Brief description of the site
The manufacturing site is located in a well developed Industrial area & is situated at T–130, Tarapur MIDC, Boisar. The site is around 115 kms. from Mumbai city, which is well connected by the National Highway No. 8. The Chemical Plant is well equipped with reactors, pumps and centrifuges. There is adequate safety control and Good Manufacturing Practices are strictly followed. Weighing scales, digital temperature indicators, pressure/vacuum gauges are calibrated periodically. A team of experienced technocrats are managing the manufacturing process right from first stage to the dispatch of the finished product. The warehouse has separate places for storage of raw materials and finished products. All materials are classified, properly labeled and kept in specified allotted places. Finished products are quarantined and kept in separate Bonded Storage Rooms. A well maintained warehouse is available for the storage of required Raw Materials, Intermediates, Packing Materials & finished products.
Finished product areas are maintained under class 100000 lac (supply through 0.3ì terminal HEPA filter) conditioned. This includes one final processing reactor, Centrifuge, Tray dryer, milling, blending, power packing and quarantine areas. Unidirectional flow of man and material is maintained right from warehouse to dispatch of the material to avoid the cross contamination. Temperature is maintained wherever necessary.There is a Purified water generation facility wherein the purified water is generated and the validation of the process carried out in accordance with the WHO guidelines. Utility department maintains a regular supply of steam, electricity, purified water etc. and keeps up the general maintenance of the factory. There is a full-fledged Workshop and trained technicians to attend any breakdown problems inside the factory.
Finished product areas are maintained under class 100000 lac (supply through 0.3ì terminal HEPA filter) conditioned. This includes one final processing reactor, Centrifuge, Tray dryer, milling, blending, power packing and quarantine areas. Unidirectional flow of man and material is maintained right from warehouse to dispatch of the material to avoid the cross contamination. Temperature is maintained wherever necessary.There is a Purified water generation facility wherein the purified water is generated and the validation of the process carried out in accordance with the WHO guidelines. Utility department maintains a regular supply of steam, electricity, purified water etc. and keeps up the general maintenance of the factory. There is a full-fledged Workshop and trained technicians to attend any breakdown problems inside the factory.
Quality Control
• The well-equipped Quality control laboratory has separate areas for wet analysis, HPLC, GC, control samples, stability chambers, balance room, hot room and microbiological analysis. Preparation, review and approval of SOPs, protocols and reports are as per applicable guidelines. A team of qualified professionals is leading process validation, cleaning validation and analytical method transfers & process technology. The quality system is defined as per Schedule M, Schedule L, ICH Q7 and TRS guidelines. A few other key features of the company’s quality system are as follows:
• Issuance, retrieval, archival and control of documents
• Release / Rejection of Raw materials and finished products
• Qualification of vendors and contract laboratories
• Self-inspection
• Training and development of the staff
• Trend analysis and annual product quality review
• Investigating batch failures, deviations and complaints. Ensuring GMP compliance of the facility
• Issuance, retrieval, archival and control of documents
• Release / Rejection of Raw materials and finished products
• Qualification of vendors and contract laboratories
• Self-inspection
• Training and development of the staff
• Trend analysis and annual product quality review
• Investigating batch failures, deviations and complaints. Ensuring GMP compliance of the facility
Certifications
• GMP by Food and Drug Administration, Maharashtra State, India.
• Written Confirmation for EU by CDSCO, India
• Written Confirmation for EU by CDSCO, India