Risk based approach is a systematic process established to encourage adoption of new technologies, modern quality management techniques, quality system approaches and regulatory reviews/inspections. It also enhances the consistency and coordination of the regulatory agency’s product quality regulatory programs to all aspects of pharmaceutical production and quality assurance. These concepts easily ties in with the concept established by the ICH Q7 under the good manufacturing practices (GMPs). The concept of current GMP guidelines is to establish the production and testing practices in manufacturing industries in order to ensure a “quality” product (Whitmore, 2004). In manufacturing terms, quality is a measure of excellence or state of being free from defects, deficiencies and significant variations (Business dictionary, n.d). Thus, risk based approach in GMP enforces strict and consistent commitments to established standards and guidelines to achieve uniformity, reproducibility of the product in question in order to satisfy specific customer or user’s requirements. Therefore, it is safe to imply that set standards may define quality as the completeness in feature and characteristics of a given product’s ability to satisfy stated needs.

The ICH quality guidelines emphasize on stability studies, defining of relevant threshold for impurities testing and more flexible approach based on risk management (ICH, 1997). The flexibility approach opens up rooms for different interpretations of the guidelines by different pharmaceutical industries and institutions. Nonetheless, in all cases, maintaining product integrity is desired. Hence, “The guiding principle for GMP is that quality cannot be tested into a product, but must be design and built into each batch of the drug..” (NG, 2009, Pg 279).  Therefore, quality assurance tests can assure the quality/integrity of a product (from the discovery, pre-clinical, clinical trials to the manufacturing phases). In addition, the FDA’s 21 CFR part 610 indicated the need for ensuring potency, quality test e.t.c before a product is released in the market.
Furthermore, considering Heparin (2008), Diphtheria (1902), Polio vaccine (1955) and Exubera (2007) faulty/withdrawal scenario, makes it clear how complicated a risk-base approach consequences could be misinterpreted or misleading for the lack of a better word, based on quality (NG, 2009). The 1902 diphtheria and the heparin situation had contamination issues, and the polio vaccine of 1955 had incomplete inactivation issue. These faulty errors (product defect) is due to lack of proper industrial manufacturing processes and probably due to lack of strict oversight in maintain the GMP integrity or quality of medicinal products that otherwise could produce efficacious effect. On the other hand, considering the exubera scenario seems to be different from the manufacturing quality control/assurance or risk base approach to GMP but rather one which is doomed from the onset (lack of better GLP, GCP and handed down to GMP). Besides the fact that exubera did not meet the Pfizer’s billions of dollars targeted revenue, it has several problems such as high cost, confused dosage calculation, cumbersome inhaler, and possible pulmonary function problems etc (NG, 2009). Hence, the exubera’s problem is not a production or GMP deficiencies or defect in a sense, but a clinical trial and product design error, which could have been corrected if the clinical trials were designed and conducted appropriately.
Finally, the risk based approach to GMP is very essential in the sense that it allows the regulatory agency the opportunity to inspect the manufacturing site. It also allows the agency the power to fine manufacturers that fail to abide by the guidelines (NG, 2009). Adoption of these practices will assure manufacturing integrity of a product. It will also allow the incorporation of GMP strategies in the discovery phases of a product. However, it will not make a product safer or more efficacious if the product lacks such effects from the beginning (assuming that the discovery, preclinical and the clinical trial did not represent/test the product fairly).

References

Business dictionary. (n.d). Quality. Retrieved from http://www.businessdictionary.com /definition/quality.html.

International Conference on Harmonization. (1997). Quality Guidelines. Retrieved from http://www.ich.org/products/guidelines/ quality/article/quality-guidelines.html.

NG. R. (2009). Drugs: From discovery to approval (2nd ed.). Hoboken, NJ: Wiley-Blackwell.

Whitmore, E. (2004). Development of FDA-regulated medical products: Prescription drugs, biologics, and medical devices. Milwaukee, WI: ASQ Quality Press.