GMP Certification

 

Good Manufacturing Practice GMP helps in ensuring the system that products are consistently produced to maintain the quality standard. It is designed to minimize the risks and enhance your food safety management system. The main aim of GMP is to see quality assurance to ensure that a food or drug product is safe for human consumption.

 GMP guidelines are not instructions on how to manufacture products for utilization after the outcome. It states certain guidelines that talk about the quality assurance approach. Many countries have legislated and made it mandatory that food, pharmaceutical, and medical device manufacturers should follow GMP certification procedures and create their GMP guidelines that correspond with their legislation.

 GMP is initiated by the WHO. GMP Certification can be obtained by the manufacturer or the retailer dealing and manufacturing in the pharmaceuticals, food, and cosmetics. Compliance with GMP requirements in the industry means that companies have implemented the GMP certification scheme for manufacturing processing and have developed and implemented quality and safety. It checks and verifies each product of manufacturing to maintain consistency.

 Good manufacturing practice guidelines guide manufacturing, testing, and quality assurance of the product to ensure that a food or drug product is safe for human consumption. Many countries have legislated that food, pharmaceutical, and medical device manufacturers follow GMP procedures and create their GMP guidelines that correspond with their legislation.

 

What does GMP Cover?

• Record maintenance of the changes made in the product
• Equipment Verification as per the guidelines of GMP standard
• Personnel Qualifications required to implement the standard
• Proper Sanitation for ensuring the safe surrounding
• Procedure Validation for due diligence
• Complaint Handling 
• Cleanliness in the case of equipment, handling, surrounding, and premises, etc.

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Guidelines to follow basic principles for GMP compliance:

1. Maintain a clean and hygienic manufacturing area.
2. Controlled environmental condition. 
3. Prevent cross-contamination of food or drug product from adulterants.
4. Validate to ensure consistency and compliance with specifications.
5. Instructions and procedures must be clear and unambiguous.
6. Deviations must be investigated and documented systematically.
7. A system must be available for recall.
8. Complaints must be examined earlier.
9. Measures need to be taken for defective products and prevent errors.

 

Practices are recommended to safeguard the health of consumers. Food or drugs deemed to be adulterated if the product has passed all the specifications but does not comply with the GMP regulations. Regulatory actions against companies with poor CGMPs by the Government, are often intended to prevent the possibility of unsafe and/or ineffective drugs. In rare cases, the FDA or the Government regulatory action is often intended to stop the distribution or manufacturing of the volatile product.

 

 Key Benefits of GMP Certification:

1. Develops good production/operations habits.
2. Reduce safety risk in products.
3. Timely detection of errors in production and management problems.
4. Better compliance with government relevant laws and regulations.
5. Enhance Corporate Credibility.
6. Enhance long term confidence in stakeholders.
7. Builds customer satisfaction.
8. Ensures safety in the surrounding.
9. Eliminate penalties.
10. Reduction in operating cost.
11. Improves Food safety management system.
12. Boost export opportunities.

 

GMP CERTIFICATION PROCESS

To make the GMP Certification process simple and quick. Hiring a consultant will guide you and your business through the following steps to achieve GMP Certification by providing.

1. Gap Analysis Training 
2. Testing  
3. Documentation & Test Report
4. Process Audit
5. External Audit
6. Certification and beyond