Marginal note:Requirements — equipment

66. An establishment that distributes cells, tissues or organs, in carrying out its processing and storage activities, must use equipment that is cleaned and maintained and, whenever applicable,

• (a) qualified for its intended purpose;

• (b) calibrated;

• (c) disinfected or sterilized before each use; and

• (d) requalified or recalibrated, as appropriate, after any repair or change is made to it that results in a change to its specifications.

Marginal note:Requirements — storage equipment

67. An establishment that distributes cells, tissues or organs that uses equipment to store cells, tissues or adjunct vessels that are not used immediately in organ transplantation must ensure that the equipment maintains appropriate environmental conditions.

Marginal note:Processing supplies

68. An establishment that processes cells, tissues or organs must use qualified supplies for those activities that could affect the safety of the cells, tissues or organs, and must store solutions, reagents and other supplies under appropriate environmental conditions.

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.

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.

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.