21362
28-Jun-16
1 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Perform routine sampling 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 prepare to
perform routine sampling in accordance with enterprise
procedure, and perform routine sampling.
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
21362
28-Jun-16
2 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Perform routine sampling 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
Sampling site means the site where the sample is
gathered.
Sampling area means the area containing the sampling
site.
5
Evidence requirements for this unit standard must cover
two different product raw materials, two different
intermediate/bulk products, and two different packaging
materials.
 New Zealand Qualifications Authority 2016
21362
28-Jun-16
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PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Perform routine sampling for
pharmaceutical and allied products
manufacturing
6
Competenz unit designation is PAMT2.2.
Elements and Performance Criteria
element 1
Prepare to perform routine sampling in accordance with enterprise procedure.
performance criteria
1.1
The correct documentation and approved method for sampling are identified.
1.2
Garmenting and personal hygiene procedures are followed.
1.3
Room and equipment status for sampling are verified.
1.4
Sampling area is checked to ensure its condition is suitable for sampling to be
undertaken.
1.5
Materials requiring special handling and storage procedures are identified, and
handling and storage procedures are followed.
1.6
Materials handling equipment hazards are identified, and safety precautions are
taken.
1.7
Personal protective equipment is identified and prepared.
1.8
Sampling equipment is identified and prepared.
1.9
Required materials are located and positioned for sampling.
1.10
The sampling site is identified.
 New Zealand Qualifications Authority 2016
21362
28-Jun-16
4 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Perform routine sampling for
pharmaceutical and allied products
manufacturing
element 2
Perform routine sampling.
performance criteria
2.1
Special instructions for preparation of the sampling site are 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 materials may include – contaminated, nonconforming, damaged packaging.
2.3
Required materials are sampled using appropriate equipment in accordance
with sampling procedures.
2.4
Sample number and material quantities are checked against sampling plan.
2.5
Sampled materials are packed, uniquely labelled, and documentation is
completed, in accordance with enterprise procedure.
2.6
Enterprise procedures for notifying and rectifying sampling errors or incorrect
sampling conditions are explained.
2.7
Sample site and packages are resealed, reconciled, labelled, and relocated, in
accordance with enterprise procedure.
2.8
Reject and waste materials are labelled and relocated in accordance with
enterprise procedure.
2.9
Sampled materials are stored or delivered in accordance with enterprise
procedure.
2.10
Documentation is delivered or filed in accordance with enterprise procedure.
2.11
Cleaning materials, cleaning equipment, and personal protective equipment
required by the enterprise for cleaning sampling area and equipment are
prepared.
 New Zealand Qualifications Authority 2016
21362
28-Jun-16
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PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Perform routine sampling for
pharmaceutical and allied products
manufacturing
2.12
Sampling area and equipment used are cleaned, status labels are applied, and
records are completed, to meet enterprise requirements.
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