Don't Try This at Home: If You are Not Expert in a Particular Operational Area, You Need an Expert to Help You Out.

As part of a routine audit of a packaging and labeling facility, The Practical Solutions Group, LLC was asked to assess the quality of the vendor's manual placebo encapsulation operations. This area was not considered to be vendor's standard service and our client wanted an assessment if this "one off" process was performed properly.

The information, while available, presented a number of issues.  For one, the vendor's standard packaging record forms were fitted to the encapsulation process.  As a result, even the individual who reviewed the batch record could not walk us through it in a timely and comprehensive fashion and needed help with figuring out how the numbers were derived.  In addition, the Mettler balance that was used and the way the weighings were recorded raised questions regarding whether our client could rely on the collected data.

Using our knowledge and understanding of packaging and manufacturing operations and focusing on the critical operational parameters, we helped the packaging and labeling vendor to reconstruct the encapsulation process that was used.  In the process, we assured ourselves – and our client - that it presented no risk to data integrity.

The practical approach always means looking at the true business risks, rather than at the mere documentation deficiencies. In this case, without any additional time/cost, our practical approach rescued the data integrity from what seemed like a regulatory and operational deficiency.