Environmental Testing : Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers

Overview:

Industrial sterilization and contamination control programs are critical in pharmaceutical and medical device manufacturing. This article by Microtest Labs reviews the key elements of a best practice environmental testing program, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments. In this paper, the author draws on his extensive experience assisting clients with program development. He reviews strategies that range from the essentials of compliance to budget development and management.