Pilot Plant Operation is a small-scale production system used to practically test and validates a production technology before commercialization.
For Pilot Plant Operation
1. Design specification.
2. Installation qualification.
3. Operational qualification.
4. Performance qualification.
5. Compliance with cGMP and FDA standards.
1. Technical skills and knowledge.
2. Safety and environmental responsibility.
3. Compliance with GMP.
4. Compliance with SOPs.
1. Design of facility.
2. Co-ordination scheduling.
3. Direction of ongoing operations.
4. Validation of facility.
5. Construction of facility.
Maintenance and Calibration:
1. To ensure the integrity and equipment reliability and research.
2. To meet cGMP norms.
1. Material control
2. Labelling (GMP-GLP)
4. Orders (FIFO)
Process and Manufacturing Activities:
1. Formulation and process development studies.
2. Technology evaluation scale-up and transfer.
3. Clinical supply and manufacture.
1. Auditing pilot plant.
2. Auditing and approval of component supplies.
3. Reviewing approval and mainframe batch records for clinical supplies.
4. Sampling and release of raw material.
5. Release of clinical supplies.
6. Maintaining and distributing facility and operating procedure (SOPS).
7. Review and approve of validation.
8. Engineering documentation.
1. Release testing of the finished product.
2. Physical, chemical and microbiological testing of finished clinical products, components required for supplies.
3. Testing for validation and revalidation.
4. QC in-process testing during development scale-up and technology transfer.
Plant: It is a place where the 5M’S like money; material men, method, and machine are brought together for the manufacturing of the products.
1. Last 25-30-year pharmaceutical researches are going in an advanced manner.
2. Have witnessed amazing inventions and innovations in the pharmaceutical field.
3. NDA and ANDA are at an all-time high.
4. Researchers are motivated to adopt new processes and technology.
5. Scale-up batches are essential for ensuring success in the clinical testing and bioequivalence study.
6. Pilot plant scale-up is one of the most important stages in product development.
Make sure you also check our other amazing Article on : Scale-Up Liquid Orals And Semisolids