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 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.

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Standards Programs

PPTA's voluntary standards programs focus on safety and quality from the donor to the patient.


International Quality Plasma Program (IQPP) provides an independent evaluation of adherence to global industry standards for source plasma, specifically focusing on donor management and health.

Find out more about IQPP


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.

Find out more about QSEAL

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.

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About PNS

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.
Download the PNS brochure

Ensuring Confidentiality

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.

Cooperative effort

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

  1. Visit 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.

  2. 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.

  3. 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.

  4. 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.

Download the PNS brochure

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: 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

  • Therapy administered

Download the PNS brochure
A man that is currently researching in a laboratory.
Blood plasma
A man that is currently researching in a laboratory.
Blood plasma