GMPs for Excipient Makers Move Ahead

The FDA is edging toward requiring pharmaceutical excipient makers to adopt quality systems and has collaborated with standards development groups in developing an excipients GMP standard.

While the standard is currently voluntary, IPEC Americas and its co-developers — NSF International and the American National Standards Institute — will petition the agency to adopt it as guidance and require drugmakers to enforce it through audits of excipient suppliers.

The standard, NSF/IPEC/ANSI 363, covers everything from cross-contamination to change control, recordkeeping and equipment maintenance. The biggest change from an earlier voluntary IPEC guideline, says Irwin Silverstein, president of IBS Consulting on Quality, is the requirement for conducting risk assessments for the purpose of determining the need for risk mitigation strategies.

Drugmakers should expect their excipient suppliers to have a plan for complying with the new GMP standard by the fourth quarter of this year, IPEC says in a recent position paper. The plan should spell out the timeframe for each manufacturing site to implement the standard.

Communication is key to complying with the new GMPs, IPEC says. Excipient and drugmakers must work together to identify the quality, labeling, legal and regulatory requirements for their products.

They must also spell out requirements for excipient makers’ deviations that could affect product quality.

To prepare for the standard, excipient makers should define how they will assess changes and alert clients, IPEC says. They should also create procedures on how they will handle customer complaints.

The standard also calls for excipient makers to have a documented system for selecting, approving and reapproving their suppliers.

This should include a risk assessment by the quality unit to identify materials and services that could affect excipient quality and track that status from delivery to customers. Excipient makers must also establish a process for tracing excipients to the finished drugmaker. — April Hollis