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2 comments:
Friends,
lthough the GMP crtification is not mandatory,I understand that the industry will hav to comply wih requirements of SCHEDULE M and COPP.
I o not know about COPP requirements.Does anyone know whre to obtain dtails on COPP?
bet regards
thakur
The State Food and Drug Administration (FDA) generally issues COPP after a joint inspection of the manufacturing facility by inspectors from the Central Drug Standard Control Authority and State FDA. “Re-inspection is required to get the new COPP, but many a times re-inspection is not possible in time due to various constraints like limited number of staff available.Regulatory authorities in most of the countries do not accept COPP with a remaining validity of 6 months. The industry has, therefore, asked DGCI to ease the process by extending the period of their test licences. The industry has suggested that NOC may be issued for exporting a specified quantity of medicines to a particular country without looking at the time limit. While DCGI is looking into the possibility of issuing consolidated export approval for a longer period, it would also have to look into other aspects so that regulatory issues do not get compromised as import laws differ from country to country.
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