Micromeritics Receives Positive Independent Audit Findings - 7/07/2003
The purpose of the audit was to determine if Micromeritics meets the quality guidelines specified by the FDA. The FDA challenged the industry to establish a standard way to assess suppliers so as to infer the structural integrity of acquired computer products, e.g. software, and to lower overall costs to the industry. The criteria checklist used was developed by PDA (International Association for Pharmaceutical Science & Technology).
The audit findings in the quality section found that Micromeritics:
• Is a ISO 9000 certified company and performs mini audits every 3 months and major audits every 3 years
• Has in place procedures that support the ISO 9000 certification and evidence of use was observed
• Performs internal audits on all quality functions
• Maintains Quality Improvement Teams to constantly monitor quality and seek ways to improve success.
The Software and Hardware Methodology portion of the audit determined that Micromeritics has processes in use for documenting product development.
These findings represent confirmation of Micromeritics’ continual effort to meet or exceed manufacturing standards for analytical instruments used in the pharmaceutical industry.