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

ISO 22716:2007(E) 20 © ISO 2007 – All rights reserved 16 Internal audit 16.1 Principle An internal audit is a tool which is designed to monitor the implementation and the status of these cosmetic Good Manufacturing Practices and, if necessary, to propose corrective actions. 16.2 Approach 16.2.1 Specially designated competent personnel should conduct internal audits in an independent and detailed manner, regularly or on demand. 16.2.2 All observations made during the internal audit should be evaluated and shared with appropriate management. 16.3 Follow-up Internal audit follow-up should confirm the satisfactory completion or implementation of corrective action. 17 Documentation 17.1 Principle 17.1.1 Each company should establish, design, install and maintain its own system of documentation that is appropriate to its organizational structure and to the type of products. An electronic system can be used to prepare and manage documents. 17.1.2 Documentation is an integral part of Good Manufacturing Practices. Therefore, the objective of documentation is to describe activities defined in these guidelines in order to relate the history of these activities and to prevent risks of interpretation, loss of information, confusion or errors inherent to verbal communication. 17.2 Type of document 17.2.1 Documents should be composed of constituents such as procedures, instructions, specifications, protocols, reports, methods, and records appropriate to the activities covered by these guidelines. 17.2.2 Documents can be hard-copy papers or electronic data processing records. 17.3 Writing, approval and distribution 17.3.1 Documents should be defined and describe, with appropriate detail, the operations to be carried out, precautions to be taken and measures to be applied in all activities connected with these guidelines. 17.3.2 The title, nature and purpose of documents should be stated. 17.3.3 Documents should be: a) written in a legible and comprehensive way; b) approved, signed and dated by authorized persons before being used; c) prepared, updated, withdrawn, distributed, classified; d) referenced to ensure that obsolete documents are not used; e) accessible to appropriate personnel; f) removed from the job area and destroyed if they are out-dated. 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).