GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR Parts 112 and 117 - ENGLISH/SPANISH

112.117_English-Spanish
1-933734-66-3

Spanish and English Food and Produce Combination:

- English - Part 112 – Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.

- Spanish - Parte 112 – Estándares Para El Cultivo, Cosecha, Empaque, y Almacenamiento De Los Productos Agrícolas Frescos Para El Consumo Humano. Complete Spanish version updated as of April 1st 2020.

- English - 21 CFR Part 117 – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food in both English and Spanish Combination.

- Spanish - Parte 117 – Prácticas Actuales De Buena Fabricación, Análisis De Peligro Y Controles Preventivos Basados En Riesgo Para La Alimentación Humana

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GMP QMS 101 The Basics - The required GMP Training for all employees who operate under Title 21 Compliance Requirements.

  • GMP - What is cGMP and the GMP Lifestyle?

  • The Agency History and Objectives

  • Roles and Responsibilities

  • The 11 General Orders of GMP

  • Good Documentation Practices (GDocP)

  • Facility Management

  • The History of GMP, the Agency Inspections and 483s

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21 CFR Part 11 Electronic Records

  • 21 CFR Part 11 Basic Overview

    • 21 CFR Part 11 Definitions, System Types and Classifications

    • 21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule

    • Part 11.10 Sections a) - k)

    - - Validation

    - - Copies of records

    - - Protection of records

    - - Limiting system access

    - - Audit trails

    - - Operational system checks

    - - Authority checks (h) Device checks

    - - Education, Training, Experience

    - - Policies and Procedures

    - - Systems documentation

    • Scope and Application Risk Analysis - Determine Which Systems Need to be Validated

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  • The Quality Manual

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