|
 Contract manufacturing
Our facility is a professional contract manufacturer and is subject to inspections by the Ministry of Health. Furthermore, the facility undergoes foreign inspections frequently as well. All productions are carried out with appropriate equipments under a quality system that had been implemented by adhering to the cGMP rules. The production methods and formulations are performed by carrying out in-process controls and as were instructed by the customers. Final products are released after they are analyzed according to the final product specifications which were obtained from the customer.
 Production Validation
Following the completion of initial (primary) production, the production is validated by performing the production validation on three batches, which are obtained after the optimization of the production method. Production is a part of our services.
 Contract Analysis
Besides performing production analyses, our Quality Control Laboratory provides outsourcing services as well.
- All chemical substance and drug analyses (humidity assessments, quantity assessments, impurity analyses, identification tests with HPLC, UPLC, GC, KF, NIR and routine test equipments)
- Water chemical analyses
- Water microbiological analyses
- Air microbiological controls
- Air particle counts
- All analyses, which can be performed by using current infrastructure, and microbiologic analyses such as personnel, environment, food etc. can be performed in our laboratory appropriately.
 Contract Stability Analysis
This service, which is included in the contract manufacturing service, is carried out by following up routinely each product that are produced, under the stability.
 Analysis Method Validation
With this service, being included in the contract analysis service, all analysis methods are validated according to the latest methods that are valid throughout the world and thus ensuring the reliability of the test results. |
|
|
|
|
info@nobelfarma.com.tr
