Oral Solid Dosage
The state-of-the-art Oral Solid Dosage unit is designed as per US FDA standards. The facility incorporates contemporary technological advancements with automated material handling systems and multilevel designs to enable gravity feed between various processing stages. The building architecture and design allows for enhanced efficiency as it ensures maximum engineering maintenance access without entry to production areas. This facility houses a total of five lines with an annual capacity to produce 5 billion tablets per shift.
The manufacturing and packaging facilities have been designed to minimize generation and maximize containment of dust particles using closed transfer system and clean in place facility. All viable measures have been taken to ensure that members of the staff are not exposed to unacceptable concentrations of dust particles.
Precise selection of equipment is also critical to improve process capability and ensure process robustness. A wide range of equipment has been procured from world renowned companies like Glatt, Romaco, Noack, Korsch and Nicomac. A state-of-the-art chemical laboratory and dedicated microbiological laboratory equipped with a wide range of equipment have been set up to facilitate the quality control activities. The major equipment include HPLCs, UV spectrophotometer, FTIR spectrophotometer, AA Spectrophotometer, Karl Fischer titrator etc.
GMP accreditation audit by an EMA regulatory authority was completed for the OSD. It has been audited and approved by regulatory authorities from Australia and the Gulf Cooperation Council, and is awaiting inspection and approvals from the US FDA and the UK MHRA, which would give Beximco Pharma access to the most stringently regulated markets in the world while providing advanced infrastructure for contract manufacturing opportunities.