A donation is considered voluntary and non-remunerated if the person gives blood, plasma or cellular components of his/her own will and received no payment for it, either in the form of cash, or in kind which could be considered a substitute of money. This would include time off work, other than that reasonable needed for the donation and travel. Small tokens, refreshments and reimbursements of direct travel are compatible with VNRBD.
Any structure or body that is responsible for any aspect of the collection and testing of human blood or blood components whatever their intended purpose, and their processing, storage and distribution when intended for transfusion. This does not include hospital blood banks.
The production of blood components from whole blood.
A component obtained from a single whole blood donation by removal of part of the plasma without further processing.
Any structure or body intended for the diagnosis and treatment of patients.
A person receiving or registered to receive medical treatment.
The amount of money that is transferred or received for a product or a service delivered.
Plasma-derived medicinal products (PDMPs) are prepared industrially from human plasma and include products such as albumin, coagulation factors and immunoglobulins, which are life-saving therapeutics for several chronic and acute life-threatening diseases.
A component derived from fresh whole blood which contains the majority of the plasma and frozen within 24 hrs.
Organisations who manufacture plasma derived medicinal products PDMPs).
Plasma obtained by plasmapheresis and frozen.
Method of obtaining plasma by processing of whole blood in which the residual components of the blood are returned to the donor during or at the end of the process.
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
A Good (best) Practice (GP) is a method or technique that has been generally accepted as superior to any alternatives because it produces results that are superior to those achieved by other means or because it has become a standard way of doing things, e.g., a standard way of complying with legal or ethical requirements
Principle or rule (with or without the coercive power of law) employed in controlling, directing, or managing an activity, organisation, or system.
Formal and objective control according to adopted standards to assess compliance with a given directive and other relevant legislation and to identify problems.
International Regulatory Systems and Regulatory Authorities
