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.

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.

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.

scholarly journals Development of a Scalable Process of Film-Coated bi-Layer Tablet Containing Sustained-Release Metoprolol Succinate and Immediate-Release Amlodipine Besylate

Pharmaceutics ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 1797
Author(s):  
Nguyen Thi Linh Tuyen ◽  
Le Quan Nghiem ◽  
Nguyen Duc Tuan ◽  
Phuoc Huu Le
Keyword(s):  
Sustained Release ◽  
Manufacturing Process ◽  
High Speed ◽  
Immediate Release ◽  
New Drugs ◽  
Batch Size ◽  
Average Weight ◽  
Amlodipine Besylate ◽  
Metoprolol Succinate ◽  
Dry Mixing

The development of new drugs that combine active ingredients for the treatment hypertension is critically essential owing to its offering advantages for both patients and manufacturers. In this study, for the first time, detailed development of a scalable process of film-coated bi-layer tablets containing sustained-release metoprolol succinate and immediate-release amlodipine besylate in a batch size of 10,000 tablets is reported. The processing parameters of the manufacturing process during dry mixing-, drying-, dry mixing- completion stages were systematically investigated, and the evaluation of the film-coated bi-layer tablet properties was well established. The optimal preparation conditions for metoprolol succinate layer were 6 min- dry mixing with a high-speed mixer (120 rpm and 1400 rpm), 30-min drying with a fluid bed dryer, and 5-min- mixing completion at 25 rpm. For the preparation of amlodipine besylate layer, the optimal dry-mixing time using a cube mixer (25 rpm) was found to be 5 min. The average weight of metoprolol succinate layers and bi-layer tablets were controlled at 240–260 mg and 384–416 mg, respectively. Shewhart R chart and X¯ charts of all three sampling lots were satisfactory, confirming that the present scalable process was stable and successful. This study confirms that the manufacturing process is reproducible, robust; and it yields a consistent product that meets specifications.

scholarly journals Problems of uniform distribution of gas flow in gas drying absorbers when preparing gas for transportation

2020 ◽  
Vol 2020 (1) ◽  
pp. 31-37
Author(s):  
Yuriy Aleksandrovich Maksimenko ◽  
Sergei Drachevskii ◽  
Natal'ya Drachevskaya
Keyword(s):  
Natural Gas ◽  
Gas Flow ◽  
Environmental Safety ◽  
Dew Point ◽  
Process Equipment ◽  
Automatic Equipment ◽  
Gas Industry ◽  
Gas Treatment ◽  
High Level ◽  
High Degree

The article highlights the important factors of gas treatment. The dew point of commercial gas is one of the main normalized indicators, since the moisture content in commercial gas has a significant impact on the uptime of automatic equipment, on reducing corrosion of gas pipelines, process equipment and compressor stations during gas transportation. Adsorption drying of natural gas is a widely used method in the Russian gas industry. This method is characterized by the high level of environmental safety. Besides, the advantages of the method include the absence of the liquid phase and corrosive fluids in the commercial gas, low specific adsorbent consumption and the high degree of process automation. The article presents an overview of practical methods of adsorption drying of natural gas when preparing it for transportation. The advantages of adsorption drying over other methods are considered; the constructive disadvantages of absorber types are described; the ways of eliminating them are proposed

Crystallinity and mesoporosity of carbon produced from ligno-p-cresol and their improvement by pulverization and acid treatment

Holzforschung ◽  
2008 ◽  
Vol 62 (2) ◽  
pp. 157-163 ◽  
Author(s):  
Kyoko Suzuki ◽  
Tsutomu Suzuki ◽  
Naohiro Takazawa ◽  
Masamitsu Funaoka
Keyword(s):  
Particle Size ◽  
Phase Separation ◽  
Sulfuric Acid ◽  
Liquid Phase ◽  
Adsorption Capacity ◽  
Manufacturing Process ◽  
Mesoporous Carbon ◽  
Acid Treatment ◽  
Wet Milling ◽  
Liquid Phase Adsorption

AbstractCrystallized mesoporous carbon was produced from ligno-p-cresol, a lignin derivative obtained by phase separation withp-cresol and sulfuric acid, onto which 3% nickel and 2% calcium were co-loaded, by carbonization at 900°C. Subsequent pulverization followed by soaking in acid improved the crystallinity of carbon with an increased volume of mesopore, attaining approximately 90% and 99% removal of nickel and calcium, respectively. These aspects implied both enhancement of electroconductivity and liquid phase adsorption capacity of the carbon with a good outlook on the recovery and reuse of the two metals. In particular, combination of wet milling using small beads and mild soaking with diluted acid was appropriate in respect of relevant properties of the carbon, including the particle size. It can thus be concluded that incorporation of such post-treatments into the manufacturing process of carbon products is greatly advantageous.

A PROPOSAL OF PROCESS VALIDATION IN THE IMPLEMENTATION OF GOOD MANUFACTURING PRACTICES IN BRACHYTHERAPY SOURCES PRODUCTION

2021 ◽  
Vol 9 (1A) ◽  
Author(s):  
Tatyana Spinosa Baptista ◽  
Anselmo Feher Feher ◽  
Bruna Teiga Rodriguez ◽  
Carlos Alberto Zeituni ◽  
João Augusto Moura ◽  
...  
Keyword(s):  
Production Efficiency ◽  
Immersion Test ◽  
Process Equipment ◽  
Metallic Structures ◽  
Process Validation ◽  
Regulatory Guidelines ◽  
Good Manufacturing Practices ◽  
Iodine 125 ◽  
Degree Of Maturity ◽  
High Consistency

New laboratories for brachytherapy sources production are being implemented in our facility at IPEN, in São Paulo. A great challenge implementing a production laboratory is to comply with the Good Manufacturing Practices (GMPs), which involves process validation and all supporting activities such as cleaning and sanitization. Much more than compliance with regulatory guidelines, required for certification and inspections, a validation builds large process knowledge, provides possibilities for optimization and improvement, increasing the degree of maturity of all people involved and the quality system. The process validation results in a document that certifies that any procedure, process, equipment, material, operation or system leads to the expected results. This work focused on the new laboratory, been assembled to produce small iodine-125 seeds. The process validation was performed three times for evaluation. The parameters evaluated in this study were: the source welding efficiency and the leakage tests results (immersion test). The welding efficiency doesn’t have an established parameter, since is visually evaluated by the operator, and the leakage detection must be under 5 nCi / 185 Bq, accordingly with the ISO 9978. We observed values were average 79-87% production efficiency and leakage tests were under 5 nCi/seed. Although established values for the global efficiency aren’t available in the literature, the results showed high consistency and acceptable percentages, especially when other similar manufacturing processes are used in comparison (average 85-70% found in the literature for other similar metallic structures). Those values will be important data when drafting the validation document and to follow the Good Manufacturing Practices (GMPs).process

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.

scholarly journals Process Validation in Pharmaceutical Product Development: An Overview

2021 ◽  
Vol 10 (5) ◽  
Author(s):  
Sreenivasa.G. M ◽  
Sriranga. T ◽  
Naveen Banakar ◽  
Vaishakha Kori ◽  
Chetankumar Vasanad ◽  
...  
Keyword(s):  
Product Development ◽  
Manufacturing Process ◽  
Process Development ◽  
Pharmaceutical Product ◽  
Product Development Process ◽  
Process Validation ◽  
Pharmaceutical Product Development ◽  
Process Qualification ◽  
Evaluation Of Data ◽  
Required Quality

As per GMP process validation is very important and required part in product development. Process Validation is required for ensuring and providing the documentary evidence and also required for giving the Surety that process by which the formulation is prepared is capable of consistently producing the product of required quality and purity. A validated manufacturing process is one which has been proved to do what it purports on is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and Continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment Systems, buildings, personnel), but it also includes the control on the entire process for repeated batches or runs. This article gives a general introduction and overview about process validation in pharmaceutical manufacturing process and its importance. Keywords: GMP, Validation, validation manufacturing process.

Sign in / Sign up

Export Citation Format

Share Document