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The U.S. Food and  Drug Administration (FDA) had recently published a warning letter for a Czech company describing considerable deficiencies about data integrity in the area of quality control with regards to current good manufacturing pratice (cGMP) for pharmaceutical industry.

According to the warning letter, the company was:

  • Failure to prevent unauthorized access or change to data, and to provide adequate controls to prevent manipulation and omission of data;
  • Failure to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records; and
  • Failure to ensure the adequacy and integrity of data to support the safety, effectiveness and quality of drug the company manufacture.

(Details refer to: FDA Website)

Since Jan 2015, there are more than 20 warning letters that concerning about data integrity published by FDA. From the above letter, apart form those letters issued to Asian manufacturers, it is realized that FDA has also extended their cocerns all over the world. Pharmaceutical industry are expected to pay more attention on how to assure data integrity and Good Documentation Practices (GDocP).

For further information on data intergrity and GDocP for pharmaceutical industry, please contact:

Certification and Business Enhancement
Tel: (852) 2765 3620