Be Patient, Says Winkle: PAT Standards Development Will Take Time

In her remarks to the ASTM Committee E55 Workshop on Application of PAT to the Pharmaceutical Industry, FDA's Helen Winkle, director of CDER's Office of Pharmaceuticals, noted that the Agency's cGMP Initiative for the 21st Century dictates the need for developing and supporting standards for PAT. However, she also said standards development may be a rocky road and realistically, once developed, standards will take time to implement.

By Helen Winkle, Director, Office of Pharmaceuticals, FDA/CDER

Click the Download Now button below to access this 3-page PDF document.

Join the discussion

We welcome your thoughtful comments. Please comply with our Community rules.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments