DESIGN OF GOOD MANUFACTURING PRACTICES (GMP) AND SANITATION STANDARD OPERATING PROCEDURE (SSOP) DOCUMENTS IN TEACHING INDUSTRY GAMBIER ANDALAS UNIVERSITY

Vadhila, Refi Wulandari (2021) DESIGN OF GOOD MANUFACTURING PRACTICES (GMP) AND SANITATION STANDARD OPERATING PROCEDURE (SSOP) DOCUMENTS IN TEACHING INDUSTRY GAMBIER ANDALAS UNIVERSITY. Diploma thesis, Universitas Andalas.

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Abstract

Teaching Industry Gambier Andalas University is a unit under the Science Techno Park of Andalas University and is located in the Andalas University medicinal plant garden area. Founded in mid-2019 , Teaching Industry Gambier Andalas University has been developed to produce gambier derivative products, namely catechins with a 90% content and gambier tea derived from gambier leaves. As a unit that will produce food and pharmaceutical products, Teaching Industry must ensure that the products produced are of high quality and safe and meet the product certification requirements from BPOM. One of them is by implementing a documented program of basic requirements for GMP and SSOP. However, currently TIG does not yet have the GMP and SSOP implementation documents. This study aims to design GMP and SSOP documents consisting of SOPs, Work Instructions, and Recording Forms. Document design begins with a review of the implementation of GMP and SSOP at TIG. The next stage is the identification of business and production processes, details of activities, the person in charge of activities through the preparation of the RACI Matrix and mapping of the documented aspects of GMP. The mapping was carried out based on the guidelines for Good Manufacturing Practices for Food Production (CPPOB) and Good Manufacturing Practices for Active Pharmaceutical Ingredients (CPBAOB). Mapping aspects of the GMP guidelines resulted in 10 documented aspects. The documented aspects are then combined with aspects in the SSOP. The final stage is the identification of document requirements for TIG activities that require documents based on documented aspects of GMP and SSOP. The results of this study are in the form of documents required by TIG based on TIG activities, GMP, and SSOP guidelines. The designed documents consist of SOPs, Work Instructions, and Record Forms covering production, facilities, and employees. The details of the document are 7 SOPs, 13 Work Instructions, and 17 recording forms.

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