Basic Principles of GMP

Apr 07, 2019

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Basic Principles of GMP. Active Pharmaceutical Ingredients. Part Three, 18. Active Pharmaceutical Ingredients. Objectives To discuss the GMP guidelines for the manufacture of Active Pharmaceutical Ingredients (APIs)

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Basic Principles of GMP

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BASIC PRINCIPLES

BASIC PRINCIPLES You cannot sell from an empty wagon! Private sector development of industrial/business parks may be adequate. If not, there is a compelling need for local economic development programs to fill the need. STATUTORY AUTHORITY N.C.G.S. §158-7.1(a) provides:

739 views • 19 slides

Basic Principles of GMP

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 Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster

686 views • 15 slides

Basic Principles of GMP

Basic Principles of GMP. Sterile Pharmaceutical Products. Annex 6. TRS 902, 2002. Sterile Production. Objectives To review basic GMP requirements in the manufacture of sterile pharmaceutical products To review air classifications for activities related to the manufacture of sterile products

2.56k views • 62 slides

Basic Principles of GMP

Basic Principles of GMP. Complaints and Recalls. Sections 5 and 6. Complaints and Recalls. Objectives To identify the key issues in product complaint and recall handling To understand the specific requirements for organization, procedures and resources

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Basic Principles of GMP

Basic Principles of GMP. Documentation Part 2. 15. Documentation. Labels What must be labelled? Containers, equipment, premises Label information? Clear, unambiguous, company format Intermediates and bulk products Colours can be used, e.g. green (accepted), red (rejected). 15.10 .

1.39k views • 33 slides

Basic Principles of GMP

Basic Principles of GMP. Documentation Part 1. 15. Documentation. Objectives 1. To review general requirements for documents 2. To review specific requirements for each document 3. To consider current issues applicable to your countries. Documentation. General Principles – I

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Basic Principles of GMP

Basic Principles of GMP. Documentation - Part 1. Workshop on GMP and Quality Assurance of TB products Kuala Lumpur Malaysia, 21 – 25 February 2005 Maija Hietava M.Sci.Pharm

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Basic Principles of GMP

Basic Principles of GMP. Materials. 14. Materials. Objectives To review specific requirements for each type of material: Starting materials Packaging materials Intermediate and bulk products Finished products Rejected and recovered materials Recalled products Returned goods

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Basic Principles of GMP Premises

Basic Principles of GMP Premises. John Startup. Training workshop: Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data submitted to regulatory authorities, February 23-27, 2009, Kampala, Uganda. Premises. Objectives

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Basic Principles

Basic Principles. Learning objectives. Understand the basic principles undelying A&T techniques Grasp the motivations and applicability of the main principles. Main A&T Principles . General engineering principles: Partition: divide and conquer Visibility: making information accessible

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Basic Principles

NMM Dynamic Core and HWRF Zavisa Janjic and Matt Pyle NOAA/NWS/NCEP/EMC , NCWCP, College Park, MD . Basic Principles. Forecast accuracy Fully compressible equations Discretization methods that minimize generation of computational noise and reduce or eliminate need for numerical filters

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Basic Principles

Basic Principles. No action will occur unless electrical current is flowing No current will flow unless it finds a complete loop out from the source and back to it Current will flow through any and all available loops, although not equally Heating occurs as current flows, due to resistance.

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Basic Principles of GMP

Basic Principles of GMP. WHO good practices for pharmaceutical microbiology laboratories. Part 1. TRS 961, 2011. Annex 2. Microbiology Laboratories. Personnel Environment Premises Environmental monitoring in the laboratory Cleaning, disinfection and hygiene

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Basic Principles of GMP

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Basic Principles of GMP

Basic Principles of GMP. Equipment. 13. Equipment. Objectives To review the requirements for equipment selection design use maintenance To discuss problems related to issues around selected items of equipment. Equipment. Principle Equipment must be l ocated designed

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Basic Principles of GMP

Basic Principles of GMP. Introduction to the Training Course. Introduction. Objectives of this Introductory Session To outline the programme To introduce your trainers To introduce you to one another and to understand your objectives and background

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Basic Principles of GMP

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