📘 Regulatory basis
The GMP guidelines published by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) are globally recognised standards and are a principal basis on which the Hong Kong Department of Health approves pharmaceutical manufacturers. Hong Kong law also requires all medicines sold in Hong Kong to be manufactured by a licensed manufacturer.
📗 Drew Tang's recommendations
Setting up a pharmaceutical manufacturing plant is a major undertaking that requires top-level professional support. Rengangyongsheng (Hong Kong) Limited has a team of experienced GMP experts with backgrounds in international pharmaceutical manufacturing. We can provide end-to-end, turnkey consultancy services, from conceptual plant design, process layout, equipment selection and system establishment to final GMP certification. This decision requires careful planning and substantial investment, so we recommend discussing it with us in depth before getting started.
📕 Risk notice
The greatest risk is underestimating the complexity of GMP and the ongoing investment it requires. GMP certification is not a one-off exercise: you must continue to invest substantial resources in maintaining the GMP system and undergo recertification periodically. Any lapse, such as loss of control over the cleanroom environment or incomplete batch records, may result in suspension of your manufacturing licence and the loss of your entire investment.