Product
Development |
- Excipient screening
- Formulation screening
- Formulation development
- Protocol writing
|
Product/Process
Development Report writing |
| A comprehensive report detailing
the development of the product and the process as
out lined under product and process development. |
Process
Development |
- Protocol writing
- Equipment selection & qualification
- Equipment cleaning and validation
- Process assessment and development
- SOP assessment and development
|
Process
Cycle time optimization |
- Standardization and consolidation of processing
steps that would reduce yet optimize the processing
time.
|
|
Technical
Services |
- Protocol Writing
- Transfer Documentation
- Product
/ Process Scale up
- Equipment Qualification
(IQ, OQ, PQ)
- Product / Process Validation
|
Troubleshooting |
- Help our clients or partners define and rectify
manufacturing or development issues
|
| Scale up / validation
report |
- A comprehensive report which details the
product / process scale - up and validation.
It includes all the optimized critical manufacturing
variables that influence the manufacture of
the dosage form and performance variables that
indicate the performance of the dosage form.
- The transfer documents describe the process,
equipment and facilities that will scale – up,
validate and manufacture the product
|
|
| Training |
- cGMP
- Operators (metric development)
- Processes
- Equipment
- Documentation
- Train the Trainer
|
| Master Batch Records
writing |
- Clearly written batch records.
- Operators or manufacturing personnel with different
level of experience can easily discern, interpret
and follow the instructions.
|
| SOP Development & Writing |
- Develop and write Standard Operation Procedure
(SOP).
- Operators or manufacturing personnel with different
level of experience can easily discern, interpret
and follow the instructions.
|
|
