GMP Certification

GMP stands for Good Manufacturing Practice, & the term is used globally for managing the control and management of manufacturing, testing and overall quality of pharmaceutical products. It defines certain guidelines that talks about the quality assurance approach. GMP certification make sure that products are produced following the quality standard norms.

GMP certification can be applied to all operators in food, ingredient or pet food supply chains – from production and packaging to retail, logistics and storage.

This advanced certification programme bestows each interested working professional with long lasting benefits. This raises awareness among the key (responsible) people about the benefits of following GMPs and correct procedure to get GMP approval so as to introduce product in market successfully.

All guidelines follow a few basic principles:

• Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area.
• Controlled environmental conditions in order to prevent cross contamination of drug product from other drug or extraneous particulate matter which may render the drug product insecure for human consumption.
• Manufacturing procedures are clearly defined and controlled. All critical procedures are validated to ensure constancy and compliance with specifications.
• Manufacturing procedures are controlled, and any changes to the procedure are estimated. Changes that have an impact on the quality of the drug are validated as required.
• Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
• Operators are trained to carry out and document processes.
• Records are made, manually or by instruments, during manufacture that demonstrate that all the steps necessary by the defined processes and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
• Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
• The distribution of the drugs minimizes any risk to their quality.
• A system is presented for recalling any batch of drug from sale or supply.
• Complaints about marketed drugs are examined, the causes of quality defects are investigated, and suitable measures are taken with respect to the defective drugs and to prevent recurrence.

Benefits of GMP Certification

• Timely recognize of manufactures and the management issues,
• Decrease safety risk in product quality and safety,
• Empower certification holders to opt great creation,
• Increases customer confidence in your products,
• Supports boost export opportunities,
• Reduced duplication of inspections,
• Compliance with important laws and guidelines,
• Increase overall credibility and public image,
• Cost saving.
• Helps to decrease operating costs due to rework and penalties due to non-compliance,