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

ISO 22716:2007(E) 16 © ISO 2007 – All rights reserved 9.5 Out-of-specification results 9.5.1 Out-of-specification results should be reviewed by authorized personnel and properly investigated. 9.5.2 There should be sufficient justification for any re-testing to be performed. 9.5.3 After the investigation, a decision by authorized personnel should be made, notably in terms of deviation, rejection or pending. 9.6 Reagents, solutions, reference standards, culture media Reagents, solutions, reference standards, culture media, etc. should be identified by the following information: a) the name; b) its strength or concentration, when appropriate; c) expiration date, when appropriate; d) the name and/or signature of the person who prepared it, when appropriate; e) opening date; f) storage conditions, when appropriate. 9.7 Sampling 9.7.1 Sampling should be performed by authorized personnel. 9.7.2 Sampling should be defined in terms of: a) sampling method; b) equipment to be used; c) amounts to be taken; d) any precautions to be observed to avoid contamination or deterioration; e) identification of sample; f) frequency. 9.7.3 Samples should be identified by: a) the name or identifying code; b) the batch number; c) the date of sampling; d) the container from which the sample was taken; e) the sampling point, if applicable. 9.8 Retain sample 9.8.1 Samples of finished product should be retained in an appropriate manner and in designated areas. 9.8.2 Sample size of finished products should allow analyses to be carried out in accordance with local regulations. 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).