Quality
Our Quality Control Department is furnished with adequate laboratory facilities for the analysis of raw materials, in-process materials and finished products. It has the required number of competent technical staff, approved by the Drugs Control Authority.
In order to provide an assured quality of the drug products, the principal activities of the Quality Control are:
- To ensure appropriate standards and comply specifications for each of the raw materials, in-process materials and finished products
- To enumerate and emphasize the controls by the QC in all aspects of production and quality control, related to the manufacture of drug products
- To ensure conformance of the incoming materials to the required standards before using in routine production
- To design and operate an appropriate inspection and control procedure and ensure validation of the systems adopted at each stage of manufacturing and process parameters
- To ensure that every batch of all the drug products at the finished bulk formulation stage comply with the requirements of the respective product specifications
- To ensure that the outgoing drug products conform to the desired standards and/or specifications in all respect
- To ensure that a drug product is stable throughout its shelf life
- To handle and investigate the field complaints
- To conduct technical audits of the manufacturing as well as QC areas
Specific QC activities are carried out in the Analytical Laboratory and Microbiological Laboratory. Each lab is provided with state-of-the-art facilities, latest instruments and adequate expert staff for performing complete analysis of a drug product and its components.
Key activities of Analytical and Microbiological Laboratory are as follows:
- To analyze raw materials, unfinished or in-process materials, finished materials with respect to the specifications (Pharmacopoeial and/or in-house)
- To evaluate the stability of finished product through shelf life studies
- To review the analytical results for respective validation of the process
- To conduct process validation whenever there is a change in the formulation, process or major equipment
- To establish standards and/or specifications whenever required
- To evaluate analytical methods whenever necessary
- Microbiological assay of Vitamin B12 in oral liquid preparation
- Sterility testing of the parenteral and ophthalmic products
- Microbiological monitoring of aseptic area
- Microbiological purity evaluation of all finished products
© Copyright 2019 East India Pharmaceutical Works Limited
GSTIN: 19AAACE5779P2ZR & 19AAACE5779P1ZS | CIN: U24231WB1936PLC008598
GSTIN: 19AAACE5779P2ZR & 19AAACE5779P1ZS
CIN: U24231WB1936PLC008598