21366
16-Apr-20
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PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Perform secondary product packing operations for pharmaceutical and allied products manufacturing level: credit: planned review date: sub-field: purpose:
2
4
May 2007
Pharmaceutical and Allied Products
People credited with this unit standard are able to demonstrate knowledge of secondary packing equipment, prepare to perform secondary product packing operations in accordance with enterprise procedure, and perform secondary product packing operations. entry information: Prerequisite: Unit 21071, Follow basic regulatory requirements in pharmaceutical and allied products manufacturing ; Unit 21072, Demonstrate knowledge of current good manufacturing practice for pharmaceutical and allied products ; and Unit 21073, Apply current good manufacturing practice for pharmaceutical and allied products ; or demonstrate equivalent knowledge and skills.
Recommended: Unit 21365, Demonstrate basic knowledge of product packaging and packing for pharmaceutical and allied products , or demonstrate equivalent knowledge and skills. accreditation option: moderation option:
Evaluation of documentation by NZQA.
A centrally established and directed national moderation system has been set up by the Competenz Incorporated.
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New Zealand Qualifications Authority 2020

21366
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2 of 6 special notes:
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Perform secondary product packing operations for pharmaceutical and allied products manufacturing
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 Secondary product packing operations mean where product in its primary packaging is being packed into secondary packaging on a packing line. This includes the operation of any required packing equipment.
5 Competenz unit designation is PAMP2.
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New Zealand Qualifications Authority 2020

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PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Perform secondary product packing operations for pharmaceutical and allied products manufacturing
Elements and Performance Criteria element 1
Demonstrate knowledge of secondary packing equipment. performance criteria
1.1 Seven types of common secondary packing equipment are identified. The basic operating principles of three types of common secondary packing equipment are described.
Range: secondary packing equipment includes
– carton erector, labeller, weighing equipment, shrink-wrapper, stretch wrapper, tamper evidence applicator, taping machines, leaflet folder/inserter, stapler, gluer, coder, bander.
1.2 element 2
The sequence, operation, and in-process checks for two secondary packing processes at the enterprise are described.
Prepare to perform secondary product packing operations in accordance with enterprise procedure.
Range: evidence is required for two different, entire, secondary product packing operations. performance criteria
2.1 The correct documentation for the product packing operation is identified.
Garmenting and personal hygiene procedures are followed. 2.2
2.3 Room and work area are checked to ensure they are clear of all previous materials, packaging, and documentation.
2.4 Room and equipment status for the product packing operation are verified.
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PHARMACEUTICAL AND ALLIED
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Perform secondary product packing operations for pharmaceutical and allied products manufacturing
2.5 Equipment, materials, and handling hazards are identified, and safety precautions are taken.
2.6
2.7
2.8
Personal protective equipment is identified and prepared.
Materials handling equipment is identified and prepared.
Picked and approved packaging is located, verified, and positioned for the product packing operation.
2.9 Secondary product packing equipment checks are performed.
Range: checks may include – consumables loaded, equipment set up, equipment on, equipment challenges, set-up verification.
2.10 Emergency stopping of the product packing equipment is demonstrated. element 3
Range: evidence may be based on a simulated situation where required.
Perform secondary product packing operations.
Range: evidence is required for two different, entire, secondary product packing operations. performance criteria
3.1 Special instructions for opening and loading picked and approved packaging are identified and followed in accordance with enterprise procedure.
3.2 Unacceptable packaging is identified, required action is taken, and documentation is completed, in accordance with enterprise procedure.
Range: unacceptable packaging may include
– contaminated, nonconforming, damaged.
3.3 Enterprise procedures for notifying and rectifying packaging shortages are explained.
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3.7
3.8
3.9
3.10
3.4
3.5
3.6
3.11
3.12
3.13
3.14
3.15
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Perform secondary product packing operations for pharmaceutical and allied products manufacturing
Packaging is loaded, equipment checks are conducted, and samples are taken, in accordance with enterprise procedure.
Line clearance and approval to commence packing operations is obtained and documented, in accordance with enterprise procedures.
Secondary product packing operations are performed in accordance with enterprise procedure.
In-process samples are taken in accordance with enterprise procedure.
Enterprise procedures for notifying and rectifying packing errors or incorrect conditions are explained.
Documentation is completed in accordance with enterprise procedure.
Surplus packaging is quantified, packed, and labelled, and details are entered into batch records, in accordance with enterprise procedure.
Range: surplus packaging – unused printed packaging, reject packaging, waste materials.
Packed finished product is relocated in accordance with enterprise procedure.
Surplus packaging is relocated in accordance with enterprise procedure.
Range: surplus packaging – unused printed packaging, reject packaging, waste materials.
Completed documentation is delivered or filed in accordance with enterprise procedure.
Cleaning materials, cleaning equipment, and personal protective equipment required by the enterprise for cleaning room and packing equipment are prepared.
Room and packing equipment used are cleaned, status labels are applied, and records are completed, to meet enterprise requirements.
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New Zealand Qualifications Authority 2020

21366
16-Apr-20
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PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Perform secondary product packing operations for pharmaceutical and allied products manufacturing
Comments on this unit standard
Please contact Competenz info@comptenz.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.
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New Zealand Qualifications Authority 2020