Quality Control

Quality Control & Quality Assurance

ETHICARE LABORATORIES’ products are manufactured under strict quality control procedures in Good Manufacturing Practices certified production facilities, using modern scientific tools and techniques. Stringent quality control and continuous quality checks are a part of every batch and process at Ethicare and a part of our long-term approach, adding to our quality competence. Modern Good Laboratory Practices are employed to ensure the quality of the products being manufactured. ETHICARE LABORATORIES’ highly qualified professionals possess expertise in method development and validation for new molecules with special emphasis on impurity profiling, particle size analysis, stability and integrity assay methods, and in-vitro dissolution profiling.

Quality Control manuals are observed and their methodology followed. From time to time the products are upgraded to improve quality, stability, shelf-life & reduce cost & overages. Ethicare's well-defined Quality Policy coupled with stringent Quality Control and Quality Assurance specifications and parameters assure safe, efficacious and quality products for the ailing masses.

The key activities under Quality Control are:

Raw material testing
In-process testing

Packing-material testing
Finished-product testing

Ethicare's Quality Assurance set up has a state-of-the-art facilities with properly trained & qualified staff, highly sophisticated modern analytical instruments with well designed, spacious laboratory. Product Quality Assurance is ensured through periodic monitoring/auditing of production and laboratory areas to comply with Good Manufacturing Practices.

Major activities of Quality Assurance:

  • Validation of :-
    Manufacturing Processes
    Analytical Methods
    Cleaning Procedures
    Water Systems
  • Calibration of Equipments / Instruments.
  • Clearance of Raw Material / Packaging Material / Finished Product.
  • Control at every stage of development & production besides in-process testing.
  • Documentation / Standard Operating Procedures.

Short description of the Quality managment system of the firm responsible for manufacturing :

  • Quality of Input Material: Well-defined specification and testing procedures exist for controlling Quality of input materials.
  • Testing and Manufacturing equipments and machines are frequently calibrated and validated to ensure their performance.
  • Written procedures are available for every operation. Manufacturing operations are carried out as per Master Formula Record.
  • Several media viz. participating in house are training. All the employees Training programmes. The operators and workers are trained for SOPs which they are supposed to perform.
  • The processes and unit operations are frequently validated.
  • In process checks are performed and finished product sampling and testing is carried out as per well-defined specifications and validated test procedures.
  • Self-Inspections are carried out and non-compliance report is prepared. Actions are initiated to rectify non-compliances observed.
  • Stability testing of the finished products is carried out to ensure the quality of products during shelf life period.