The first floor is dedicated to the manufacturing of non-contraceptive oral solid hormone products, with a specialized containment system. This level also features an independent material loading/unloading area, advanced HVAC and water systems, and comprehensive firefighting equipment for safety. The second floor, currently under design, will house the production of sterile non-contraceptive hormone products. The third floor focuses on the production of contraceptive oral solid hormone products, complete with a dedicated materials loading/unloading area and HVAC and water systems designed to maintain strict environmental control.
The Hormone Unit adheres to Good Manufacturing Practices (GMP) and is certified by the Directorate General of Drug Administration (DGDA), Ministry of Health & Family Welfare, Government of Bangladesh. HPL is also pursuing additional certifications from the EU, FDA, and ANVISA to further enhance compliance with international standards.
The unit specializes in manufacturing hormone-based tablets and, once operational, sterile hormone injections. It features the latest pharmaceutical manufacturing technology and is operated by a highly skilled workforce committed to excellence. The HVAC system is designed with independently dedicated units for stringent control over air quality and environmental conditions, ensuring optimal production conditions while preventing cross-contamination.
HPL’s Quality Management System (QMS) aligns with global regulatory standards such as EudraLex Volume 4 and 21 CFR 210 & 211. The QMS includes Deviation Management, Change Control, and Quality Risk Management, monitored through digital platforms such as eQMS, DMS, and LMS. This framework ensures quality control and compliance, with finished products released through SAP for traceability.
Advanced water treatment facilities provide high-purity water essential for pharmaceutical use, and comprehensive fire safety measures, including detection and suppression systems, ensure the protection of both personnel and assets. Designed with sustainability in mind, the Hormone Unit minimizes environmental impact while maintaining a safe and efficient workspace.
With its commitment to innovation and adherence to international standards, HPL’s Hormone Unit stands at the forefront of hormone product manufacturing, delivering safe and effective treatments that meet the highest global quality standards.