Saturday, December 10, 2016

What is SAP Global Batch Traceability? (SAP GBT)

SAP GBT is SAP’s enterprise solution for providing for the GMP requirements around batch management:
  • Manufacturing and Distribution records are enabled to capture a complete history of a batch. These records must be in a comprehensible and accessible form
  • A system is in place that allows for the recalling of any drug from sale or supply 
Simply put, it is an enterprise repository of the complete history of batch transaction records that allows for easy querying in order to produce distribution records for the purpose of targeted recalls and holds.
The following shortcomings are addressed by SAP GBT:
  • If there is an issue with a particular batch, serialized item or handling unit no complete product genealogy exists for tracing the issue. All materials purchased, consumed, manufactured and distributed in the related supply chain network are not easily identified.
  • Today’s SAP ERP based solution is limited to one instance for tracing the product genealogy. I.e. there is no ability to trace the genealogy if you have several SAP ERP systems managing your batches then you have no visibility in to the cross-system product genealogy.
  • There is an inability to analyze multiple tracking objects bottom up or top down in a single run of the report. With SAP GBT you can analyze batches, serial numbers and handling units in one run.
  • Inconsistent data often leaves the product genealogy broken, with missing links between objects or across systems. When the chain is broken the complete genealogy is not visible. 
With many companies looking at improving traceability and visibility in to their batch genealogy maybe one of the following statements resonate with you…
  • We are unable to explore and report on the enterprise product genealogy from a single source
  • We cannot view the batch genealogies originating from distributed batch record systems across our organization
  • We have no insight in to bad batch quantities across all our organizational and partner locations
  • We are unable to easily retrieve the delivery addresses for all affected batches, making targeted holds, withdrawals or recalls less efficient and timely
  • Our batch genealogy breaks down when we don’t receive the relationship links between batches as my process traverses different systems. How can we repair the tree to reflect the complete genealogy?
  • We can’t easily retrieve the distribution record for multiple batches and their related batches with a single click. It takes too much time and effort to retrieve this detail.

The Value Proposition

The main value proposition provided to applicable companies, with batch managed processes, is Time to Insight… What does “Time to Insight” mean?
It means that, with SAP GBT in place, you have the ability to greatly reduce the time needed to get to the point where you understand the ramifications or impact that your batch analysis has for your company. E.g. you need to understand just how many customers are affected by a bad batch of oranges that were introduced in to the process on a particular date. With SAP GBT in place this could be visually seen with a click of a button. With another click you can retrieve the distribution record showing address detail of the current location of all downstream customers that have, in some way, consumed parts of that bad batch.
By getting to the complete distribution record in a short amount of time, this allows the company to execute a precise targeted hold, withdrawal or recall of just those products affected by the issue.
By executing these fast targeted holds, withdrawals and recalls, companies gain the following advantages:
  • First and foremost, in the pharmaceutical industry, the consumer is protected from potential illness or death
  • In other industries, the consumer is also protected against faulty products that could be potentially dangerous to operate of consume
  • Brand protection. The company does not want their name to be associated with inferior or unsafe products. With a targeted recall there is the potential that just the consumers with the faulty or defective products are aware of the issue
  • Corporate liabilities are contained due to the prompt action taken because of the “Time to Insight” benefit. Fewer folks are affected by the issue resulting in reduced overall liability
  • Financial risk and exposure is limited
  • Compliance to regulatory reporting requirements within the required deadlines

SAP GBT

SAP GBT, first and foremost, acts as the enterprise batch repository. What does this mean? It is the single place to store and query all transaction data as it relates to batches within the enterprise.
Parent child relationships as they relate to batches are stored in the SAP GBT repository allowing you to be able to query and visually see the batch genealogy (See Figure 1).

Figure 1: SAP GBT batch genealogy tree

The advantages of being able to visually browse your batch genealogy include:
  • Efficiencies during exploration of related batch transactions
  • Time to Impact… The entire enterprise’s batch genealogy is available for browsing and the potential impact of a spoiled batch can be visually seen
  • The top down and bottom up details are shown on one screen
SAP GBT provides the ability to launch reporting against the repository with a single click of a button. These reports can help target a precision recall or withdrawal in a timely fashion. These reports also assist in fulfilling regulatory requirements. 
E.g. the distribution record showing the location for each transaction as it pertained to the batch. The FDA’s current good manufacturing practice for finished pharmaceuticals requires the distribution record to be retained 1 year after the expiration of the drug or 3 years after distribution of it has no expiration date.
This optimized SAP batch repository meets this requirement 100%.