Microbiologic validation protocol

The Validation Team has overall responsibility for validating the facility. The Quality Assurance Manager has responsibility for approval of all validation protocols, final reports, standard operating procedures, chemical and microbiological testing, as well as other critical cGMP documentation. 

The modified ITT, where unqualified patients are excluded, and patients with clinically and or microbiologically documented infections (as stated in the protocol), who have received at least one dose of the investigated drug thus addressed, is particularly valid for regulatory purposes. ... 

A validation programme should be co-ordinated by a multidisciplinary committee comprised of the different functions that are involved in the programme. Typically, the members of the validation committee would be drawn from departments such as production, quality assurance, microbiological and analytical quality control, pharmaceutical development, engineering, and maintenance. The committee approves and issues written protocols, and reviews the data obtained in order to approve or reject the programme results. 

Rault A, Gaudin V, Maris P, Fuseher R, Ribouchon JL, Cadieu N, Validation of a microbiological method The STAR protocol, a five-plate test, for the screeiung of antibiotic residues in milk. Food Addit. Contam. 2004 21 422-433. 

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