Examinando por Materia "Good Manufacturing Practices"

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Acceso abierto
Control de proceso en la fabricación de comprimidos recubiertos de diclofenaco sódico 50 mg tableta con recubrimiento entérico
(Universidad Privada Norbert Wiener, 2017-12-07) Rodriguez Bardalez, Ireny; Jáuregui Maldonado, José Fidel
The present work validates the activities carried out during the manufacturing process control of 50 mg coated diclofenac sodium tablets, with the objective of demonstrating, through documented evidence, that the specific manufacturing process is under control and consistently and reproducibly provides a product that meets the previously established quality specifications. In the mixing phase, the following tests were performed: appearance, particle size distribution, bulk density, and moisture content. In the pre-lubrication granulate phase, the tests conducted were: appearance and moisture content. In the third phase, the lubricated granulate, the following parameters were evaluated: appearance, particle size distribution, bulk density, mixing of the active pharmaceutical ingredient with excipients and lubricants, moisture content, and angle of repose. During the compression phase, the following tests were carried out: appearance, weight uniformity, hardness, thickness, friability, active pharmaceutical ingredient content uniformity, dosage uniformity, dissolution, and moisture content. In the coating phase (coating 2), the tests performed were: appearance, weight uniformity, dissolution, and moisture content. For data analysis, statistical methods were employed, using control charts for means (X) and standard deviation (S) for each selected variable. The data for the appearance test of the tablets with coating 2 were analyzed using a proportion chart (p). Process capability was calculated for critical variables such as weight uniformity, hardness, and content uniformity, obtaining acceptable values.
Acceso abierto
Validación de procesos de limpieza basado en las Buenas Prácticas de Manufactura en el área de productos naturales en Laboratorios Barton – Callao, Perú 2024
(Universidad Privada Norbert Wiener, 2025-03-03) Flores Cóndor, Blanca Nelida; Rafaele Huamani, Cristina; Parreño Tipián, Juan Manuel
This study was carried out with the aim of determining the level of compliance with the validation parameters based on Good Manufacturing Practices in the natural products area at Barton Laboratories, Callao - Peru, 2024. A deductive methodology with an applied quantitative approach was used, with a non-experimental and cross-sectional design. The validation parameters were analyzed in 3 consecutive production batches. The results showed that the disinfectants are effective against the strains studied (S. aureus, P. aeruginosa, E. coli, A. brasiliensis and C. albicans) and that the microbiological controls complied with the established limits: for environments < 100 CFU for bacteria and < 10 CFU for fungi and yeasts, on surfaces < 20 CFU for bacteria and < 5 CFU for fungi and yeasts. Likewise, the absence of detergent residues is evident, using the 0.04% bromothymol blue indicator solution, a test for oxidizable substances and obtaining a conductivity of less than 1.3 us/cm, confirming the effectiveness of the cleaning processes. In addition, the impregnation oven hose (EI-02) was identified as high-risk equipment with a risk priority number (RPN) of 27. Conclusion, the validation parameters reached a very high level of compliance, which demonstrates that the cleaning methods are highly efficient and reproducible.