“Fixing problem “is the main activity at pharmaceutical industry now a day. Rather than manufacturing medicine, we are focusing on the failure investigations, root cause identification, CA-PA implementation & effectiveness verification. When a facility or a product is designed, the risk based approach not followed. Maximum problems observed during tech transfer from R&D to commercial manufacturing. […]
The Indian pharma industry is on a good growth path and is likely to be in the top 10 global markets by value by 2020. High burden of disease, good economic growth leading to higher disposable incomes, improvements in healthcare infrastructure and improved healthcare financing are driving growth in the domestic market. Pharma companies are […]
New era of Indian Pharmaceutical industry is going to begin. Major regulatory pharmaceutical companies are under USFDA alert. Repeated/similar observation are reported against data integrity and GMP practices. Now a day’s process are dependent on the human being, however transition from human to automation is very high. But it is not like that automation can […]
One of the most critical operations in pharmaceutical manufacturing is the processing of sterile products. The production of sterile products, specifically the ones that cannot be terminally sterilized,involve complex and demanding processes to prevent the products’ contamination and require a great amount of resources. The objectives of review includes: Obtain information on operations impacting on […]
Few facts about Dynamic Pass Box Through this blog we will be providing you the qualification and routine maintenance of dynamic pass boxes in your critical and non critical area. As per the industrial practices some time we do more than the requirement and that create an additional burden for us. Rather than doing extra […]
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 […]
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 […]
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
