A Probability Based Equivalence Test of NIR Versus HPLC Analytical Methods in a Continuous Manufacturing Process Validation Study

2019 ◽  
pp. 45-54
Author(s):  
Areti Manola ◽  
Steven Novick ◽  
Jyh-Ming Shoung ◽  
Stan Altan
Keyword(s):  
Validation Study ◽  
Analytical Methods ◽  
Manufacturing Process ◽  
Continuous Manufacturing ◽  
Equivalence Test ◽  
Process Validation

scholarly journals Smart manufacturing analytics application for semi-continuous manufacturing process – a use case

2018 ◽  
Vol 26 ◽  
pp. 1041-1052 ◽  
Author(s):  
Parikshit Mehta ◽  
Sergio Butkewitsch-Choze ◽  
Christopher Seaman
Keyword(s):  
Manufacturing Process ◽  
Smart Manufacturing ◽  
Use Case ◽  
Continuous Manufacturing

scholarly journals Development of a Multi-Step Synthesis and Workup Sequence for an Integrated, Continuous Manufacturing Process of a Pharmaceutical

2014 ◽  
Vol 18 (3) ◽  
pp. 402-409 ◽  
Author(s):  
Patrick L. Heider ◽  
Stephen C. Born ◽  
Soubir Basak ◽  
Brahim Benyahia ◽  
Richard Lakerveld ◽  
...  
Keyword(s):  
Manufacturing Process ◽  
Continuous Manufacturing

Assessment of Robustness for a Near-Infrared Concentration Model for Real-Time Release Testing in a Continuous Manufacturing Process

2016 ◽  
Vol 12 (1) ◽  
pp. 14-25 ◽  
Author(s):  
Yleana M. Colón ◽  
Jenny Vargas ◽  
Eric Sánchez ◽  
Gilfredo Navarro ◽  
Rodolfo J. Romañach
Keyword(s):  
Real Time ◽  
Manufacturing Process ◽  
Near Infrared ◽  
Continuous Manufacturing ◽  
Release Testing

Process Validation of Isoniazide and Rifampin Tablet

2021 ◽  
pp. 105-110
Author(s):  
Priyanka Kailas Borse ◽  
Kiran B. Dhamak
Keyword(s):  
Manufacturing Process ◽  
Critical Parameter ◽  
Tablet Formulation ◽  
Process Equipment ◽  
Wet Milling ◽  
Validation Data ◽  
Process Validation ◽  
Validation Criteria ◽  
Dry Mixing ◽  
High Degree

The plethora subscribed in this research is directed towards the process validation of tablet formulation containing Isoniazide and Rifampin. The different process parameters were identified and studied for the tablet formulation batches. Three process validation batches of same size, manufacturing process, equipment and validation criteria was taken. The critical parameter involved in sifting, dry mixing, preparation of granulating agent, wet mixing, wet milling, drying, sizing, lubrication and compression stages were identified and evaluated. The outcome indicated that this process validation data provides high degree of assurance that manufacturing process produces product meeting its predetermined specifications and quality attributes.

Continuous manufacturing process monitoring of pharmaceutical solid dosage form: A case study

2020 ◽  
Vol 179 ◽  
pp. 112971 ◽  
Author(s):  
Yves Roggo ◽  
Victoria Pauli ◽  
Morgane Jelsch ◽  
Laurent Pellegatti ◽  
Frantz Elbaz ◽  
...  
Keyword(s):  
Process Monitoring ◽  
Manufacturing Process ◽  
Dosage Form ◽  
Continuous Manufacturing ◽  
Solid Dosage Form ◽  
Solid Dosage

scholarly journals Process validation: An essential process in pharmaceutical industry

2015 ◽  
Vol 1 (4) ◽  
pp. 179
Author(s):  
Brahmaiah Bonthagarala ◽  
Sandhya Ch. ◽  
Pusuluri Dharani Lakshmi Sai ◽  
Konkipudi Venkata Sivaiah
Keyword(s):  
Quality Assurance ◽  
Quality Management ◽  
Pharmaceutical Industry ◽  
Manufacturing Process ◽  
Iso 9000 ◽  
Pharmaceutical Manufacturing ◽  
Process Validation ◽  
The Us ◽  
Tablet Manufacturing

The purpose of this work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process with special reference to the requirements stipulated by the US Food and Drug Administration (FDA).Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.

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