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.

MONITORING OF CRITICAL PROCESS VARIABLES FOR PILOT PLANT SCALE-UP STUDIES OF PARACETAMOL TABLETS

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (10) ◽  
pp. 65-67
Author(s):  
H Kathpalia ◽  
◽  
K. Sharma ◽  
S. Juvekar
Keyword(s):  
Manufacturing Process ◽  
Pilot Plant ◽  
Scale Up ◽  
Immediate Release ◽  
Process Variables ◽  
Relative Standard ◽  
Pilot Plant Scale ◽  
Tablet Compression ◽  
Critical Process

The objective of the study was to undertake pilot plant scale-up batches of paracetamol immediate release tablets by designing, optimizing and validating the tablet manufacturing process. A process design was developed to define the critical process variables and monitor it throughout the manufacturing process. Critical processes such as blending of intragranular ingredients, drying of the granules, lubrication and tablet compression were optimized. The process optimization was carried out based on the critical quality attributes of the formulation and their predetermined limits. Process validation was carried out to assure reproducibility in the quality of the product. The scale-up process produced batches showing good reproducibility with a relative standard deviation of less than 2%.

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.

An investigation of the effects of autobrazer parameter variations on the quality of return bend joints

1997 ◽  
Vol 211 (6) ◽  
pp. 443-450 ◽  
Author(s):  
E I Agba ◽  
E W Jones ◽  
A S Penaherrera ◽  
B Thrift
Keyword(s):  
Temperature Profiles ◽  
Process Variables ◽  
Heating Rates ◽  
High Quality ◽  
Parameter Variations ◽  
Brazed Joints ◽  
Temperature Monitor ◽  
Low Probability ◽  
And Control

A temperature monitor that can record brazing temperatures inside an autobrazer for process control and qualification was developed. The monitor was made of a heat exchanger coil instrumented with multiple thermocouples at statistically selected return bend joints that had a high or low probability of leaking. The brazing temperatures recorded at the selected return bends were compared with control temperature profiles for high-quality brazed joints. The results clearly accentuated the disparities in the heating rates, the cooling rates and the peak bonding temperatures between the non-leaking joints and the leaking joints. The autobrazer process parameters were then correlated with a number of leaks and leak locations to determine how to configure the autobrazer and control the process variables to ensure similar brazing conditions at all joints. By so doing, the repeatability of the brazing process and the production of high-quality joints was guaranteed.

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.

Pharmaceutical process validation: An overview

2003 ◽  
Vol 217 (2) ◽  
pp. 141-151 ◽  
Author(s):  
H Aleem ◽  
Y Zhao ◽  
S Lord ◽  
T McCarthy ◽  
P Sharratt
Keyword(s):  
Health Care ◽  
Quality Assurance ◽  
Pharmaceutical Industry ◽  
Special Reference ◽  
Product Quality ◽  
Regulatory Requirement ◽  
Process Validation ◽  
Critical Elements ◽  
The Us

Drugs are critical elements in health care. They 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. In the pharmaceutical industry, process validation performs this task, ensuring that the process does what it purports to do. It is also a regulatory requirement. This paper presents an introduction and general overview of this process, with special reference to the requirements stipulated by the US Food and Drug Administration (FDA).

scholarly journals Recommendations for validation testing of home pregnancy tests (HPTs) in Europe

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Catharine Sturgeon ◽  
Stephen A. Butler ◽  
Fiona Gould ◽  
Sarah Johnson ◽  
Sam Rowlands ◽  
...  
Keyword(s):  
Best Practice ◽  
Clinical Sample ◽  
Laboratory Setting ◽  
High Quality ◽  
Validation Data ◽  
European Directive ◽  
Fit For Purpose ◽  
Validation Testing

Abstract Home pregnancy tests (HPTs) available in Europe include accuracy and other performance claims listed on their packaging. Due to the lack of guidance on the standardisation of such products, it is often difficult to replicate these claims when tested on a clinical sample, whether in a laboratory setting or by lay users. The In Vitro Diagnostic Regulation is a set of requirements that mandate comprehensive validation data on human pregnancy tests and other in vitro devices. It is due to replace the current European Directive (98/79/EC) and fully implemented in Europe by 2022. In June 2019, a panel of seven experts convened to discuss the validation studies required to provide the information needed to meet the new regulation for HPTs in Europe and proposed 15 recommendations for best practice. Defining best practice at all stages of validation of these important tests may ensure that tests marketed in Europe are fit for purpose, enabling lay users to be confident of the high quality of the HPT results they obtain. The panelists believe that the recommendations proposed here for the validation of HPTs may constructively contribute to improved standardisation of validation procedures in Europe.

scholarly journals A Review on process validation of solid dosage form

2021 ◽  
Vol 11 (4) ◽  
pp. 157-160
Author(s):  
Maulikkumar D Vaja ◽  
Bhoomi D Patel ◽  
Krina A Patel ◽  
Ankit B Chaudhary
Keyword(s):  
Compression Process ◽  
Concurrent Process ◽  
Validation Data ◽  
Granulation Process ◽  
Process Validation ◽  
Solid Dosage ◽  
Weight Variation ◽  
Stable Product ◽  
Tapped Density ◽  
Critical Process

Objective: The purpose of this work is to perform a study on concurrent validation of levonorgestrel tablet BP 0.03mg that will deliver process validation approach as a quality assurance means. The process validation program will be investigated so that the plan will be designed to the character of the procedure under study. This can be performed by checking and controlling the various critical in process parameters. Method: The samples from the three consecutive batches of levonorgestrel tablet 0.03mg are collected at the different stages of the manufacturing from dispensing, mixing, granulation process, drying process, blending process, compression process. Each and every parameter are analyzed and tested as per the specifications and all the data are recorded. The obtained results must be within the specified limit range. Result: The results obtained from the evaluation of different parameters like bulk density, tapped density, friability, hardness, weight variation, and assay were found to be within specification limit range. Conclusion:  The conclusion of the concurrent process validation of levonorgestrel tablet BP 0.03mg is based on the result of the validation data of three consecutive batches. It is concluded that the manufacturing process used for levonorgestrel consistently producing the stable product meeting it is predetermined specification and quality attributes. Keywords: Concurrent process validation, Process validation, Levonorgestrel, Critical process parameter. 

Influence of technology parameters of free-cutting steel continuous casting on the billet internal structure

2020 ◽  
Vol 76 (2) ◽  
pp. 139-142
Author(s):  
A. T. Kunakbaeva ◽  
A. M. Stolyarov ◽  
M. V. Potapova
Keyword(s):  
Regression Analysis ◽  
Continuous Casting ◽  
Internal Structure ◽  
Sulfur Content ◽  
Manganese Content ◽  
High Quality ◽  
Correlation And Regression Analysis ◽  
Cutting Steel ◽  
Continuously Cast

Free-cutting steel gains specific working properties thanks to the high content of sulfur and phosphorus. These elements, especially sulfur, have a rather high tendency to segregation. Therefore, segregation defects in free-cutting steel continuously cast billets can be significantly developed. The aim of the work was to study the influence of the chemical composition of freecutting steel and casting technological parameters on the quality of the macrostructure of continuously cast billets. A metallographic assessment of the internal structure of cast metal made of free-cutting steel and data processing by application of correlation and regression analysis were the research methods. The array of production data of 43 heats of free-cutting steel of grade A12 was studied. Steel casting on a five-strand radial type continuous casting machine was carried out by various methods of metal pouring from tundish into the molds. Metal of 19 heats was poured with an open stream, and 24 heats – by a closed stream through submerged nozzles with a vertical hole. High-quality billets had a cross-sectional size of 150×150 mm. The macrostructure of high-quality square billets made of free-cutting steel of A12 grade is characterized by the presence of central porosity, axial segregation and peripheral point contamination, the degree of development of which was in the range from 1.5 to 2.0 points, segregation cracks and strips – about 1.0 points. In the course of casting with an open stream, almost all of these defects are more developed comparing with the casting by a closed stream. As a result of correlation and regression analysis, linear dependences of the development degree of segregation cracks and strips both axial and angular on the sulfur content in steel and on the ratio of manganese content to sulfur content were established. The degree of these defects development increases with growing of sulfur content in steel of A12 grade. These defects had especially strong development when sulfur content in steel was of more than 0.10%. To improve the quality of cast metal, it is necessary to have the ratio of the manganese content to the sulfur content in the metal more than eight.

Experience of clinical testing of personal telemedicine system ‘Obereg’ for remote monitoring of patients in intensive care units

2020 ◽  
pp. 52-58 ◽  
Author(s):  
A. A. Eryomenko ◽  
N. V. Rostunova ◽  
S. A. Budagyan ◽  
V. V. Stets
Keyword(s):  
Intensive Care ◽  
Intensive Care Units ◽  
Remote Monitoring ◽  
Clinical Testing ◽  
Transportation Of Patients ◽  
High Quality ◽  
Telemedicine System ◽  
Accuracy Of Measurements ◽  
Hospital Equipment

The experience of clinical testing of the personal telemedicine system ‘Obereg’ for remote monitoring of patients at the intensive care units of leading Russian clinics is described. The high quality of communication with the remote receiving devices of doctors, the accuracy of measurements, resistance to interference from various hospital equipment and the absence of its own impact on such equipment were confirmed. There are significant advantages compared to stationary patient monitors, in particular, for intra and out-of-hospital transportation of patients.

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