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Good Manufacturing Practice Guide for Active Pharmacetuical Ingredients

View Resource (HTM)

Category

Document

Published on CMKC

Abstract

Guideline highlgihts important aspects of manufacturing API.

Journal

ICH Q7

Type of publication

Document

Affiliations

  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Article Classification

Guideline

Classification Areas

  • Regulatory

Tags

  1. and Relabellers
  2. Brokers
  3. Distributors
  4. Guideline
  5. Personnel / Buyildings and Facilities / Laboratory Controls / Contract Manufacturers / Agents
  6. Process Equipment / Materials Management / Storage and Distribution / Packaging and Identification
  7. Production and In-Process Controls / Validation
  8. Quality Management / Documentation and Records / Change Control
  9. regulatory
  10. Rejection and Reuse materials / Complaints and Recalls
  11. Repackers
  12. Traders