ISO 15378:2017 pdf download – Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP).
3.3.4 clean zone defined space within which the number concentration of airborne particles is controlled and classified, and which is constructed and operated in a manner to control the introduction, generation, and retention of contaminants inside the space Note 1 to entry: This class of airborne particle concentration is specified. Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be specified and controlled. Note 3 to entry: A clean zone(s) can be a defined space within a cleanroom or might be achieved by a separative device. Such a device can be located inside or outside a cleanroom. Note 4 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature, humidity, pressure, vibration and electrostatic. [SOURCE: ISO 14644-1:2015, 3.1.2] 3.3.5 controlled area controlled environment area or environment constructed and operated to control the possible introduction of potential contaminants 3.3.6 working area defined area where origination (3.2.6), production (3.5.7), packaging, test or inspection operations are carried out and where such activity will usually be subject to a line clearance (3.5.4) Note 1 to entry: These areas are physically defined by the use of barriers, floor marking or similar means of definition, and can contain equipment, e.g. production machinery, test equipment, computers, work benches, proofing equipment. 3.4 Terms related to requirement 3.4.1 expiration date expected suitable use limit Note 1 to entry: See also definition shelf-life (3.4.2). Note 2 to entry: This is typically the period during which a primary packaging material (3.6.4) is expected to remain suitable for use if stored under defined conditions and after which it should not be used.
5.2 Policy 5.2.1 Establishing the quality policy Top management shall establish, implement and maintain a quality policy that: a) is appropriate to the purpose and context of the organization and supports its strategic direction; b) provides a framework for setting quality objectives; c) includes a commitment to satisfy applicable requirements; d) includes a commitment to continual improvement of the quality management system. 5.2.2 Communicating the quality policy The quality policy shall: a) be available and be maintained as documented information; b) be communicated, understood and applied within the organization; c) be available to relevant interested parties, as appropriate.