Cephalosporin and Penem Facilities
Cephalosporin and Penems are widely used beta-lactam antibiotics that require completely separate and dedicated facility to be manufactured. BEACON Cephalosporin PLC, being considered among the most technologically advanced cephalosporin plants of the country, is spread over an area of 3 acres of land in Baluka, Mymensingh (79 km North of Dhaka). Beacon Cephalosporins Limited has achieved the European Union Good Manufacturing Practice (EU GMP) certification.
It features an independent and segregated production space, a separate cepha and penem production floor, a fully automated manufacturing facility for various pharmaceutical dosage forms, and dedicated personnel with employee restrictions. The plant assembled the most advanced equipment and machines. It also has effluent bio-waste treatment systems. The factory was designed to meet the worldwide regulatory criteria of WHO-cGMP, UK MHRA, and European GMP under the supervision of renowned international experts.
About Cephalosporin and Penem facilities
Facility Design: The facility adheres to GMP compliance standards, focusing on preventing contamination, ensuring proper flow design for materials and personnel, and employing containment systems to prevent various forms of contamination.
Product Formulation Design: The formulation design matches that of the originator, ensuring equivalence in quality and efficacy.
Material Selection: Active Pharmaceutical Ingredients (APIs) are chosen based on CEP/COS grade quality standards from the European Directorate for the Quality of Medicines (EDQM).
Manufacturing Process: The manufacturing process complies with GMP standards, following established quality procedures.
Production Machine Containment and Data Auditing: Machines are equipped with containment systems, and data recording follows CFR Part 11 requirements, ensuring auditability.
Good Engineering Practices (GEP) Compliance: Utilities such as HVAC, water systems, and control systems adhere to GEP standards.
Laboratory Practices: Laboratory operations follow Good Laboratory Practices (GLP), including software-based services and integrity systems for data management.
Validation and Qualification: All systems and processes are validated and qualified according to GMP validation practices.
Sterile Manufacturing: Sterile manufacturing processes, testing, and guidance comply fully with EU standards.
Gowning System: Proper hygiene and safety protocols are maintained through Good Housekeeping Practices and the use of Personal Protective Equipment (PPE).
Environmental Safety: The facility ensures environmental safety following GMP guidance and adhering to ISO 14001 and ISO 45001 standards.
Warehouse Compliance: Warehousing for raw materials, excipients, packaging materials, and finished goods meets EU GMP standards.
