Standardization News

ASTM International and the Parenteral Drug Association recently signed a memorandum of understanding that launches a pilot program to streamline efforts and conserve resources as both organizations develop technical guidance for the pharmaceutical industry.

The MOU was signed by Katharine Morgan, executive vice president, ASTM, and Richard M. Johnson, president, PDA.

"The MOU between ASTM International and PDA demonstrates ASTM's flexibility and evolution as a solutions provider," says Daniel Smith, vice president of ASTM technical committee operations. "The migration of PDA's intellectual property into ASTM's best-in-class development process is a wonderful example of our commitment to cultivate the highest technical quality technical content into trusted standards of choice worldwide."

Russell Madsen, president of the Williamsburg Groups, a pharmaceutical consulting organization, has worked with both ASTM and PDA. He says, "The MOU is important because it aligns PDA's strengths in producing guidance documents and technical reports with the strengths of ASTM, which produces internationally recognized consensus standards. Many of PDA's technical reports can serve as a basis for ASTM standards, enhancing their value, acceptance and regulatory importance."

Formed in 2003, ASTM Committee E55 on Manufacture of Pharmaceutical Products addresses issues related to process control, design and performance as well as quality acceptance/assurance tests for the pharmaceutical manufacturing industry.

PDA, founded in 1946, is a leading global provider of science, technology and regulatory information as well as education for the pharmaceutical and biopharmaceutical community.