Technical Tip

Introduction to Regulatory Resources

Government regulatory agencies and industry organizations develop guidelines to ensure pharmaceutical and biotechnology manufacturers have robust cleaning processes. This article will provide an overview of resources related to cleaning validation in the pharmaceutical and biotechnology industries.
July 23, 2021

Key Takeaways:

  • Cleaning validation in pharmaceutical and biotechnology industries is governed by global regulatory agencies, including the FDA, EMA, PMDA and WHO, all of which require documented evidence of contamination control and residue reduction.
  • Current Good Manufacturing Practices (cGMPs), particularly 21 CFR Parts 210 and 211, form the regulatory foundation for cleaning validation in the U.S., with similar standards adopted globally.
  • Industry organizations like USP, ISPE and PDA provide detailed technical guidance, including USP <1111>, <61>, <797> and PDA Technical Reports 29 and 49, to support cleaning validation and contamination control.
  • ISO 9001:2015 and Risk-MaPP (ISPE) frameworks help manufacturers implement quality management systems and risk-based approaches to cross-contamination prevention.
  • A robust cleaning validation program must integrate regulatory expectations, industry best practices and technical expertise, ensuring product safety and compliance across global markets. 

Global government agencies oversee select industries to confirm manufacturers follow regulations designed for consumer safety. Food processing facilities, dairy farms, vaccine and drug manufacturers, and blood banks are among those industries inspected to protect consumers from unsafe products (FDA, 2021). The pharmaceutical and biotechnology industries produce life-saving drug products for “use in the diagnosis, cure, mitigation, treatment, or prevention of disease” (FDA, 2021). These industries control manufacturing and cleaning processes to the highest level to ensure the health and safety of consumers.

Government regulatory agencies and industry organizations develop guidelines to ensure pharmaceutical and biotechnology manufacturers have robust cleaning processes. This article will provide an overview of resources related to cleaning validation in the pharmaceutical and biotechnology industries.

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