GMP Certification

Advantages of GMP Certification

• Improved product quality and safety assurance
• Compliance with national and international regulations (FDA, WHO, EU GMP)
• Increased market credibility and customer trust
• Reduced risk of product recalls, contamination, and liability
• Facilitates export to regulated markets like the USA and Europe

Eligibility Criteria

• Manufacturers of pharmaceuticals, cosmetics, food, or medical devices
• Facility must follow hygiene, cleanliness, and documentation standards
• Production systems must allow for traceability and process validation
• Management commitment to maintaining quality control systems
• Must comply with applicable national or international GMP guidelines

Documents Required

• Company registration and manufacturing license
• List of equipment, raw materials, and production layout
• Standard Operating Procedures (SOPs)
• Quality control and assurance protocols
• Product list and specifications
• Environmental and hygiene compliance reports

GMP Certification Process

1. Step 1: Application and documentation review
2. Step 2: Pre-audit and gap analysis (optional)
3. Step 3: On-site facility inspection by a certification body
4. Step 4: Corrective actions and implementation (if needed)
5. Step 5: Final audit and compliance verification
6. Step 6: Issuance of GMP Certificate
7. Step 7: Annual surveillance audits (as required)

Why Choose Corporate Analytica?

• Expert guidance on WHO, US FDA, and EU GMP standards
• Assistance with facility layout, SOP creation, and training
• End-to-end documentation and audit support
• Collaboration with accredited GMP certifying bodies
• Affordable packages with fast-track audit scheduling

Post‑Certification Compliance

• Regular internal audits and SOP updates
• Ongoing staff hygiene and quality training
• Batch documentation and traceability maintenance
• Product quality monitoring and reporting
• Annual or biannual GMP surveillance audits

Penalty for Non-Compliance

• Operating without may attract heavy fines.
• Non-renewal of license before expiry can lead to penalties.
• False or misleading may result in legal action.
• Severe violations can even lead to business closure.