GMP Publications - Code of Federal Regulation Handbooks by the FDA

503B Compounding and Packaging

503B.CompoundingandPackagingMasterGuideHandboo

503 B Compounding and Packaging Master Guide Handbook:


Regulations:

 

21 CFR Part 11 Electronic Records; Electronic Signatures

21 CFR Part 201 Drug Labeling

21 CFR Parts 210/211 (use current title)

21 CFR Part 801 Device Labeling

21 CFR Part 820 Quality Regulations

Food, Drug and Cosmetic Act 503B Outsourcing Facilities - January 2013

- - - - - - - - - - - - - - - - - -

Guidance for Industry:

 

cGMP - Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act - Dec 2018

Insanitary Conditions at Compounding Facilities - August 2016

Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities - January 2017

 

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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
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  • The 10 Principals of GMP
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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
    • 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
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  • Validation Documentation
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The QMS Basics

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- - Out of Specifications / Out of Trend
- - Complaints
- - Recalls
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- - Audit - Internal, Agency, Customers and External Audit
- - Vendors, Suppliers, Contractors and Consultants
- - Basic Risk Management
- - Training Program

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