Stringent Quality Control
Eurolife has put into place a comprehensive quality policy, which covers raw materials, all stages of product manufacture, as well as packaging and storage and complies with the most exacting domestic and international standards.
Stringent quality control and continuous quality checks are a part of every batch and process at Eurolife, in order to ensure the highest process integrity.
The company strives to consistently improve its facilities, its internal policies and procedures in order to maintain quality standards that meet and exceed customers’ expectations.
The in-house Quality Control laboratory is staffed by a qualified and experienced team. It is well equipped with latest analytical instruments as well as sophisticated microbiological testing facilities to ensure the highest levels of pharmaceutical quality, purity and formulation accuracy.
All of these quality efforts are part of Eurolife’s commitment to ensuring that every product that comes off its production lines meets the most exacting international standards.
QC- Chemistry Section
- Sampling , analysis And Release Of RM/PM
- Analysis of Bulk, Intermediate and finished products of FFS
- Preparation and handling Of Reagents In Laboratory.
- Trend Analysis
- Preventive Maintenance Of laboratory Equipment/Instruments
- Preparation of Specification and Method of Analysis, Analytical Test Reports
- Barcode and Control Number Assignment
- Stability Studies
- Handling of Non-conforming material and product
- Validation Of Analytical Methods
- Handling of Out of Specification (OOS) Results
- Disposal Of Remainder Test Samples
QC – Microbiology Section
- Environmental Air Monitoring
- Microbiological Testing of Water, Raw Material, Finished Product etc.
- Investigation of Microbiological OOL Results
- Sampling of Air and Water
- Preparation and Certification of Microbiological Media And Reagents
- Calibration of Laboratory instrument
- Sterility Testing of Sterile Dresses
- Evaluation of Disinfectant
- BET and Sterility and Product Bioburden testing
- Sterility test of Sterile dresses
- Isolation and Identification of Environmental Isolates
- Monitoring of SIP Process Using Biological Indicators
Stringent Quality Assurance
Eurolife has put into place a comprehensive quality policy, which covers raw materials, all stages of product manufacture, as well as packaging and storage and complies with the most exacting domestic and international standards.
Stringent quality control and continuous quality checks are a part of every batch and process at Eurolife, in order to ensure the highest process integrity.
The company strives to consistently improve its facilities, its internal policies and procedures in order to maintain quality standards that meet and exceed customers’ expectations.
The in-house Quality Control laboratory is staffed by a qualified and experienced team. It is well equipped with latest analytical instruments as well as sophisticated microbiological testing facilities to ensure the highest levels of pharmaceutical quality, purity and formulation accuracy.
All of these quality efforts are part of Eurolife’s commitment to ensuring that every product that comes off its production lines meets the most exacting international standards.
Quality Assurance - Functions
- NCR and CAPA management
- Handling of Product complaint and adverse events
- Product Recall
- GMP Training to all concerned personnel
- Vendor Qualification and management
- Risk Management
- Self Inspection
- Annual Product Review
- Change Control management
- Document Management (Sops, BMR, BOM, MFM, Log books, Validation and Qualification protocol etc.)
- Batch Numbering, Line clearance, In-process inspection, Release/Rejection of Finished product
- Final Physical Check (Defects per million) of FG Batches
- Receipt & Maintenance and disposal of Control Samples
- Preventive Maintenance Of laboratory Equipment/Instruments
- Process Validation and validation & Calibration of Instrument/Equipment
