In the current century, the pharmaceutical industry has been increasing its quality assurance and standards at a dizzying pace. While pharmaceutical manufacturers are audited under regulations and standards known as GMP (Good Manufacturing Practices), they are required to certify their compliance with these rules, demonstrating that the products they manufacture are produced reliably. GMP consists of rules established by the FDA (Food and Drug Administration) and the WHO (World Health Organization) following human deaths caused by pharmaceutical manufacturing issues and hygiene failures. GMP ensures whether production is carried out to quality standards. GMP covers products that concern human health. These are the pharmaceutical, cosmetic, food, and cleaning sectors. These sectors are obliged to comply with GMP rules.
The pharmaceutical industry adopted GMP practices in 1984. In pharmaceutical manufacturing plants, GMP aims to increase drug reliability and reduce errors. There are regulatory bodies that inspect whether pharmaceutical manufacturing plants comply with GMP rules. These auditing organizations vary by country. In the USA, the body overseeing GMP is the FDA (Food and Drug Administration), while in Turkey, it is monitored by the Ministry of Health. Exporting companies are also audited by international organizations for GMP compliance.
The goal of a pharmaceutical manufacturer is to provide high-quality products to patients. Negligence and carelessness regarding life-saving and life-protecting substances are unforgivable. In the pharmaceutical sector, poor quality means not only a financial loss, but also a loss of credibility and the demise of the company.
In the process of magistral compounding in pharmacies; health authorities in our country, as well as worldwide, do not require GMP rules for the preparation of magistral formulations compounded in pharmacy laboratories within the framework of high trust placed in pharmacists. Pharmacists, on the other hand, should not abuse this high level of trust, and must avoid practices that endanger patient health by ensuring the necessary hygiene conditions in their laboratories.
In this context, it is of great importance that pharmacists and auxiliary staff involved in drug compounding in pharmacy laboratories comply with personal hygiene rules. Foremost among these rules are basic precautions such as when and how to wash hands, selecting proper hand disinfectants, ensuring laboratory staff do not handle banknotes, always wearing gloves when working with open products, and refraining from blowing one’s nose or sneezing.
During compounding, considering that products—especially aqueous formulations, such as creams—can be contaminated by saliva droplets inevitably produced while talking during conversations, work should be conducted quietly, or surgical masks should be worn if necessary.
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Although the greatest risk of contamination originates from people working in pharmaceutical compounding, microorganisms can also originate from raw materials. In particular, water used in compounding must be freshly boiled. Airborne microbial drift is generally not a major issue in well-cleaned rooms, but dusty surfaces, especially floors and shelves, are potential sources of danger.
Although a meticulously cleaned pharmacy floor determines the external appearance, it is not sufficient on its own. Laboratory work surfaces, tools and utensils used in the laboratory, and equipment used in compounding must be systematically cleaned. The concentration of cleaning products and the selection of suitable disinfectant solutions cannot be left to the discretion of staff.
Contamination of raw materials and products used in drug compounding with other substances and products must be prevented. Cross-contamination means the transfer of impurities to a substance. In the pharmaceutical industry, microbial contamination originates from humans, the environment, equipment, manufacturing processes, and packaging materials.
Cross-contamination occurs from surrounding dust, gases, and sprays. Personnel working in manufacturing must wear special garments to protect themselves and prevent pharmaceutical contamination, and they must not leave the work area in these garments, nor should anyone other than authorized personnel enter the laboratory. Wearing wristwatches and jewelry in the laboratory, as well as eating, smoking, and chewing gum, causes contamination in the product. Personnel working in compounding must not have hepatitis, pathogen-spreading diseases, or open skin lesions. All staff should undergo periodic medical examinations.
To prevent contamination, containers, utensils, and work surfaces used must be kept clean. Cleaning must be carried out in the same preparation area before switching to the production of a different product. The secret to success in pharmaceuticals is cleanliness. To prevent contamination, no other product should be handled concurrently while working with highly toxic substances. Keeping doors and windows closed and ensuring effective ventilation prevents contamination. The best way to avoid contamination is attentiveness. Carelessness is unforgivable in drug preparation. Another way to prevent contamination is to design doors, walls, and ventilation systems in such a way that prevents substances within the laboratory from spreading to other areas of the pharmacy. The best way to avoid contamination is taking precautions. For example, anticipating that items such as pens in the breast pocket of a lab coat could fall out into the product being prepared and consequently keeping nothing in the breast pocket is an act of precaution.
Wet kitchen towels in the laboratory are ideal breeding and harborage grounds for microorganisms. A cleaning schedule discussed with staff at appropriate intervals ensures that improper practices are prevented. It is sensible to establish such rules in writing as generally binding within the context of a quality management system and to have relevant staff sign the notification.
According to Ph. Eur., drugs are known to be divided into four categories based on permissible bacterial and fungal limits. Non-sterile preparations for topical use are considered Category 2. For these, a maximum of 102 colony-forming units (CFU) per gram or milliliter is permitted, excluding pathogenic and coliform bacteria. Category 3 preparations include oral, rectal, or transdermal dosage forms. They may contain up to 103 or 101 aerobic bacteria per gram and 102 yeasts and molds per gram.
Contamination, beyond changes in the physical appearance of the product, can lead to severe consequences in terms of patient infections. For example, a lanolin hand cream contaminated with Klebsiella pneumoniae caused the death of a patient in an intensive care unit.
In the hygiene cleaning procedures of pharmacy laboratories, Ethanol 70% stands out as an excellent disinfectant.
In these days when discussions on restrictions regarding the supply of Ethanol to pharmacies are taking place, it should not be forgotten that Ethanol, which is irreplaceable in magistral compounding, is not only an organic solvent used in magistral formulations but also of vital importance for the hygiene of the laboratory environment and equipment.
Wishing you a happy holiday…
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Source:
- Gerd Wolf / Rezepturen / Probleme erkennen, lösen, vermeiden / Gerd Wolf, Grafschaft-Ringen
Specialist Pharmacist Ahmet Nezihi Pekcan
Pekcan Pharmacy – Konya
[email protected]
Tel: (332) 3520657
http://www.majistralformul.com/
