21945
28-Jun-16
1 of 3
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Demonstrate knowledge of water for
manufacture of pharmaceutical and
allied products
level:
2
credit:
2
planned review date:
August 2007
sub-field:
Pharmaceutical and Allied Products
purpose:
People credited with this unit standard are able to
demonstrate knowledge of water for manufacture of
pharmaceutical and allied products.
entry information:
Recommended: Unit 21943, Demonstrate basic knowledge
of engineering for pharmaceutical and allied products
manufacturing, or demonstrate equivalent knowledge and
skills.
accreditation option:
Evaluation of documentation by NZQA.
moderation option:
A centrally established and directed national moderation
system has been set up by Competenz
special notes:
1
Current Good Manufacturing Practice (cGMP) is the
term used to define the latest best practice for the
manufacture of pharmaceutical and allied products in
various countries around the world. In New Zealand,
this requirement is set out in the New Zealand Code of
Good Manufacturing Practice for Manufacture and
Distribution of Therapeutic Goods published by the
Ministry of Health (refer
www.medsafe.govt.nz/regulatory/guidelines.htm). In
practice, these provisions mean compliance with the
requisite domestic and/or international legislation and
regulations.
2
Enterprise means the organisation where training
and/or assessment is taking place. This may or may
not be where the trainee is employed.
3
Competenz unit designation is PAME2.3.
 New Zealand Qualifications Authority 2016
21945
28-Jun-16
2 of 3
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Demonstrate knowledge of water for
manufacture of pharmaceutical and
allied products
Elements and Performance Criteria
element 1
Demonstrate knowledge of water for manufacture of pharmaceutical and allied products.
performance criteria
1.1
The various grades of water which may be used within manufacturing facilities
that comply with cGMP are identified.
Range:
grades – potable water; water for manufacture; pharmacopoeia
grades of purified water; water for injection; water for irrigation.
1.2
The incoming water and final grades for water quality used within the enterprise
manufacturing facility are identified, and the specifications for each are
explained.
1.3
The major components of a water treatment and distribution system that
complies with cGMP are identified, and their purpose is explained.
Range:
major components – storage vessels, sand filters, depth filters,
softeners, carbon filters, chemical dosing units, deionisation plant,
reverse osmosis, electro-deionisation (EDI), continuous
deionisation (CDI), distillation, sterile filtration, distribution
pipework, heat exchangers, pumps, outlet droppers and valves,
control and monitoring instruments and equipment;
evidence is required for twelve major components.
1.4
The routine operation, sanitisation and maintenance of the enterprise water
treatment and distribution system are explained.
1.5
The routine monitoring requirements for a water system that complies with
cGMP are identified.
Range:
monitoring requirements – pressure differentials, filter integrity,
conductivity, pH, total organic carbon (TOC), flow, system
 New Zealand Qualifications Authority 2016
21945
28-Jun-16
3 of 3
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Demonstrate knowledge of water for
manufacture of pharmaceutical and
allied products
pressure, temperature, titration, chemical and microbial testing,
calibration.
Comments on this unit standard
Please contact Competenz info@competenz.org.nz if you wish to suggest changes to the
content of this unit standard.
Please Note
Providers must be accredited by the Qualifications Authority or a delegated interinstitutional body before they can register credits from assessment against unit standards
or deliver courses of study leading to that assessment.
Industry Training Organisations must be accredited by the Qualifications Authority before
they can register credits from assessment against unit standards.
Accredited providers and Industry Training Organisations assessing against unit standards
must engage with the moderation system that applies to those standards.
Accreditation requirements and an outline of the moderation system that applies to this
standard are outlined in the Accreditation and Moderation Action Plan (AMAP). The
AMAP also includes useful information about special requirements for providers wishing to
develop education and training programmes, such as minimum qualifications for tutors and
assessors, and special resource requirements.
This unit standard is covered by AMAP 0134 which can be accessed at
http://www.nzqa.govt.nz/site/framework/search.html.
 New Zealand Qualifications Authority 2016