Clipping of news on Brazilian Culture, Law and Citizenship
01.18.2016
This article was translated by an automatic translation system, and was therefore not reviewed by people.
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The gathering of nimesulide drugs 50mg / ml and 50mg erythromycin estolate / ml pharmaceutical suspension medium, it was a precautionary action Anvisa, manufactured because of the stability and dissolution studies with altered production process. The stability studies results are used to establish or confirm the expiration date and to recommend storage conditions. In this context, it is possible not to ratify the validity and performance of these drugs compared with the recorded condition. For diclofenac sodium 50mg, tablet, Anvisa's decision was also precautionary, based on the validation of the production process, which ensures the reproducibility of the lots within the parameters established in the drug registration. The change in the production process may involve inclusion or modification of equipment or some modification during production of the drug.
The post-registration changes are classified according to their potential impact on the quality, safety and efficacy of the drug and may be of immediate implementation with or without filing or require prior approval from ANVISA. From the classification and the type of change regulatory requirements are established that the company should follow. The production process and equipment changes require that the quality characteristics are maintained in the approved drug registration.
Source: Anvisa
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This article was translated by an automatic translation system, and was therefore not reviewed by people.