Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharmaceutical quality system with less need for extensive regulatory oversight prior to implementation.
This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.
In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.
While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation within the company and serialization efforts in place?
Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and contract manufacturing organizations (CMO) carefully select equipment, outline processes and deploy appropriate containment strategies. Read how partnering with a knowledgeable and experienced CMO for this important stage of a drug’s life cycle can reduces costs and timelines, and ensures the safety of employees, the environment and the patient.
While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. Without thorough and comprehensive testing data a biologics license application (BLA) for the manufacture of a biopharmaceutical for commercial distribution will invariably be denied by regulatory bodies such as the US FDA. AbbVie’s five-step process results in a thorough understanding of the biologic and process control strategies to ensure drug safety, purity, and potency at the commercial scale, and since it is much harder to implement changes post- commercialization, continued process validation is employed.
3D printing allows drug companies to not only boost efficacy and adherence but also contribute to their brand longevity by expanding and capturing market share with other dosage form options.
Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and process that provide critical advantages for sustainable initiatives.
Everyone is fixated on streamlining production processes and reducing the bottom line. This means getting new instruments into the workflow as soon as possible.
While there are some that choose to install a facility monitoring system just because regulatory guidance states one should be installed and used, many, given the choice, would choose not to.
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