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) |