On 18 October, the PDA published the long time expected revision of the Technical Report No. 33 "Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods". The report focuses on the use of these methods in pharmaceutical, biotechnological and medical device industries to assure product quality. The report covers methods for testing of sterility, microbial limits, environmental monitoring, water and microbial effectiveness. Furthermore it includes methods for microbial characterization and identification and in-process control.
The technical report addresses staff who is involved in implementation and validation of microbiological test methods. This includes microbiologists and validation specialists in the laboratory as well as suppliers of testing equipment and laboratory managers and supervisors. Amongst these, it will be of interest for those responsible in quality control and regulatory agencies.
The aim of these report is to establish industry-wide criteria on what constitutes an acceptable alternative microbiological method to the compendial method and how to prove it to fulfill expectations of quality organizations as well as regulatory authorities.
The report is structured in 7 chapters covering the following topics:
Together with the current revision of the EP chapter about Rapid Microbiological Methods, the TR 33 will be an important step forward to establish modern microbiological methods in the GMP regulated industries.
The complete report is available on the PDA website.