Quality Assurance System (continued)
Standard Operating Procedures
Marginal note:Standard operating procedures required
72 An establishment must have standard operating procedures with respect to the safety of cells, tissues and organs for all activities that it carries out.
73 The standard operating procedures must meet all of the following requirements:
(a) be in a standardized format;
(b) be approved by the medical director or scientific director;
(c) be available for use at all locations where the relevant activities are carried out;
(d) have any changes to the procedures approved by the medical director or scientific director before being implemented; and
(e) be kept up-to-date.
Marginal note:Routine review
Marginal note:Supplementary review
(2) An establishment that receives a summary of a final report of an error, accident or adverse reaction investigation or the report of an audit either of which reveals a deficiency in a standard operating procedure must review that procedure.
Marginal note:Records of compliance
75 An establishment must keep records that demonstrate that it has implemented its standard operating procedures.
76 An establishment must conduct an audit every two years of the activities that it carries out to verify that those activities comply with these Regulations and with its standard operating procedures, by a person who does not have direct responsibility for the activities being audited.
Powers of Inspectors
Marginal note:Taking photographs
77 An inspector may, in the administration of these Regulations, take photographs of any of the following:
(a) any article that is referred to in subsection 23(2) of the Act;
(b) any place where the inspector believes on reasonable grounds that any article referred to in paragraph (a) is processed; and
(c) anything that the inspector believes on reasonable grounds is used or is capable of being used in the processing of any article referred to in paragraph (a).
Marginal note:Processed within 5 years before registration
78 (1) Subject to subsection (2), the following establishments may import, distribute or transplant, as the case may be, cells and tissues that were processed within five years before the day on which these Regulations are registered:
(2) An establishment may not import, distribute or transplant, as the case may be, cells or tissues under subsection (1) unless the requirements of subsection 56(2) and section 57 are met.
Coming into Force
Marginal note:Six months after registration
(2) Subsection 26(1) comes into force one year after the day on which these Regulations are registered.
Marginal note:Transitional provision
(3) Section 78 ceases to be in force five years after the day on which these Regulations are registered.
Return to footnote *[Note: Regulations, except subsection 26(1), in force December 8, 2007; Subsection 26(1) in force June 8, 2008.]
- Date modified: