Quality Control Laboratory (QC)
List of Major Instruments:
- HPLC System from Shimadzu (Detector: Florescence, Refractive Index, PDA Photo Diode, UV Detector)
- GC with Head Space and Auto Sampler
- Dissolution Tester
- Friability
- TOC from Shimadzu
- UV Spectrophotometer
- Refractometer
- FTIR
- Polarimeter
- Karl Fischer
- Potentiometer
List of Major Instruments in Microbiology Lab:
- BOD Incubator
- Autoclave (Horizontal & Vertical)
- Microscope
- Colony Counter
- Biosafety Cabinet
Quality Assurance Department (QA)
Documentation Cell:
- Storage of Master Document
- Issuance of SOPs/Logs.
- BMR/BPR/AWP issuance.
- Retrieval of SOPs/Logs.
- Verification of executed BMR/BPR/QC Report as per checklist.
- Management of QMS documents.
- Executed Document storage/destruction management.
Training:
- Annual training plan.
- GMP training.
- In-house & External Training.
- Need based training (Self-Inspection / CAPA /Mkt. Complaint etc)
- Training Evaluation
Validation Section:
- Validation Master Plan.
- Dedicated validation Team.
- Qualification of new equipment.
- Periodical validation of Major equipment’s
- Calibration of measuring devices.
- Process Validation.
- Cleaning Validation/ Verification
- Media fill validation.
- Hold time studies.
- Validation/Qualification Protocol
IPQA:
- Dedicated IPQA personnel’s.
- Certification of line clearance.
- In-process checks.
- Verification of clean room status.
- Periodical Verification of machine/activity logs.
- Sampling of In-process bulk/Finish Product for Analysis.
- Withdrawn of control and stability samples.
- Participation in process/cleaning validation.
