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While advances in chemocatalysis for chiral synthesis continue apace, many companies have focused attention on the development of a wider array of enzymes that can be used under commercial manufacturing conditions for the selective conversion of various substrates into more complex intermediates.

The recovery of an occasional mold does not merit any particular concern. On the other hand, evidence of mold proliferation indicative of infection of facilities or equipment must be taken seriously and requires the prompt implementation of corrective and preventive actions.

PTSM: Pharmaceutical Technology Sourcing and Management

Quality is a matter of culture more than metrics. In this opinion article, the author presents arguments for an FDA Dean's List as a means to nurture a quality culture within the industry.