Safety of Human Cells, Tissues and Organs for Transplantation Regulations (SOR/2007-118)

Marginal note:Cleaning supplies

69 An establishment that processes cells, tissues or organs must ensure that it uses supplies for cleaning, maintenance, disinfection or sterilization that do not react with, or that are not absorbable by, the cells, tissues or organs.

Quality Assurance System

General

Marginal note:Application

70 Sections 71 to 76 apply only to establishments that distribute cells, tissues or organs.

Marginal note:Quality assurance system required

71 An establishment must ensure that it has a quality assurance system in place that complies with the requirements of these Regulations for all activities that it carries out.

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.

Marginal note:Requirements

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

• 74 (1) An establishment must review its standard operating procedures every two years and again after any amendment to these Regulations.

• 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.

Marginal note:Audits

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).

Transitional Provision

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:

  • (a) a registered establishment; and

  • (b) a transplant establishment that does not distribute cells or tissues.

• Marginal note:Prohibition

  (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

• Footnote ^*79 (1) These Regulations, except subsection 26(1), come into force six months after the day on which they are registered.

• Marginal note:Exception

  (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.]