PDA is very pleased to announce the launch of the Parenteral Drug Association’s fourth standard! We are seeking volunteer participants to assist in developing, writing, and fine tuning the following proposal:
Phage Retention Nomenclature Rating for Small and Large Virus Retentive Filters (new standard).
Virus retentive filters are a key product safety tool to ensure that biopharmaceuticals and plasma derived medicines are safe from viral contamination. This is a practical standard approach to categorizing virus retentive filters. This initiative would benefit the filter industry, end users, regulators, and patients. It would help improve biotech and plasma derived product manufacturing and reduce risk to patients from a viral safety perspective.
This proposed American National Standard (ANS) was presented by Dr. Kurt Brorson, Vice President, Technical, PAREXEL International.
Those individuals involved in:
- Filter firms,
- Biotech firms,
- Plasma derived product manufacturers,
- Quality Assurance,
- Process Virology,
- Operations,
- Production, and Manufacturing,
- MSAT and Process Development,
- Engineering and Maintenance,
- Validation,
- Consultants,
- Regulatory,
- International Health Authority Reviewers and
- Inspectors are being sought.
Nominations/Volunteers to serve as a member of the technical team (consensus body) must have some subject matter expertise, and willing to help write/contribute to this standard. Applicants should apply by contacting the PDA Standards Manager at standards@pda.org. The deadline to submit notification of interest in serving on the consensus body is May 31, 2019.