Pilot Scale Manufacturing FDF
PharmaZell (Vizag) operates a pilot plant for formulations to
- Ensure technology transfer from Lab development to Pilot/ Pivotal scale up, inline simulation to commercial scale production
- Produce formulations Exhibit/ Submission/ Pivotal batches under cGMP for BA/BE studies
- Conduct stability studies as per the ICH and regulatory requirements
- manufacture small scale commercial batches (high value products, which are usually required in small batch sizes).
We contribute a scale-up experience which guarantees the process optimization as per all regulatory guidelines with all safety and efficiency aspects.
Key characteristics of Pilot/Pivotal Plant
- The Facility is a class 1,000,000 area with a cGMP compliant documentation and equipment
- Separate well-equipped and demarcated rooms as material hold area, granulation area, compression room, a coating room, IPQC room, primary and secondary packaging room and wash area.
- Capable of taking up batch size up to 15 kg to 75 kg.
- Capable of wet/dry granulation, direct compression, film coating and blister/strip/alu-alu packing of oral solid dosage finished products.
- Analytical method validations.
- Validation studies for Pilot/ Pivotal
- Dossier registration support to all regulated and ROW markets
- Product launch after patent expiry
- Absolute focus on Safety, Health & Environment
- Having space for new/ novel drug delivery systems like technology platforms (modifier release, delayed release, dry syrups)