Safety & Quality
Safety and quality of plasma protein therapies is the top priority of the plasma protein therapeutics industry. Both collectors and manufacturers adhere to strict regulatory policies and have instituted Good Manufacturing Practices in every step of plasma collection and manufacturing processes.
Furthermore, PPTA member companies have adopted voluntary standards and other criteria that apply to the collection and fractionation of plasma for plasma protein therapies. These robust programs showcase the industry's commitment to continuous improvement and help to ensure the availability of effective and high-quality plasma protein therapies. Combined, they put quality and safety in the forefront for patients worldwide.
To further improve the quality and safety of source plasma, PPTA developed the International Quality Plasma Program (IQPP) which provides independent, third-party evaluation and recognition of a center's adherence to global industry standards for source plasma.
Established in 2000, the Quality Standards of Excellence, Assurance and Leadership (QSEAL) provides voluntary standards related to the collection, processing, and testing of source plasma by fractionators.
PPTA's voluntary standards program provides global leadership for the plasma protein industry's goal of continuous improvement with a focus on safety and quality from the donor to the patient. The standards program will be transparent, credible, innovative and responsive to stakeholder and industry needs
People around the world depend on therapies derived from human plasma proteins to treat bleeding disorders, primary immune deficiencies, Alpha-1 antitrypsin disease and certain neurological conditions. Plasma protein therapies are also used in emergency and surgical medicine.
Safety of plasma protein therapies is the top priority of the plasma fractionation industry. PPTA, on behalf of its industry members, supports efforts by regulatory authorities to establish minimum requirements to ensure the safety of these products.
Patient notification system
The Patient Notification System (PNS) is a free, confidential, 24-hour communication system providing patients and all other registrants with information on withdrawals and recalls of plasma protein therapies. PNS allows receiving this information directly via email, telephone, text messaging, or fax.
In 1998, the Plasma Protein Therapeutics Association (PPTA) and its members collaborated with patient organizations to develop this first-of-its-kind Patient Notification System (PNS). This system is:
- Easily accessible, comprehensive, and up-to-date with information about all brands of immune globulins, blood clotting factors, alpha-1 proteinase inhibitors, and other lifesaving plasma protein therapies.
- Confidential: all registrants; patients, physicians, family members, nurses, or pharmacists, are guaranteed that their information is never shared nor is it accessible by anyone other than the third-party company that houses the computers to run the system and send the notifications.
Maintaining registrant confidentiality is a primary consideration. To ensure confidentiality, the Patient Notification System is operated by Sedgwick, an independent vendor that specializes in pharmaceutical notifications. All registrant information will be held in strict confidence by Sedgwick.
PPTA designed the Patient Notification System in 1998, working closely with the Alpha-1 Foundation, Committee of Ten Thousand, Hemophilia Federation of America, Immune Deficiency Foundation, the National Bleeding Disorders Foundation, and Canadian Blood Services. The system is administered by PPTA and is supported and funded by all participating companies including: ADMA Biologics Inc., Bayer Healthcare LLC, CSL Behring, CSL Behring Canada, Genentech, a member of the Roche Group, Grifols Therapeutics LLC, Kedrion Biopharma Inc., Novo Nordisk, Octapharma USA Inc., Octapharma Canada Inc., Pfizer Inc., Saol Therapeutics, and Takeda. An advisory panel made up of patient groups, the FDA, and company representatives provides input on the system and makes recommendations for future enhancements.
How to register
Visit www.patientnotificationsystem.org or call the toll-free number, 1-888-UPDATE-U (1-888-873-2838). When you sign up, some basic contact information will be required, such as your name, address, email, and phone number. You will set up your own password.
Choose your primary notification preference. During the registration process, you will be asked to select your “Primary” method of notification. Registrants currently have the option of being notified by email, telephone, text messaging, or fax. Please consider email or text messaging as your primary method of notification, as both are instantaneous, trackable, and immediately accessible, even when away from home. Your primary notification is always followed up by a duplicate notification sent via first class mail.
Choose the therapies that you would like to receive notifications. Choose “other” if you are unsure of what medicine you are taking or you wish to receive all notifications.
Once you submit the required information, you will receive a confirmation and unique identification number. You will need this number and your password to access the system.
PNS in action
If a therapy is withdrawn or recalled, the company involved immediately contacts Sedgwick, which then directly notifies the registrant by their primary notification method. Each registrant will also receive a first-class USPS letter as a redundancy. The redundancy of two types of notification is intended to ensure that you receive your notification and are aware before you infuse or inject your therapy that there has not been an event. “Event” is the term that is used for a recall or a withdrawal.For current information on therapy recalls or withdrawals, please visit: www.PatientNotificationSystem.org or call a 24-hour, toll-free number: 1-888-UPDATE-U (1-888-873-2838). To maximize the usefulness of the system, it is important for patients to keep accurate infusion logs and record the lot number, therapy, and manufacturer for all therapies they use. Infusion logs are available by calling the toll-free number 1-888-UPDATE-U (1-888-873-2838). Log books are provided to patient organizations upon request to distribute within their communities.For each infusion, you should record:
Manufacturer of the therapy
The lot number
Other safety information
National donor deferral registry (NDDR)
The NDDR is a database listing all the permanently deferred plasma donors across North America. This voluntary, self-regulating initiative supports the main plasma industry component — the safety of the therapies.
Donor history questionnaire
The DHQ helps evaluate a prospective donor’s history relative to current known safety risks, FDA regulations, PPTA voluntary standards, and optionally, European requirements.
Pathogen safety is focused on donor screening, selection of starting material, testing, and elimination of pathogens. These safeguard measures ensure that only plasma from healthy donors is entering the manufacturing process.
PPTA supports regulatory policies that help ensure the safety and quality of plasma protein therapies across Europe and the U.S. These policies are integrated into each step of the plasma protein therapy lifecycle.