Good Manufacturing Practice

"Good manufacturing practice" or "GMP" is part of a quality system requirement for the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical, and medical devices. Basic concept of GMP is same in all countries but varies slightly according to their legislations.

Good Manufacturing Practice basic principles:

  • Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
  • Manufacturing processes are controlled, and any changes to the process are evaluated.
  • Instructions and procedures are written, controlled and followed during day to day activity.
  • Operators are trained to carry out respective duties.
  • Records are made as proof to demonstrate quality of the product.
  • Deviations are investigated and documented.
  • Batch manufacturing Records to be retained till in a secure form.
  • Batch / product recall methods should be available
  • Complaints are examined, the causes of quality defects are investigated, and appropriate measures are taken to prevent recurrence.

Benefits of Implementing GMP

GMP implementation improves / leads to the following:

  • Quality Policy and Objectives set by Top Management.
  • Profitability of the organization.
  • Reputation of the organization.
  • Compliance to Legal and Regulatory Requirements.
  • Recognition by regulators around the world.
  • Consistent quality of the manufactured products.
  • Increase productivity, efficiency and cost controlling.
  • Wide marketing opportunities.
  • Improve organization's image.
  • Improved internal and external Communications.
  • Better understanding of the organization's processes.
  • Clear duties, responsibilities and authorities for all staff.
  • Reduced wastage.
  • Greater consistency and traceability of products and services.

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