21361
28-Jun-16
1 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Demonstrate knowledge of quality
control for pharmaceutical and allied
products manufacturing
level:
2
credit:
3
planned review date:
May 2007
sub-field:
Pharmaceutical and Allied Products
purpose:
People credited with this unit standard are able to
demonstrate knowledge of quality control for pharmaceutical
and allied products manufacturing.
entry information:
Recommended: Unit 21071, Follow basic regulatory
requirements in 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
21361
28-Jun-16
2 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Demonstrate knowledge of quality
control for pharmaceutical and allied
products manufacturing
2
Competenz unit designation is PAMT2.1.
Elements and Performance Criteria
element 1
Demonstrate knowledge of quality control for pharmaceutical and allied products
manufacturing.
performance criteria
1.1
The difference between quality assurance and quality control in relation to
current good manufacturing practice is identified and explained.
1.2
The purpose of having the quality assurance department independent from
manufacturing operations is explained.
1.3
The role of quality assurance in maintaining the principal purposes of current
good manufacturing practice is explained.
Range:
1.4
The scope of quality control activities is identified.
Range:
1.5
principal purposes – product quality, product safety, product
integrity, product release.
scope includes – product raw materials; primary product
packaging; secondary product packaging; in-process products;
intermediate/bulk products; cleaning materials; consumables;
reference standards; environmental conditions; services including
air, water, and gas;
evidence is required for eight.
The purpose of standards is explained, and sources are identified.
Range:
sources include – pharmacopoeia, national or international
standards organisations, clients.
 New Zealand Qualifications Authority 2016
21361
28-Jun-16
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PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Demonstrate knowledge of quality
control for pharmaceutical and allied
products manufacturing
1.6
The purpose of approved methods is explained, and sources are identified.
Range:
1.7
The principles of sampling are identified.
Range:
1.8
documentation components include – specification, sampling plan,
test method, laboratory report, certificate of analysis, certificate of
conformance;
evidence is required for four documentation components.
The factors affecting the suitability of equipment for sampling and testing are
identified and explained.
Range:
1.11
principles include – trained personnel, approved methods,
comparing results with a reference standard or specification,
reporting results.
The documentation components of sampling and testing are identified, and their
purpose is explained.
Range:
1.10
principles include – trained personnel, approved methods,
representative sample, sample integrity, labelled and identified
samples.
The principles of testing are identified.
Range:
1.9
sources include – pharmacopoeia, company, clients, national or
international standards, codes of practice;
evidence is required for three sources.
factors – calibration, preparation, capacity, environment, status for
use, contamination.
The factors necessary to ensure sample and product integrity during sampling
and testing are identified and explained.
Range:
factors – preparation of the product, equipment, protective
garments, sample container cleanliness, sample container
closure, sample container labelling.
 New Zealand Qualifications Authority 2016
21361
28-Jun-16
4 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Demonstrate knowledge of quality
control for pharmaceutical and allied
products manufacturing
1.12
The requirements for accepting testing by others are identified and explained.
Range:
requirements – testing specific to batch or equipment, authentic
certificate of analysis, traceable, approved vendor, approved
tester.
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