Planning and pre-testing are keys to successful validation.

Validation of a critical or precision cleaning process is a good idea whether or not there are specific regulatory requirements to do so. A validated cleaning and contamination control process is important in placing you above the competition.

Consider yourself to be your own customer. A validated method provides an updated benchmark, a statement that says, “here is how the process works, and here is the measure of how well it works.” Any material or process changes that occur subsequently can be compared to this benchmark.

DETERMINING RESIDUE
It is important to determine and explain the rationale for your selection of the appropriate tests and procedures. We know that “zero” residue is an unachievable and unnecessary fantasy.

Establishing a “safe” level of any surface residue may require risk analysis.^1,2,3 The U.S. FDA and international agencies (Fig 1) are increasingly emphasizing the importance of risk-based analyses for food, drug, and medical device acceptance. ASTM Standard E2500⁴ adopts the FDA guidelines for pharmaceutical manufacture. ⁵