Control of raw materials in pharmaceutical industry – comparison of pharmacopoeia regulations

Miteva, Sofce and Gjorgjeska, Biljana and Petkovska, Sofija (2016) Control of raw materials in pharmaceutical industry – comparison of pharmacopoeia regulations. In: 24th Congress of the society of chemists and technologists of Macedonia with international participation, 11-14 Sept 2016, Ohrid, Macedonia.

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Abstract

The production of safe and effective pharmaceutical products with standard quality requires permanent monitoring, control and quality assurance of everything that is involved in the production process. To meet the stringent requirements of the pharmacopoeia regulations, it is necessary to carry out quality control tests of incoming raw materials continuously, including quality control of active substances, excipients and packaging material. A huge number of manuals, protocols, standard operating procedures, pharmacopoeia regulations and guidelines which provide additional information for monitoring and ensuring the quality of raw materials in the pharmaceutical industry are available. The aim of this study was to compare the requirements included in the monographs of the European, American and Indian Pharmacopoeia, as well as, in the Handbook of Pharmaceutical Excipients and to estimate them as in process control parameters for evaluation of the quality of raw materials in production of Paracetamol tablets á 500 mg. The monographs for paracetamol, sodium starch glycolate, stearic acid, pregelatinized starch and povidon were compared. The comparison of the pharmacopoeia regulations for packing material dedicated for oral use included in the European, United States and Indian Pharmacopoeias was also done. From the comparisons made, it can be noted that the requirements included in the monographs of these three pharmacopoeias are largely similar, so we can conclude that there is compliance within the pharmacopoeia requirements. The only significant differences were observed in the part concerning the packing material. European Pharmacopoeia contains monograph specific for each type of packaging material while applications relating to packaging materials in the US and Indian Pharmacopoeia are not placed in separate monographs. In industrial conditions, the quality control specifications may also include other requirements and tests that are not included in the monographs of the pharmacopoeia, as is necessary for defining the quality of incoming raw materials. Fulfilling all the requirements included in the specifications for quality of all incoming raw materials and respecting the standards of good manufacturing practice provides assurance that we will achieve the required quality, efficiency and reliability of the finished pharmaceutical product.

Item Type: Conference or Workshop Item (Poster)
Subjects: Medical and Health Sciences > Health sciences
Engineering and Technology > Industrial Biotechnology
Medical and Health Sciences > Other medical sciences
Divisions: Faculty of Medical Science
Depositing User: Biljana Gorgeska
Date Deposited: 27 Sep 2016 13:40
Last Modified: 27 Sep 2016 13:40
URI: http://eprints.ugd.edu.mk/id/eprint/16319

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