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Relevant bibliographies by topics / CQA-Critical Quality Attributes

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Academic literature on the topic 'CQA-Critical Quality Attributes'

Author: Grafiati

Published: 7 June 2025

Last updated: 2 August 2025

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Journal articles on the topic "CQA-Critical Quality Attributes"

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Pebriani, Alifia Syifa, Sandra Megantara, and Rina Wijayanti. "Tinjauan Critical Quality Attributes (Cqa) dan Critical Process Parameter (Cpp) Sebagai Bagian dari Pendekatan Quality by Design dalam Proses Pengembangan Tablet Salut Selaput Film." Majalah Farmasetika 7, no. 4 (2022): 255. http://dx.doi.org/10.24198/mfarmasetika.v7i4.38841.

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Quality by Design (QbD) merupakan suatu pendekatan sistematis untuk pengembangan produk yang dimulai dengan penetapan tujuan dan menekankan pemahaman produk, proses serta kontrol proses, berdasarkan ilmu pengetahuan dan manajemen risiko mutu. Terdapat beberapa elemen yang termasuk ke dalam QbD, diantaranya adalah Critical Quality Attributes (CQA) dan Critical Parameter Process (CPP). Sebagian besar bentuk sediaan tablet di pasaran merupakan tablet salut film. Sehingga, tujuan dari review ini adalah untuk mengetahui CQA dan CPP pada proses pengembangan tablet salut film. Dalam membuat review in

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2

Ramadhani, Anietta Indri Nur, Sri Yuliana, and Teuku Nanda Saifullah Sulaiman. "QUALITY ASSURANCE OF SMALL VOLUME PARENTERAL PRODUCT WITH QUALITY BY DESIGN APPROACH: A REVIEW." Journal of Pharmaceutical Science and Application 6, no. 2 (2025): 65. https://doi.org/10.24843/jpsa.2024.v06.i02.p02.

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Background: Nowadays, many small-volume injection products are circulating on the market. Small-volume parenteral (SVP) products are usually designed for treatment purposes that provide systemic effects. If it is not produced strictly, the product will be hazardous and even life-threatening. Quality assurance is one of the primary tools used to ensure the acceptable performance of SVP products. Quality by design (QbD) represents a systematic strategy for product development that starts with setting a target product quality and emphasizes product process control based on a scientific approach a

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Manish Majumder, Ramesh B, and Minaketan Tripathy. "Development and Validation of a Ultra Flow Liquid Chromatography Method for the Assay of Boceprevir Using a Quality-by-Design Approach." International Journal of Research in Pharmaceutical Sciences 11, SPL4 (2020): 3023–32. http://dx.doi.org/10.26452/ijrps.v11ispl4.4599.

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Quality by design guided. The assay method of Boceprevir is developed in accordance with ICH Q8(R2) guideline with due validation. .In this process, the Target analytical profile (TAP) of the drug was set and critical method parameters (CMP) were investigated by systematic risk assessment experimentation to control critical Quality Attributes (CQA). In this, A Cause Effect Risk Assessment Matrix with Control-Noise-Experiment (CNX) is used for identifying the high-risk variables i.e Percentage of Organic Modifier (% methanol), pH of the Buffer and flow rate of the mobile phase. The surface resp

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Obaid, Shaikh, Zaheer Zahid, Z. Ahmad Rana, and Shaikh Tazim. "QBD in Analytical Method Development and Validation: A Review." Journal of Pharmaceutical Quality Assurance and Quality Control 1, no. 2 (2019): 30–38. https://doi.org/10.5281/zenodo.3249784.

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<em>Quality advisedly is the current approach to the category of prescription drugs. The aim of the pharmaceutical development is to provide a prime quality factory-made product and its manufacturing technique to often deliver the approaching performance of the products. Quality can not be tested into product however quality ought to be inbuilt advisedly. It's a vital part of the trendy approach to pharmaceutical quality. During this construct of QBD, it's essential to stipulate need product expression profile [Target Product Profile &#40; TPP&#41, Object Product Quality Profil

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Daram Sushma Reddy, Vadla Pranay Kumar, Thalaari Shyam, Vadagam Chandana, Trunugu Sai Priya, and Vankunavath Sandeep. "Critical evaluation of quality by design software." International Journal of Science and Research Archive 14, no. 2 (2025): 1548–59. https://doi.org/10.30574/ijsra.2025.14.2.0343.

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Quality by design (QbD) represents the modern approach to ensuring pharmaceutical quality. This concept has significantly influenced the progress of pharmaceutical sciences, having been established and applied globally in accordance with the International Conference on Harmonization (ICH) Guidelines. The proposed ICH guidelines—Q8 for pharmaceutical development, Q9 for quality risk management, and Q10 for pharmaceutical quality systems—provide a foundation for integrating quality into products. In the QbD framework, it is crucial to define the desired product performance profile, known as the

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Soans, Deborose, R. Chandramouli, A. N. Kavitha, S. K. Roopesh, and Sangam Shrestha. "Application of Design of Experiments for Optimizing Critical Quality Attributes (CQA) in Routine Pharmaceutical Product Development." Journal of Pharmaceutical Research 15, no. 3 (2016): 96. http://dx.doi.org/10.18579/jpcrkc/2016/15/3/103041.

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7

Almakaiev, M. S., O. G. Bashura, and L. M. Sidenko. "The risk assessment of the combined medicine in the capsule dosage form at the pharmaceutical development stage." News of Pharmacy, no. 2(102) (October 19, 2021): 75–84. http://dx.doi.org/10.24959/nphj.21.54.

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Aim. To determine the potential risk factors associated with the critical quality indicators of the combined medicine “Neuronucleos” in the capsule dosage form for the treatment of polyneuropathies using the general risk assessment methodology while planning the drug quality at the stage of pharmaceutical development (PD). Materials and methods. The series of the combined medicine “Neuronucleos” in the capsule dosage form, critical indicators of the drug quality, the flowchart of the drug production, critical control points of the drug manufacturing process were developed. The method of causal

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8

Swain, Suryakanta, Rabinarayan Parhi, Bikash Ranjan Jena, and Sitty Manohar Babu. "Quality by Design: Concept to Applications." Current Drug Discovery Technologies 16, no. 3 (2019): 240–50. http://dx.doi.org/10.2174/1570163815666180308142016.

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Background: Quality by Design (QbD) is associated with a modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also lead to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify the desired and required product performance report, such as Target Product Profile, typical Quality Target Product Profile (QTPP) and

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Bhise, Jayashri J., Omprakash G. Bhusnure, Shrikrishna T. Mule, Imran N. Mujewar, Sachin B. Gholve, and Pallavi U. Jadhav. "A Review on Quality by Design Approach (QBD) for Pharmaceuticals." Journal of Drug Delivery and Therapeutics 9, no. 3-s (2019): 1137–46. http://dx.doi.org/10.22270/jddt.v9i3-s.3014.

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Quality by Design is the modern approach for quality of pharmaceuticals. It describes use of Quality by Design to ensure quality of Pharmaceuticals. In this review, the Quality by Design is described and some of its elements identified. Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities and steps involved in Quality by Design of Pharmaceutical products are described. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quali

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Priani, Sani Ega, Taufik Muhammad Fakih, Gofarana Wilar, Anis Yohana Chaerunisaa, and Iyan Sopyan. "Quality by Design and In Silico Approach in SNEDDS Development: A Comprehensive Formulation Framework." Pharmaceutics 17, no. 6 (2025): 701. https://doi.org/10.3390/pharmaceutics17060701.

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Background/Objectives: The Self-Nanoemulsifying Drug Delivery System (SNEDDS) has been widely applied in oral drug delivery, particularly for poorly water-soluble compounds. The successful development of SNEDDS largely depends on the precise composition of its components. This narrative review provides an in-depth analysis of Quality by Design (QbD), Design of Experiment (DoE), and in silico approach applications in SNEDDS development. Methods: The review is based on publications from 2020 to 2025, sourced from reputable scientific databases (Pubmed, Science direct, Taylor and francis, and Sco

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Book chapters on the topic "CQA-Critical Quality Attributes"

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Gupta, Sanjeev K. "Implementation of CQA (Critical Quality Attribute) Based Approach for Development of Biosimilars." In Continuous Processing in Pharmaceutical Manufacturing. Wiley-VCH Verlag GmbH & Co. KGaA, 2014. http://dx.doi.org/10.1002/9783527673681.ch14.

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Vivekanandan, Sundaramurthy. "Quality by Design in Pharmaceutical Formulation." In Advances in Medical Technologies and Clinical Practice. IGI Global, 2019. http://dx.doi.org/10.4018/978-1-5225-7326-5.ch010.

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Quality by design (QbD) is a systematic, scientific, risk-based approach to product development and manufacturing process to consistently deliver the quality product. In this chapter, application, benefits, opportunities, regulatory requirements involved in quality by design of pharmaceutical products are discussed. In quality by design approach, during development, the developer defines quality target product profile (QTPP) and identifies critical quality attributes (CQA). Critical process parameters (CPP) of unit operations which impacts critical quality attributes need to be identified to u

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Conference papers on the topic "CQA-Critical Quality Attributes"

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Gao, Shang, and Brahim Benyahia. "Robust Techno-economic Analysis, Life Cycle Assessment, and Quality and Sustainability by Digital Design of Three Alternative Continuous Pharmaceutical Tablet Manufacturing Processes." In The 35th European Symposium on Computer Aided Process Engineering. PSE Press, 2025. https://doi.org/10.69997/sct.104102.

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This study presents a comprehensive comparison of the three alternative downstream manufacturing technologies for pharmaceuticals: i) Dry Granulation (DG) through roller compaction, ii) Direct Compaction (DC), and iii) Wet Granulation (WG) based on the economic, environmental and product quality performances. Firstly, the integrated dynamic mathematical models of the different downstream (drug product) processes were developed using gPROMS formulated products based on data from the literature or/and our recent experimental work. The process models were developed and simulated to reliably captu

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