Section 4.1 states that facilities should be designed to minimize potential contamination and to
limit exposure to objectionable microbiological contaminants, as appropriate, where
microbiological specifications have been established for the intermediate or API. In addition,
Section 8.5 states, “production operations should be conducted in a manner that prevents
contamination of intermediates or APIs by other materials”. However, Q7A does not define
specific environmental specifications for API processing areas or powder handling areas.
Development of such requirements is based upon your own scientific studies and local regulatory
requirements.
