Regulatory observations (483) over past years has forced quality executives to be on their toes. The top 5 key issues for 2016 are related to inadequate procedures and investigations, laboratory controls and aseptic processing.
1. Procedures not in writing and fully followed.
2. Lack of scientifically sound laboratory controls.
3. Thorough investigation of discrepancies and failures.
4. Absence of written procedures.
5. Deficient environmental monitoring system.
How can these be prevented?
Establishing a culture of quality is critical to prevent some of these issues. The mindset of companies should be not to start any task until SOP is effective and to always follow procedures.
A robust training program on conducting investigations and aseptic processing as a new employee orientation is a must to ensure product quality and patient safety.
Laboratory controls issues can be prevented with robust method development in R&D. Most of the time, all the required data is not collected during method development to support the investigations conducted during manufacturing, resulting into inadequate justifications. This should be followed by training, routine internal audits and standardization in quality laboratories, such as creating a guideline or standards for method validation, stability etc.