21943
28-Jun-16
1 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Demonstrate basic knowledge of
engineering for pharmaceutical and
allied products manufacturing
level:
2
credit:
4
planned review date:
August 2007
sub-field:
Pharmaceutical and Allied Products
purpose:
People credited with this unit standard are able to
demonstrate basic knowledge of engineering for
pharmaceutical and allied products manufacturing.
entry information:
Recommended: Unit 21071, Follow basic regulatory
requirements in pharmaceutical and allied products
manufacturing, and Unit 21072, Demonstrate knowledge of
current good manufacturing practice for pharmaceutical and
allied products, 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 the Competenz Incorporated.
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.
 New Zealand Qualifications Authority 2016
21943
28-Jun-16
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PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Demonstrate basic knowledge of
engineering for pharmaceutical and
allied products manufacturing
3
Competenz unit designation is PAME2.1.
Elements and Performance Criteria
element 1
Demonstrate basic knowledge of engineering for pharmaceutical and allied products
manufacturing.
performance criteria
1.1
Common utilities and plant services used in pharmaceutical and allied products
manufacturing are named, and an example of a common use for each is
described.
Range:
1.2
The primary equipment required to produce plant services are named.
Range:
1.3
plant services – air conditioning and ventilation, compressed air,
process water, water for product manufacture, lighting, dust
extraction, vacuum, steam, hot water, refrigeration.
The plant services used in the enterprise are identified, and their function is
explained.
Range:
1.4
utilities – electricity, potable water, gas, effluent disposal;
plant services – air conditioning and ventilation, compressed air,
process water, water for product manufacture, lighting, dust
extraction, vacuum, steam, hot water, refrigeration;
evidence is required for eight plant services.
plant services may include – air conditioning and ventilation,
compressed air, process water, water for product manufacture,
lighting, dust extraction, vacuum, steam, hot water, refrigeration.
An example of the influence each of the enterprise plant services can have on
product quality is described.
 New Zealand Qualifications Authority 2016
21943
28-Jun-16
3 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Demonstrate basic knowledge of
engineering for pharmaceutical and
allied products manufacturing
Range:
1.5
The routine operating, testing, calibration, and maintenance of enterprise plant
services are outlined.
Range:
1.6
construction of manufacturing facilities includes – structure and
materials, weatherproofing, pest proofing, security, cleanability,
surface finishes, sealants;
maintenance of manufacturing facilities includes – access control,
contractor control, activity control, emergency procedure control,
signage, lighting, damage repair, cleaning;
evidence is required for five examples of construction and five
examples of maintenance.
The impact of cGMP requirements on the maintenance of manufacturing
equipment is outlined.
Range:
1.8
plant services may include – air conditioning and ventilation,
compressed air, process water, water for product manufacture,
lighting, dust extraction, vacuum, steam, hot water, refrigeration.
The impact of cGMP requirements on the construction and maintenance of
manufacturing facilities is outlined.
Range:
1.7
plant services may include – air conditioning and ventilation,
compressed air, process water, water for product manufacture,
lighting, dust extraction, vacuum, steam, hot water, refrigeration.
maintenance – surface finishes, cleanability, cleaning, lighting,
signage, contractor control, activity control, emergency
procedures, damage repair, parts, equipment failure;
evidence is required for seven examples of maintenance.
The impact of cGMP requirements on engineering practice is explained.
Range:
engineering practice includes – dedicated tools, change control,
approved lubricants and additives, documented work practices,
approved materials, approved tools, documented maintenance
records, reporting of deviations, status labelling, configuration
changes;
evidence is required for six examples of engineering practice.
 New Zealand Qualifications Authority 2016
21943
28-Jun-16
4 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Demonstrate basic knowledge of
engineering for pharmaceutical and
allied products manufacturing
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