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Product Documentation: Essential to an Effective Quality Program

Quality Management - 4 January 2017

Provenance – Not Just for Fine Art!

The term “provenance” is used in the art world in reference to the evidence that supports the authenticity of a work of art. It is what differentiates a valuable classic painting from a clever copy. In the production of pharmaceutical products, I like to think of the documentation that accompanies a product as its provenance. This documentation is just as valuable as the physical product itself.

When we produce a pharmaceutical product, we take great care to link its physical form to a body of documentation. While probably not something that crosses the mind of the consumer, the lot number on the package is the last link in a chain of control that assures that the many attributes of the product are present. These attributes include:

  • Appropriate packaging and storage conditions
  • Analytical testing that verifies the product meets specifications
  • Production by trained personnel
  • Investigation and resolution of any unusual events occurring during production
  • The quality, identity and purity of ingredients
  • Production according to a master formula that links to a qualitative and quantitative formula approved by regulatory authorities
  • Linkage to the original clinical data that established the safety and efficacy of the product

"When we think of the documentation not as a cumbersome regulatory burden, but as a driver of value creation, it becomes evident that the appropriate resources need to be invested in documenting the product properly."

John Carkner
Sr. Consultant, SOLABS QA & Best Practices Unit

A Driver of Value Creation

The absence of any of this documentary evidence diminishes the value of the product by creating risk – risk that the product may not perform as expected. If documentation and data integrity are absent, it is not unlike a forgery in the art world- value is diminished because the reliability of the source is suspect.

Once we think of our product in this way, it allows for a more complete understanding of the product’s value. When we think of the documentation not as a cumbersome regulatory burden, but as a driver of value creation, it becomes evident that the appropriate resources need to be invested in documenting the product properly.

When determining how many resources to set aside for documentation, we should apply the methodology of lean thinking and attempt to add this value (the documentation) as efficiently as possible. Remember that “more is not always better” when documenting quality. In fact, documentation should strive to demonstrate all of the product’s critical attributes with the minimum resources required.

Reliability, predictability and consistency are created by a robust documentation system, effective training and a history of corrective and preventative action (CAPA). As verified by internal and external audits, these elements of an effective quality program build the “provenance” of a pharmaceutical product and provide the assurance that a product can be used with confidence.

About the Author
John Carkner is Senior Consultant in SOLABS’ Quality Assurance & Best Practices Unit and has had a career spanning more than 35 years in the pharmaceutical industry. A microbiologist by training, he began his career in Quality Control with Pfizer Canada. John gradually took on more responsibility, including overall Quality for Pfizer’s Canadian manufacturing operations, eventually became Site Leader of their Arnprior, Ontario manufacturing site. When Pfizer divested the Arnprior site in 2009, John began a new phase of his career leading a contract manufacturing organization. He concluded his career as President and CEO of Pillar5 Pharma Inc., and after five years in contract manufacturing, moved to a less structured role as a consultant to the industry.

Other Recent Articles from John Carkner
Apr. 26, 2017: Issue Escalation: 5 Tips for Communicating with Senior Management
Mar. 22, 2017: Quality and Safety Have A Lot in Common
Feb. 1, 2017: FDA Contract Manufacturing Guidance and EQMS

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