21071
28-Jun-16
1 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Follow basic regulatory requirements in
pharmaceutical and allied products
manufacturing
level:
1
credit:
3
planned review date:
February 2007
sub-field:
Pharmaceutical and Allied Products
purpose:
People credited with this unit standard are able to
demonstrate basic knowledge of current good manufacturing
practice (cGMP) in pharmaceutical and allied products
manufacturing, and follow basic enterprise procedures for
current good manufacturing practice.
entry information:
Open.
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.
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
21071
28-Jun-16
2 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Follow basic regulatory requirements in
pharmaceutical and allied products
manufacturing
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
Individual activity authorisation means having authority
to undertake any task only if trained and specifically
authorised.
5
Competenz unit designation is GMP 1.
Elements and Performance Criteria
element 1
Demonstrate basic knowledge of current good manufacturing practice (cGMP) in
pharmaceutical and allied products manufacturing.
performance criteria
1.1
The principal purposes for cGMP are described.
Range:
principal purposes – product quality, safe and contaminant-free
products, traceability, honesty, integrity.
 New Zealand Qualifications Authority 2016
21071
28-Jun-16
3 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Follow basic regulatory requirements in
pharmaceutical and allied products
manufacturing
1.2
Sources of contamination and examples of each, are identified. The normal
control measures used for each example are described.
Range:
1.3
Employee actions which influence product quality are identified.
Range:
1.4
sources of contamination – physical, microbiological, chemical;
evidence is required for two examples of each.
employee actions include – following instructions and company
rules, documenting activity and changes, training, record keeping;
evidence is required for three employee actions.
Product categories covered by cGMP are identified, and an example of a
common product from each category is described.
Range:
product categories – medicines, medical devices, dietary
supplements, diagnostic products, animal remedies and veterinary
products, cosmetics and sunscreens, related products;
evidence is required for four product categories.
1.5
The applicable cGMP regulations and regulatory authority for the enterprise are
identified.
1.6
An enterprise example for each of five different aspects of manufacturing
covered by cGMP is described.
Range:
1.7
aspects – quality management, personnel, premises and
equipment, documentation, production, quality control, contract
manufacture, contract analysis, complaints, product recall, self
inspection.
Consumer and manufacturer consequences when enterprise cGMP procedures
are not followed, are described.
Range:
consumer consequences may include – illness, injury, impairment,
death, miscarriage;
manufacturer consequences may include – fines, imprisonment,
product recall, plant shutdown, loss of licence, company closure;
evidence is required for two consumer consequences and two
manufacturer consequences.
 New Zealand Qualifications Authority 2016
21071
28-Jun-16
4 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Follow basic regulatory requirements in
pharmaceutical and allied products
manufacturing
element 2
Follow basic enterprise procedures for cGMP.
Range:
evidence is required for three separate occasions.
performance criteria
2.1
Garmenting and garment change procedures are followed.
2.2
Personal hygiene procedures are followed.
Range:
2.3
personal hygiene procedures include – jewellery, make-up,
sickness reporting, food, drink, handwashing, chewing, smoking,
illicit substances.
Room status, controlled areas, and individual activity authorisation procedures
are followed in restricted areas.
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.
 New Zealand Qualifications Authority 2016
21071
28-Jun-16
5 of 5
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Follow basic regulatory requirements in
pharmaceutical and allied products
manufacturing
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