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Trend toward New Facilities

In the previous blog in our series on GMP Asset Management in New Manufacturing Facilities, we discussed the trend that Biotech companies are increasingly building new facilities rather than outsourcing the manufacturing of their products. While this trend may not be the majority, it has been occurring more frequently in recent years. Much of this growth is due to the complexities of the drugs that are being manufactured. Many of them involve proprietary processes and technologies throughout their manufacturing process. We welcome feedback on this trend in the blog comments below. Here is an interesting article on this topic from Reuters: http://in.reuters.com/article/2015/10/30/us-pharmaceuticals-cancer-factories-anal-idINKCN0SO0F520151030


Register for Live Webinar

Throughout this series, we’ll discuss the best practices for GMP asset management in new facilities with a special focus on the unique needs of Biotech companies. We’ll cover the importance of implementing an EAM/CMMS early on in a new facility, handling new and transferred equipment, driving process consistency and automation, managing records, validating software and strengthening FDA compliance. The series will be followed by a live webinar on 11/17 that will include a live question and answer session. I encourage you to join us for the webinar as well as continuing to read the rest of the blog series.

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Role for EAM/CMMS in New Facilities

In any GMP facility, new or old, one will find a standard operating procedure that governs the lifecycle of manufacturing equipment and instruments. In a new facility, the effort to add new equipment is exaggerated because of the volume of new assets being added in a short period of time. Below is an example of the process that could be followed to introduce a new asset into a GMP environment:

newequipment

First a User Requirement Specification is established to outline the role of the new asset, then the equipment goes through the purchasing process. After the equipment is purchased, an equipment record must be created – either paper-based or in an EAM system. Typically, spare parts are then identified and obtained. Finally, the equipment is qualified, maintenance and calibration schedules are set, SOPs are generated and users are trained.

With a validated EAM/CMMS system that can meet Part 11 requirements, a new facility can significantly improve compliance and streamline their productivity from the start.

Productivity Drivers – EAM and New Equipment

For new facilities and those with un-validated asset management systems, repeating this process for each new asset is time consuming and costly. This is where utilizing an EAM / CMMS like Blue Mountain RAM can streamline the process.

Each new piece of equipment could require the following documentation:

  • URS*
  • Safety Assessment*
  • Purchasing  Information
  • Criticality/Risk Assessment*
  • Formal Equipment Record
  • Commissioning
  • IQ
  • OQ
  • PQ
  • Equipment Manual*
  • Calibration Plan Template*
  • Preventive Maintenance Plan Template*
  • Spare Parts Inventory list*

Typically, the files for EACH piece of equipment would need to contain these documents. This means quite a bit of space is needed to store these securely, and be easily accessible. Depending on company specific requirements, many of these also need to be routed for review and signature. The review and approval process is often a rate limiting step in getting equipment “production ready.” Having as many of these documents in a validated electronic database, rather than on paper, would provide major benefits. First, the information available in an electronic format would make storage and future reference more efficient. Anyone with access would be able to view the equipment records from anywhere, rather than only the physical location. Second, with an EAM system, redundant documentation and maintenance/calibration schedules can be referenced throughout the induction process. Documents in the list that are marked with an * could reference a common source (if multiple pieces of the same equipment). Even with just 100 assets, this can save a facility large amounts of time preparing paper records and manually routing and approving documents. Third, with all the commotion of starting a facility, once the equipment record is set up in an EAM system, automatic electronic notifications can help to ensure the equipment remains in a usable state.

Utilizing a validated EAM/CMMS system from the beginning of startup can streamline and reduce the number of duplicate steps for similar equipment. Along with this also comes the more important benefit of compliance, specifically error reduction.

In the next blog, we’ll discuss this and other compliance benefits of implementing an EAM in a new facility.