditing for Quality and Regulatory Compliance, ...

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

Date added: August 19, 2013 - Views: 75