The PDA Journal of Pharmaceutical Science & Technology will publish a technical guide for evaluating, validating and implementing new microbiological testing methods for use in the biopharmaceutical and medical device industries. A spokesperson for the Parenteral Drug Association (PDA; Bethesda, MD) says that the organization has not determined the report's publishing date.
Technical Report No. 33 contains methods for validating microbiological test methods with routine laboratory testing environments. Using these methods gives microbiologists and others validating testing reliable work practices for their government-regulated laboratories.
The PDA Task Force on the Evaluation, Validation, and Implementation of New Microbiological Methods drafted the report. This group consists of representatives from test manufacturing, medical device manufacturing, pharmaceutical developers, and standards and regulatory organizations. LMN