In India, the approval of Good Manufacturing Practice (GMP) is authorized to the Joint Commissioner by the Commissioner, Food & Drug Administration, who holds the legal authority to sign and issue GMP certificates under the WHO-GMP certification scheme.
Explanation:
The approval process for GMP certification involves a thorough evaluation of a manufacturing facility to ensure it adheres to the guidelines outlined in the GMP standards. These standards are designed to guarantee the quality, safety, and efficacy of products, particularly pharmaceuticals.
Key Authorities and Their Roles:
- Commissioner, Food & Drug Administration: Holds the ultimate legal authority regarding GMP certification.
- Joint Commissioner: Legally authorized by the Commissioner to sign and issue GMP certificates specifically under the WHO-GMP certification scheme. This delegation of authority streamlines the certification process.
The GMP Certification Scheme:
The World Health Organization (WHO) GMP certification scheme is a globally recognized standard. Adherence to this scheme is crucial for companies seeking to export pharmaceutical products or demonstrate their commitment to quality manufacturing practices.
In summary, while the Commissioner of the Food & Drug Administration has the overall legal authorization, the Joint Commissioner is the one who usually issues the GMP certificate under the WHO-GMP scheme.
