PHARMACEUTICAL AND ALLIED PRODUCTS QUALITY ASSURANCE Perform routine sampling for. Pharmaceutical and Allied Products.

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1 1 of 5 level: 2 credit: 3 planned review date: May 2007 sub-field: purpose: entry information: Pharmaceutical and Allied Products People credited with this unit standard are able to prepare to perform routine sampling in accordance with enterprise procedure, and perform routine sampling. Prerequisite: Unit 21071, Follow basic regulatory requirements in ; and Unit 21072, Demonstrate knowledge of current good practice for pharmaceutical and allied products; or demonstrate equivalent knowledge and skills. Recommended: Unit 21073, Apply current good practice for pharmaceutical and allied products; and Unit 21361, Demonstrate knowledge of quality control for ; 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 Competenz

2 2 of 5 special notes: 1 Current Good Manufacturing Practice (cgmp) is the term used to define the latest best practice for the manufacture of 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 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 Sampling site means the site where the sample is gathered. Sampling area means the area containing the sampling site. 5 Evidence requirements for this unit standard must cover two different product raw materials, two different intermediate/bulk products, and two different packaging materials.

3 3 of 5 6 Competenz unit designation is PAMT2.2. Elements and Performance Criteria element 1 Prepare to perform routine sampling in accordance with enterprise procedure. performance criteria 1.1 The correct documentation and approved method for sampling are identified. 1.2 Garmenting and personal hygiene procedures are followed. 1.3 Room and equipment status for sampling are verified. 1.4 Sampling area is checked to ensure its condition is suitable for sampling to be undertaken. 1.5 Materials requiring special handling and storage procedures are identified, and handling and storage procedures are followed. 1.6 Materials handling equipment hazards are identified, and safety precautions are taken. 1.7 Personal protective equipment is identified and prepared. 1.8 Sampling equipment is identified and prepared. 1.9 Required materials are located and positioned for sampling The sampling site is identified.

4 4 of 5 element 2 Perform routine sampling. performance criteria 2.1 Special instructions for preparation of the sampling site are followed in accordance with enterprise procedure. 2.2 Unacceptable materials are identified, required action is taken, and documentation is completed, in accordance with enterprise procedure. Range: unacceptable materials may include contaminated, nonconforming, damaged packaging. 2.3 Required materials are sampled using appropriate equipment in accordance with sampling procedures. 2.4 Sample number and material quantities are checked against sampling plan. 2.5 Sampled materials are packed, uniquely labelled, and documentation is completed, in accordance with enterprise procedure. 2.6 Enterprise procedures for notifying and rectifying sampling errors or incorrect sampling conditions are explained. 2.7 Sample site and packages are resealed, reconciled, labelled, and relocated, in accordance with enterprise procedure. 2.8 Reject and waste materials are labelled and relocated in accordance with enterprise procedure. 2.9 Sampled materials are stored or delivered in accordance with enterprise procedure Documentation is delivered or filed in accordance with enterprise procedure Cleaning materials, cleaning equipment, and personal protective equipment required by the enterprise for cleaning sampling area and equipment are prepared.

5 5 of Sampling area and equipment used are cleaned, status labels are applied, and records are completed, to meet enterprise requirements. Comments on this unit standard Please contact Competenz info@compentenz.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