Early clinical batches may be produced in laboratory equipment as opposed to plant facilities because of limited batch size requirements. What are the expectations for environmental controls in laboratory facilities versus pilot plant?

Section 19.3 states that “procedures for the use of facilities should ensure the materials are handled in a manner that minimizes the risk of contamination and cross-contamination”. There are no absolute requirements for room classification or other environmental controls. Regardless of whether the API is made in a laboratory, pilot plant or commercial manufacturing facility, appropriate controls should be in place to minimize the risk of contamination.