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GMP Certification
GMP Certification will be issued by a third-party organization after inspection of the facility based on a guideline. It can be issued by Government organization and certification bodies. Good manufacturing practice helps your organization to ensure regulatory compliance while demonstrating your knowledge and commitment to produce safe, quality healthcare products to the public.
GMP Certification Process (Already Implemented GMP at facility)
GMP Certification Process (New Facility)
GMP Certificate Requirements
GMP certification 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.
GMP certification 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.
How to get GMP Certification?
- 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
- 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 for GMP Certification
- 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.