1. What is the acceptable media fill frequency in relation to the number of shifts? Normally, media fills should be repeated twice per shift per line per year. Is the same frequency expected of a process conducted in an isolator?A firm’s justification for the frequency of media fills in relation to shifts should be risk […]
Figure: Aseptic filling operation Assessment made based on the FDA 2004 Aseptic guidance: 1. Initial clean room qualification includes, in part, an assessment of air quality under as-built, static conditions. A. True B. False 2. Air in the immediate proximity of exposed sterilized containers/closures and filling/closing operations would be of appropriate particle quality when […]
Process simulation studies (media fills) are simulating the whole process in order to evaluate the sterility confidence of the process. Process simulation studies include formulation (compounding), filtration and filling with suitable media. Simulations are made to ensure that the regular process for commercial batches repeatedly and reliably produces the finished product of the required quality. […]
Air pattern or “smoke” studies demonstrating laminarity and sweeping action over and away from the product under dynamic conditionsshould be conducted. The studies should be well-documented with written conclusions. Videotape or other recording mechanisms have been found to be useful in assessing airflow initially as well as facilitating evaluation of subsequent equipment configuration changes. However, […]
Now a days the topic “Data integrity and non compliance” is the hot topics. Lots of references available online that deals with the Data integrity issue. One of the major example am going to give today, that can be control by the management only. Extended shift/working hour or over time:We know that “Human error” is the […]
Why inspection ? • To assess & evaluate the ability of a facility to manufacture quality products which consistently meet specification and regulatory requirements. • To confirm and assure the validity of: Identification, traceability and integrity of lots Manufacturing & packaging procedures Analytical methods • Confirm that the procedures, processes and methods described in registered […]
Software Classification Categories Comparison of software categories in GAMP 4 and GAMP 5 As I mentioned earlier, the software categories in GAMP 5 have been revised. To appreciate the scope of these changes fully we need to look at the classification of software from GAMP 4 and compare this with GAMP 5. In the beginning, […]
We know the available elements of ALCOA. We will discuss latter on the ALCOA topic. But currently we want to emphasis on the issue why we are getting this issues? Data integrity no only the problem of a specific organization, reflects how country are acting on the integrity issue. It will give very bad impact […]
Interview for the position of manager position in QA for aseptic formulation plant: 1. What is the interpretation between Re-Qualification and Performance re-qualification? Re-Qualification considered with again qualify the system/equipment in terms of IQ, OQ and PQ. Performance Re-qualification means revisit or re-verification of established limit within specified periodic interval. 2. Other […]
Now a days the pattern of interview is very interesting in pharma industry. The main argument comes with following points, Expected designation Experience Expected salary Expected Stability As we know the vertical is different from organization to organization. Normally the company followed below mention designation Trainee officer/ technical trainee: It is the initial or […]
