21073
28-Jun-16
1 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Apply current good manufacturing
practice for pharmaceutical and allied
products
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 follow
enterprise procedures for: documentation; deviation and
change control; work area status labelling; work area
cleaning; and work area environmental control.
entry information:
Recommended: 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 or
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.
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.
 New Zealand Qualifications Authority 2016
21073
28-Jun-16
2 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Apply current good manufacturing
practice for pharmaceutical and allied
products
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
Work area is the work area(s) where normal
manufacturing duties are performed.
5
Evidence requirements for this unit standard must cover
three separate occasions while performing normal
manufacturing duties.
6
Competenz unit designation is GMP 2.2.
Elements and Performance Criteria
element 1
Follow enterprise procedures for documentation.
performance criteria
1.1
Relevant documents are located.
Range:
1.2
relevant documents may include – standard operating procedures,
records, log books, instructions, specifications.
Document status is recognised.
 New Zealand Qualifications Authority 2016
21073
28-Jun-16
3 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Apply current good manufacturing
practice for pharmaceutical and allied
products
Range:
1.3
document status – master copy, controlled copy, current version,
uncontrolled copy.
Records are completed.
Range:
completion includes – copying, corrections, permanent marking,
signing, dating, spacing and gaps, accuracy, authority, timeliness
of entries.
1.4
Documents are used.
1.5
Documents are stored.
element 2
Follow enterprise procedures for deviation and change control.
Range:
evidence may be simulated if required.
performance criteria
2.1
Deviations are recognised and reported.
Range:
deviations may include – failure to meet or follow policies,
operating procedures or instructions; unsigned or incomplete
documentation; results or conditions not meeting specification;
unusual incidents; equipment breakdowns.
2.2
Procedure for dealing with deviations is followed.
2.3
Change control system is explained.
element 3
Follow enterprise procedures for work area status labelling.
performance criteria
3.1
The function of status labels is explained.
 New Zealand Qualifications Authority 2016
21073
28-Jun-16
4 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Apply current good manufacturing
practice for pharmaceutical and allied
products
3.2
Status labels are used and completed.
3.3
Status labels are controlled and stored.
element 4
Follow enterprise procedures for work area cleaning.
performance criteria
4.1
Work area cleaning requirements are explained.
4.2
Cleaning materials and cleaning equipment are identified.
4.3
Personal protective equipment is identified.
4.4
Cleaning materials and cleaning equipment are prepared and used.
4.5
Cleaning procedures are followed.
4.6
Records and labels are completed and labels are applied.
4.7
Cleaning materials and cleaning equipment are stored.
4.8
Status is identified.
element 5
Follow enterprise procedures for work area environmental control.
performance criteria
5.1
Environmental control systems are identified, and their operation is described.
Range:
environmental controls systems may include – pressure,
temperature, humidity, air quality.
5.2
Environmental monitoring equipment is identified.
5.3
Records and labels are completed and labels are applied.
 New Zealand Qualifications Authority 2016
21073
28-Jun-16
5 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Apply current good manufacturing
practice for pharmaceutical and allied
products
5.4
Environmental control procedures are followed.
Range:
environmental control procedures may apply to – people
movement, material movement, equipment movement.
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