21074
28-Jun-16
1 of 3
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Demonstrate knowledge of inwards
materials for pharmaceutical and allied
products manufacturing
level:
1
credit:
2
planned review date:
February 2007
sub-field:
Pharmaceutical and Allied Products
purpose:
People credited with this unit standard are able to
demonstrate knowledge of inwards materials for
pharmaceutical and allied products manufacturing.
entry information:
Recommended: prior credit for Unit 21071, Follow basic
regulatory requirements in pharmaceutical and allied
products manufacturing, or demonstrate equivalent
knowledge or 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:
Competenz unit designation is PAMR 1.
 New Zealand Qualifications Authority 2016
21074
28-Jun-16
2 of 3
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Demonstrate knowledge of inwards
materials for pharmaceutical and allied
products manufacturing
Elements and Performance Criteria
element 1
Demonstrate knowledge of inwards materials for pharmaceutical and allied products
manufacturing.
performance criteria
1.1
Starting and inwards material categories are identified and an example of each
described.
Range:
1.2
The physical forms of product raw materials are identified.
Range:
1.3
physical forms – liquids, powders, granules, pastes, solids, gases,
tablets, capsules;
evidence is required for six physical forms.
Common types of product raw material packaging are identified, and the
importance of package integrity and cleanliness is explained.
Range:
1.4
starting material categories – product raw materials, primary
product packaging, secondary product packaging;
inwards material categories – cleaning materials, consumables,
reference standards.
product raw material packaging includes – multiwall bags, drums,
pails, large tanks, small tanks, bulk tanks, bulk bags;
evidence is required for five types of product raw material
packaging.
Potential product raw material hazards are described, and sources of and
locations for information on hazards are identified.
Range:
hazards – fume, dust, flammable, chemical corrosion, chemical
burn, explosive, toxic, sensitiser, infectious agent;
sources – material safety data sheets (MSDS), company data
sheets, raw material labels, supervisor.
 New Zealand Qualifications Authority 2016
21074
28-Jun-16
3 of 3
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Demonstrate knowledge of inwards
materials for pharmaceutical and allied
products manufacturing
1.5
Types of primary product packaging are identified.
Range:
1.6
primary product packaging includes – glass or plastic or metal
containers, closures, plastic and/or foil blister packs, plastic bags,
plastic or foil sachets, desiccant, cotton wool or cellophane filler;
evidence is required for five types of primary product packaging.
Types of secondary product packaging are identified.
Range:
secondary product packaging includes – printed or unprinted
cartons, printed or unprinted labels, leaflets, plastic liners,
shippers, protective wrapping;
evidence is required for four types of secondary product
packaging.
Comments on this unit standard
Please contact Competenz info@compentenz.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