21075
28-Jun-16
1 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Receive inwards materials for
pharmaceutical and allied products
manufacturing
level:
2
credit:
3
planned review date:
February 2007
sub-field:
Pharmaceutical and Allied Products
purpose:
People credited with this unit standard are able to receive
inwards materials for pharmaceutical and allied products
manufacturing.
entry information:
Recommended: Unit 21071, Follow basic regulatory
requirements in pharmaceutical and allied products
manufacturing, Unit 21072, Demonstrate knowledge of
current good manufacturing practice for pharmaceutical and
allied products, Unit 21073, Apply current good
manufacturing practice for pharmaceutical and allied
products, and Unit 21074, Demonstrate knowledge of
inwards materials 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.
 New Zealand Qualifications Authority 2016
21075
28-Jun-16
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PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Receive inwards materials for
pharmaceutical and allied products
manufacturing
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
Enterprise Procedure means actions that comply with
the policies, systems, and directives in a particular
enterprise. Enterprise procedures must comply with the
requirements of the Health and Safety in Employment
Act 1982, and subsequent amendments. They must
also comply with the requisite Good Manufacturing
Practice provisions for the enterprise such as the
following New Zealand legislation and regulations:
Medicines Act 1981; Medicines Regulations 1984;
Dietary Supplements Regulations 1985; Agricultural
Compounds and Veterinary Medicines Act 1997; and
Agricultural Compounds and Veterinary Medicines
Regulations 2001.
4
Evidence requirements must be in accordance with
enterprise procedure.
5
Competenz unit designation is PAMR 2.1.
 New Zealand Qualifications Authority 2016
21075
28-Jun-16
3 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Receive inwards materials for
pharmaceutical and allied products
manufacturing
Elements and Performance Criteria
element 1
Receive inwards materials for pharmaceutical and allied products manufacturing.
Range:
evidence is required for one product raw material, one primary product
package, and one printed label;
evidence may be simulated for two of these categories;
evidence for any of these categories on three other occasions is also required.
performance criteria
1.1
Materials requiring special handling and storage procedures are identified, and
handling and storage procedures are followed.
1.2
Materials handling equipment hazards are identified, and safety precautions are
taken.
1.3
Personal protective equipment is identified and prepared.
1.4
Materials handling equipment is identified and prepared.
1.5
Materials, quantities, and documentation are received, and package integrity,
seals, and labelling are verified.
1.6
Unacceptable materials are identified and labelled, required action is taken, and
documentation is completed.
Range:
unacceptable materials may include – non-approved supplier,
damaged packaging, incorrect material, unidentifiable material.
1.7
Acceptable materials are uniquely labelled, moved, handled, and quarantined in
a manner preventing damage and mix-ups, and documentation is completed.
1.8
Appropriate personnel are notified for sampling and testing of inwards materials.
1.9
Inwards materials are held under quarantine until released or rejected.
 New Zealand Qualifications Authority 2016
21075
28-Jun-16
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PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Receive inwards materials for
pharmaceutical and allied products
manufacturing
1.10
Released or rejected materials, and associated documentation, are stored
according to status.
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