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 […]
1. Put a weight machine to measures paper waste in QA…to check how many paper we shredded per months.. May be tons off.. 2. Build awareness among the people by showing the data.. 3. Make a campaign to reduced the waste.. That not only for the organization, for society also..because Good Health can’t wait.. 4. […]
Web presentation is an innovative idea to share pharmaceutical Knowledge, following PPT’s are updated currently 1. QRM – On Quality Risk Management 2. Make your company presentation 3. A brief review on HVAC system [youtube=https://www.youtube.com/watch?v=3UQL-J2YedE&w=320&h=266] http://www.slideshare.net/PalashDas10/slideshelf
Audit is always additional headache for Pharmaceutical industry. People from lower level to higher management are afraid for any regulatory audit. But facing of audit is not like a rocket science. As we are working for our organization same way auditors are working for their regulatory authority. We are the knowledgeable fellow of our organization, […]
What is a DMF? Ans- A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Important facts regarding DMFs It is submitted to FDA […]
Like procedures, protocols, methods, and specifications, documents provide instructions to perform tasks and make decisions safely, effectively, compliantly, and consistently. Records such as batch manufacturing records, cleaning logs and laboratory data sheets and notebooks provide evidence that actions were taken and decisions were made in keeping with procedures and GMP expectations. Reports are yet another […]
Observation 1 Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards The firm inspected lacked accurate raw laboratory data records for batches of API that were shipped. The inspection revealed that batch samples were retested until acceptable results were obtained. In addition, Quality Control (QC) […]
