What is GMP Certification?
Good Manufacturing Practices (GMP) is a system that ensures products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff.
Why is GMP Certification Important?
- Quality Assurance: Ensures that products are safe, effective, and of high quality.
- Regulatory Compliance: Mandatory for pharmaceutical and food manufacturers to operate legally.
- Global Market Access: WHO-GMP certification is often a prerequisite for exporting products to international markets.
- Consumer Trust: Builds confidence among consumers and stakeholders regarding product safety.
- Risk Reduction: Minimizes the risk of product recalls and legal liabilities.
Types of GMP Certification
- Schedule M: Mandatory for all pharmaceutical manufacturers in India under the Drugs and Cosmetics Act.
- WHO-GMP: Voluntary certification based on World Health Organization guidelines, essential for exports.
- Ayush GMP: For manufacturers of Ayurvedic, Siddha, and Unani medicines.
- Food GMP: Ensures hygiene and safety in food processing units (often integrated with FSSAI).
- Cosmetics GMP: Ensures safety and quality in cosmetic manufacturing.
Documents Required
- Business Registration: Certificate of Incorporation, Partnership Deed, etc.
- Site Plan: Layout of the manufacturing facility.
- List of Machinery: Details of equipment installed.
- SOPs: Standard Operating Procedures for various processes.
- Staff Details: List of technical staff and their qualifications.
- Water & Air Reports: Test reports for water and air quality.
- Product List: List of products to be manufactured.
- Stability Data: Stability study reports of products.
Certification Process
- Application: Submit the application to the relevant state or central licensing authority.
- Documentation Review: The authority reviews the submitted documents and SOPs.
- Facility Inspection: Inspectors visit the manufacturing unit to audit compliance with GMP standards.
- Non-Compliance Report: If any gaps are found, a report is issued for corrective actions.
- Compliance Verification: Once corrective actions are taken, compliance is verified.
- Grant of Certificate: Upon successful verification, the GMP certificate is issued.
Schedule M vs. WHO-GMP
Schedule M is the Indian standard for Good Manufacturing Practices, mandatory for domestic manufacturing. It focuses on facility requirements, equipment, and quality control.
WHO-GMP is an international standard set by the World Health Organization. It is more stringent and is required for exporting pharmaceutical products to many countries. It emphasizes comprehensive quality management systems.
