GMP Publications - Code of Federal Regulation Handbooks by the FDA

ICH Q7 with Q7 Auditors Check List

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ICH Q7 is a worldwide harmonized GMP guideline for active pharmaceutical ingredients (chemical and biological), which covers all GMP aspects of manufacturing, quality control and trading. ICH Q7 - GMP for APIs This document was abstracted by the International Conference of Harmonisation (ICH).

Pharmaceutical manufacturers should know this guideline to make sure that their suppliers are in compliance with the necessary GMP rules. Includes the ICH Q7 Auditor's Checklist.

Table of contents:

  • Introduction
  • Quality Management
  • Personnel
  • Buildings and Facilities
  • Process Equipment
  • Documentation and Records
  • Materials Management
  • Production and In-Process Controls
  • Packaging and Identification Labelling of APIs and Intermediates
  • Storage and Distribution
  • Laboratory Controls
  • Rejection and Re-Use of Materials
  • Complaints and Recalls
  • Contract Manufacturers (including Laboratories)
  • Agents, Brokers, Traders, Distributors, Repackers and Relabellers
  • Specific Guidance for APIs Manufactured by Cell Culture/Fermantation
  • APIs for Use in Clinical Trials
  • Glossary
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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 10 Principals of GMP
  • Good Documentation Practices (GDocP)
  • Facility Management
  • The History of GMP, the Agency Inspections and 483s
  • Warning Letter Reviews

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
    • Steering Committee and Part 11 Initiatives

Good Auditing Practice

  • The Auditor's Basics 101 'From the Auditor's Perspective'
  • The 5 Basic Binders
  • The Quality Manual
  • IT Strategy Plan
  • Standard Operating Procedures
  • Validation Documentation
  • Drug/Device Documentation

The QMS Basics

- - CAPA
- - Non-Conformance
- - Change Control
- - Deviations
- - Out of Specifications / Out of Trend
- - Complaints
- - Recalls
- - Product Traceability
- - Audit - Internal, Agency, Customers and External Audit
- - Vendors, Suppliers, Contractors and Consultants
- - Basic Risk Management
- - Training Program

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