Once the appropriate excipients and the basic process are determined for your product, a larger scale batch is manufactured in our GMP facilities. This will be used to evaluate operational parameters, and to assure that an elegant dosage form is produced that meets the defined QTPP, CQA and physical and chemical specifications.
A cross-functional Mikart team will review your product’s processes and procedures with you and discuss potential quality and cost enhancement opportunities. Additional batches may be made to evaluate the benefit of identified improvements.
- Quality by Design (QBD) Principles
- Thermal Cycling Studies
- Site Transfers
- Low Humidity Environments