Core Experience in:
- Designing & qualification of formulation manufacturing facilities
- Manufacturing operations of wide spectrum for formulations
- GMP compliance and regulatory audits.
Core Competency:
- Designing and Operations of:
- Isolator based manufacturing facility for Cytotoxic / high potency injectable formulations, including Lyophilized formulations.
- Manufacturing facility for Aseptic or terminally sterilized Injectable formulations
- Manufacturing facility for Oral Solid dosage forms – Tablets and capsules
- Manufacturing facility for External Preparations (Ointments and Creams)
- Upgradation of existing facilities for GMP compliance and productivity improvements
- Designing of formulation manufacturing facilities
- Preparation of URS for manufacturing facility and equipment
- Preparation of Qualification documents: IQ/OQ/PQ
- Equipment and facility qualification
- Clean Room qualification and designing facility monitoring program
- Developing equipment cleaning processes and Cleaning Validation
- Risk Assessment and risk mitigation
- GMP Training
- Facility Audit and gap identification.
- GMP compliance
- Deviation investigation and root cause identification