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Documentation Basics That Support Good Manufacturing Practices and Quality System Regulations / Edition 2

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PAPERBACK Good 092987062X 2nd edition. Pages 60-65 are highlighted in orange. Binding solid, pages crisp and clean, no other markings found. Cover bright and shiny with small ... creases, a few scratches, scuffs and dents. Extremities lightly bumped, some bent page tips. Read more Show Less

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Overview

A comprehensive reference that includes data about establishing company-wide documentation systems, this information will allow businesses to meet good manufacturing practices and quality system regulations. Provided is a minimum set of standards to consider when designing document identification numbering systems or writing standard operating procedures, specifications, quality manuals, and logbooks. Those benefiting from this might be the medical products industry that develops diagnostic or biologic products, technicians who manufacture, test, package, and distribute products for commercial use, and those who train new employees in the basic requirements for GMP/QSR-compliant documentation.
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Product Details

  • ISBN-13: 9780929870625
  • Publisher: Tamarack Associates LLC
  • Publication date: 4/28/2002
  • Series: Basics Series
  • Edition description: 2ND
  • Edition number: 2
  • Pages: 124
  • Product dimensions: 8.46 (w) x 10.90 (h) x 0.36 (d)

Table of Contents

Introduction to the Second Edition
Sect. I Identifiers
Ch. 1 Identification Numbers 3
Ch. 2 Control Numbers 11
Ch. 3 Status Identifiers 15
Sect. II Documents
Ch. 4 Specifications 21
Ch. 5 Standard Operating Procedures/Forms 27
Ch. 6 Logbooks 39
Ch. 7 Quality Manuals 43
Sect. III Functional Area Documentation Basics
Ch. 8 Material Handling Documentation Basics 59
Ch. 9 Maintenance Documentation Basics 69
Ch. 10 Quality Control Documentation Basics 77
Ch. 11 Quality Assurance Documentation Basics 81
Ch. 12 Production Documentation Basics 87
Ch. 13 Validation Documentation Basics 107
References 131
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