Monitoring the production for the customer, once the facility is approved and ready for use.
- Monitoring the production for the customer, once the facility is approved and ready for use.
- Preparing production planning as per the requirements of the customer or on monthly, quarterly and yearly basis and monitoring and controlling it.
- Getting acquainted with the synthetic route of synthesis of the API by taking pilot, trial & test batches.
- Monitoring the production on behalf of the customer to ensure that the product is being manufactured exactly as per the customers' manufacturing process in the qualified set of equipment.
- Ensuring that the ‘critical process parameters’are identified and controlled so that these lie in acceptable ranges.
- Ensure that the batch records, cleaning records are filled up Filling up & maintained properly.
- Ensuring proper packaging and storage of in-process & finished goods as per the laid standards.
- Ensuring that the product is anaysed as per the agreed valid test methods and release by QA as per the standard quality System. Ensuring that product is dispatched in approved packaging material with correct labels.
- Ensuring that any deviation in manufacturing or supplies is informed to the customer well in advance.