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GMP Certificate

Drugs, Nutraceuticals, APIs & Medical Devices

US FDA Approval

GMP Certificate will be issued by a third-party organization after inspection of the facility based on a guideline. GMP Certificate can be issued by Government organization and Certification Bodies.

 

GMP Certificate helps your organization to ensure regulatory compliance while demonstrating your knowledge and commitment to produce safe, quality healthcare products to the public.

GMP Certificate

Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) is part of an organization’s quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, cosmetics, pharmaceutical products, and medical devices till it reaches the point of use.

 

Current Good Manufacturing Practice (CGMPs) standards and guidance provide requirements for proper design, monitoring, and control of manufacturing processes and facilities.

 

Adherence to the CGMP regulations assures meeting specifications declared by the manufacturers by establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations,

and maintaining reliable testing and outsourcing controls in a neat and dedicated environment.

Requirements of GMP Certification

The following are the GMP Certification requirements:

  • Shop floor layout adequate for the manufacturing, storing and testing of the products
  • Environmental controls maintained as per product specifications and requirements.
  • Trained manpower
  • GMP Grade manufacturing equipment and utensils.
  • Housekeeping
  • Waste management
  • Online Documentation practices

GMP Certification Procedure

The following are the procedures for the certification:

  • Quality Manual
  • Mandatory procedures as per the standard ( WHO-GMP/FDA QSR,  etc.)
  • Online tractability documentation
  • Training
  • Validations and Calibrations
  • Process Validations
  • Internal Audit
  • CAPA

Basic principles of GMP

The following are the basic principles of GMP:

  • Lean manufacturing practices covering a safe work environment.
  • Maintain a clean and hygienic manufacturing shop floor area, including laboratories and warehouses.
  • Manufacturing facility layout, operating principles and environmental conditions must be controlled in order to prevent cross-contamination
  • Well-defined manufacturing processes validated and controlled to ensure consistency and compliance with specifications.
  • Standard operating procedures must be written in clear and unambiguous language.
  • Trained personnel for dedicated activity in production and control of products.
  • Records should be made during manufacture and quality control
  • Deviations are investigated and documented.
  • Traceability records of released items in an accessible format that can trace the complete history of a batch.
  • Written down system for recalling any batch from sale or supply.
  • Causes of quality defects investigated, and appropriate measures taken with respect to the defective products and to prevent recurrence taken against each compliant.