As front liners whose activities play a vital role in supporting patient outcomes, pharmaceutical manufacturers need to get it right the first time. Recreating activities and reproducing products require extra time, cost, and effort and can leave the company prone to quality risks.
The concept of Right First Time originates from the implementation of Six Sigma, and it ensures that you can produce the perfect batch, or golden batch, on the first try. With the advent of Industry 4.0, IoT, and new forms of technology, making the right decision is easiest than ever. U tools such as e-logbooks and e-forms can support excellent results (your golden batch).
The importance of a right first time in pharmaceutical and biotech manufacturing cannot be overemphasized, and they include:
1. Enhanced Effective Management
Right first time requires order and control in all aspects of production. With standardization and harmonization, you can effectively keep account of usage, repair, and maintenance of equipment without the risk of damage or loss. Real time process visibility and control are key to maintaining this ecosystem. Technology enables new means of visibility to promote process improvement and data driven decision making.
Data collection and information gathering can be simple and less time-consuming with the right choice of technology and tools. Not only can you save time and money, but more importantly, you can effectively manage manufacturing affairs in all areas of production.
2. Controls Compliance Risks
Pharmaceutical operations must comply with a set of regulations, which assure quality of products and machinery. The inability to make the right decision can put an operation at risk and compromise the quality of the finished product. In particular, US FDA 21 CFR Part 11 and EU Annex 11, outline the regulations for electronic record and documentation. Maintaining compliance can go a long way in ensuring that not only are you covered from a risk perspective, but also embracing current good manufacturing practices.
3. Eliminates Paper Cost
Achieving right first time production with paper documentation is challenging. Paper in pharmaceutical and biotech manufacturing is at risk. Illegible handwriting, data loss, inaccurate records, incorrect calculations, paper damage are not only compliance risks, but also serious record keeping risks. Quality of record keeping is essential for understanding the quality of a process and continuous improvement.
Why should you spend time, effort, and cost on managing paper logbooks and forms when you can go paperless? With digital forms and records, you can achieve right first time production in a cost-effective manner.
eLogbooks and eForms can help solve these risks by safeguarding your records, online. Your data is stored digitally, where it can be securely stored and retrieved. All data and entries in your electronic use-logs, forms, and spreadsheets are secured and are only accessible to authorized personnel.
4. Prevents Performance Drop/ Productivity Loss
Maintaining optimal operating conditions is critical for right first time manufacturing. Although challenging, failing to achieve right first time manufacturing reveals performance and productivity losses. Inputs may not correlate with outputs, a clear sign of a decline in performance and productivity. Documentation and validation of entries in pharmaceutical manufacturing are quite critical, and are key to getting things right the first time.
These mistakes can be prevented by making the right decisions at the right time. Understanding the process variables and limiting the variance is key. When you have the right tools and technology, this can be accomplished.
5. Data Accuracy
Just as important as documentation, is data accuracy. As much as you need to pen down processes and activities so that you can refer back to them, recording accurate data is just as important. What’s the point of documentation if they end up failing to accurately represent the process?
With the right tools and great decision-making ability, data inaccuracy can be combated. Employing a detailed approach to the use of digital logbooks and forms will prevent data inaccuracy, and protect data integrity.
6. Work-Flow Execution
In an ideal world, pharmaceutical operations can achieve a perfect workflow. There are many variables to achieving the golden batch, but balancing the benefits with the costs is a complicated venture. They key is to make incremental improvements, and identifying key areas for opportunity. The effort and costs of maintaining paper records is a common area for improvement. That is why doing digital with electronic logbooks and forms is key to achieving the golden batch, without sacrificing quality or documentation. Activities can be made by the right personnel, at the right time.
Making the right decision at the very beginning comes in handy to pharmaceutical and biotech companies as it is cost-effective, saves time and money, and is staff-friendly.
OpsTrakker’s workflow engine can be a major help to your GMP operations. The effort and time required to support paper records is significant. Lengthy review cycles, found with paper come at a major cost. With electronic logbooks and forms, no longer do you have to worry about requiring extra authorizations and approvals. With the support of review by exception, or computer aided decision making, you can significantly improve the quality and time of your review cycles. Not sure about what decision is right or confused about how to make one? Well, don’t be because OpsTrakker has you covered. It is a cost-effective, lightweight alternative that can achieve right-first-time manufacturing where appropriate.
Ready to try it out? Feel free to get in touch with us today!