CTFA Standards - SANS 22716:2011 – Cosmetics – Good Manufacturing Practices(GMP) – Guidelines on Good Manufacturing Practices

ISO 22716:2007(E) © ISO 2007 – All rights reserved 9 5.2.4 The material used in the construction of equipment should be compatible with products and the cleaning and sanitizing agents. 5.3 Installation 5.3.1 The design and the installation of equipment should ease its drainage in order to facilitate cleaning and sanitization. 5.3.2 Equipment should be placed so that movement of materials, mobile equipment and personnel do not pose a risk to quality. 5.3.3 Reasonable access under, inside and around equipment should be provided for maintenance and cleaning. 5.3.4 Major equipment should be readily identifiable. 5.4 Calibration 5.4.1 Laboratory and production measuring instruments that are important for the quality of the product, should be calibrated regularly. 5.4.2 If results of calibration are out-of-acceptance criteria, measuring instruments should be appropriately identified and removed from service. 5.4.3 An out-of-calibration condition should be investigated to determine if there is any impact to the quality of the product and appropriate steps taken based on this investigation. 5.5 Cleaning and sanitization 5.5.1 All equipment should be subject to an appropriate cleaning and, if necessary, sanitization programme. 5.5.2 Cleaning and sanitizing agents should be specified and effective. 5.5.3 Where equipment is assigned to continuous production or production of successive batches of the same product, equipment should be cleaned and, if necessary, sanitized at appropriate intervals. 5.6 Maintenance 5.6.1 Equipment should be regularly maintained. 5.6.2 Maintenance operations should not affect the quality of the product. 5.6.3 Defective equipment should be identified accordingly, excluded from use and isolated if possible. 5.7 Consumables Consumables used for equipment should not affect the quality of the product. 5.8 Authorizations Equipment or automated systems used in production and control should be accessed and used by authorized personnel. 5.9 Back-up systems Adequate alternative arrangements should be available for systems which need to be operated in the event of a failure or breakdown. SANS 22716:2011 © SABS. This non-printable standard is exclusively for members of the Cosmetic, Tolietry and Fragrance Association of South Africa (ctfa) granted access online through its password-protected and member-specific portal in accordance with publishing and copyright exploitation agreement no. 014/009/20-049. The agreement will expire after one year unless renewed. © SABS. This non-printable standard is exclusively for members of the Cosmetic, Tolietry and Fragrance association of South Africa (ctfa).

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