Manufacturers to get insider tips from big guns

The Best Practices report "The Quality Function: Structures, Staffing and Execution" reflects the increased regulatory scrutiny pharmaceutical companies have to face in regards to their manufacturing operations. With the US Food and Drug Administration (FDA) recently citing manufacturers for a variety of deficiencies in quality control, while also releasing a number of guidelines to improve manufacturing quality and safety, the Best Practices report goes some way in giving companies an insight into tightening processes to keep out of the FDA's bad books and possible plant closure. Executives from Abbott, Eli Lilly, GlaxoSmithKline (GSK), Johnson & Johnson, Wyeth, Alcon and medical device company Medtronic were all interviewed with the final report comparing the companies' structure, staffing, roles and responsibilities, and what factors were attributed to the companies' success. The key findings in the report included a focus on training and certification programs, creating a proactive culture by systemizing quality principles, and strengthening auditing roles to solve problems internally before regulatory difficulties occur. One of the insights in the report was: "Savvy companies recognize that quality auditors can prevent internal issues from becoming external problems for a manufacturer. When correctly trained, auditors can proactively identify potential problem areas and start the improvement process long before a regulatory action or patient safety issue emerges."​ All manufacturing employees at "Company C" complete 12 standard training modules, regardless of job position, the report stated. Another insight was: "Successful companies integrate quality checks into the process on an ongoing basis. Companies have found that effectively training and preparing production personnel for a task reduces the amount of quality oversight required. By ensuring manufacturing employees understand aspects they control that can affect the overall quality of a batch, companies reduce the need for constant oversight by the quality staff." ​ One company used a flowchart idea to outline the manufacturing process and to highlight the hazards. Each potential hazard became a checkpoint on a checklist and was ticked off if it passed the necessary quality measures. Another company was moving away from floor auditing of its manufacturing operations and toward having quality review manufacturing records, the report stated. In October last year, the FDA released guidelines for Quality Systems Approaches to Pharmaceutical Current Good Manufacturing Practice (cGMP) Regulations. The guidance explained the FDA's opinion of cGMP at the current time since it was issued in 1978 and how companies could comply with the regulations.