FDA AUDIT NOW TARGET ON :- EXTRA WORKING BEFORE AUDIT

If you soon going to face any audit... Read and share with your colleague...
Most important

Over time or extra working hours issues.

Thursday, August 25, 2016

Untouched area of Data Integrity in Pharmaceutical Industry

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 "Risk" for GMP. For this reason we always induced technology/automation every where and try to reduce the human intervention as much as we can.

Because Human being are driven through emotion & sentiments. Mental peace and physical relaxation is just like preventive maintenance for human being. Usually we use to send our automobile for maintenance with defined interval, same our body deserve too.

We know that during audit preparation or other priorities we need to stay for extended hour. But if it is a regular or routine job then it caused frustrations and from where the chances Non compliance or data integrity begins.

We should not consider this as one of the reason of Data Integrity. Otherwise we cant able to track and rectify the real reason for non conformance. we should focus on the time management and as a part of audit we should verify the attendance log.

For Example: One of the major regulatory body ask for the attendance registerd for emplyee before one week of proposed audit date and they found that majority of people are staying more than 12 hr in the organization. Same has been came as an major observation and they ask for a justification from management. Why emplyees are started staying for an extended hour before audit.