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WHO & GMP


WHO (World Health Organization) defines GMP (Good Manufacturing Practices) as “ the part of quality assurance which makes sure that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.” The goal of GMP is to see that the manufactured products are good for utilization by consumers. GMP regulates the product at every step involved in manufacturing. It also ensures that the standards are maintained and followed properly. Standards can be maintained by maintaining the process of manufacturing. This can be done by maintaining the controls such as raw material, procedure, testing, labeling, and storage.

All the features of manufacturing process are covered by GMP including:

  1. Defined manufacturing process.
  2. Sufficient facilities of laboratory.
  3. Officially agreed procedures and instructions.
  4. Validated critical manufacturing steps.
  5. Suitable premises, storage, transport, qualified and trained production and quality control personnel.
  6. Records are maintained to show all steps of defined procedures have been taken.
  7. System for recall and investigation of complaints.
  8. Through batch records and distribution records a product can be traced.

Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers. A poor quality medicine may contain toxic substances that have been unintentionally added. That is GMP is considered important. GMP is necessary is there is a quality control laboratory. At the time of manufacturing process good quality must be built in because once the product is manufactured it cannot be tested after that. GMP prevents the errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to test the quality or unit of medicine. Poor quality of medicines is the waste of money and time. It becomes very expensive in the long run to change the product once it has been manufactured. Implementation of GMP is an investment in good quality medicines. It helps to improve the health of the patients as well as pharmaceutical industries are also benefitted. Manufacturing and distributing poor quality medicines leads to loss of credibility for everyone.

GMP operates in the following essential areas:

  • Crucial processes
  • Suitability
  • Storage
  • Transport
  • Qualified and trained personnel
  • Quality of production
  • Facilities
  • Maintenance records
  • Customer care

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