Consistency, quality and safety are all important factors in process manufacturing, even more so when it comes to pharmaceuticals. Being compliant is one of the biggest challenges a pharmaceutical and life sciences company faces and no compromises can be made.
Health and life sciences manufacturers perform various tests at every level of manufacturing and follow strict guidelines such as the Good Manufacturing Practice (GMP) or regulations issued by the FDA. This inevitably puts a lot of pressure on them that can fortunately be alleviated by the right enterprise resource planning (ERP) software.
Tip: Read this blog post to find out what the five most important features in a pharmaceutical and life sciences ERP are
Any ERP solution that is suitable for pharmaceutical manufacturers contains a quality management and control functionality. It should cover the whole process – from the purchase of raw materials to the manufacturing and post-manufacturing stage.
Purchase of raw materials
A solid ERP allows the manufacturer to buy raw material from approved and verified vendors only. Once the raw ingredients have arrived, they need to pass inspections and go through a checklist to determine whether they are safe to use. In other words, further processing begins only after thorough quality standard testing. A recipe management functionality can be very helpful in this stage – besides tracking ingredient details, it should let you not only manage recipes but also save each revision with details on how, when and who changed it.
During the manufacturing stage, documents that describe each process in detail and which must be followed to the letter help employees maintain quality standards. One of them is the so-called Master Batch Record, a document that provides step-by-step instructions for manufacturing each batch like when, how, by whom, with what tools and in which environment the product should be produced – the so-called standards of procedure. Additionally, it includes input material lists which makes tracking raw materials a much easier task.
One thing you should be looking for in an ERP is whether it supports the first expiring, first out (FEFO) principle in manufacturing. This will help you maintain consistent quality, lessen the risk of selling an expired product, and cut costs.
After the product has been manufactured, it is tested to ensure it is up to the quality and specification standards. Last but not least, once the product is on the market, the ERP system lets the manufacturer track its distribution. In case a product needs to be recalled, the problematic batch can be easily tracked.
Additionally, an industry-specific ERP can let you set different levels of approval and establish an internal workflow and segregation of duties. It allows for the use of E-signatures and electronic records related to approvals and validation which are often required by a number of guidelines.
Something that may not seem directly linked to quality assurance but is in fact deeply intertwined is plant maintenance. A good pharmaceutical ERP system lets you perform plant maintenance and prevent issues according to CAPA or GMP regulations, leading to timely and cost-effective production, increased quality control and enhanced delivery performance.
Do you want to know what else you should look for in an ERP system? Contact us to learn more!