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Navigating GDP Regulations for API’s

Examining the shift to monitoring biopharma product quality throughout their lifecycle.

Major market regulators and international standards bodies have upped the ante for control of the end-to-end pharmaceutical supply chain, starting with the ingredients.

In 2015, the EU Commission published Good Distribution Practices for Active Pharmaceutical Ingredients, not just Good Manufacturing Practices.

Mark Paxton, CEO of Rx360, the international consortium for safe supply of medicines, says, “Concern has been growing across all regulatory authorities in all regions about the ability to ensure the quality of drugs and their components as they move in international commerce. Thus, collaboration (between regulatory agencies) has increased out of necessity. Implementation of the EU’s Falsified Medicines Directive in 2012 serves as a catalyst for much of this collaboration.”

The U.S. Drug Supply Chain Security Act (DSCSA) of 2013 is the other major overarching guidance.

Regulatory expectations

Any company procuring, importing, supplying, manufacturing or exporting active substances is required to follow the new EU GDP for APIs guidelines, whose core principles include the following:

• You need a QMS—“2.1. Distributors of active substances should develop and maintain a quality system setting out responsibilities, processes and risk management principles.” The QMS should include deviations from SOPs are documented; CAPAs undertaken to correct and prevent deviations; and changes that may affect storage and distribution of active substances are evaluated.

• You need Quality Agreements—“6.12. Where storage or transportation of active substances is contracted out, the distributor should ensure that the contract acceptor knows and follows the appropriate storage and transport conditions.”

• One QP responsible—“3.1. The distributor should designate a person at each location… that should be trained on the requirements of GDP for active substances.”

• Effective temperature monitoring—“5.1. Monitoring devices that are necessary to guarantee the quality attributes of active substances should be calibrated according to an approved schedule against certified traceable standards.”

• Prove temperature control in your facilities—“6.4. Active substances subject to specific storage measures, e.g. narcotics and products requiring a specific storage temperature or humidity, should be immediately identified and stored in accordance with written instructions and with relevant legislative provisions.”

Dear API supplier: Where is your QMS?

Today’s APIs have strict temperature monitoring, analytic testing and quality control requirements. Most shipments contain little QC information accompanying the delivery of drug substances to the pharmaceutical company.

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