PENDEKATAN QUALITY BY DESIGN (QbD) DALAM VALIDASI PROSES PRODUKSI SEDIAAN TABLET SEBAGAI SALAH SATU ALAT PENJAMINAN MUTU PRODUK DI INDUSTRI FARMASI

Dede Jihan Oktaviani, Sriwidodo Sriwidodo

Abstrak


Validasi proses produksi merupakan proses terdokumentasi yang membuktikan bahwa suatu proses akan menghasilkan produk yang sesuai spesifikasi dan atribut mutu yang telah ditetapkan sebelumnya secara konsisten. Untuk melakukan validasi proses, tren yang berkembang saat ini ialah dengan menggunakan pendekatan Quality by Design (QbD). Artikel review ini bertujuan untuk memberikan informasi terkait penerapan pendekatan QbD dalam validasi proses produksi sediaan tablet yang menjadi salah satu alat dalam penjaminan mutu produk di industri farmasi. Metode yang dilakukan yaitu penelusuran pustaka dari database yang tersedia secara online dari Google Scholar. Hasil yang diperoleh berdasarkan review yaitu penerapan QbD berguna dalam tahap 1 validasi proses produksi obat (desain proses), dalam artikel ini mengacu pada tablet, dimana terdapat elemen-elemen kritis yang ditetapkan dalam proses untuk menjamin mutu sediaan. Selain itu, validasi proses menjadi penting untuk diterapkan di industri farmasi karena validasi proses merupakan elemen kunci dalam penjaminan mutu produk farmasi karena pengujian akhir dari produk jadi tidaklah cukup untuk menjamin mutu suatu produk.


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Referensi


Agalloco, J. 2011. Validation: An Unconventional Review and Reinvention. PDA J. Pharm. Sci. Technol. 49(4): 175-179.

Ahir, K. B., K. D. Singh, S. P. Yadav, H. S. Patel, and C. B. Pohyari. 2014. Overview of Validation and Basic Concepts of Process Validation. Sch. Acad. J. Pharm. 3(2): 178.

Akers, J. 2009. Simpliying and Improving Process Validation. Journal of Parenteral Science and Technology. 47(6): 281-284.

Anjani, P. and S. W. Hati. 2021. Design of Standard Operating Procedures (SOP) and Implementation at PT. BSP. Journal of Applied Business Administration. March 2021: 106- 115.

Anju, G. and P. Pandey. 2017. Process Validation of Pharmaceutical Dossage Form: A Review. Biomed J. Sci & Tech Rest. 1(5): 1467-1475.

Bhitre, M. J., A. V. Ingale, and R. A. Mene. 2013. Implementation of Quality by Design to the Process Validation with Risk-Based Approach for Quality Assurance of Salbutamol Sulphate Tablets. IJPRS. 2(I).

BPOM RI. 2018. Peraturan Badan Pengawas Obat dan Makanan No. 34 Tahun 2018 tentang Pedoman Cara Pembuatan Obat yang Baik. Jakarta : BPOM RI.

Chaudhari, R. A., A. Pingle, C. Chaudhari, C. Yewale, and A. Kantilal. 2014. Quality by Design (QBD): An Emerging Paradigm For Development of Pharmaceuticals. Int. J.Pharm. 4(2): 138-146.

Chen, C., S. Li, and C. Qiu. 2016. Standard Operating Procedures: The Devils is in The Detail. Journal of Long Term Effect of Medical Implants.

Dahmash, E. Z., A. Al-khatawi, A. Iyire, H. Al-Yami, T. J. Dennison, and A. R. Mohammed. 2018. Quality by Design (QbD) Based Process Optimisation to Develop Functionalised Particles with Modified Release Propertie Using Novel Dry Particle Coating Technique. PloS ONE. 13(11): 1-20.

Das, P., S. R. Mishra, and B. S. Nayak. 2017. The Colossal Role of QbD and PAT Tools in the Pharmaceutical Process Automation. Int J Pharma Res Health Sci. 5(6): 1909-1914.

Elsie, J. and O. Augustine. 2002. An Overview of Pharmaceutical Validation and Process Control in Drug Development. Tropical Journal of Pharmaceutical Research. 1(2): 115-122.

FDA. 1987. Guidelines on General Principles of Process Validation. United States: U.S. Department of Health and Human Services Food and Drug Adminisitration.

FDA. 2002. Guidance for Industry, Validation Procedures for Processing of Human Tissue Intended for Transplantation. United States: U.S. Department of Health and Human Services Food and Drug Administration.

FDA. 2005. Guide to Inspection Validation of Cleaning Processes. United States: U.S. Department of Health and Human Services Food and Drug Administration.

FDA. 2011. Guidance for Industry, Process Validation: General Principles and Practices. United States: U.S. Department of Health and Human Services Food and Drug Adminisitration.

Gupta, A. and N. K. Fuloria. 2012. Short Review on Quality by Design: A New Era of Pharmaceutical Drug Development. International Journal of Drug Development and Research. 4(3): 19-26.

Jain, K., P. Argawal, and M. Bharkatiya. 2018. A Review on Pharmaceutical Validation and Its Implication. International Journal of Pharmacy and Biological Science. 8(2): 117- 125.

Jena, S., G. Arjun, N. V. A. K. Ravipati, D. S. Kumar, and D. Banji. 2010. Industrial Process Validation of Solid Dossage Forms – An Overview. International Journal of Pharmaceutical Sciences Review and Research. 4(2): 145-153.

Kanuri, P. 2016. Science and Risk Based Approach to the Process Validation – Link from Quality by Design to Process Validation. IJPSR. 7(3): 914-929.

Kaur, H., G. Singh, and N. Seth. 2013. Pharmaceutical Process Validation: A Review. The Pharma Innovation Journal. 4(3): 1-7.

Lakshmana, P. S., T. N. K. Suriyaprakash, K. Ruckmani, and R. Thirumurugan. 2014. Concepts of Process Validation in Solid Dosage Form [Tablet] An Overview SAJ. Pharma Pharmacology. 1(1): 1-12.

Nikam, U. A., A. V. Jadhav, V. R. Shalunke, and C. S. Magdum. An Overview of Pharmaceutical Process Validation of Solid Dossage Form. Current Pharma Research. 3(2): 824-835.

Paruchuri, R., S. Trivedi, G. Pavuluri, B. Prasanthi, and S. M. Kumar. 2012. Process Validation of Finasteride Tablets. International Journal of Pharmaceutical, Chemical, and Biological Sciences. 2(1): 11-28.

Patel, C., D. Desal, and A. K. Setha. 2015. Process Validation of Arthemether and Lumefenantrine 80/480 mg Tablet. Pharma Science Monitor. 6(1): 233-243.

Patni, M. P., A. Singh, and A. Kumar. 2013. Review on Process Validation of Famciclovir 500 mg Tablets. International Journal of Advances in Pharmacy, Biology, and Chemistry. 2(3): 569-584.

PIC/S. 2007. Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation. Jenewa: Pharmaceutical Inspection Co-operation Scheme.

Ravikanth, K., K. Anil, T. Deepak, S. Anirudh, H. Sudheer, et al. 2015. Quality Assurance by Effective Manufacturing Process Validation. International Journal of Pharmaceutical Quality Assurance. 6(4): 109-113.

Roy, S. 2012. Quality by design: A Holistic Concept of Building Quality in Pharmaceuticals. International Journal of Pharmaceutical and Biomedical Research. 3(2): 100-108.

Sabale, S. and S. Throat. 2021. An Overview on Validation Process in Pharmaceutical Industry. Scholars Academic Journal of Pharmacy. 10(6): 95-101.

Sarvani, V., R. P. Elisha, S. Nama, L. M. Pola, and C. B. Rao. 2013. Process Validation: An Essential Process in Pharmaceutical Industry. International Journal of Medicinal Chemistry and Analysis. 3(2): 49- 52.

Satyabratajena, G. Ajun, N. V. Anilkumarravipati, D. Satishkumar, K. R. Vinod, et al. 2013. Process Validation: An Essential Process. Current Pharma Research. 3(2): 824-835.

Sharma, T. 2012. Basic Aspects of Process Validation of Solid Oral Dossage Form. International Journal of Pharmaceutical Erudition. 1(4): 1- 15.

Sharma, M. and S. Agarwal. 2015. Prospective Validation A Review. The Pharma Innovation Journal. 4(3): 1-7.

Sindhurnag, N., B. Gouthami, L. Madhuri, L. V. Reddy, N. Khrisnaveni, et al. 2012. The Concept of Process Validation in Tablet Manufacturing: Review. Journal of Pharmacy Research.

WHO. 1992. Good Manufacturing Practices for Pharmaceutical Products, WHO Experts Commite on Spesification for Pharmaceutical Preparation. Geneva: WHO.




DOI: https://doi.org/10.24198/farmaka.v19i3.34899

DOI (PDF): https://doi.org/10.24198/farmaka.v19i3.34899.g16540

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