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Welcome to Indonesia International Institute for Life Sciences Repository: Test Item Control and Project of Quality Control at PT Kalbio Global Medika

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References

BPOM. (2018). Pedoman Cara Pembuatan Obat yang Baik (CPOB). Jakarta: Badan Pengawas Obat dan Makanan.

Davani, B. (2017). Pharmaceutical Analysis for Small Molecules: Good Documentation Practices. In John Wiley & Sons, Inc. (1st ed., pp. 127–164). John Wiley & Sons, Inc.

https://doi.org/10.1002/9781119425021.ch8

Dispas, A., Sacré, P.-Y., Ziemons, E., & Hubert, P. (2022). Emerging analytical techniques for pharmaceutical quality control: Where are we in 2022? Journal of Pharmaceutical and Biomedical Analysis, 221, 115071. https://doi.org/10.1016/j.jpba.2022.115071

FDA. (2014). Pharmaceutical Quality Control Labs (7/93). Food and Drug Administration. Retrieved from https://www.fda.gov/inspections-compliance-enforcement-and-criminal- investigations/inspection-guides/pharmaceutical-quality-control-labs-793

FDA. (2016). Data Integrity and Compliance With CGMP Guidance for Industry DRAFT GUIDANCE Pharmaceutical Quality/Manufacturing Standards (CGMP). Food and Drug Administration.

Retrieved from https://www.fda.gov/files/drugs/published/Data-Integrity-and-Compliance- With-Current-Good-Manufacturing-Practice-Guidance-for-Industry.pdf

FDA. (2023, May 31). Facts About the Current Good Manufacturing Practices (cGMP). Food and Drug Administration. Retrieved from https://www.fda.gov/drugs/pharmaceutical-quality- resources/facts-about-current-good-manufacturing-practices-cgmp

ISO. (2005). ISO 9000:2005. International Organization for Standardization.

https://www.iso.org/standard/42180.html

Kolekar, P. D., & Bhagwat, A. M. (2021). Good Documentation Practices: A Need of Pharmaceutical Industry. Asian Journal of Research in Chemistry, 14(5), 368–374.

https://doi.org/10.52711/0974-4150.2021.00063

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Kumar, K. (2017). Good Documentation Practices (GDPs) in Pharmaceutical Industry. Journal of Analytical & Pharmaceutical Research, 4(2). https://doi.org/10.15406/japlr.2017.04.00100 Patel, K. T., & Chotai, N. P. (2011). Documentation and Records: Harmonized GMP Requirements.

Journal of Young Pharmacists, 3(2), 138–150. https://doi.org/10.4103/0975-1483.80303 Rattan, A. K. (2017). Data Integrity: History, Issues, and Remediation of Issues. PDA Journal of

Pharmaceutical Science and Technology, 72(2), 105–116. doi:10.5731/pdajpst.2017.00776 Sandle, T. (2014). Good documentation practices. Journal of Validation Technology.

Sanjay, R., Narayan, S., & Manupriya, C. (2017). In-Process Quality Control (IPQC): A Review.

International Journal of Applied Pharmaceutical and Biological Research, 2(6), 29-32.

Schniepp, S. (2019). ALCOA+ and Data Integrity. Pharmaceutical Technology, 43(10).

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