From drug production to water purification, there are a number of ways automated processes can improve efficiency and consistency in your products. Maximizing output is critical in any industry but it particularly affects pharmaceuticals when the supply chain is interrupted.
Identify Bottlenecks Through Process Optimization
Process optimization and automation in the pharma industry enable higher yields while minimizing your costs. With industries as tightly controlled as pharmaceuticals, stable plant operations are an absolute must. Process optimization is a process whereby you analyze each and every step of the production process to look for areas of inefficiency or bottlenecks to determine where improvements can be made. From eliminating waste to cutting utility consumption, there are plenty of ways your plat operations can be optimized.
First used in traditional manufacturing, process optimization practices quickly spread to pharma. As regulatory structures became more strict, as productivity requirements rose, and as manufacturing costs increased, the application of process optimization became critical. Chief among these concerns is regulatory compliance.
Optimization and automation were first adopted by manufacturing plants, with the pharma industry following the lead. In addition to increasing productivity, minimizing costs, and reducing waste, the pharmaceutical industry has to achieve one more thing—compliance and safety. Pharma products can potentially threaten the lives of consumers if they deviate from the required standards.
Fortunately, pharma automation companies like HEXA Engineers specialize in supervisory control and data acquisition (SCADA) systems and distributed control systems (DCS), which are critical to maintaining quality and production standards.
Always Know and Follow Regulatory Guidelines
Pharmaceutical manufacturing controls guarantee a certain level of quality that is quite unlike standards required in other industries. Quality standards can mean the difference between life and death, which is why regulatory agencies maintain strict guidelines for any firm involved in the manufacturing of pharmaceuticals.
Thankfully, a properly designed automation system can maintain quality standards to a far greater degree than people ever could on their own.
ISPE and the FDA
GAMP, or Good Automated Manufacturing Process, is a set of guidelines from the International Society for Pharmaceutical Engineering (ISPE). According to the ISPE, the GAMP 5 (the most recent edition of the GAMP guidelines) “provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner.” In combination with the U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 regulations that outline requirements for electronic records and signatures, every part of the manufacturing process is tightly controlled.
Compliance must be maintained during both the manufacturing and packaging processes for any given drug or other pharmaceutical product. If an automation process is properly designed from the beginning with all of this in mind, compliance can be less of a stressor on your organization. Maintaining compliance is far easier than achieving it in the first place, especially when working with skilled automation experts like HEXA Engineers.
Always Consult With Automation Experts
Having process optimization and automation experts in your corner when designing, implementing, and maintaining automated systems offers a distinct advantage over hiring a lean in-house team.
HEXA Engineers is a premier automation consulting firm with rich experience in the pharmaceutical industry. If you’re struggling with compliance issues or are looking for ways to optimize your process and eliminate waste, connect with us. We’d love to help.