Sub-Field: Pharmaceutical and Allied Products

21365

11-Nov-13

5 of 5

level: 1

credit: 4

planned review date: May 2007

sub-field: Pharmaceutical and Allied Products

purpose: People credited with this unit standard are able to demonstrate basic knowledge of product packaging for pharmaceutical and allied products, and product packing procedures for pharmaceutical and allied products.

entry information: Recommended: Unit 21071, Follow basic regulatory requirements in 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: Competenz unit designation is PAMP1.

Elements and Performance Criteria

element 1

Demonstrate basic knowledge of product packaging for pharmaceutical and allied products.

performance criteria

1.1 The common physical forms of solid and liquid pharmaceutical and allied products are named.

Range: solid – powders, granules, tablets, capsules;

liquid – solutions, suspensions, gels, lotions, creams, pastes, capsules.

1.2 Types of primary product packaging are identified.

Range: primary product packaging includes – glass or plastic or metal containers, closures, plastic and/or foil blister packs, plastic bags, plastic or foil sachets, desiccant, cotton wool or cellophane filler; evidence is required for five types of primary product packaging.

1.3 Types of secondary product packaging are identified.

Range: secondary product packaging includes – printed or unprinted cartons, printed or unprinted labels, leaflets, plastic liners, shippers, protective wrapping;

evidence is required for four types of secondary product packaging.

1.4 Product protection functions of packaging are identified, and an example of each is described.

Range: product protection functions include – physical protection, packaging identification, packaging integrity, packaging stability, protection from light, protection from moisture, protection from microbiological contamination, protection from temperature, protection from gases, protection from physical contamination;

evidence is required for seven product protection functions.

1.5 Consumer protection functions of packaging are identified, and an example of each is described.

Range: consumer protection functions include – precautions information, prescribing information, tamper evidence, child resistance, dosage, product identification, batch identification, expiry dating; evidence is required for five consumer protection functions.

1.6 Common types of solid product packages, and an example of a product packaged in each, are identified.

Range: types of solid product packages include – blister packs, bottles, vials, sachets, pots, pails, cans, bags, drums;

evidence is required for five solid product packages.

1.7 Common types of liquid product packages, and an example of a product packaged in each, are identified.

Range: types of liquid product packages include – bottles, tubes, ampoules, sachets, pots, vials, bags, drums;

evidence is required for five liquid product packages.

1.8 Types of processes used for product packing are identified.

Range: types of processes include – blister packing, tube filling, container filling, sachet filling, sealing, capping, labelling, cartoning, wrapping, coding;

evidence is required for seven types of processes.

1.9 Types of product and process tests used during product packing are identified, and their purpose is described.

Range: types of tests include – product weight, product count, pack count, leak, pack integrity, closure torque, appearance, bulk product identification, packaging component verification, equipment challenge, product coding, environmental;

evidence is required for eight types of tests.

1.10 The types of solid and liquid product packages produced at the enterprise are named.

Range: types of solid product packages may include – blister packs, bottles, vials, sachets, pots, pails, cans, bags, drums;

types of liquid product packages may include – bottles, tubes, ampoules, sachets, pots, vials, bags, drums.

1.11 The types of solid and liquid product packing processes used by the enterprise are named.

Range: types of processes may include – blister packing, tube filling, container filling, sachet filling, sealing, capping, labelling, cartoning, wrapping, coding.

element 2

Demonstrate basic knowledge of product packing procedures for pharmaceutical and allied products.

performance criteria

2.1 Packing line clearance is defined and explained.

Range: line clearance – clear of previous product and documentation, correct product, correct packaging on line, correct coding, correct line settings, operational challenges completed, start-up samples comply with specifications, approval to proceed.

2.2 Packing line reconciliation requirements are identified and the purpose of reconciliation is explained.

Range: reconciliation requirements – bulk product, packed product, printed packaging, surplus materials.

2.3 Product identification requirements and product identification criteria are identified.

Range: product identification requirements – product name, batch/lot identification, expiry or shelf-life details;

product identification criteria – correct, verified, legible, permanent, reproducible.

2.4  Common packing area controls are identified and explained.

Range: controls – process flow; cleanliness; access; minimised product exposure; and segregation of in-process material, samples, surplus materials, waste material, and reject material.

Comments on this unit standard

Please contact Competenz 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 inter-institutional 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.

Ó New Zealand Qualifications Authority 2013