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GMP Certification

Good Manufacturing Practice (GMP) is a term that is known worldwide for the control and management of manufacturing, testing and overall quality control of food and pharmaceutical products. GMP takes quality assurance approach, which make sure that products are dependably produced and controlled to the quality standards suitable to their intended use and as mandatory by the marketing authorization.

Compliance with GMP necessities entails minimum common sense sanitary and processing requirements applicable to all food processing establishments. Many food industry companies have implemented the GMP certification scheme for food processing as the foundation upon which they have developed and implemented other quality and food safety management systems, including HACCP, ISO 22000, SQF and ISO 9001.

It is believed that GMP is a good business tool, which will help to refine both compliance and performance of the Company. GMP requirements are largely common sense practices, which will support companies better itself as it moves toward a quality approach using continuous development.

All guidelines follow a few basic principles:
  • Hygiene: Pharmaceutical manufacturing ability must maintain a clean and hygienic manufacturing area.
  • Controlled environmental conditions in order to avoid cross contamination of food or drug product from adulterants that may render the product unsafe for human consumption.
  • Manufacturing procedures are clearly defined and controlled. All critical procedures are validated to make sure consistency and compliance with specifications.
  • Manufacturing processes are controlled, and any changes to the procedure are evaluated. Changes that have an impression on the quality of the drug are validated as essential.
  • Instructions and procedures are written in clear and unambiguous
  • Operators are trained to carry out and document procedures.
  • Records are made, manually or by instruments, during manufacture that demonstrate that all the steps mandatory by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations are investigated and documented.
  • Records of manufacture (including distribution) that support the complete history of a batch to be traced are retained in a comprehensible and accessible form.
  • The distribution of the food or drugs minimizes any risk to their quality.
  • A system is available for recalling any batch from sale or supply.
  • Complaints about marketed products are examined, the causes of quality defects are investigated, and suitable measures are taken with respect to the defective products and to prevent recurrence.
Benefits of GMP Certification
  • Make available guideline on how to produce safe and quality products.
  • Develops motivation and team work between the employees of the organization.
  • Develops customer gratification by deliver the safe and quality product and services.
  • Improves brand value or image in the market

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