Design Transfer and Process Validation

2003 ◽  
Author(s):  
Venky Gopalaswamy
Keyword(s):  
Process Validation

scholarly journals Injectable Hydrogels: From Laboratory to Industrialization

Polymers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 650
Author(s):  
Jose Maria Alonso ◽  
Jon Andrade del Olmo ◽  
Raul Perez Gonzalez ◽  
Virginia Saez-Martinez
Keyword(s):  
Industrial Process ◽  
Functional Materials ◽  
Point Of View ◽  
Industrial Scale ◽  
Injectable Hydrogels ◽  
Safety And Efficacy ◽  
Process Validation ◽  
Characterization Techniques ◽  
Hyaluronic Acid Hydrogel ◽  
Lack Of Knowledge

The transfer of some innovative technologies from the laboratory to industrial scale is many times not taken into account in the design and development of some functional materials such as hydrogels to be applied in the biomedical field. There is a lack of knowledge in the scientific field where many aspects of scaling to an industrial process are ignored, and products cannot reach the market. Injectable hydrogels are a good example that we have used in our research to show the different steps needed to follow to get a product in the market based on them. From synthesis and process validation to characterization techniques used and assays performed to ensure the safety and efficacy of the product, following regulation, several well-defined protocols must be adopted. Therefore, this paper summarized all these aspects due to the lack of knowledge that exists about the industrialization of injectable products with the great importance that it entails, and it is intended to serve as a guide on this area to non-initiated scientists. More concretely, in this work, the characteristics and requirements for the development of injectable hydrogels from the laboratory to industrial scale is presented in terms of (i) synthesis techniques employed to obtain injectable hydrogels with tunable desired properties, (ii) the most common characterization techniques to characterize hydrogels, and (iii) the necessary safety and efficacy assays and protocols to industrialize and commercialize injectable hydrogels from the regulatory point of view. Finally, this review also mentioned and explained a real example of the development of a natural hyaluronic acid hydrogel that reached the market as an injectable product.

Life Cycle Approach to Process Validation

2018 ◽  
pp. 1-7
Author(s):  
Ajay Babu Pazhayattil ◽  
Naheed Sayeed-Desta ◽  
Emilija Fredro-Kumbaradzi ◽  
Jordan Collins
Keyword(s):  
Life Cycle ◽  
Life Cycle Approach ◽  
Process Validation

A REVIEW ON PHARMACEUTICAL VALIDATION AND ITS IMPORTANCE AND IMPUTATION

2021 ◽  
Vol 12 (10) ◽  
pp. 23-26
Author(s):  
M Mohankumar ◽  
G Sivakamasundari
Keyword(s):  
Quality Assurance ◽  
Creative Process ◽  
Process Validation ◽  
The Us ◽  
Measurement Control ◽  
Quantitative Validation ◽  
Measurement Validation ◽  
Quality Of Products ◽  
Pharmaceutical Production

Validation is a notable step in fulfilling and keep the character of the last decision. In the event that every progress of the creative process is recognized, we can guarantee that the end result will be of the best quality. Validation is specialized for planning and rehearsing a closely planned step with documents. Verification and quality assurance are inseparable, which guarantees careful quality of products. The process validation underscores the components of the measurement scheme and adheres to the measurement control during commercialization and realizes that it is nothing more than a continuous program and adjust the measurement validation exercises with the item life cycle. The motivation behind this survey is to introduce a presentation and general disclosure on quantitative validation of pharmaceutical production with a unique note to the requirements specified by the US Food and Drug Administration (FDA).

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