THE NATIONAL ASSEMBLY
QUESTION FOR WRITTEN REPLY
3365. Ms D Carter (Cope) to ask the Minister of Trade and Industry:
(Interdepartmental transfer on 25 November 2011)
(1) Whether the new SA Bureau of Standards laboratory complex in
Groenkloof, Pretoria, fully met current good manufacturing process
(GMP) and good laboratory process (GLP); if not, why not; if so,
(a) how was this conclusion reached, (b) who participated in the
inspection and (c) which international laboratories undertook a
peer review to validate this standing;
(2) whether all the equipment on show at the time of the opening by
the President had been purchased and not hired and is still in
place; if not, what is the position in this regard; if so, what
are the relevant details? NW4028e
Reply
1) Current Good Manufacturing Practices (cGMP) are regulations that
manufacturers of pharmaceuticals, medical devices and food products
comply with as they produce and test products for human
consumption. The new SA Bureau of Standards laboratory complex in
Groenkloof, Pretoria is not required to comply with cGMP because it
is not a manufacturing facility.
Good Laboratory Practices (GLP) regulate quality systems of
management control to ensure that results of tests carried out in
laboratory facilities are consistent, reproducible and reliable.
Whenever a whole laboratory facility is moved from one building to
another, the international requirement is that the new laboratory
goes into voluntary suspension until it has been reassessed and re-
accredited for GLP compliance. This is currently in progress at
the SABS.
2) All the equipment on show and demonstrated during the opening of
the new laboratory is the property of SABS and is still in place.