Questions & answers about good manufacturing practice
January 2007
Will there be different Good Manufacturing Practice (GMP) requirements for New Zealand and Australia?
GMP requirements will be the same for both countries because, once established, this will be a joint regulatory scheme.
What will the GMP requirements be for different types of therapeutic products?
All therapeutic products will be required to meet GMP requirements for safety and quality. The level of GMP requirements will be aligned to the risk of the product.
Will there be separate good manufacturing practice auditors for complementary medicine manufacturers and prescription medicine manufacturers?
There will be separate offices for complementary medicines, medical devices, prescription and over-the-counter medicines in the Authority. However, there is currently no proposal for there to be dedicated GMP auditors for the different types of medicines since this would be a more costly approach. It is expected however that manufacturers will generally be audited by staff who are experienced in that area (eg. it is expected that complementary medicine manufacturers will generally be audited by staff with experience in complementary medicines).
In New Zealand will companies which manufacture complementary medicine products, such as deer velvet, and animal products be subject to manufacturing practice audits by the new Authority and by the New Zealand Food Safety Authority Verification Agency?
Medsafe is working with officials at the New Zealand Food Safety Authority regarding the proposed requirements for audits of factories which manufacture or process complementary medicine products of animal origin. Further information about the progress of this work will be made available, however it has been agreed that unnecessary duplication of audits will be avoided.
Will New Zealand and Australian manufacturers have to use the Authority’s auditors to comply with GMP requirements under the joint scheme?
Yes.
How will GMP requirements for prescription and non-prescription medicines change under the new scheme?
There will not be any major changes to current practice.
Can manufacturers get an interim GMP licence? When do manufacturers have to apply for a licence under the new scheme?
Yes, manufacturers can get an interim manufacturing licence. Manufacturers will be required to have applied for the ANZTPA manufacturing licence by the start of the last year of the transition period to ensure that they are able to meet the GMP requirements by the end of the transition period.
When should a manufacturer apply for the joint Authority GMP licence?
By the start of the last year of the transition period.
If a manufacturer already makes products for the New Zealand and or Australian market, do they need to apply for a joint Authority licence?
Yes.
Under the Mutual Recognition Agreement (MRA) scheme, what will the situation be regarding recognising the US Food and Drug Administration (FDA) approval of manufacturers? Will the joint Authority recognise the FDA systems?
The FDA does not regulate medicines for 'export only' or 'complementary medicines' to an equivalent standard of GMP. Therefore, for those categories of products, ANZTPA officers will continue to conduct on-site GMP inspections of manufacturers in the US.
However, for other categories of medicines, the ANZTPA’s Office of Manufacturing Compliance will, on a case by case basis, consider accepting the FDA’s compliance status for manufacturers in the decision to grant GMP clearance.
Would the quality management system ISO485 be recognised?
No, this is not a quality management system standard.
How long will conformity assessment licences be valid for?
It is proposed that conformity assessment certificates will be valid for 5 years.
URL: http://www.anztpa.org/manuf/qagmp.htm