Abstract
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.
Highlights
Organized validation of technological processes according to international standards is an integral part of the life cycle of pharmaceutical production, one of the processes in the quality management system of modern pharmaceutical companies, and incorporates the approaches set forth in the rules of Good Manufacturing Practice (GMP) and ISO 9000 series standards [1, 2] Requirements of Good Manufacturing Practice (GMP) are measures to ensure the quality of products through which the appropriate organization of production and quality standards are achieved, taking into account the intended nature of the use of these drugs and requirements
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
We have identified the critical parameters of the technological process for each stage
Summary
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. The purpose is to determine the critical parameters of the technological stages of obtaining tablets based on the dry extract of the Scutellaria baicalensis and hard gelatine capsules on the basis of native raw material – roots and rhizomes of Scutellaria baicalensis; to establish critical limits when introducing the obtaining technology into industrial production, which will allow obtaining high-quality, effective, safe and affordable preparations with nootropic action
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