The PDA Technical Report No. 88 presents a holistic approach for performing a microbiological investigation. It provides a framework to assist with focusing on the investigational areas that may contain or contribute to the root cause of data deviations, such as sampling, test methodology, and suitability of the test, as opposed to providing methods for analysis of batch acceptability.
The distinct areas where microbial data is collected and inspected for deviation investigations are the focus of this document, including:
1) Roles and responsibilities of personnel, especially microbiologists, in the laboratory investigations and cross-functional teams responsible for manufacturing investigations
2) Conducting laboratory investigations
3) Conducting manufacturing investigations
The roles of other contributors to deviation investigations required for effective root cause analysis, such as representatives from manufacturing, process engineering, and quality assurance, are also briefly described.
This technical report promotes a lifecycle approach, but greater emphasis is placed on laboratory and manufacturing investigations of marketed drug products.
As a non-member of PDA, you can purchase this technical report for $325. Or, you can join PDA by 13 February for only $279 and download your personal digital copy for FREE! And, when you become a PDA member, you will gain on-demand access to the entire online library of more than 90 peer-reviewed Technical Reports—valued at more than $10,000. This is an opportunity you cannot afford to pass up—join PDA for less than the non-member price of this Technical Report and gain access to all technical reports and technical documents and a wealth of other members-only benefits. Be sure to join by 13 February to gain FREE access to Technical Report No. 88 (TR 88): Microbial Data Deviation Investigations in the Pharmaceutical Industry .