Sumit Raghuvanshi

• Manpower handling and supervision of process-related activities of all sections of the Ophthalmic and Vial line (Plant III).
• Ensuring all activity is strictly adhered to cGMP standards, SOP's, logbook and BMR.
• Capex and Opex management.
• Qualification and validation of equipment's.
• To maintain productivity continuously.
• Here, I am looking after the exhibit and commercial batch activities.
• Expertise in different formulation as below:

1. Injectable, like suspension and simple liquid.

2. Ophthalmic-like suspension, emulsion, gel, and liquid products.

• Handling the different equipment's:

1. Vessels having a scraper, agitator, and high-shear mixer.

2. Mill, like Netzsch mill, Gea homogenizer, and Silverson homogenizer.

3. Isolator-based facility for manufacturing and filling of products.

4. Groninger line and GF line for ophthalmic products.

5. Trucking line for vial products.

• Two US FDA audits faced during my tenure.

• Manpower handling and supervision of process-related activities of all sections of Line II, Oncology Division (Plant III).
• We have liquid and lyophilized products.
• Handling of Equipment

1. Isolator-based sterile filling line.

• Manpower handling and supervision of process-related activities of all sections of the vial line (trucking line).
• Installation of trucking vial line (including washing machine, depyrogenation tunnel, filling machine, and capping machine), machine fabric autoclave, and Adams vessels.
• Handling of different formulations, like liquid, suspension, and lyophilized products.

• The installation of the Toflon vial line (includes washing machine, depyrogenation tunnel, filling machine, and sealing machine), Pharmalab autoclave, Adams vessels.
• Handling of liquid products.

• To supervise and handle five line activities, including the planning of dispensing, preparation of components/articles, autoclaving, manufacturing, filling, capping, and terminal sterilization of vials and bottles.
• Handling of different machines like Groninger (vial and bottle), washing m/c, Groninger depyrogenation tunnel, truking vial washing m/c, HM DPT, Bosch (vial and ampoule) washing m/c, Plummet liquid filling m/c, Plummet manual bag filling m/c, Bosch filling m/c, Groninger sealing m/c, Bomer bag printing m/c, Pharmalab autoclave, rotary sterilizer for emulsion product, and SBM for terminal sterilized product.
• Handling of different formulations, like general parenteral and emulsion (Propofol).

• To supervise the activity of the dry powder injection line.
• Handling of products like amoxicillin potassium clavulanate.