Quality Assurance
- Strict In-process Quality Checks at all stages of operation
- Sampling of products at all stages (Process Blend, Intermediate and Finished Products)
- Internal Quality Audits/Self Inspection and Evaluation
- Complaint handling and Reporting.
- Deviation control, Change Control and Incident Report
- Out of specifications results
- Annual product quality review
- Control of Master Documents, Formats, BMRs & BPRs.
- Validation
- As per approved Validation Master Plan
- Equipment Qualification (DQ, IQ, OQ and PQ)
-Process Validation
-Area Validation
-Cleaning Validation
-Vendor Qualification and Rating
-Analytical Method Validation
- Requalification & Revalidation
Quality Control Laboratory
- In-house analysis of all Raw / Packing Material receipts, Intermediate & formulated finished products
- Separate area for Physicochemical analysis, Instrumental analysis & Microbiological analysis
- Separate section for Documentation & Stability Chambers.
- Wet Chemistry Section
Furnished with Fuming chamber, hot zone, Eye Wash and Bath facility.
- Instrumentation Section
HPLC, FTIR, UV, KF Titrator, Dissolution Apparatus, Polarimeter, Analytical Balances and other sophisticated instruments
- Microbiology Section
Separate Microbial Limit Test & Bioassay Area with LAF and HVAC facility.
Separate autoclaves for sterilization and disposal of discards.
