NZQF 1
Application for Approval to Develop
a Qualification at Levels 1-6
1. Qualification Developer Details
Qualification
developer name
Plastics and Materials Processing Industry Training Organisation
Incorporated
Provider No.
8126
Contact name and
title
Kathryn Henderson, Quality and Qualifications Manager
Contact details
kathryn@pampito.org.nz
09 2544877
Will the
qualification be
jointly developed?
If Yes, include other TEO
No
name(s) and Provider No(s)
2. Proposed Qualification Details
Title
New Zealand Certificate in Good Manufacturing Practice in
Manufacturing Operations
Level
4
Credits
60
Type
Certificate
NZSCED
030199
Strategic purpose
statement
The purpose of this qualification is:
•to provide competent employees for the manufacturing sector who are able to apply
the principles of GMP in industrial situations in order to further the general exposure of
GMP skills in an organisation
•to provide for those individuals, a credential that will recognise the skills and knowledge
gained from structured training, and enhance their employment opportunities in the
manufacturing sectors where GMP is applied.
Good Manufacturing Practice (GMP) is the internationally recognised term used to define
required practice for the manufacture of pharmaceutical and therapeutic products in
various countries around the world and also has applications in the food processing and
packaging industries, particularly where organisations export products internationally. In
practice, these requirements involve compliance with relevant domestic and/or
international legislation and regulations.
Graduates will be capable of working without supervision.
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3. Proposed Outcome Statement
Graduate profile
Graduates of this qualification will be able to:
•State the underlying principles of GMP and their significance in industry
•Develop practical strategies to apply GMP principles in the workplace
•Implement GMP requirements in own organisation
•Collaborate with a range of people to meet organisation GMP requirements
Education pathway
This qualification can lead to further qualifications in quality management, and business
management.
Employment
pathway
People completing this qualification will be able to work as Quality Supervisors,
Technicians and Team Supervisors in the manufacturing industry.
4. Strategic Need for New Qualification
Confirmation of
NZQF search and
identification of
substantially similar
qualifications
No similar qualifications registered (replacing and rationalising current
qualifications through TRoQ process)
Where duplication does not exist – Explanation of strategic
need or gap the qualification will fill on the NZQF
Where duplication does exist – Explanation of strategic need
and justification for proposed new qualification
Employees of manufacturing organisations
in New Zealand who apply GMP principles
in their workplace will benefit from a
nationally recognised qualification that
makes their in-house training transferable
to another workplace in their own sector or
to other sectors where GMP is applicable.
New Zealand manufacturers who apply
GMP that look to export internationally will
be able to target a wider range of export
markets where application of GMP
principles is a key requirements.
PaMPITO has run two blocks of short
courses in 2012 on GMP requirements with
good uptake from the pharmaceuticals and
plastics manufacturing industries, and has
also been reviewing unit standards at the
behest of the pharmaceuticals industry
with the intent to include GMP as the
standard for assessment.
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Full details on consultation and research is
available in the attached business case
“Submission for the Manufacturing TRoQ
(Pre-approval).
5. Stakeholder Profile for Qualification
Stakeholder name (Individual, group or
organisation)
New Zealand Therapeutic
Products Manufacturers
Association Incorporated
Andrew Brownlee – Competenz
Barbara Wilkinson – PaMPITO
Reason for Inclusion (why they are appropriate, credible, representative)
The New Zealand Therapeutic Products Manufacturers Association Inc.
(“TPMA”) is the voice for members representing laboratories,
manufacturers and packers operating under codes of Good
Manufacturing Practice and/or Good Laboratory Practice, in relation
to the production and testing of therapeutic products.
The stakeholders listed are included because they are all mandatory
stakeholders (qualification developers) in the case of Competenz,
PaMPITO, MITO, Print NZ (CMITO), all being ITOs and Waiariki
Institute of Technology (ITP) and NZ Fashion Technology (PTE).
Kathryn Henderson – PaMPITO
David Mohn – NZMEA
David Norris – NZMEA
Bill Butler – EMA
Industry Stakeholders include NZMEA, EMA and Business NZ. These
stakeholders have been included as they are all peak bodies for the
sectors that this qualification is relevant to.
Carrie Murdoch – Business NZ
Joan Grace – Print NZ
Russell Dive – MITO
John Kelly – Waiariki Institute of
Technology (ITP representative)
Kevin Chambers – EMA
Val Marshall-Smith – NZ Fashion
Tech
6. Stakeholder Involvement in Pre Development Stage
Stakeholder name and contact details
Nature of involvement
Reason for involvement
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Andrew Brownlee –
Competenz
Mandatory Stakeholders
actively involved in
development of
qualifications
Barbara Wilkinson –
PaMPITO
Manufacturing Cluster ITO’s
Kathryn Henderson –
PaMPITO
Russell Dive – MITO
Val Marshall-Smith – NZ
Fashion Tech
Explanation and justification for
n/a
proceeding where one or more mandatory
stakeholders have not supported the new
qualification
7. Timeframe for development and submission of qualification for approval
Timeframe for development and submission of qualification for approval subsequent to
Approval to Develop being granted
6 months
8. Attachment Checklist
Evidence required
Attached
No. of
attachments
A report confirming the need for the qualification
Yes
Attestations completed and signed by key stakeholders identified in Section 6 (using
Yes
NZQA template: Involvement in Pre-Development Stage Stakeholder Attestation (NZQF2))
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