A formal audit establishing the ability of a manufacturing facility (or set of facilities) to acceptably produce Serial Numbers (or lots) of a design for a CI. A new PCA must be held for each line, and each time a line is restarted. The length of down time prior to such a re-start is usually the subject of contractual negotiation.
Successful completion of PCA is sometimes referred to “qualification of the facility” or “…of the line”, which is an unfortunate overloading of the word “qualification”.