Your Quality Assurance (QA) and production departments failed to provide adequate oversight and ensure the reliability of data related to the quality of finished drug products manufactured at your facility.
Since 2021, visual inspectors manipulated particle and other defect counts on manual visual inspection records in many instances, in order to keep the finished product batches within rejection limits.
More specifically, the investigation found that operators manipulated the defect quantities “to keep the category wise rejections within limits to avoid a deviation and investigation.”
In addition, multiple operators manipulated the reported defects, including (b)(4) attributes and particle counts, on manual visual inspection records to have identical numbers.
This practice was repeatedly performed by at least nine different manual visual inspectors on trays of (b)(4). The records, filled out by multiple operators, had an identical number of defects listed for all drug product defect categories.
Production managers including, but not limited to, front line supervisors failed to ensure reliable data, leading to significant data integrity deficiencies in your production records.
In addition, there was a lack of QA department review and oversight of visual inspection records, and your firm continued this egregious pattern of recording and altering defect counts. These findings indicated that your QA department was not exercising its basic responsibilities including, but not limited to, oversight and control over the adequacy and reliability of all CGMP data at your facility.
The reason is the Quality Culture Problem. This is done due to the following;
1.To save money. Maybe to save financial losses.
2. To save time.
3. Avoiding the QMS procedures.
4. To meet the timelines.
5. Due to the pressure of deliverables.
The company got a Warning Letter.
Compliance is more beneficial than non-compliance and Data Integrity.
When you make the strategy for 2024 keep in mind that Compliance is to be prioritised above non-compliance.
If you follow Compliance you will be developing the systems that will give you profit in your business and if following compliance is your habit you will reach compliance paradise......
1. List down the non-compliance problems on your site.
2. Make a plan to solve these.
3. How you will prioritize compliance over non-compliance in upcoming year 2024?