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PLANT TECHNICAL OVERVIEW

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)
Maiden Group

Maiden Group