Abstract

All Pharmaceutical industries endeavour to produce good quality products which are achieved by allowing in-process and finished product quality control approaches. In-process quality control is concepts that are carried out before, after and during production covering all steps, counting the establishment of specifications, sampling, relevant testing and analytical clearance assuring that the intermediates, packaging materials and finished pharmaceutical tablets conform with approved specifications or standard for efficacy, safety and elegance which assure the consumer that the products perform consistently and in a manner satisfactory for the purpose for which it is recommended. Quality control highlights testing of products for defects which ease the producer to refuse the releases of products or carry out the possible investigation to make pharmaceutical tablets perfect before released into the market. Since different pharmacopoeias have set the diverse specified limits to some extent within which the value ought to fall with respect to be acquiescent as per the standards. Hence by comparing pharmacopoeias, an effort is made to convey the harmonized limits so that the products should meet the requirements as specified in pharmacopoeias specification to confirm the quality of pharmaceutical dosage form. The endeavour of this study is to compare various quality control assessments for pharmaceutical tablets according to different pharmacopoeias standards.

Highlights

  • Quality is a broad term which cannot be tested into the product; it should be built into it [1]

  • In-process quality control is concepts that are carried out before, after and during production covering all steps, counting the establishment of specifications, sampling, relevant testing and analytical clearance assuring that the intermediates, packaging materials and finished pharmaceutical tablets conform with approved specifications or standard for efficacy, safety and elegance which assure the consumer that the products perform consistently and in a manner satisfactory for the purpose for which it is recommended

  • Some tests are described in pharmacopoeias which are traditionally concerned with content and in vivo release of active substances, while other than pharmacopoeias are known as non-compendia test concerning with quality attributes and need to be used in quality evaluation of tablets [6]

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Summary

Introduction

Quality is a broad term which cannot be tested into the product; it should be built into it [1]. Quality control of medicinal products is a notion that swathes all measures taken, including the establishment of specifications, sampling, relevant testing and analytical clearance, to make certain that the starting materials, intermediates, packaging materials and finished pharmaceutical products conform with approved specifications or standard for identity, strength, purity and other attributes [7]. Some tests are described in pharmacopoeias which are traditionally concerned with content and in vivo release of active substances, while other than pharmacopoeias are known as non-compendia test concerning with quality attributes and need to be used in quality evaluation of tablets [6] Finished products are those dosage forms that have undergone every phase of production, including the packaging in its final container and labelling [7]. It is determined by tooling [12]

Thickness
Unique identification marking
Hardness
Friability
Disintegration test
Uniformity of dosage units
Content of active ingredients
Dissolution
Findings
Conclusion
Full Text
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