How Often Should GMP Controlled Temperature Units be Requalified?

Determining the appropriate requalification interval and testing approach used on GMP Controlled Temperature Units depends on numerous factors. The Code of Federal Regulations Title 21 §211.68(a) states that: “Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained.” The “shall be routinely... checked...to assure proper performance” part of that statement clarifies that CTUs do require more than an initial qualification and expects that a lifecycle approach is implemented to maintain compliance.

Chambers • Qualification