21077 28-Jun-16 1 of 4 PHARMACEUTICAL AND ALLIED PRODUCTS MANUFACTURING Pick and assemble finished pharmaceutical and allied products for despatch level: 2 credit: 2 planned review date: February 2007 sub-field: Pharmaceutical and Allied Products purpose: People credited with this unit standard are able to pick and assemble finished pharmaceutical and allied products for despatch. entry information: Recommended: 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, Unit 21073, Apply current good manufacturing practice for pharmaceutical and allied products, and Unit 21074, Demonstrate knowledge of inwards materials 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. 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. New Zealand Qualifications Authority 2016 21077 28-Jun-16 2 of 4 PHARMACEUTICAL AND ALLIED PRODUCTS MANUFACTURING Pick and assemble finished pharmaceutical and allied products for despatch 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 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 Evidence requirements must be in accordance with enterprise procedure. 5 Competenz unit designation is PAMR 2.3. Elements and Performance Criteria element 1 Pick and assemble finished pharmaceutical and allied products for despatch. Range: evidence is required for picking and assembly of one order of finished product; evidence for picking and assembly is also required for three other orders. performance criteria 1.1 The correct information for picking is identified. 1.2 Materials requiring special handling and storage procedures are identified, and handling and storage procedures are followed. New Zealand Qualifications Authority 2016 21077 28-Jun-16 3 of 4 PHARMACEUTICAL AND ALLIED PRODUCTS MANUFACTURING Pick and assemble finished pharmaceutical and allied products for despatch 1.3 Materials handling equipment hazards are identified, and safety precautions are taken. 1.4 Personal protective equipment is identified and prepared. 1.5 Materials handling equipment is identified and prepared. 1.6 Required finished products are located, status checked, and batch details verified. 1.7 Required finished products are picked, assembled and packed. 1.8 Records are completed for picked products. 1.9 Picked products, and associated documentation, are despatched. Comments on this unit standard Please contact Competenz info@compentez.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 21077 28-Jun-16 4 of 4 PHARMACEUTICAL AND ALLIED PRODUCTS MANUFACTURING Pick and assemble finished pharmaceutical and allied products for despatch 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