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Инспекторат Польши выявил пять критических несоответствий на китайском заводе Chengdu Okay Pharmaceutical Co. Ltd.

Добавлено: 07 мар 2016 15:15
Sergey
Инспекторат Польши выявил пять критических несоответствий на китайском заводе Chengdu Okay Pharmaceutical Co. Ltd. при проверке производства субстанций

Nature of non-compliance : Overall, 21 deficiencies were observed during the inspection, including 5 critical and 10 major deficiencies.
The critical deficiencies were observed in QC Dept. including calculation of impurities of Diosmin and there were no records of standard (used as a reference) for testing in-house standard.
Also the data integrity was not guaranteed.
In manufacturing Dept. presented measuring methods were inadequate to the results.
The condition in clean area was not acceptable for final product.

Critical deficiences:
Testing of the final product: There was incorrectly way of calculation the impurities and Diosmin content.
There were no records of prepared in-house HPLC standard.
There was no confirmation of the conditions HPLC analysis.
Computerized systems - documentation and control: There was found in HPLC system that the method was changed, without any savings of previous method. There were no logins and passwords to the HPLC system and no procedure for granting permission to access to the HPLC system. There was no register of persons autorized to access to to the HPLC system. On the same computer station there were two different HPLC software.
Manufacturing documentation: Presented measuring methods of pH during the inspection time were inadequate to the results recorded in the batch report.
Premises: Crude Diosmin drying was carried out in an area which did not provide the appriopriate coditions during the discharge from the dryer.
Qualification of equipment: Some data of HVAC system qualification had been falsified.
The major deficiencies were observed among others: in the warehouse, in the manufacturing documentation and in the production area.