21 CFR 211

Current Good Manufacturing Practices (CGMP)

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What Is GMP?

Good manufacturing Practices (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product

Country by country, legislation has emerged requiring medical device and pharmaceutical companies to follow good manufacturing practice in their operations. Many countries have assembled their own GMP requirements that fall in line with their legislation. A list of the top standards is below:

  • EU-GMP
  • FDA 21 CFR Part 211 (Drug)
  • ICH Q7
  • IPEC Guide for Excipient Mfg.
  • FDA 21 CFR Part 820 (Device)

The sections of the FDA 21 CFR Part 211 standard:

  • Subpart A – General Provisions
  • Subpart B – Organization and Personnel
  • Subpart C – Buildings and Facilities
  • Subpart D – Equipment
  • Subpart E – Control of Components
  • Subpart F – Production & Process Controls
  • Subpart G – Packaging and Labeling Control
  • Subpart H – Holding and Distribution
  • Subpart I – Laboratory Controls
  • Subpart J – Records and Reports
  • Subpart K – Returned & Salvaged Products

What Type Of Businesses Comply To GMP?

Typical businesses that claim compliance to the standard are as follows:

  • Finished device/drug manufacturers
  • Suppliers to device/drug manufacturers
  • Distributors to device/drug manufacturers

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What Type Of Auditing Does GMP Require?

To ensure adherence to the requirements of GMP, the following types of auditing are required:
1. Internal Audits – Audits by internal or contracted staff that are specifically trained to the applicable GMP standard and internal procedures/requirements.

Below is an excerpt from the IPEC guide:

“The manufacturer should carry out a comprehensive system of planned and documented internal quality audits. These should determine whether quality activities comply with planned arrangements and the effectiveness of the quality management system. Audits should be scheduled on the basis of the status and importance of the activity. Audits and follow-up actions should be carried out in accordance with documented procedures.”

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