Quality assurance procedures means all activities necessary to assure the quality of the process used to provide radiopharmaceu- tical services, including authentication of product history and maintenance of all records as required by pertinent regulatory agencies.
Quality assurance procedures means the quality assurance and quality control procedures as set forth in Exhibit N.
Quality assurance procedures means all activities necessary to assure the quality of the process used to provide radiopharmaceutical services, including authentication of the product history, internal test assessment, and maintenance of all required records;
Examples of Quality assurance procedures in a sentence
Whenever possible, such as in the case of engine qualification tests, economy of combined qualification tests should be considered.(c) Quality assurance procedures (steps 32-33).
Quality assurance procedures, including methods to assure accuracy of insurance or other input data, will be reviewed.
Quality assurance procedures shall be designed, implemented and reviewed to monitor the conduct of each step of the process of testing for drugs.
Quality assurance procedures shall include methods to assure accuracy of insurance data.
Quality assurance procedures were applied to the design, implementation, analysis, and preparation of this report.
More Definitions of Quality assurance procedures
Quality assurance procedures. The Tisseel is manufactured as part of an integrated, three-stage viral safety program. The program consists of (1) donor-selection procedures, (2) serologic testing for viral contaminants, and (3) viral inactivation by two-step vapor heating. Prior to acceptance, donor plasma must pass two rounds of testing for antibodies against HIV and hepatitis. The tests are separated by a three-month interval to check for seroconversion. Viral inactivation of the pooled plasma is performed by two-step vapor heating, a process that has been shown to reduce viral titers by a cumulative log reduction factor of up to 12.8 for HIV. After more than two decades of international use and more than 5 million doses, not a single case of confirmed viral transmission has been detected from Tisseel. EXHIBIT B Regentis Biomaterials has developed a technology platform called Gelrin for tissue regeneration. Gelrin is an in-situ photopolymerizable hydrogel material comprised of PEGylated fibrinogen.
Quality assurance procedures means all activities necessary to assure the quality of the process used to provide radiopharmaceu-
Quality assurance procedures means all procedures referred in the Supplier's QA Manual including qualification, certification and manufacturing test and acceptance procedures reviewed and accepted by the Purchaser.
Quality assurance procedures means a coherent system of policies, procedures, accountabilities and review mechanisms that establish the quality of products and services offered;
Quality assurance procedures means the Procedures approved from time to time by Academic Board and recorded in the Taught Provision Manual for the approval, review and modification of courses, including collaborative provision;
Quality assurance procedures means the Procedures approved from time to time by Academic Board and recorded in the Quality Assurance Handbook for the approval, review and modification of courses, including collaborative provision;
Quality assurance procedures. The Tisseel is manufactured as part of an integrated, three-stage viral safety program. The program consists of (1) donor-selection procedures, (2) serologic testing for viral contaminants, and (3) viral inactivation by two-step vapor heating. Prior to acceptance, donor plasma must pass two rounds of testing for antibodies against HIV and hepatitis. The tests are separated by a three-month interval to check for seroconversion. Viral inactivation of the pooled plasma is performed by two-step vapor heating, a process that has been shown to reduce viral titers by a cumulative log reduction factor of up to 12.8 for HIV. After more than two decades of international use and more than 5 million doses, not a single case of confirmed viral transmission has been detected from Tisseel. EXHIBIT B Metamorefix is active in the field of health care product, intended for Pharmaceutical Aesthetic applications. This product includes the use of fibrin powder in a matrix gel, to be injected as a dermal filler. This fibrin powder will consist of the fibrin sealant kit, and will be further processed to form a powder. EXHIBIT C Notice to FDA _____________________________ U.S. Food and Drug Administration Division of Blood Applications HFM-370 Center for Biologics Evaluation And Research (CBER)