Trained staff key to manufacturing QC
control, the key to avoiding non-compliance notices lies in
well-trained, knowledgeable personnel, says new report.
As the US Food and Drug Administration and other regulatory bodies increase their scrutiny of manufacturing and quality control processes, the key to avoiding damaging non-compliance notices lies in creating well-trained, knowledgeable teams of personnel, according to a study from pharmaceutical research firm Best Practices.
"The FDA has recently cited manufacturers for a variety of deficiencies in quality control, such as data handling, computer system validation, and manufacturing review processes," according to the report. "These deficiencies have resulted in extraordinary attention being placed on companies' quality functions, and missteps in this area can potentially lead to manufacturing shutdowns by the US government, severely impacting product launch, supplies, patient health and corporate profitability."
The new study, entitled 'The Quality Function: Structures, Staffing and Execution', holds up as a role model one pharmaceutical drugmaker which ensures it has well-trained staff by requiring candidate quality auditors to follow a three-month training period with certified auditors to gain experience. Following training, auditors also undergo compulsory refresher courses annually.
Among the findings of the report are that training and certification programmes pay dividends in terms of keeping employees up-to-date on developments in the QA/QC field. In addition, it advises companies to switch from a reactive approach to quality problems in production to one which seeks to identify problems before they occur.
"Building an effective auditing function requires going beyond merely identifying issues with batches before they leave the plant. While this is a crucial task, successful auditing functions also uncover larger systemic problems and monitor improvement efforts," according to Best Practices.