Responding to Observations - - BioPharm International

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Responding to Observations


BioPharm International


The committee is also responsible for determining the priority of each observation and assigning individual managers or functions to implement each item and report back. Status reports should be given weekly or monthly based on the severity of the issues.

To assist in reporting, design an internal system to track the status of each observation and monitor actual completion dates. Compare the completion dates to the commitment dates. Most large companies use corrective and preventive action (CAPA) systems for this purpose, but a spreadsheet also works. When using the CAPA system or developing the spreadsheet, consider the number of observations, the size of the company, and the number of people involved in resolving each issue. If the data are stored electronically, back up your observation monitoring system regularly. Eventually, the system should provide real-time status reports.

Lessons learned. Finally, develop a "lessons learned" document. This document will provide an overview of the entire inspection, explain the thought processes behind the decisions made, and identify strengths and weaknesses. Talk to individuals involved in the inspection, and get their feedback on areas of improvement. Publish this "lessons learned" document internally, and ask employees, "What would you do differently if you had to go through the inspection all over again?" Chances are they will have to apply their responses in the next inspection.

Turning Lemons into LemonadeWhen faced with a difficult issue or problem, turn it into something positive. Biopharmaceutical companies need to look beyond enforced compliance and be aware of the residual benefits of an audit, like these.
  • Employee productivity improves as a result of better and more frequent training initiatives.
  • The implementation of new computer systems and manufacturing equipment can reduce overhead costs.
  • Documentation and process improvements can lead to more efficient operations.
  • Breakthrough ideas can change industry standards and lead to new scientific and technological advancements. BPI


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