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21 CFR Part 211 - Drug GMP Requirements

Finished Pharmaceutical manufacturers in the USA and foreign manufacturers who distribute their pharmaceutical product in the USA are required to comply with GMP regulations. The manufacturer must implement a quality system in the organization which helps to make sure the drugs meets or exceeds the quality requirements and are safe and effective for the intended use.

The GMP requirements for finished pharmaceutical products are described in 21 CFR Part 211

The sections in quality system regulations are

  • 21 CFR 211 Subpart A - General Provisions
  • 21 CFR 211 Subpart B - Organization and Personnel
  • 21 CFR 211 Subpart C - Buildings and Facilities
  • 21 CFR 211 Subpart D - Equipment
  • 21 CFR 211 Subpart E - Control of Components and Drug Product Containers and Closures
  • 21 CFR 211 Subpart F - Production and Process Controls
  • 21 CFR 211 Subpart G - Packaging and Labeling Control
  • 21 CFR 211 Subpart H - Holding and Distribution
  • 21 CFR 211 Subpart I - Laboratory Controls
  • 21 CFR 211 Subpart J - Records and Reports
  • 21 CFR 211 Subpart K - Returned and Salvaged Drug Products

(Source U.S. Food and Drug Administration)

LMG provide assistance in

  • GAP Analysis
  • Facility design and environmental controls
  • Documentation
  • Internal Audit
  • Implementation
  • FDA pre audit and post audit support

If interested, Please contact us with detailed information for an approximate budgetary quote.



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