AIT’s manufacturing facilities implement a range of quality control measures to ensure the safety, efficacy, and consistency of its pharmaceutical products. These measures include:
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- Raw Material Testing: AIT conducts rigorous testing of raw materials upon receipt to verify their identity, purity, and quality. Tests may include visual inspection, chemical analysis, microbiological testing, and physical characterization to ensure compliance with specifications.
- In-process Testing: During the manufacturing process, AIT performs regular in-process testing to monitor critical parameters such as temperature, pressure, pH, and viscosity. This ensures that the process remains in control and that products meet specifications at each stage of production.
- Finished Product Testing: Prior to release, finished pharmaceutical products undergo comprehensive testing to confirm their compliance with quality standards and regulatory requirements. Tests may include assay, dissolution, content uniformity, impurity analysis, stability testing, and microbiological testing.
- Environmental Monitoring: AIT conducts environmental monitoring within its manufacturing facilities to ensure cleanliness and control of airborne contaminants. This includes routine monitoring of air quality, surface sampling, and microbial monitoring to prevent contamination of products.
- Equipment Calibration and Maintenance: AIT maintains a program for the calibration and maintenance of manufacturing equipment to ensure accuracy, reliability, and reproducibility of processes. Regular calibration of instruments and equipment is performed according to established schedules, and maintenance activities are documented and tracked.
- Personnel Training and Hygiene: AIT provides extensive training to its personnel on proper hygiene practices, gowning procedures, and contamination control measures. Employees undergo regular training to ensure compliance with Good Manufacturing Practices (GMP) and maintain a clean and sanitary working environment.
- Documentation and Recordkeeping: AIT maintains comprehensive documentation and records of all quality control activities, including testing results, equipment logs, calibration records, and batch records. These records provide traceability and accountability and serve as evidence of compliance with regulatory requirements.
- Quality Assurance Oversight: AIT’s quality assurance team provides oversight of all quality control activities and ensures adherence to established procedures and standards. They conduct regular reviews of documentation, audit manufacturing processes, and investigate any deviations or non-conformances to ensure corrective actions are implemented promptly.
By implementing these quality control measures, AIT Pharmaceuticals Project ensures that its manufacturing operations consistently produce high-quality pharmaceutical products that meet the needs and expectations of customers and regulatory authorities.
