- Responsibility of customer communication with the customer on QbD related topics is assigned to a senior technical person.
- There is process to review and discuss customer special specifications.
- The customer application for the product is understood and guidance is given to them to select most appropriate product or grade.
- To optimize robustness to the formulation, correct level of the product is suggested.
- All potential physical and chemical variables for the product are identified.
- Manufacturing process is under sufficient control to be able to relate process parameters to physical or chemical attributes to the product.
- Manufacturing process is sufficiently robust and able to manage variability in the starting materials.
Ø Quality and characterization of product
To build quality into the drug product, without compromising its physicochemical properties, characterization of excipient is must.
Excipient is characterized with regard to their functionality, physicochemistry & safety and ensured for processability, compliance & stability.
Ø Analytical development
Preformulation studies which are based on the formulation requirements (solid or liquid dosage forms) are conducted and physicochemical properties e.g. solubility at various pH, temp etc are determined.
Ø Product development strategy
Product development strategy has given importance to the integration of biophysical and biochemical characterization of a molecule ensuring stability and compliance.
Ø Lab scale development
NB provides lab scale developed batches for obtaining various regulatory clearances or to test the dosage integrational properties and co-efficiency with MCC.
Ø Product development and its grading
Development of a product is very critical. Depending upon formulation requirements, preformulation studies are conducted and physicochemical properties are studied.
Ø Scale-up and process optimization
For stability and compliance purpose, lab scale batches are tested and validated. To maintain same methods and processes throughout the large scale manufacturing process, a detailed Technology Transfer procedure is applied.
Ø Stability study and product development report
Product stability study is done in detail, keeping in view the possible querries like formulation optimization stability, primary packaging re-formulation etc.
Various date required by clients is generated regularly and provided as required, for the development of product.
- Strict adherence to all regulatory norms.
- Drug Master Files with US FDA, GMP Certification & Drug license registration is available.
- IPEC GMP Compliant.
- ISO 9001 certified.
- Kosher certificate is also available.
WE MAINTAIN
- Regulatory reference database
- Preparation, procurement and maintenance of licenses and Drug Master Files (DMF) for up to date regulatory status.
