FADILA AMALINA PUTRI, NIM. 202413056 (2025) IDENTIFIKASI VALIDASI PEMBERSIHAN SESUAI DENGAN CARA PEMBUATAN OBAT YANG BAIK (CPOB) DI INDUSTRI FARMASI LAFI PUSKESAD. Professional Project Practice thesis, UNIVERSITAS MUHAMMADIYAH GOMBONG.

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Abstract

Background, Cleaning validation is a crucial aspect of implementing Good Manufacturing Practices (GMP) in the pharmaceutical industry to ensure product quality and safety by preventing cross-contamination. Objective, This study aimed to identify and evaluate the compliance of cleaning validation implementation at LAFI PUSKESAD Pharmaceutical Industry with the latest GMP guidelines. Methods, This study employed a descriptive design with an observational approach and document review. The methods included on-site observations, review of Cleaning Validation Protocols, evaluation of Maximum Allowable Carry Over (MACO) calculations, analysis of testing reports, and assessment of cleaning procedures applied to the Super Mixer Jaw Chuan SM-100. Results, The results indicated that LAFI PUSKESAD has established documented and validated cleaning procedures. Residue testing of the active ingredient sulfamethoxazole showed an average value of 1.2 ppm, which was below the acceptance limit of <10 ppm. Microbiological testing met the acceptance criteria with results of 0 cfu/25 cm², and visual inspection confirmed that the equipment was clean and dry. However, several aspects require alignment with current GMP regulations. The acceptance criteria and marker compound selection still rely on conventional approaches (10 ppm limit and LD₅₀-based evaluation) and have not yet adopted a risk-based approach such as Health-Based Exposure Limits (HBEL). In addition, recovery study documentation for sampling methods (swab and rinse) was not explicitly presented. Conclusion, LAFI PUSKESAD has implemented cleaning validation in accordance with the fundamental principles of GMP. Recommendation, Further improvements are recommended to align cleaning validation practices with updated regulatory requirements and global best practices

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