When it comes to being prepared for an inspection from a regulatory authority, the combination of practice and preparation will often make the difference between success and failure. Contract Development Manufacturing Organizations (CDMO) that are routinely successful in these inspections are aware of the pitfalls and obstacles and incorporate a plan for compliance into their company culture. The chances for success increase greatly in those companies where awareness of how to achieve a successful inspection is a priority. And while it is possible that a CDMO could get through one or two inspections, it is unlikely their success will continue if they do not stay abreast of what regulatory authorities are demanding to achieve compliance. Having a regulatory inspection that is a positive experience begins with awareness of the challenges and obstacles, and continues with on-going preparation and frequent inspection readiness practice. Following are some key considerations from a CDMO perspective on how to successfully manage a regulatory inspection.
Be Familiar With The Challenges
The rapid increase in the complexity of drug compounds and, in particular, biotechnology drugs, has led to a significant change in the way the international drug industry is regulated. Implemented policy changes by the FDA and other worldwide regulatory authorities have led to an increase in the number of inspections of sterile contract manufacturers. These inspections have not only changed in their frequency. The actual degree of vigilance by inspectors in certifying that all processes and procedures meet stringent quality control will further increase. This regulation should not be viewed as a negative. After all, increased regulation of the industry has led to even stronger quality control systems, safer medications for the patients who rely on them, and a more positive view of the industry as a whole. Successful companies are those that are aware of, and prepared for, the changes in the regulatory climate and the challenges that must be overcome in achieving a successful inspection.
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