Quality Systems for Drugs and Biologics - Pharmaceutical Technology

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Quality Systems for Drugs and Biologics
FDA is modernizing and streamlining current good manufacturing practices. The author examines FDA's evolving approach to quality systems and how a manufacturer can implement a quality system framework.

Pharmaceutical Technology

Internal audits should be conducted according to planned intervals for evaluation of implementation, maintenance of the quality system, and determination of whether processes and products meet established parameters and specifications. Although the CGMP regulations require product review on at least an annual basis, a quality-system approach calls for trending on a more frequent basis as determined by risk. Trending analysis can help focus internal audits.

An internal audit procedure should be established. It should call for a planned audit schedule that takes into account the relative risks of the various quality-system activities, the results of previous audits, and corrective actions. There is an obvious need to audit the complete system. Be sure to include a section on how auditors are trained in evidence gathering, their responsibilities, and auditing procedures. It is critical to maintain records of audit findings and assign responsibility for follow up to prevent problems from recurring.

Quality risk management is a reiterative evaluation process and a tool in development of product specifications and critical process parameters. It also helps manage and control change.

Corrective action is a reactive tool to ensure problems do not recur. Effective decision making in a quality system environment is based on an informed understanding of quality issues. The corrective action procedure should be developed and documented to ensure that the need for action is evaluated, the root cause investigated, actions determined, selected action is taken within a defined timeframe and the effectiveness of the action taken is evaluated.

A preventive action process is an essential tool in quality system management. The selected preventative action should be evaluated, recorded, and monitored. Improvement should be promoted, and senior management should be involved. Being proactive is an essential tool in quality system management. Examples are succession planning, training, capturing institutional knowledge, and so forth.


It will take a long time and a lot of work to complete the change. However, companies simply can't afford to sit on the sideline and wait for the new paradigm to be better defined before taking action. FDA's Quality Systems train has left the station and the effects are already being seen in enforcement actions.


1. FDA, CGMP for the 21st Century, available at http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm , accessed Jan. 7, 2008.

2. FDA, Quality System Regulation for Devices, 21 CFR Part 820 (1996).

3. ANSI/ISO/ASQ Q9001-2000, Quality Management Systems—Requirements (American Society for Quality, 2000).

4. ISO/DIS 13485 (April 1996).

5. FDA, Process Analytical Technology (PAT) Initiative (2002), available at http://www.fda.gov/Cder/OPS/PAT.htm, accessed Jan. 7, 2008.

6. I. Maes and B. Van Liederkerke, "The Need for a Broader Perspective if Process Analytical Technology Implementation Is to be Successful in the Pharmaceutical Sector," J. Pharm. Innovation, (Sept./Oct., 2006).

7. FDA, Quality Systems Approaches to Pharmaceutical Current Good Manufacturing Practice (CGMP) Regulations (Sept. 2006), available at http://www.fda.gov/cder/guidance/7260fnl.htm, accessed Jan. 7, 2008.

8. CPGM 7356.002 Compliance Program—Drug Manufacturing Inspections, available at http://www.fda.gov/cder/dmpq/compliance_guide.htm.

9. FDA, Q8 Pharmaceutical Development (May 2006), available at http://www.fda.gov/cder/guidance/6746fnl.htm.

10. FDA, Q9 Quality Risk Management (June 2006), http://www.fda.gov/cder/guidance/7153fnl.htm.

11. Pharmaceutical Manufacturing Research Project—Final Benchmarking Report (Sept. 2006), available at http://www.olin.wustl.edu/faculty/nickerson/results/.

12. G. Cokins, Quality Progress (Sept. 2006), definition is from the article entitled "Measuring the Cost of Quality For Management", available at http://www.asq.org/qualityprogress/past-issues/index.html?fromYYYY=2006&fromMM=09&index=1, accessed Jan. 22, 2008.

13. P.B. Crosby, Quality is Free: The Art of Making Quality Certain (McGraw-Hill, New York, NY, 1979 and Mentor Books, Denver, CO, 1992).

Andrew G. Edwards is a senior consultant at EduQuest, 1896 Urbana Pike, Suite 14, Hyattstown, MD 20871, tel. 301.874.6031, fax: 310.874.6033,

What would you do differently? Email your thoughts about this paper to
and we may post them on pharmtech.com.

For more on this topic, see:
FDA Moves to Implement New GMP Policies|~www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/452004/132382/article.pdfNov. 2004
Out of Specification Results and the Quality System Approach to GMPsSept. 2006
ICH-Q10: A Recipe for the Product LifecycleSept. 2007

Submitted: Aug. 6, 2007. Accepted: Nov. 26, 2007


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