@article {Campbell185, author = {Cliff Campbell}, title = {FDA 2011 Process Validation Guidance: Lifecycle Compliance Model}, volume = {68}, number = {2}, pages = {185--191}, year = {2014}, doi = {10.5731/pdajpst.2014.00972}, publisher = {Parenteral Drug Association (PDA)}, abstract = {This article has been written as a contribution to the industry{\textquoteright}s efforts in migrating from a document-driven to a data-driven compliance mindset. A combination of target product profile, control engineering, and general sum principle techniques is presented as the basis of a simple but scalable lifecycle compliance model in support of modernized process validation. Unit operations and significant variables occupy pole position within the model, documentation requirements being treated as a derivative or consequence of the modeling process. The quality system is repositioned as a subordinate of system quality, this being defined as the integral of related {\textquotedblleft}system qualities{\textquotedblright}. The article represents a structured interpretation of the U.S. Food and Drug Administration{\textquoteright}s 2011 Guidance for Industry on Process Validation and is based on the author{\textquoteright}s educational background and his manufacturing/consulting experience in the validation field. LAY ABSTRACT: The U.S. Food and Drug Administration{\textquoteright}s Guidance for Industry on Process Validation (2011) provides a wide-ranging and rigorous outline of compliant drug manufacturing requirements relative to its 20th century predecessor (1987). Its declared focus is patient safety, and it identifies three inter-related (and obvious) stages of the compliance lifecycle. Firstly, processes must be designed, both from a technical and quality perspective. Secondly, processes must be qualified, providing evidence that the manufacturing facility is fully {\textquotedblleft}roadworthy{\textquotedblright} and fit for its intended purpose. Thirdly, processes must be verified, meaning that commercial batches must be monitored to ensure that processes remain in a state of control throughout their lifetime.}, issn = {0006-3363}, URL = {https://journal.pda.org/content/68/2/185}, eprint = {https://journal.pda.org/content/68/2/185.full.pdf}, journal = {PDA Journal of Pharmaceutical Science and Technology} }