Good Manufacturing Practice - GMP is a term that is accepted worldwide for the control and management of manufacturing, testing and general quality control of food and pharmaceutical products. GMP guidelines take quality assurance approach, which ensures that products are generally produced and managed according to the quality standards. Actually, it is designed to reduce the risks involved in any pharmaceutical production that cannot be removed through testing the final product. It is concluded that GMP is a good business tool, which assists to clarify both compliance and performance of the company.
GMP Guidelines for Certification
GMP Certification confirms the product's identity, arrangement, quality, purity and strength which they represent in the market. Under the GMP certification, there is a set of guidelines that provides a structure of procedures and documentation by which the authentication of the products are given. The certificate is sustainable till 3 years from the date of issue. Observation audits are managed by the Certifying body within the period of 3 years at the interval of 9 months or 12 months, depending upon the nature and size of the organization. On completion of 3 years, the renewal audit is done for a new 3-year cycle.
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Benefits of GMP Certification
1. Reduces the food safety hazards/ contamination in food.
2. Ensures that raw materials used in the manufacture of drugs are of known and of possibly standardized quality, and are free from contamination.
3. Ensures that the manufacturing process has been proven to produce a pharmaceutical product meeting its quality attributes.
4. Ensures that adequate quality control testing measures have been employed to assure that the product meets its quality specifications at the time of release to market, and at the end of its shelf life.
5. Enables employees to develop good production/operations habits.
6. Reduces safety risk in product quality and safety.
7. Timely detects production and management problems, reduces cost.
8. Helps better understand and comply with the relevant laws and regulations.
9. Enhances the international credibility and public image.
10. Increases customer’s long-term confidence in the enterprise.
11. Helps boost export opportunities.
12. Reduces duplication of inspections
Operon Strategist provides consulting service related to GMP guidelines for medical devices plant as well as primary packaging material plant. We have expertise team who guide manufacturers with their medicinal product manufacturing plant layout design according to GMP guidelines.