STUDIES IN PROSPECTIVE PROCESS VALIDATION OF ALLOPURINOL USP AS ACTIVE PHARMACEUTICAL INGREDIENT

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (10) ◽  
pp. 42-50
Author(s):  
Hemant S. Kandle ◽  
Sangram S. Patil ◽  
Sujata S. Sawant ◽  
Ganesh B. Vambhurkar ◽  
Asha M. Jagtap ◽  
...  
Keyword(s):  
Active Pharmaceutical Ingredient ◽  
Process Parameter ◽  
Regulatory Requirements ◽  
Validation Data ◽  
Process Validation ◽  
Critical Process Parameter ◽  
Quality Control Testing ◽  
Quality Product ◽  
High Degree ◽  
Critical Process

Allopurinol USP batches of same size, method, equipment and validation criterion were taken. The critical process parameter involved were reaction, drying, milling, sifting, milling, and blending stages were validation. Quality cannot be assured by daily quality control testing because of the limitations of statistical samples, and the limited facilities of finished product testing. Validation checks the accuracy and reliability of process. Aim of this work was to study prospective process validation of allopurinol USP designed to meet the current regulatory requirements and prove with assurance that the product meets the predetermined specifications and quality attributes. The critical process parameter was identified with the help of process capability and evaluated by challenging its in house and compendial specification. Three initial process validations batches APL/008, APL/009 and APL/010 were identified and evaluated as per validation master plan. The outcome indicated that this process validation data provides high degree of assurance so that manufacturing process produces a quality product.

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.

Research of the True Flow with High Polymers as a Critical Process Parameter

2014 ◽  
Vol 490-491 ◽  
pp. 34-37
Author(s):  
Xian Wei Wang ◽  
Guang Liang Cheng
Keyword(s):  
Intermolecular Interaction ◽  
Process Parameter ◽  
Polymer Materials ◽  
Practical Significance ◽  
Fixed Temperature ◽  
Polymer Swelling ◽  
Chain Flexibility ◽  
Critical Process Parameter ◽  
Critical Process ◽  
True Flow

In this article should be noted that the accuracy of determining the viscosity of the flow is particularly low in the highly elastic with state of the polymer. It is therefore very important to identity the viscosity of the flow, which has great practical significance. solidity can be changed as a result of intermolecular interaction which can be observed in the process of polymer swelling, which means improving its chain flexibility and lowering the temperature of vitrifying. It should be noted that the processing of the experiment showed no pronounced dependence of the voltage, so it is under-read as the average results for all levers of the stress at a fixed temperature. Processed a method for determining the viscosity of polymer materials, which allows you to divide segmental strength and toughness of the true flow.

scholarly journals PREPARATION AND SCALE-UP STUDY OF TREATED FAMOTIDINE FOR THE DEVELOPMENT OF ORALLY DISINTEGRATING TABLETS USING A COMPLEX FLUIDIZED-BED GRANULATOR EQUIPPED WITH A PARTICLE-SIZING MECHANISM

2018 ◽  
Vol 10 (5) ◽  
pp. 35
Author(s):  
Shouichi Hosaka ◽  
Masaki Yamazawa ◽  
Yoshiteru Takahashi
Keyword(s):  
Particle Size ◽  
Fluidized Bed ◽  
Scale Up ◽  
Process Parameter ◽  
Air Pressure ◽  
Particle Sizing ◽  
Critical Process Parameter ◽  
Orally Disintegrating Tablets ◽  
Critical Process ◽  
Scale Up Study

Objective: Bitter taste-masked drug substance should be needed for the development of orally disintegrating tablets (ODT). We selected a new type of a complex fluidized-bed granulator equipped with a particle-sizing mechanism for treating famotidine (FAM). This study was conducted to demonstrate the critical process parameter, which controls particle size of treated FAM, to determine its acceptable particle size considering uniformity of assay and to perform scale-up study from a laboratory scale to a commercial scale.Methods: Particle size of treated FAM was evaluated by changing spraying air pressure on the operation of a complex fluidized-bed granulator. Uniformity of assay in granules after blending and tablets were compared at different particle size of treated FAM. On the scale-up study, particle size and assay of treated FAM in both scales were evaluated.Results: The particle size of treated FAM decreased as the increase in spraying air pressure in relation to the spraying mist size. Better uniformity of assay was observed when the diameter of treated FAM was 20 µm compared to that of 50 µm. Therefore, target particle size of treated FAM was set at approximately 20 µm. Similar qualities could be obtained between both scales in the points of particle size and assay.Conclusion: On the operation of a complex fluidized-bed granulator, spraying air pressure was the critical process parameter that controlled particle size of treated FAM. On Scale-up study of treated FAM, spraying air pressure in relation to the spraying mist size was important.

Evaluation of a critical process parameter: Oxygen limitation during cultivation has a fully reversible effect on gene expression ofBordetella pertussis

2009 ◽  
Vol 102 (1) ◽  
pp. 161-167 ◽  
Author(s):  
Mathieu Streefland ◽  
Bas van de Waterbeemd ◽  
Joeri Kint ◽  
Leo A. van der Pol ◽  
E. Coen Beuvery ◽  
...  
Keyword(s):  
Gene Expression ◽  
Oxygen Limitation ◽  
Process Parameter ◽  
Reversible Effect ◽  
Critical Process Parameter ◽  
Ofbordetella Pertussis ◽  
Critical Process

scholarly journals Cryopreservation timing is a critical process parameter in a thymic regulatory T-cell therapy manufacturing protocol

Cytotherapy ◽  
2019 ◽  
Vol 21 (12) ◽  
pp. 1216-1233 ◽  
Author(s):  
Katherine N. MacDonald ◽  
Sabine Ivison ◽  
Keli L. Hippen ◽  
Romy E. Hoeppli ◽  
Michael Hall ◽  
...  
Keyword(s):  
T Cell ◽  
Cell Therapy ◽  
Regulatory T Cell ◽  
Process Parameter ◽  
T Cell Therapy ◽  
Critical Process Parameter ◽  
Critical Process

scholarly journals PROCESS VALIDATION AND REGULATORY REQUIREMENTS OF METERED-DOSE INHALERS: AN OVERVIEW

2018 ◽  
Vol 11 (2) ◽  
pp. 79 ◽  
Author(s):  
Ashrani Sunil ◽  
Goyal Anju ◽  
Vaishnav Rajat
Keyword(s):  
Quality Characteristics ◽  
Chronic Obstructive ◽  
Metered Dose Inhalers ◽  
Regulatory Requirements ◽  
Obstructive Pulmonary Disease ◽  
Process Validation ◽  
Specific Process ◽  
Metered Dose ◽  
High Degree ◽  
Specific Amount

 The goal of the validation is to assure that quality is built into the system at every step, and not just tested for at the end. The validation activities will commonly include training on production material and operating procedures, training of people involved, and monitoring of the system while in production. Each and every doses form needs to be validated to reduce the chances of batch failures and market recalls. In case of metered-dose inhalers (MDIs) also it becomes mandatory. US Food and Drug Administration defines process validation as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics.” MDIs are known as device that is made to deliver a specific amount of aerosolized medication in the form of short burst directly to the lungs when inhaled by the patient. Furthermore, the inhalational drug delivery causes less pain and is convenient for administration. The patients of asthma, emphysema, and chronic obstructive pulmonary disease are prescribed for quicker relief. The present paper is a summary of process involved in the manufacturing of MDIs and focuses on the regulatory requirements along with their process validation.

scholarly journals Process validation of sucralfate oral suspension

2021 ◽  
Vol 12 (3) ◽  
pp. 2005-2013
Author(s):  
Aluri Nandini ◽  
Ravi G
Keyword(s):  
Manufacturing Process ◽  
Oral Suspension ◽  
Process Variables ◽  
High Quality ◽  
Validation Data ◽  
Process Validation ◽  
Critical Elements ◽  
Commercial Purpose ◽  
Critical Process

Drugs are the critical elements in the health care system. They must be manufactured in the high-quality levels. End product testing by itself does not guarantee of the quality of the product. Quality assurance techniques must be used. In pharmaceutical industry, process validation performs this task, by ensuring that the process does what it purports to do. Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated, we can assure that the final product is of the best quality. This study is intended to demonstrate and standardize the data that should be routinely included in the marketing authorization dossier describing evolution and validation of the manufacturing process and distinguish from the validation data which more properly fall under the remit of GMP inspection. During the study of critical process variables of sucralfate oral suspension were validated to demonstrate consistency of manufacturing process to produce the produce the product of desired quality. The validation studies were conducted which were intended for the use of commercial purpose so this validation study is concurrent type. All the in-process variables and finished product characteristics were monitored; the statistical analysis of data was carried out. Further from the results, it is inferred that the manufacturing process of sucralfate oral suspension was validated.

Sign in / Sign up

Export Citation Format

Share Document