The goals of any manufacturing company that adheres to Good Manufacturing Practices (GMP) are to effectively, efficiently and accurately produce quality products that are safe for the end customer. However, manufacturers that rely on a paper-based system to ensure the production of quality products are often operating inefficiently, ineffectively and potentially in violation of GMP compliance.
To improve operations and ensure full GMP compliance, manufacturers can benefit from investing in a cloud-based Manufacturing Execution System (MES).
In the following article, we’ll discuss the many ways an MES (such as the software included in InstantGMP™ PRO all-in-one manufacturing and quality system) can improve efficiency, reduce operator error, lead to the production of high quality products, and assure that the manufacturing facility is in GMP compliance.
Improves Operational Efficiency
When manufacturers are operating with a paper-based system, they are hampered by their reliance on multiple documents stored in various locations of the facility. This system is drastically inefficient. Any time an operator needs to review an SOP or a quality assurance specialist has to verify a log book, they must walk to a specific area of the plant, locate and retrieve a physical binder, and spend time finding the specific document.
A cloud-based MES with an integrated Document Management System (DMS) and electronic logs eliminates the need for a paper-based system and improves operational efficiency. With a cloud-based MES, operators, QA specialists, or any authorized member of the company can use the database to easily access, review, and interact with all of the necessary documents.
In the manufacturing of any product (especially pharmaceuticals and dietary supplements) where GMP compliance is required, it is imperative that manufacturers reduce all risk to the end user. Reducing risk eliminates the possibilities that the finished product will make a patient sick and/or cause an adverse reaction in a customer.
A cloud-based MES helps reduce risks in the manufacturing process by establishing standards that allow operators to have greater control over the various flows and steps the raw materials take through the facility.
An example of risk-reducing control standards established by an MES is as follows:
Upon receipt, the raw materials are quarantined in an isolated area until they are quality tested to ensure that they are free from impurities. Once the raw materials are approved for use in production, they are relocated to an appropriate storage area.
Next, the approved materials are incorporated into a batch where it is tracked through each step of the production process for greater accuracy and traceability.
At the end of the batch production process, the MES database provides a pathway that facilities can follow from the arrival of raw materials to the finished product. In turn, the traceability can be followed in reverse order from the finished product to the origins of the raw material.
Having control over these steps and flows significantly reduces risk in the manufacturing process from preparation to finished product. A cloud-based MES makes this possible.
In a paper-based system, manufacturing companies adhere to GMP compliance by creating Standard Operating Procedures (SOP). Once these SOPs are implemented in the manufacturing process, operators and QA specialists are expected to follow these procedures to the letter.
Unfortunately, not every operator can remember every step of a complex SOP. That being said, the possibilities of production process steps being performed out of sequence or completely overlooked are considerably increased. When mis-sequenced or missing steps occur, then the facility is no longer in compliance with GMP rules and regulations.
Utilizing a cloud-based MES, manufacturers can record the SOP directly into the database. Once an SOP is available in the database, it is automatically presented to the operator in the batch record. This requires operators to perform each step of the process in a necessary order with certain controls. It also prompts a QA specialist to double check each step to ensure that it has been executed correctly according to the SOP.
Rather than expecting operators to rely on paper-based documentation and memory, the MES automatically presents this information via the database during the actual production process to ensure GMP compliance.
Reduces Cycle Time
One of the biggest challenges of manufacturing any product is dealing with fluctuating cycle times. The periods of time between the initial request to produce a batch to the point that the finished product is released to distribution can range anywhere from a few days to a couple of weeks to several months.
In a paper-based system, it may take a facility a week to produce a batch (raw materials to a finished product in a package). However, the quality review of the product may take an additional six weeks. This is due to the time QA specialists spend locating, retrieving and reviewing physical SOPs, log books and various paperwork associated with the respective batch production to confirm that the batch was manufactured correctly and in compliance with GMP standards.
Introducing efficiencies in the quality assurance process via a cloud-based MES can help significantly reduce the cycle time. With the MES, quality checks are performed in real-time during the entire production process to ensure greater accuracy and consistency. At the end of production, the “Review by Exception” feature in InstantGMP’s electronic records can be used to identify any issues that were unresolved during the process. If no issues are found, then the batch is available for release to distribution.
By integrating these QA measures in the process, the MES reduces the quality assurance process from six weeks to a few minutes. This in turn reduces the entire cycle time.
Provides Greater Access to Data
A reliance on a paper-based system requires operators and QA specialists to spend a great deal of time traversing the multiple areas of a facility to locate, retrieve and review SOPs, log books, equipment maintenance guides, and various documents associated with the production process.
A cloud-based system eliminates this time-consuming practice by allowing all authorized personnel to easily and quickly access all necessary data. This is essential to operational efficiencies, control, traceability, accuracy and compliance especially since many staff members are working remotely.
Provides a Significant Return on Investment
When manufacturers are asked to define quality their common answer is “meeting specifications”. Since specifications are the established standards that ensure all processes are correct, any manufacturer that adheres to specifications will deliver quality products.
In pharmaceutical and dietary supplement manufacturing, if the final inspection reveals that a product does not meet specifications, it will be rejected. This rejection means that the whole batch will have to be scrapped and the whole manufacturing process begins from scratch.
As the MES introduces efficiency, reduces risk and automates compliance, it improves the overall quality of products and reduces scrapping. By doing so, the MES provides the manufacturer with a substantial return on investment.
As you can see, a paper-based management system is inefficient and leaves a great deal of room for error. Whereas a cloud-based Manufacturing Execution System allows manufacturing companies to introduce operational efficiencies, reduce risk, ensure GMP compliance, reduce cycle time, provide convenient access to data from anywhere, improve product quality, and reduce scrapping. All of these benefits work together to provide a considerable return on investment.
Investing in an all-in-one manufacturing and quality solution like InstantGMP PRO not only provides manufacturers with an industry-leading Manufacturing Execution System, it also features fully integrated Document, Inventory and Quality Management Systems.