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Guidelines for Good Wholesaling and Distribution Practices ...

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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: 100

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ANSI/NSF 4 B 2000 - NSF International: Welcome

IPEC-PQG: International Pharmaceutical Excipients Council and the Pharmaceutical Quality Group. impurity: ... The organization shall prepare a Quality Manual describing the quality management system, the Quality Policy, ...

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

This quality manual provides details on the policies and procedures Sobhan Chemotherapeutical Co. uses to meet ISO 9001:2000 Quality management ... (Insert relevant regulatory bodies requirements that meeting theses requirements are mandatory in pharmaceutical industry and organization ...

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

Date added: October 23, 2012 - Views: 13

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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 ... (RFID) tags for drugs. This Compliance Policy Guide (CPG) ...

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

Date added: May 11, 2012 - Views: 25

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

4.2.2 Quality Manual. ... There shall be no upgrading (relabeling) technical or industrial grade material to pharmaceutical grade quality only on the basis of analytical results found in conformance with the requirements of a pharmacopoeial monograph.

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: 6

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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. The checklist assists designated reviewers in determining whether specifications meet criteria established in HUD’s System Development Methodology (SDM).

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

Date added: September 18, 2011 - Views: 604

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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: 29

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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: 14

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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: 36

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Section 4 - Testmetric

In support of ISO 9001:2008. Table of Contents. Quality manual presentation. Control of the ... Industries served include Pharmaceutical, Aerospace, Manufacturing, Educational and Utility ... The Quality Management System described in this manual conforms to ISO 9001:2008 and follows ...

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

Date added: May 2, 2013 - Views: 21

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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: 10

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行政院衛生署 - FDA

... Has the original manufacturer established procedures for reporting to central competent health authority that authorize medical device permit holding pharmaceutical firm to report adverse ... version of quality manual, ... Practice for medical devices in the US) Quality system ...

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

Date added: December 7, 2013 - Views: 9

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February 19, 1997_DRAFT

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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Auditing of Quality Systems of Medical Device Manufacturers ...

Guidelines for Regulatory Auditing of Quality Systems . of Medical Device Manufacturers – Part 1: General Requirements. Authoring Group: SG4. ... such as the quality manual, ... Pharmaceutical Affairs Law. USA. Title 21 Code of Federal Regulations, ...

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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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: 2

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Pharmaceutical Engineering Guide for New and Renovated Facilities

Background. The design, construction, validation (commissioning and qualification) of water and steam systems for the pharmaceutical industry represent key opportunities for manufacturers, engineering proffesionals, and equipment suppliers.

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

Date added: March 1, 2014 - Views: 19

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PQG headed paper template

Quality Manual – Di Morris continues to work on the Quality Manual. Website – there has been a good response to the website. ... PHARMACEUTICAL QUALITY GROUP. Web Site: www.pqg.org Draft AGM 2006 Minutes V1.0 16-05-06.doc HC 16-05-06 Page 1 of 2

http://www.pqg.org/pharma/wp-content/uploads/2010/07/AGMMinutes2006.doc

Date added: August 14, 2013 - Views: 1

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Quality Assurance for the Biosciences Orientation Manual

BITC 1240 Quality Assurance for the Biosciences is a course designed to introduce the student to quality principles as they ... The lifecycle of Pharmaceutical products . CHAPTER 3. June 30th. July 2nd. June 30th. Week 6. Module 7 ... Quality Assurance for the Biosciences Orientation Manual Subject:

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

Date added: July 25, 2014 - Views: 1

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SUPPLIER QUALITY EVALUATION QUESTIONNAIRE - objectives

Yes No N/A 2.4 Is your personnel aware that the products supplied are used for the manufacturing of active pharmaceutical ingredients? ... Yes No N/A 9.21 Does your carrier have a Quality Manual? ... Supplier Quality Questionnaire Supplier Questionnare - Section E Extended Quality ...

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

Date added: February 10, 2012 - Views: 25

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Quality Systems Policy Manual

Quality Systems Policy Manual; This document contains the policies and reference procedures followed the laboratory to ensure that the study is conducted in accordance with OECD GLP guidelines; ... Division of pharmaceutical product development. SAI UNIVERISTY.

http://memberfiles.freewebs.com/01/33/44143301/documents/final%20GLP%20assign.docx

Date added: April 26, 2012 - Views: 9

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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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From:

Tabuk Pharmaceutical Manufacturing Company, Tabuk, Saudi Arabia Jan 2000 – Apr 2004 Chemist ... ( Site Master File, Validation Master Plan, Cleaning Validation Master Plan, Quality Manual, Quality Control Manual, Calibration Master Plan, etc. ( Master lists and formats ( Standard ...

http://www.pharmaniaga.com:8080/pharmaweb/files/resume-20140427112540-KRA_CV-KSA-12-02-2014%20(4).doc

Date added: July 23, 2014 - Views: 1

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For ENAS use only - ESMA

For ENAS use only LAB ID NAL Case Manager Date of Handing over ... 4 B - pharmaceutical testing . Part 5 - About your quality system All new applicants . ... Yes No Quality Manual reference/other comment 1.

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

Date added: March 14, 2012 - Views: 11

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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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Pharmacy Operations Manual - Massachusetts General Hospital

Quality. QUA-001 Pharmacy Policy Manual. QUA-002 Documentation Control Procedures. QUA-003 Pharmacy Quality Assurance Program. ... 3.3 Pharmaceutical Calculations. 3.4 USP Chapter 797 Training. 3.5 High-Risk-Level CSP. 3.5.1 Validation. 3.5.2 Challenge Testing.

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

Date added: July 31, 2012 - Views: 73

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GUIDANCE DOCUMENT:

GUIDELINES ON INSPECTIONS INVOLVING THE GMP INSPECTORS This document has been prepared to serve as guidance about the GMP Inspectorate responsible for performing inspections for compliance with current Good Manufacturing Principles asserted to by Pharmaceutical Medicine Manufacturers as ...

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

Date added: October 20, 2011 - Views: 84

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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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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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Policies and Procedures for ACPE Criteria for Quality and ...

Administrative Responsibility: The Director of the Division for Continuing Pharmacy Education (DCPE) is responsible for assuring that all activities offered for continuing education credit follow the ACPE Criteria for Quality and Interpretive Guidelines.

http://www.temple.edu/pharmacy/documents/Handbook_of_CPE_Policies_and_Procedures.docx

Date added: September 27, 2013 - Views: 2

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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: 15

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MSL936001A Maintain quality system and continuous improvement ...

The laboratory supervisor with a pharmaceutical company had participated in the production of a company wide quality manual. This manual was distributed to the various work teams and an induction program for all workers was undertaken to familiarise them with the demands of the quality system.

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

Date added: August 2, 2013 - Views: 6

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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: 13

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State of the Art (SOTA) - New Jersey

Air Quality Permitting Program State of the Art (SOTA) Manual . Table of Contents. ... (SOTA) 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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Pharmacy Services NC II - TESDA

Quality procedures manual. Evaluation report forms. Logbooks. Operational manual. Assessment instruments. METHODOLOGIES: Lecture. Group Discussion. ... Identify the Responsibilities of a Pharmacy Aide/Pharmaceutical Assistant. LO2. Discuss drugs categories, storage and handling requirements and ...

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

Date added: January 29, 2012 - Views: 46

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Scheme of Instruction and Evaluation for M

Quality assurance of pharmaceutical (A compendium of guidelines and selected materials) Vol. I & II, WHO, Geneva, Pharma book syndicate, ... ASQC Quality Press, Milwaukee, 2005. Manual on drugs and cosmetics, 2nd ed., Commercial law publishers (India) Pvt. Ltd., Delhi, 2004.

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

Date added: May 3, 2013 - Views: 82

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

Compliance Policy Guides Manual, Chapter 4 Human Drugs. Compressed Medical Gases Guideline. Guideline on General Principles of Process Validation. ... Guide to Inspections of Pharmaceutical Quality Control Laboratories.

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

Date added: November 9, 2011 - Views: 45

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For ENAS use only

A copy of the laboratory's Quality Manual A copy of the laboratory's procedures . Applicant fee-see note below ... 4 B: Scope of application: for Pharmaceutical testing only. Raw material / Finished products Active ingredients Types of medicine Uncertainty of Measurement

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

Date added: June 17, 2013 - Views: 2

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

A copy of the laboratory's Quality Manual . A copy of the laboratory's Quality Procedures . A copy of the laboratory's Technical Procedures . ... *Please also mention Active Pharmaceutical Ingredient (API) in case of Pharmaceutical Testing 4C.

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

Date added: July 18, 2013 - Views: 2

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Pharmaceutical Compounding Calculations - KSU

TRAINING MANUAL FOR PHARMACEUTICAL TECHNOLOGY ... It takes practice to ensure that each capsule has the same amount of drug. A quality control procedure should be executed with each batch of capsules produced with the machine. Final Processing .

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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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: 78

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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: 10

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Auditing Guidelines

GMP. Auditing Guide. Quality Elements. Sub-Elements. Points to consider Quality System The QA-System has been laid down in writing. The QA-System has been approved by the appropriate level of management The QA-System addresses all GMP elements related to the manufacture, testing ...

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

Date added: October 1, 2011 - Views: 79

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SCHEME OF INSTRUCTION AND EVALUATION FOR - Webs

Course Structure and Syllabus for M. Pharm- Pharmaceutical Analysis. ... QA manual by D.H.Shah. Basic test for pharmaceutical substances WHO 1988. ... Differential thermal analysis. 7. Quality control of crude drugs- ash value, ...

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

Date added: September 18, 2013 - Views: 33

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COLORCON, NO-TOX PRODUCTS GENERAL QUESTIONNAIRE RESPONSE BOOKLET

Colorcon, No-Tox Products Division is committed to providing superior products and services that exceed our customer’s expectations. We are dedicated to continuous quality improvement and regulatory compliance.

http://www.colorcon.com/notox/literature/sales/CC%20NTPD%20Audit%20Book-2007.doc

Date added: February 1, 2012 - Views: 7

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FDF20211 Certificate II in Pharmaceutical Manufacturing

Job Roles The Certificate II in Pharmaceutical Manufacturing targets those working within production or production support roles, ... Inspect quality of work on an ongoing basis. ... Use manual handling technologies in the workplace.

http://training.gov.au/TrainingComponentFiles/FDF10/FDF20211_R2.docm

Date added: December 21, 2013 - Views: 5

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Glossary Pharmaceutical - سایت دارويی دکتر ...

Added to Pharmaceutical Glossary. Quality Plan: A plan created by the supplier to define actions, ... 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 ...

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

Date added: October 19, 2011 - Views: 24

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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: 9

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Pharmaceutical Manufacturer Inspection Measures

Pharmaceutical manufacturers that shall be inspected in accordance with this set of Regulations are as follows: Firms in the manufacturing, ... Quality manual; Factory registration certificate; Permit license of pharmaceutical manufacturer.

http://www.fda.gov.tw/EN/includes/GetFile.ashx?id=596&chk=66070517-b987-45fa-831c-bb5dee7c41df&mid=172&name=fdContent

Date added: July 7, 2013 - Views: 7

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Pharmaceutical Sector Scan - Medicines Transparency

Pharmaceutical Sector Scan. Part of Component 1 of MeTA Baseline Assessments Part II ... Total number of samples tested for quality in past year, ... National medicines formulary manual exists.

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

Date added: May 10, 2012 - Views: 6

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Audit Report with GMP Questionnaire - TLI Development

Quality Manual 14. 5.3. SOP ... milling, or packaging) of highly toxic non-pharmaceutical materials such as herbicides and ... approved contract or formal agreement between the contract giver and the contract acceptor that defines in detail the GMP responsibilities, including the quality ...

http://tlidevelopment.com/templates/Audit%20Report%20with%20GMP%20Questionnaire%20(template).doc

Date added: August 1, 2013 - Views: 83