An Overview of Validation and Basic Concepts of Process Validation: Quality Assurance View Point

Mohammad, Abdul Saleem; Devidi, Swetha; Fatima, Nikhat; Badar, Humera; Sulthana, Syeda Saba; Sulthana, Mohammad Akthar; Rasheed, Nuha

doi:10.5958/2231-5713.2016.00024.6

Cited by 5 publications

(3 citation statements)

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“…In fact the aim is to observe the on-line and off-line performance of the manufacturing process and then validate it. In addition, after the manufacturing process is validated, cGMP also needs so that a well-written procedure for process controls is established to monitor its performance [22,23].…”

Section: Introductionmentioning

confidence: 99%

Quality Control Tests for Ophthalmic Pharmaceuticals: Pharmacopoeial Standards and Specifications

Uddin

Mamun

Kabir

et al. 2017

JAMPS

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The therapeutically performance of the pharmaceuticals must be constant and expectable. In order to claim a pharmaceutical to be a quality drug, it must fulfill certain standards and specifications. The quality of pharmaceuticals is strongly related to the patient's well-being. Quality control (QC) is an historical process in which proof is obtained that the appropriate level of quality has been achieved. QC can have no effect on the quality of the pharmaceuticals. It is merely a measuring process. QC must ensure that all the finished products contain active ingredients that comply with the qualitative and quantitative composition of the finished product described in the product

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Section: Introductionmentioning

confidence: 99%

Quality Control Tests for Ophthalmic Pharmaceuticals: Pharmacopoeial Standards and Specifications

Uddin

Mamun

Kabir

et al. 2017

JAMPS

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“…The GMP guideline is that quality is built in in the process of products manufacturing, and not only controlled in the finished product. Validation and qualification are just that section of the GMP rules, which provides control of both the state of technological systems, equipment and processes, and the order of testing, which allows the production of invariably high-quality products [3]. Validation of technological processes in accordance with the requirements of good manufacturing practice is carried out in order to confirm that a process, personnel actions and the functioning of systems that provide this technological process are fully consistent with the purpose and allow obtaining the expected results.…”

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confidence: 99%

“…It has to be proven that the established process with the use of specific materials and equipment permits continuous release of products of the required quality. Significant changes in the manufacturing process, equipment or materials must be validated [3].…”

mentioning

confidence: 99%

Determination of the critical parameters of the technological process of obtaining solid dosage forms with dry extract and crushed roots and rootes of Scutellaria baicalensis

Сліпченко

2019

Farm Zh

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An important condition for obtaining a high-quality drug is the determination of critical points and parameters of the production process, which is divided into several successive stages. The aim study of the critical parameters of the production of tablets and capsules with vegetable raw materials. For this purpose, validation studies of technological processes were carried out for tablets with dry extract of Scutellaria baicalensis and hard gelatin capsules with vegetable raw materials. The subject of our research was the technological process of obtaining tablets based on dry extract of the roots and rhizomes of Baikal skullcap and hard gelatin capsules based on crushed raw materials. We have identified critical process parameters for each stage. Validation tests were carried out for certain critical process parameters and acceptance criteria were calculated. Quality control of finished tablets based on dry extract of Baikal skullcap and finished hard gelatin capsules based on crushed roots and rhizomes of Baikal skullcap was performed according to the following indicators: appearance, identification, average weight, mass uniformity, disintegration, dissolution, abrasion, microbiological purity, quantitative determination . The obtained validation data of experimental-industrial series meet the acceptance criteria, and the developed technology is reproducible and promising for further validation. On the basis of the obtained results, it can be concluded that the established critical values of the parameters of the production processes and their conditions of carrying out allow for stable and reliable production of semi-finished and finished products that meet the quality standards in accordance with regulatory documents.

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Quality Control Analysis of Neomycin, Gramicidin and Triamcinolone in Ointment Formulation using HPLC Methodology: Methodology Development, Validation and Application

Pushpa,

Rajeswari

2023

RJPT

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The combination of gramicidin (GMN), a bactericidal agent; neomycin (NMN), an aminoglycoside; and triamcinolone (TAA), a glucocorticoid, is used for treating eye infections that are accompanied by inflammation. The contents of GMN, NMN, and TAA in eye ointments must be monitored for quality. In this research, a quick, selective, and robust stability-indicating HPLC method has been developed for the concurrent assay of GMN, NMN, and TAA in bulk and ointment formulations. Analysis was performed using ODS, a250mm × 4.6mm column and mobile phase having 0.1% aqueous formic acid-acetonitrile with a ratio of 20:80 v/v; PDA analysis was performed at 225nm. The elution times for GMN, NMN, and TAA were 2.597min, 4.440min, and 3.251 min, respectively. The GMN, NMN, and TAA linear ranges were 0.625 µg/ml to 3.75 µg/ml, 6.25 µg/ml to 37.50µg/ml and 2.5µg/ml to 15.0µg/ml, respectively. The method is precise with 0.68-0.96% (GMN), 0.52-1.02% (NMN), and 0.26-0.62% (TAA) RSD values. The method is accurate with 98.75-101.25% (GMN), 98.61-100.33% (NMN), and 98.67-100.23% (TAA) recovery values. In degradation investigation, the degradant’s peak elution times are different from the elution times of GMN, NMN, and TAA. Thus, the proved specificity and stability indicating the power of the method. Finally, this developed analytical approach was efficaciously applied to a commercial ointment formulation containing afixed dose of GMN, NMN, and TAA, demonstrating its usefulness for quality control and degradation investigations on GMN, NMN, and TAA.

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An Overview of Validation and Basic Concepts of Process Validation: Quality Assurance View Point

Cited by 5 publications

References 0 publications

Quality Control Tests for Ophthalmic Pharmaceuticals: Pharmacopoeial Standards and Specifications

Quality Control Tests for Ophthalmic Pharmaceuticals: Pharmacopoeial Standards and Specifications

Determination of the critical parameters of the technological process of obtaining solid dosage forms with dry extract and crushed roots and rootes of Scutellaria baicalensis

Quality Control Analysis of Neomycin, Gramicidin and Triamcinolone in Ointment Formulation using HPLC Methodology: Methodology Development, Validation and Application

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