Manufacturing Demystified

The need to validate automation systems in pharmaceutical laboratories and manufacturing plants has moved on, as the traditional focus on information technology and process control solutions has expanded. Building management systems (BMS) such as heating, ventilation and air conditioning (HVAC) were often brushed aside in the belief that they did not impact product quality. Today, however, Good Manufacturing Practice (GMP) requires records confirming temperature, humidity and particulate matter in critical cleanroom, laboratory and production environments. As a result, forward-thinking pharmaceutical manufacturers are validating their HVAC environmental controls to reduce the risk of non-compliance and business disruption.

But it doesn’t stop there. Those who adopted the requirements early on are now looking to manage and validate physical access to their laboratories and manufacturing facilities. These organisations recognise that access control solutions can impact product quality and may be the focus of regulatory requirements in the future. In the meantime, however, validated access control solutions help pharmaceutical manufacturers sharpen their competitive edge.

ACCESS CONTROL SYSTEMS IMPACT PRODUCT INTEGRITY

Thinking about GMP’s impact on access control solutions in a pharma manufacturing environment, it is important to consider whether your current system preserves the product status and produces data to support product acceptance/rejection. Does it control a process that can impact on product quality? Is there independent verification that the automated process is performing as intended?