21072
28-Jun-16
1 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Demonstrate knowledge of 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
demonstrate knowledge of current good manufacturing
practice (cGMP) for pharmaceutical and allied products.
entry information:
Recommended: Unit 21071, Follow basic regulatory
requirements in pharmaceutical and allied products
manufacturing, 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 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
Primary hygiene requirement for manufacturing means
that product must not be contaminated.
3
Competenz unit designation is GMP 2.1
 New Zealand Qualifications Authority 2016
21072
28-Jun-16
2 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Demonstrate knowledge of current good
manufacturing practice for
pharmaceutical and allied products
Elements and Performance Criteria
element 1
Demonstrate knowledge of current good manufacturing practice (cGMP) for
pharmaceutical and allied products.
performance criteria
1.1
The primary hygiene requirement for manufacturing is identified, and the basic
systems for personnel hygiene control are outlined.
Range:
1.2
The primary environmental requirements for manufacturing are identified, and
the basic environmental controls are outlined.
Range:
1.3
personnel hygiene control – personal hygiene, work practices,
clothing, health, medical conditions, personal medication, product
contact.
environmental requirements – controlled areas, cleanliness,
segregation;
environmental controls – air pressure, air locks, air filtration
(particulate and microbial), temperature, humidity, people
movement, product movement, cleaning, pests, monitoring.
The primary documentation requirements for manufacturing are identified, and
the basic documentation controls and procedures are explained.
Range:
documentation requirements – standard operating procedures,
specifications, records, manufacturing instructions, packaging
instructions;
documentation controls and procedures – copying, corrections,
version recognition, permanent marking, signing, dating, spacing
and gaps, storage, accuracy, changes, accountability, deviations,
timeliness of entries.
 New Zealand Qualifications Authority 2016
21072
28-Jun-16
3 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Demonstrate knowledge of current good
manufacturing practice for
pharmaceutical and allied products
1.4
The primary cleaning requirements for manufacturing are identified, and the
basic systems for cleaning control are explained.
Range:
1.5
The purpose of validation is described, and basic validation and re-validation
requirements for manufacturing are identified and explained.
Range:
1.6
quality assurance – quality control and procedures, testing, self
inspection, rejects, product recalls, complaints, regulatory
compliance, supplier auditing, equipment calibration, document
control, record retention.
The basic training requirements for personnel are explained.
Range:
1.8
purpose – to effectively and reproducibly produce a product
meeting predetermined specifications and quality attributes;
validation and re-validation requirements may include –
equipment, process, computer systems, test methods, cleaning,
facilities, documented evidence.
The basic systems for manufacturing quality assurance are explained.
Range:
1.7
cleaning requirements – premises, buildings, machinery,
equipment, garments;
cleaning control – status, monitoring, procedures, equipment,
materials, records.
training requirements – applicable personnel, prior qualifications,
specific duties, process, quality assurance systems, health and
safety, good manufacturing practice, training plan and schedule,
training records, assessment and reassessment, contractors and
visitors.
The basic requirements for manufacturing materials control are explained.
Range:
requirements – approved suppliers, identification, status,
segregation, storage, traceability.
 New Zealand Qualifications Authority 2016
21072
28-Jun-16
4 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS QUALITY ASSURANCE
Demonstrate knowledge of current good
manufacturing practice for
pharmaceutical and allied products
1.9
The basic requirements for manufacturing premises, plant services and
equipment are explained.
Range:
requirements – cleanable, maintainable, calibration, identification,
safe, location, isolation, design, construction materials, approved
consumables, records, correct application.
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