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Effect of the material of primary packaging containers on providing of visual inspection of pharmaceutical products

Victor G. Demyanenko, Dmitry V. Demyanenko, Svetlana V. Breusova, Inna I. Baranova, Liliya A. Karpenko

Abstract

Introduction:

Today all over the world requirements to drug quality have become more and more strict and its evaluation is one of the most important tasks. Usually input quality control of medicines and other groups of goods is carried out organoleptically (mainly visually) by authorized persons of pharmaceutical establishments. Primary packaging is one of the most critical components in this process, because it strongly influences on possibility of visual control of goods and, of coarse, it should be transparent. 

Aim:

The aim of this article was to analyze primary packaging of some drugs and possibility of their identification and quality evaluation.

Materials and Methods:

Objects of this study were primary packages of 65 randomly taken drugs produced by some leading manufacturers in different dosage forms. Inspection analysis of quality of the researched medicinal products was provided in 8 steps: checking of the accompanying documents, checking quantity of the goods, organoleptic control of packaging, checking of labeling, checking of barcodes, checking of completeness, visual control of a product, composing of documentation for acceptance of the goods.

Results and Conclusion:

All investigated drugs passed the first 6 stages of inspection analysis positively. 46 samples among 65 (or 71%) could not be visually controlled (stage 7) and their appearance was impossible to check because of non-transparency of the containers. If in terms of dosage forms 53% of studied tablet drugs, 88% of eye drops and 100% of suppositories can not be evaluated visually.


Keywords

visual inspection, drugs, packaging materials, primary packaging, quality

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References

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DOI: http://dx.doi.org/10.14748/ssp.v1i1.1685

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About The Authors

Victor G. Demyanenko
National University of Pharmacy, Full Professor, Doctor of Pharmacy
Ukraine

Dmitry V. Demyanenko
National University of Pharmacy, associated Professor, PhD
Ukraine

Svetlana V. Breusova
National University of Pharmacy, associated Professor, PhD
Ukraine

Inna I. Baranova
National University of Pharmacy, Full Professor, Doctor of Pharmacy
Ukraine

Liliya A. Karpenko
National University of Pharmacy, associated Professor, PhD
Ukraine

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