While buying food and pharmaceutical products, safety and quality assurance is very important for consumers. GMP or Good Manufacturing Process is a certification by SGS for the manufacturing process as well as safety requirements. To maintain safety requirements some guidelines are followed while manufacturing. Let’s see in detail the importance and application of GMP in India
Points covered in this article are:
1. Purpose of GMP
2. Standards of GMP Certification
3. Process of getting GMP certification
4. Documents required for certification
5. Benefits of GMP certification
6. Difference between GMP and cGMP
7. Who conducts GMP inspections in India?
8. WHO GMP guidelines?
1. Purpose of GMP
GMP certification includes safety in materials, equipment’s and hygiene of employees. To maintain the quality of products certain procedures are to be followed and proof of such procedures have to be maintained. This certification issued ensuring that the products are produced according to the quality standards so that risks involved in production is reduced. Mostly GMP certification is given on food and medication products
2. Standards of GMP Certification
Guidelines are set for every step of production that has to be followed for quality assurance. Different countries may have different GMP guidelines, based on their requirements
The basic guidelines for GMP certification are
· Manufacturing processes are specified and clear so that all the compliances are met. Especially in case of medication products and food products difference in manufacturing process can lead to different
· Hygiene in the production premises is very important to maintain safety and quality
· Environmental considerations are important so that production does not cause pollution or risk of contamination
· Instructions and how to use steps should be specified in the product. In medicines, drugs etc doses have to be given
· Records or documents have to be made on manufacturing process and demonstration of all steps to be taken before consumption
The principles followed by each company may be different from each other but the standards maintained much be effective and ensure the quality and safety.
3. Process of getting GMP Certification
1. Firstly, an application is to be sent to the certification body with the details of the product which requires GMP certification. Only when the authorised person accepts the application further steps can be followed
2. Review of application is done once the application is received. Documents on all the compliances followed must be given with the application
3. After reviewing price quotation is given to the clients. And a Gap analysis is to be conducted to see the difference between the set guidelines and the goal achieved
4. Audit has to be conducted by the manufacturer as well as the auditor to ensure that the guidelines are followed as per the documentation. If any steps are not confirmed corrective actions are to be taken and verification is done
5. Once the certification body is satisfied with all the specifications, GMP certificate shall be issued
6. A surveillance audit should be conducted within 6 months or 1 year of granting GMP certification and re-certification should be made at the end of every 3 years
4. Documents required for certification
· Name of the applicant and company along with address and contact details
· Manufacturing license of the company
· Equipment’s and instruments used for production
· Staff details who work with technical equipment’s, their qualification and experience
5. Benefits of GMP Certification
· It increases the consumer reliability on the product
· Improves brand value
· Improves food safety system
· Reduces risk of duplication or fake products
6. Difference between GMP and cGMP
GMP certification is issued to ensure the safety and quality of the food and pharmaceutical product are as per the GMP principles. It requires sanitation, equipment’s verification to get GMP Certification
Whereas, ‘c’ in cGMP refers to current i.e., The "current," methodologies of manufacture, testing, design and control are adopted. The Manufacturers must employ technologies and systems, which are up-to-date. Methodology and equipment used for production are adequate by today's standards.
7. Who conducts GMP inspections in India?
FDA conducts inspections on products to be sold in the US. It does not include CTM and clinical stage products. Some of the companies in India are inspected by the FDA. The rest are inspected by the local inspectors in India
8. WHO GMP Guidelines?
WHO has drafted GMP guidelines in 1968. It is incorporated in more than 100 countries. It is mainly adopted for biological medicines such as vaccines, antigens, cell and tissue therapies etc. Many countries have adopted WHO guidelines in their national GMP requirements
GMP ensures both quality and production control. Food and pharmaceutical products involves risk of danger on health and life of the consumer. That is why strict compliance to guidelines are important. It includes sanitation, inspection of equipments, and qualifications of employees to get GMP certification.
Comments