21076
28-Jun-16
1 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Pick materials for pharmaceutical and
allied products manufacturing and
receive manufactured product
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, in
accordance with enterprise procedure, pick materials for
manufacturing, and receive manufactured product and
surplus materials.
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 the Competenz Incorporated.
 New Zealand Qualifications Authority 2016
21076
28-Jun-16
2 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Pick materials for pharmaceutical and
allied products manufacturing and
receive manufactured product
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
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
Competenz unit designation is PAMR 2.2.
 New Zealand Qualifications Authority 2016
21076
28-Jun-16
3 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Pick materials for pharmaceutical and
allied products manufacturing and
receive manufactured product
Elements and Performance Criteria
element 1
Pick materials for manufacturing in accordance with enterprise procedure.
Range:
evidence is required for one product manufacturing operation and one product
packing operation;
evidence may be simulated for one of these;
evidence for either operation is also required on three other occasions.
performance criteria
1.1
The correct information for picking is identified.
1.2
Materials requiring special handling and storage procedures are identified, and
handling and storage procedures are followed.
1.3
Materials handling equipment hazards are identified, and safety precautions are
taken.
1.4
Personal protective equipment is identified and prepared.
1.5
Materials handling equipment is identified and prepared.
1.6
Required materials are located and identified, and status and expiry dates are
checked.
1.7
Required materials are picked and assembled.
1.8
Records are completed for picked and assembled materials.
1.9
Picked and assembled materials, and associated documentation, are issued
and delivered.
 New Zealand Qualifications Authority 2016
21076
28-Jun-16
4 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Pick materials for pharmaceutical and
allied products manufacturing and
receive manufactured product
element 2
Receive manufactured product and surplus materials in accordance with enterprise
procedure.
Range:
manufactured product – finished product, intermediates, reject product;
surplus materials – unused materials, reject materials, waste materials;
evidence is required for one manufactured product and one surplus material;
evidence on three other occasions is also required.
performance criteria
2.1
Manufactured product, surplus materials, quantities, and documentation are
received and verified, and package integrity, seals, and labelling are checked.
2.2
Manufactured product and surplus materials are moved, handled, and stored in
a manner preventing damage and mix-ups.
2.3
Non-conforming materials are identified, labelled, and required action is taken.
Range:
non-conforming materials include – reject product, reject
materials, waste materials, damaged packaging, unidentifiable
products or materials.
2.4
Unused materials are stored.
2.5
Documentation is completed.
2.6
Manufactured products are held under quarantine until released or rejected.
2.7
Released products or materials, and associated documentation, are stored
according to status.
2.8
Rejected products or materials are segregated and secured, and documentation
is stored.
 New Zealand Qualifications Authority 2016
21076
28-Jun-16
5 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Pick materials for pharmaceutical and
allied products manufacturing and
receive manufactured product
Comments on this unit standard
Please contact the 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