QA - QC


Stringent Quality Control

Trugen 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 Trugen, 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 Trugen’s commitment to ensuring that every product that comes off its production lines meets the most exacting international standards
 



 

QC- Chemistry Section QC- Microbiology Section
● Sampling , analysis And Release Of RM/PM
● Analysis of Bulk, Intermediate and finished products.
● 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
● 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
●  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
● Evaluation of Disinfectan




 

Stringent Quality Assurance

Trugen 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 Trugen, 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 Trugen’s commitment to ensuring that every product that comes off its production lines meets the most exacting international standards.

Quality Assurance - Function

● 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, Log books, Validation and Qualification protocol etc.)
 ● Batch Numbering, Line clearance, In-process inspection, Release/Rejection of Finished product
 ● Final Physical Check of FG Batches
 ● Receipt & Maintenance and disposal of Control Samples
 ● Process Validation and validation & Calibration of Instrument/Equipment
 
We maintain highest standards of quality by testing in our GLP accredited Quality Control Laboratory ensuring that the product shall meet relevant pharmacopoeial standards and statutory requirements. In addition, the company ensures that all the steps involved in the design, development, and manufacturing of a product that leads to the intended level of quality performance in the market.



Quick Enquiry!