GMP

GOOD MANUFACTURING PRACTICE

Good Manufacturing Practice (GMP) is a part of Quality Assurance which as a system ensures the products manufactured are consistently produced and controlled according to quality standards requirements.

This is a practice to minimize risks involved in any production activity that cannot be rectified/ eliminated through testing the final product.

GMP Certification

what are the benefits of GMP certification?

  • Reduced operating costs as rework and penalties due to non-compliance would reduce and further improve efficiency.
  • Reduction in food safety hazards and reduced contamination of food.
  • Raw materials used in the manufacture of drugs are of known, and of possibly
    standardized, quality and are free from contamination.
  • The manufacturing process is proven to meet its quality attributes.
  • Adequate quality control testing measures to ensure that the product meets its quality specifications at time of release to market, and at the end of its shelf life.
  • GMP helps boost export opportunities.

What are the requirements of GMP Certification?

  1. Quality System through Risk Management and Quality Review:
  • QRM is a systematic process for identification, understanding, assessment and review of risks to the quality of the products manufactured.
  • Regular and periodic quality reviews of all products should be performed with the objective of verification and consistent practices of existing processes.
  1. Complaints and Product Recalls:
  • Complaints and other related information concerning potential defective products should be reviewed according to written procedures.
  • A process must be defined to recall from the market rightly and effectively, for the products identified or suspected as defectives.
  1. Self-Inspection, Quality Audits and Approval:
  • Self-inspection is a process to evaluate the manufacturer’s compliance with regards to GMP in terms of production and Quality Control.
  • A quality audit is a process of examination and assessment of either all or part of quality system with an intention of improving the process involved in the system.

Who can get GMP Certification?

Good Manufacturing Practice (GMP) is a term that is recognized worldwide for the control and management of manufacturing, testing and overall quality control of food and pharmaceutical products.

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