21363
28-Jun-16
1 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Perform routine testing for
pharmaceutical and allied products
manufacturing
level:
2
credit:
4
planned review date:
May 2007
sub-field:
Pharmaceutical and Allied Products
purpose:
People credited with this unit standard are able to prepare to
perform routine testing in accordance with enterprise
procedure, and perform routine testing.
entry information:
Prerequisite: 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.
Recommended: Unit 21073, Apply current good
manufacturing practice for pharmaceutical and allied
products; and Unit 21361, Demonstrate knowledge of quality
control 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
 New Zealand Qualifications Authority 2016
21363
28-Jun-16
2 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Perform routine testing for
pharmaceutical and allied products
manufacturing
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 1992, 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 Supplement Regulations 1985; Agricultural
Compounds and Veterinary Medicines Act 1997; and
Agricultural Compounds and Veterinary Medicines
Regulations 2001.
4
Routine testing may include tests for appearance,
contaminants, uniformity of content, weight, moisture
content, bulk density, particle size, specific gravity,
thickness, hardness, dissolution, friability,
disintegration, pH, viscosity, odour, conductivity,
temperature, calibration, physical measurements,
colour comparisons, and titration.
5
Evidence requirements for this unit standard must cover
five different routine tests.
 New Zealand Qualifications Authority 2016
21363
28-Jun-16
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PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Perform routine testing for
pharmaceutical and allied products
manufacturing
6
Competenz unit designation is PAMT2.3.
Elements and Performance Criteria
element 1
Prepare to perform routine testing in accordance with enterprise procedure.
performance criteria
1.1
The correct documentation and approved method for the test are identified.
1.2
Garmenting and personal hygiene procedures are followed.
1.3
Work area and equipment are checked to ensure they are clear of all previous
materials, packaging, and documentation, and are appropriate for use.
1.4
Equipment, materials, and handling hazards are identified, and safety
precautions are taken.
1.5
Personal protective equipment is identified and prepared.
1.6
Testing equipment is identified and prepared.
1.7
Test materials are located, checked, and positioned for testing.
1.8
Testing equipment checks are performed.
Range:
checks may include – calibration status, equipment challenge,
suitability checks.
 New Zealand Qualifications Authority 2016
21363
28-Jun-16
4 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Perform routine testing for
pharmaceutical and allied products
manufacturing
element 2
Perform routine testing.
performance criteria
2.1
Special instructions for opening and handling test materials are identified and
followed in accordance with enterprise procedure.
2.2
Unacceptable materials are identified, required action is taken, and
documentation is completed, in accordance with enterprise procedure.
Range:
unacceptable may include – contaminated, untraceable, expired,
non-conforming, insufficient quantity, incorrect.
2.3
Tests are performed in accordance with the approved method and enterprise
procedure.
2.4
Test results are entered into test records and verified in accordance with
enterprise procedure.
2.5
Enterprise procedures for notifying test failure and rectifying testing errors or
incorrect conditions are explained.
Range:
enterprise procedures include – investigation of failed results, no
immediate re-test of sample, re-sampling and re-test instructions.
2.6
Retention and unused materials are packed, labelled, and stored, and details
are entered into test records, in accordance with enterprise procedure.
2.7
Waste materials are disposed of in accordance with enterprise procedure.
2.8
Testing records are delivered or filed in accordance with enterprise procedure.
2.9
Cleaning materials, cleaning equipment, and personal protective equipment
required by the enterprise for cleaning work area and testing equipment are
prepared.
2.10
Work area and testing equipment used are cleaned, status labels are applied,
and records are completed, to meet enterprise requirements.
 New Zealand Qualifications Authority 2016
21363
28-Jun-16
5 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Perform routine testing 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