FDA updates the Pharmaceutical Manufacturing Inspection Compliance Manual with remote assessments and examples of advanced quality system indicators

On September 16, the U.

Today we take a look at CPGM 7356.

The revised CPGM adds information that FDA may enter into agreements with foreign regulatory agencies to recognize the drug inspections it performs if it determines that foreign regulatory authorities are competent to perform inspections

The FDA notes that as part of its overall approach, the FDA may use other sources of information to assist in assessing the compliance of the facility's facilities, including 1) other inspections performed by the FDA (e.

The new CPGM emphasizes the goal of gaining insight into the effectiveness of pharmaceutical manufacturers' quality systems, noting that "this may contribute to understanding plant practices that not only support meeting CGMP compliance requirements to establish and maintain robust control status, but also promote a quality culture

The FDA writes in the newly revised CPGM that "a robust quality system relies on robust records and strong oversight by senior management over CGMP operations and quality-related matters, supporting and facilitating activities under all six systems, monitoring the effectiveness of the quality system, and ensuring commitment to

The manual states that the quality system (usually described in the quality manual of the enterprise) should provide effective senior management oversight of the quality of the drug and support the quality department of the

On the basis of traditional quality system inspections, the FDA states that quality system inspections should also cover contract outsourcing operations and quality oversight of material suppliers; Management's oversight of the establishment, implementation, monitoring and continuous improvement of the quality system; Quality risk management program; and product audits

After the inspection, if the inspection of an enterprise that has been approved with established conditions (EC) is classified as OAI (official action required) and there are significant concerns about the quality system, in particular the change management system, the offices of the Center for Drug Evaluation and Research (CDER) will collaborate to assess the potential impact

The FDA states that manufacturers can demonstrate proven quality practices that, if implemented effectively, can provide the basis

The FDA lists some examples of advanced quality systems in Appendix B:

Management Responsibilities o Communication and reward system for employees to bring quality issues to management's attention

o Monitor external regulatory and business environment to identify unexpected quality risks

o Improve employee understanding, belonging and engagement, resulting in a company-wide commitment to quality

o Trained all staff on the impact of poor quality on patients

Investigate the effective use of standardized tools (e.

o Actively solicit and analyze customer feedback (not just complaints) related to quality and delivery Training programs o Extensive training of employees in Six Sigma and/or other advanced quality assurance tools to improve process competence Quality supervision o Electronic systems implemented using analytical methods to optimize knowledge management related to products, processes and components

o Continuous improvement program to optimize quality indicators to measure process parameters, product quality monitoring and annual product review o Plan to improve production processes by employing the latest beneficial innovations and technologies

o Use visuals across the enterprise to indicate quality performance status