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Title: Basic Principles of GMP Subject: WHO template and recommendations Keywords: communication, photos, text Last modified by: Angela Maria Ferreira LOPES
Date added: October 31, 2011 - Views: 583
Title: Basic Principles of GMP Subject: WHO template and recommendations Author: loconte Keywords: communication, photos, text Last modified by: Alexander Polishchuk
Date added: October 10, 2011 - Views: 404
... health and clothing practices waste disposal Implementation and training ... Basic Principles of GMP Active Pharmaceutical Ingredients Active ... Basic Principles of GMP Active Pharmaceutical Ingredients Active Pharmaceutical Ingredients Active ...
Date added: October 31, 2011 - Views: 55
... Calibration and operation of analytical apparatus Maintenance, cleaning and sanitation Personnel recruitment, training, ... Basic Principles of GMP Author: David Richard Buckley Last modified by: Alexander Polishchuk Created Date: 3/17/2000 11:45:32 AM
Date added: March 28, 2012 - Views: 54
Basic Principles of GMP Documentation - Part 1 Workshop on GMP and Quality Assurance of HIV products Shanghai, China 28 Feb - 4 March 2005 Maija Hietava M.Sci.Pharm ... Qualifications and Training ...
Date added: May 16, 2013 - Views: 26
Basic Principles of GMP ... Calibration and operation of analytical apparatus Maintenance, cleaning and sanitation Personnel recruitment, training, clothing and hygiene Environmental monitoring Pest control Complaints Recalls Returned goods.
Date added: August 27, 2013 - Views: 37
Radiopharmaceutical Production. Content. US FDA Philosophy. Radiation protection and facility design. GMP and facility design. Cleanrooms and facility design
Date added: June 3, 2013 - Views: 25
Supplementary Training Modules on Good Manufacturing Practices Validation Validation Objectives of Part 1 To provide an introduction to the subject of Validation To provide information on the Validation Master Plan Validation Introduction Three basic principles of Quality Assurance: Quality ...
Date added: November 13, 2011 - Views: 106
ASEAN GMP TRAINING MODULE QUALITY MANAGEMENT SYSTEM ... Laos PDR Davong Oumavong ... Principles of Quality Management Basic Principles of Quality Assurance Basic Requirements of Quality Assurance Basic Principles of GMP Basic Requirements of GMP Basic Principles of Quality Control ...
Date added: June 10, 2012 - Views: 71
... 10 minutes for each group to make its presentation. At the end of each of the modules on Basic Principles of GMP (except this one) ... I want to prepare two GMP training modules for use in my own country by the year 2003. Show how this is specific, measurable, action-oriented, realistic and ...
Date added: June 15, 2013 - Views: 20
ASEAN Cosmetic GMP Team ... 21 November 2002 SUPPLEMENTARY ASEAN GMP TRAINING MODULE EQUIPMENT SANITATION EQUIPEMNT SANITATION The main principle for equipments should be that it is ... cross contamination mix-up * ASEAN Guideline for Cosmetic GMP, 2003 WHO Basic Principle of GMP ...
Date added: December 3, 2011 - Views: 94
ASEAN GMP TRAINING MODULE QUALITY MANAGEMENT SYSTEM Prepared by Hui Foong Mei – Singapore Vongsavanh Insixiengmay – Laos PDR Davong Oumavong ... Basic Principles of Quality Management Basic Principles of Quality Assurance Basic Requirements of Quality Assurance Basic Principles of GMP Basic ...
Date added: May 6, 2013 - Views: 15
WHO GMP Certification M. Mitra CDSCO(NZ) WHO GMP CERTIFICATION Originally promugulated in 1969 and revised in 1975. Main objectives were : Guidelines be developed for official inspections of dug manufacturing facilities To assess compliance of GMP This would facilitate implementation of the ...
Date added: October 30, 2011 - Views: 41
... and their fundamental importance to the production and control of pharmaceutical products Quality Management Principles of Quality ... Operators not only need initial training but also follow-up training. Basic requirements for GMP ... Good Manufacturing Practice (GMP) is the ...
Date added: May 18, 2012 - Views: 66
... Homeopathic medicines GMP Good Manufacturing Practice Good Management Practice Get More Profit Give more Production GMP Training with out tears Ten Principles of GMP Design ... These are Good manufacturing practices Reduction ... Basic Requirements of GMP Why GMP is ...
Date added: May 22, 2013 - Views: 35
GOOD MANUFACTURING PRACTICE is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. Basic GMP Rules Suitable ... of the principles of GMP.
Date added: October 23, 2013 - Views: 22
ASEAN GMP TRAINING MODULE ... Individual responsibilities must be clearly understood by individuals concerned All personnel should be aware of the principles of cosmetic GMP that ... Prompt the QC functions, for initiating any investigation and measures. JOB DESCRIPTION EXAMPLE Training, ...
Date added: November 1, 2011 - Views: 58
... in Homeopathic medicines GMP Good Manufacturing Practice Good Management Practice Get More Profit Give more Production GMP Training with ... Safety Efficacy Good Manufacturing Practices A basic tenet of GMP is that ... Ten Principles of GMP Design and construct the ...
Date added: October 15, 2011 - Views: 420
... Training - induction, ongoing, refresher etc.alonwith such documents like SOP, ... Chennai_12 * Chennai_12 * WHO GMP CERTIFICATION Basic principles of WHO Good Manufacturing Practice is similar to any established GMP requirement. Allied documents like Schedule M, ...
Date added: March 24, 2013 - Views: 49
... On completion of the GMP Basic Training Modules, ... IV Basic principles of GMP in more detail 17. dia European Union Directive The Quality Management Quality Management Quality Management Quality Management Quality Management Requirements for QA Systems Quality Management ...
Date added: August 26, 2013 - Views: 27
... water must conform to Good Manufacturing Practice It must be “potable” and ... 14-16 Nov 2005 This training module on Water for Cosmetic Manufacturer is a supplement to the series of the ASEAN GMP Training Modules This supplement ... OBJECTIVE BASIC PRINCIPLES WATER ...
Date added: April 19, 2012 - Views: 79
... Guiding Principles GMP Training Pyramid HIPAA Privacy and Security Training Basics of Good ... and procedures General More stringent state privacy rules Permissible uses Permissible disclosures Availability Basic March 2003 Intermediate August 2003 GMP for FPP Job/Task ...
Date added: October 8, 2011 - Views: 70
For example, cGMP is an acronym for "current Good Manufacturing Practices ... 28 March 2011 Department of Pharmaceutics * Good Manufacturing Practices A basic ... Sterile parenteral for injection Packaging Packaging Packaging Biotechnology Manufacturing Process Ten Principles of GMP ...
Date added: May 27, 2012 - Views: 174
An Outline Legal bases for CGMP CGMP legal principles CGMP Implementation Tools CGMP Resources Overview of CGMP Requirements ... This can also include basic ... or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice ...
Date added: May 22, 2013 - Views: 35
Managers and supervisors should have enough knowledge of principles of food hygiene ... and responsibilities Training programs Instruction and supervision Refreshing training Minimum program for GMP training courses ... GOOD MANUFACTURING PRACTICE EVALUATION Verification ...
Date added: September 11, 2011 - Views: 188
... • Describe the basic principles of GMP and how they relate to ... Describe the basic principles of good manufacturing practice and how they relate to ... working in partnership with the NHS and professional bodies to provide high quality e-learning content for the training of the ...
Date added: February 28, 2014 - Views: 9
... How Your World is Changing Basic Quality System Purposes and Principles Management ... and Challenges Critical Awareness and Recommendations for Success The Changing World of GMP New quality systems based ... and training Truly affecting day-to-day operations and behavior A ...
Date added: January 30, 2012 - Views: 30
GLP Training Daniel W ... GLP compliance statement Takes Responsibility for GLP compliance Terms to Know GLP Good Laboratory Practice GMP Good Manufacturing Practice GCP Good Clinical Practice Terms to Know Protocol A document which ... Research Misconduct Basic GLP Principles ...
Date added: March 3, 2012 - Views: 114
... What is GCP Guidelines for GCP The history of Good Clinical Practices Basic principles Practices and strategy for staying compliant with Good ... and stored in accordance with applicable good manufacturing practice ... Good Clinical Practice Guidelines Good Clinical Practice ...
Date added: October 30, 2011 - Views: 98
Training Objectives. References. ... To provide a high level introduction to the principles of Qualification and Validation for people not working directly with this area. ... Company name DEPARTMENT Management of GMP Documentation
Date added: September 7, 2012 - Views: 54
... China, Ukraine) Three GMP training courses (South-Africa, China), GMP training course in Tanzania (with PQ participation) Training of QC lab officials Specific to antimalarial medicines ... resistance Prequalification basic principles Voluntary for participating manufacturers Legitimate ...
Date added: March 8, 2012 - Views: 42
... Manufacturing process itself - Training and ... Overview of manufacturing process International Pharmacopoeia Martindale PowerPoint Presentation Guides to Good Manufacturing Practice PowerPoint Presentation Principles outlined in GMP Principles regarding Premises and ...
Date added: September 11, 2012 - Views: 54
... On their knowledge Experience in manufacturing and QC principles as well as years of first hand experience dealing with GMP ... Defining Auditor Qualification Two formats Scientific Principles Training ... - Receive Some basic training More exclusive training Highly trained ...
Date added: August 2, 2013 - Views: 27
The training program should be ... Environment Packaging materials Factors contributing to Product Quality FACTORS AFFECTING PRODUCT QUALITY BASIC PRINCIPLES BASIC ... CALIBRATION LABELS CHANGE CONTROL TRAINING PROGRAM REFERENCES ASEAN Guidelines for Cosmetic GMP (2003) WHO EDM, Basic Principle ...
Date added: June 11, 2012 - Views: 9
Introduction Basic Principles Basic Principles, ... Worker Health and Hygiene Training of Workers Must Include The importance of good personal ... Water should be of drinkable quality. Counter flow of water and produce in reuse systems is recommended. Good Manufacturing Practices (GMP) ...
Date added: October 9, 2013 - Views: 13
... Principles of GMP Process design / optimisation Economics DEVELOPMENT OF A MICROBIAL ... Chp 8 p124. 1.1 MANAGEMENT AND GOOD MANUFACTURING Good Manufacturing Practice ... A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built ...
Date added: November 22, 2011 - Views: 84
... resistance Prequalification basic principles Voluntary for participating manufacturers Legitimate ... China, Ukraine) Three GMP training courses (South-Africa, China) Upcoming GMP training course in Tanzania (with PQ participation) Training of QC lab officials Specific to antimalarial ...
Date added: May 5, 2013 - Views: 7
To give an overview of the principles involved in the manufacture of sterile products. ... Training is required for cleaning and disinfection of clean rooms. ... Basic GMP. Fundamentals of microbiology. Personal hygiene, ...
Date added: September 14, 2012 - Views: 49
Good Manufacturing Practices (GMP) Az előállítási és minőségellenőrzési folyamatok olyan kombinációja, ... The basic document is the Codex text General Principles of ... lecture 01 * HACCP training course; module 03 - lecture 01 GMP * This lecture will highlight some aspects of Good ...
Date added: May 4, 2013 - Views: 35
... should comply with the basic requirements of the Part II while manufacture of medicinal gases should comply with the basic requirements of Part I. GMP ... in line with the principles of good manufacturing practice and specific to ... and training, sanitation, cleanliness ...
Date added: May 29, 2012 - Views: 86
Good Manufacturing PracticesGMPممارسات التصنيع ... Although there are a number of them, all guidelines follow a few basic principles: ... GMP basic requirements . 3.
Date added: May 4, 2013 - Views: 36
It specifically provides guidance on the principles ... The Q documents are a part of the knowledge. Establishing new knowledge Combining basic ... Validation Q3 Impurities Q4 Pharmacopoeias Q5 Quality of Biotechnological Products Q6 Specifications Q7 Good Manufacturing Practice Q8 ...
Date added: October 15, 2011 - Views: 52
Good Manufacturing Practices Validation ... information on the Validation Master Plan Validation Validation Introduction Three basic principles of Quality ... Modules on GMP expands on the subject of VALIDATION that was introduced to you in WHO Basic Training Module 4. It ...
Date added: May 2, 2013 - Views: 35
The reason for this training is to …. Historical Backdrop leading to GCP Guidelines. Key Developments & Landmark Documents. ... Most horrendous example of disregard for basic ethical principles in research. $10 million paid out in settlements; formal apology in late 1990s by President Clinton.
Date added: November 21, 2013 - Views: 1
Good Manufacturing Practice Water for ... Water requirements and uses general principles for pharmaceutical water systems water quality specifications application of specific types of water to ... GMP Updated Training Modules Subject: Basic Prinicples of GMP Author: loconte ...
Date added: September 7, 2014 - Views: 1
All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, ... 2.4.2 Beside the basic training on the theory and practice of Good Manufacturing Practice, ...
Date added: October 15, 2011 - Views: 281
Good Manufacturing Practice Water for Pharmaceutical Use ... untreated raw water Pre-treatment of water Principles (1) ... This training module on Water for Pharmaceutical Use is a supplement to the series of the WHO Basic Training Modules on GMP, ...
Date added: November 5, 2011 - Views: 101
... New hire Investigators Training completed in first 12 months Demonstrate competency via audit of results Level I Training Web Based Classroom Basic Food and Drug Law ... concepts and principles Principles for ... and training in pharmaceutical ...
Date added: September 11, 2012 - Views: 25