Page 90 - Assurance of Sterility for Sensitive Combination Products and Materials

76 Assurance of sterility for sensitive combination products and materials

3. Develop and use the best methods available and feasible to control process vari-
ability. Design and choose contamination control strategies and actions
that best match the contamination control objective. Do not merely try
to monitor or validate risk out of a process. Instead, design controls and
technology into the process that reduce risk and address process weak-
ness and variability. Traditional methods of process control that might
have appeared to be adequate in the past may not be the best methods
available for modern aseptic process controls. Challenge the status quo
and strive to innovate. Use the data and information obtained from risk
assessments to help drive process improvement.
4. Be cautious of the unintended consequences on process control measures. Actions
may have both intended and unintended consequences. There may be
residual, new, or additional risk, as a result of the unintended conse-
quence of that change.
5. Understand the metrics for success. Know the relationship between what
can be tested and monitored and the desired or the undesired outcome.
Be prepared to interpret and act on the data obtained from monitoring
and testing to improve the process. Analysis of trends, even where those
results do not exceed limits, may provide valuable predictive contami-
nation control information. Use technology and new approaches where
they are available. Even the best processes can be improved.
Exciting new innovations in the biotechnology and personalize medi-
cine areas are challenging the “status quo” of aseptic processing to the limits.
Industry and regulators need to embrace technology to enable patients to
benefit from these advances. The convergence between high tech (advances
in modeling, simulations, and data management), biotech (genetic engi-
neering) with changes in the regulatory environment has created a tre-
mendous opportunity to create new treatment options while minimizing
sterility risk to the patient using aseptic practices.

References
[1] US FDA: Guidance for Industry and FDA Staff: Current Good Manufacturing Practice
Requirements for Combination Products, January 2017.
[2] US FDA: Title 21: Food and Drugs PART 3—PRODUCT JURISDICTION Subpart
A—Assignment of Agency Component for Review of Premarket Applications.
[3] US FDA: Guidance for Industry: Sterile Drug Products Produced by Aseptic Process-
ing—Current Good Manufacturing Practice, September 2004.
[4] EMA, EudraLex, the rules governing medicinal products in the European Union, in:
EU guidelines to good manufacturing practice, medicinal products for human and
veterinary use, vol. 4, November 2008. Annex 1.