With operating efficiencies increasingly dependent on 'right first time', there is a need to change the status quo in the way processes are controlled.

The design of accurate and robust analytical methodology is instrumental to developing orally inhaled and nasal drug products (OINDPs) and their appropriate control programmes.

Choosing to optimize the test methods may have greatest effect on future test method performance, but this is usually the most expensive recovery process... and may require significant time to complete.

Historically, the main purpose of laboratory information management systems (LIMS) has been to track and manage samples in the laboratory. LIMS originated nearly 30 years ago as a rudimentary method of automating manual, error-prone processes in the laboratory and, with the growth in adoption of technology, became the de facto benchmark for laboratory control and management.

A checklist of how to achieve regulatory compliance by validation of laboratory information management systems. Validation costs and cost-effective validation strategies are considered for pharmaceutical manufacturers to validate their systems and maintain a validated state for continued compliance.

Understandably, the thought of implementing a closed-loop PAT strategy throughout the global enterprise and for all products can keep pharmaceutical executives awake at night.

Missed or late calibration dates can accumulate, and even if the equipment is labelled appropriately, it can suggest poor management of resources and priorities.

All sectors of manufacturing are under continual pressure to bring new products to market quicker, stealing a march on the competition and maintaining their revenue stream.

All sectors of manufacturing are under continual pressure to bring new products to market quicker, stealing a march on the competition and maintaining their revenue stream.