| Quality Assurance |
| Supreme and independent body reporting to management only |
| Strict control over all aspects of quality like engineering, production, quality control and employee induction + training |
| Validations and Qualifications |
| Root c |
| Periodical self inspections |
| Controls vendor approval and development |
| Deviation and change control |
| Customer complaint, CAPA, product recall, if any and verification of CAPA |
| Following guideline of WHO, PICS, MHRA,ICH, 21 CFR part 210 and 211 |
| Control samples and documentation under access control |
| Stability chambers and data controlled by qa |
| Area segregated by separate building for qa, qc and production |
| Stability Conditions are Accelerated (400C/75% RH), Intermediate (300C/65% RH ), Long Term (250C/60% RH) |