In-Process Control (IPC)
Intermediate Product tested by IPC
Bulk Powder
- Moisture Analysis
Tablets / Capsules
- Hardness
- Disintegration
- Friability
- Av. Wt.
Strips
- Leakage Test
- Visual Inspection
Finished Product
- Sampled Retain Samples
- Visual Inspection
Microbiological Testing
The laboratory is also provided with the necessary equipment
including incubators, laminar airflow units, etc. to handle.
Environmental Monitoring
Air ,water and personals under go routine microbiological testing to assure that the air and the water meet the quality requirements
Product Stability
Stability of our products under different environment conditions is one of our main concerns.
All Stability studies are carried out according to International conference on Harmonization (ICH) guideline
-
Microbiological Testing
The laboratory is also provided with the necessary equipment
including incubators, laminar airflow units, etc. to handle. -
Environmental Monitoring
Air ,water and personals under go routine microbiological testing to assure that the air and the water meet the quality requirements
-
Product Stability
Stability of our products under different environment conditions is one of our main concerns.
All Stability studies are carried out according to International conference on Harmonization (ICH) guideline
DOCUMENTS SYSTEM INCLUDE THE FOLLOWING:
- Quality Policy
- Site Master file
- Standard Operating Procedures
- Technical Procedures
- Training procedures
- Cleaning procedures
- Quality Control procedures
- Validation documents
- Calibration documents
- Storage procedures
- Master manufacturing formula
- Batch manufacturing record
- Batch packing record
- specifications
Equipment Qualification And Calibration
- Validation studies as per protocol are carried out.
- All new equipment are subjected to installation and qualification evaluations before being put into regular use.
- Prequalification assessments are also carried out for any major modifications to exiting equipment.
- üEquipment calibration is done at regular intervals.
Handling Of Materials
Only starting materials which have been released
by QC and which are within the retest period are used.
Handling Of Rejected Materials
Rejected materials and products are clearly marked and stored separately in a segregated area.
