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

ISO 22716:2007(E) 12 © ISO 2007 – All rights reserved 7.2 Manufacturing operations 7.2.1 Availability of relevant documents 7.2.1.1 Relevant documentation should be available at each stage of manufacturing operations. 7.2.1.2 Manufacturing operations should be carried out according to manufacturing documentation, including: a) suitable equipment; b) formula for the product; c) list of all raw materials identified according to relevant documents indicating batch numbers and quantities; d) detailed manufacturing operations for each stage, such as addition of raw materials, temperatures, speeds, mixing times, sampling, cleaning and, if necessary, sanitizing of equipment, and bulk product transfer. 7.2.2 Start-up checks Before starting any manufacturing operations, it should be ensured that: a) all documentation relevant to the manufacturing operations is available; b) all raw materials are available and released; c) suitable equipment is available for use, in working order, cleaned and, if necessary, sanitized; d) clearance of the area has been performed to avoid mixing with materials from previous operations. 7.2.3 Assignment of a batch number A batch number should be assigned to each batch of manufactured bulk product. This number does not need to be identical with the batch number that appears on the label of the finished product, but, if not, it should be easy to relate to that number. 7.2.4 Identification of in-process operations 7.2.4.1 In accordance with the formula, all raw materials should be measured or weighed, into clean and suitable containers labelled with appropriate identification or directly into the equipment used for manufacturing. 7.2.4.2 At all times, it should be possible to identify major equipment, containers of raw materials and containers of bulk products. 7.2.4.3 Identification of containers of bulk products should indicate: a) name or identifying code; b) batch number; c) storage conditions when such information is critical to assure the quality of the product. 7.2.5 In-process control 7.2.5.1 In-process controls and their acceptance criteria should be defined. 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).