The Quality control system is an integral part of cGMP and ensures that the necessary and relevant tests are done & that neither the material not the products are released for use or supply, until their quality has been judged to be satisfactory.
The Quality Control Laboratory is responsible for sampling and testing of all starting materials, and packaging materials in accordance to the predetermined specifications and established procedures. In case of raw materials, 100% sampling is carried out for identification and composites samples are tested as per the specifications. The QC Laboratory is also responsible for testing of in-process and finished product samples. The stability studies are carried out at Quality Control Laboratory.
The Microbiological testing includes Assays for vitamins, sub-culturing of different micro-organisms, Viable Environmental Monitoring of Non Aseptic areas and Sampling & Analysis of different grades of water.
The production Operations are performed under the strict GMP norms. All the production operations are done under the strict supervision of qualified personnel in accordance with approved Batch Manufacturing Records. The manufacturing activity is commenced only after the clearance of the manufacturing and packaging line by in process Quality Assurance personnel. The documentation at production floor is carried on line. The continuous in-process checks are monitored during manufacturing and packaging operations.
Type of products
(references to Appendix 1 or 2 can be made):
The site is dedicated to manufacture tablets, hard gelatin capsule, oral solutions and suspensions, powders for oral solutions and suspensions under oral dosage forms and external formulations viz. topical semi-solid preparations viz. ointment, creams and gels.
Toxic or hazardous substances handled (e.g. with high pharmacological activity and/or with sensitising properties);
Process Analytical Technology (PAT) applications, if applicable: general statement
The site intends to adopt the Process Analytical Technology applications through product development considering product life cycle phase.
J.Duncan Healthcare Pvt. Ltd. operates under the control of a Quality Management System as per guidelines stated in the Company Quality Policy & Quality Manual.
The Quality Policy of J. Duncan Healthcare Pvt. Ltd. is to,
o To assure product quality by adopting product life cycle through quality risk management process.
o To manufacture pharmaceutical products with adequate resources and systems and affordable to customer.
o To upkeep and maintain the cGMP and cGLP standards.
o To train and improve the knowledge of the employees and co-workers.
o To invest in new pharmaceutical manufacturing technologies.
o To improve the process and systems continuously through development and monitoring.
o To control waste and support the eco-friendly processes.
o To assure Quality and timely delivery of the pharmaceutical products.