Managing Supplier Data Collection

March 2, 2015
Siegfried Schmitt

Siegfried Schmitt, PhD, principal consultant at PAREXEL.

Pharmaceutical Technology, Pharmaceutical Technology-03-02-2015, Volume 39, Issue 3

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses good engineering practices.

 

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses good engineering practices.

Q. Our engineering department is managed by a small team of professionals who supervise and manage a large number of service suppliers that perform the majority of engineering tasks. We find that it typically takes more than a month before these suppliers provide us with necessary documents, such as calibration reports or updated piping and installation diagrams (P&IDs). The engineering manager explained that this process cannot be expedited. We are concerned that this long delay may lead to a negative observation during our next inspection. How can we change this pattern?


A. Outsourcing services is a common industry practice in the pharmaceutical business. The regulatory agencies are well aware of this fact and have issued rules and regulations governing outsourced activities (1, 2). These regulations and guidance documents, however, do not provide information that would define an acceptable period of time for providing data and records to the contract giver. In this specific case, the engineering department is the contract giver, but there are no specific regulations you can cite to ensure timely documentation. However, it is important to fix this challenge, due to the possible impact on operations and quality this document delay may create. 

You mention two examples: calibration and engineering drawings. There can be major impacts on each of these due to slow response service suppliers. Let us first look at the calibration data and records. For both manufacturing operations and process validation, it is crucial to know the current calibration status of your equipment and instrumentation. If that information is unavailable, then you simply cannot proceed, seriously impacting your ability to operate. Also, in the case of deviations, such missing information can impede on the root cause investigation. Most companies attempt to complete this type of investigation within 30 days, which may be difficult if you must wait even longer for the relevant engineering information and documents. It is important to note that the validation in not confirmed until the engineering department verifies and approves the third party’s report and conclusion.

In the case of the P&IDs, it will be difficult, if not impossible, to present the as-is build of your facility in case of an inspection. Without current drawings, making changes to the facility will be challenging at best. Not having a picture of the as-is situation may also hinder investigations if and when deviations occur. In either case, the slow response time of your suppliers can have critical impact on your engineering department and will need to be addressed.

The time span from having the activity performed until you receive the data and reports from your suppliers seems excessively long, from both a compliance and a business perspective. If possible, work with your engineering department to review the quality/technical agreements in place with their suppliers (3). These should detail defined timeframes and modes of delivery. The agreement, for example, may specify that sending a scanned copy, instead of a paper copy, of a report is acceptable. You will find that a scanned copy may save time. Where suppliers are unable to deliver within a reasonable amount of time (e.g., days), your company may need to consider bringing the services back in-house.

Should you find it difficult convincing your engineering department of the need to improve timelines, you should escalate this issue to your senior management. After all, senior management has the ultimate responsibility for quality and compliance. It is in the best interest off all involved parties to assure your compliance status reflects current good manufacturing practices. 

References
1. EC, EudraLex, Vol 4, Chapter 7 “Outsourced Activities,” http://ec.europa.eu/health/files/eudralex/vol-4/vol4-chap7_2012-06_en.pdf, accessed Jan. 19, 2014. 
2. FDA, FDASIA Title VII Drug Supply Chain Provisions, www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm365919.htm, accessed Feb. 17, 2015.
3. Quality-Technical Agreements, Pharmaceutical Technology 38 (5), pp. 70 (May 2014).