It is not only the hospital world that is plagued by the emergence and occurrence of infections. The pharmaceutical sector also needs good practices to sanitize and disinfect properly.
AMIL Care’s developed system enables and supports GMP in sterilization and disinfection of microbial-controlled areas, particularly in the pharmaceutical world, thus supporting proper pharmaceutical sanitization.
What is GMP?
What is GMP? Difficult, to know, if you are not an expert in pharmaceuticals or even just in environmental sanitation and sanitization in the pharmaceutical industry. GMP is an acronym for Good Manufacturing Practices (GMP).
GMP consists of a set of rules that describe the methods, equipment, means, and management of production to ensure the appropriate quality standards. They are mainly used in the food and pharmaceutical fields.
Among the fundamental components of the GMP, we find the documentation, through appropriate records, of every aspect of the process, every activity, and every operation; or the use of specially trained personnel to actively deal with cleaning and sanitization; regular verification of the proper functioning of tools and machinery; process validation.
Why GMP in the pharmaceutical industry?
In short, it is a system ensuring that products are consistently manufactured and controlled according to quality standards.
Poor quality medicines are a major health risk and a waste of money for both governments and individual consumers.
The study ‘Low perceived service quality in community pharmacy is associated with poor medication adherence’, which you can read in its entirety by clicking directly on the title, shows results in this regard that should not be underestimated.
A poor-quality medicine may contain toxic substances or contain little or none of the stated ingredients and therefore not have the desired therapeutic effect.
This is why most countries only accept the import and sale of medicines produced according to internationally recognized GMP. Governments that seek to promote the export of pharmaceuticals from their countries can do so by making GMP mandatory for all pharmaceutical production and by training inspectors.
Good manufacturing practices are a system designed to minimize those risks related to any pharmaceutical production that cannot be eliminated by testing the final product. The main risks are unexpected contamination of products, which can cause damage to health or even death; incorrect labeling on containers, which could indicate that patients have received the wrong medicine; insufficient or excessive active substances, resulting in ineffective treatment or adverse effects.
GMP covers all aspects of production: from starting materials to premises and equipment to staff training and hygiene. Detailed written procedures are essential for every process: systems must exist to provide documented evidence that the correct procedures are consistently followed at every stage of the manufacturing process, every time a product is made.
WHO has established detailed guidelines for good manufacturing practices. Many countries have formulated their own GMP requirements based on the WHO GMP. Others have harmonized their requirements, for example in the Association of Southeast Asian Nations (ASEAN), the European Union and through the Pharmaceutical Inspection Convention.
GMP and Sanitation
However, what do sanitation and sanitization have to do with all this? We can say that they are essential elements. GMP, as we said, covers all aspects of production (from the receipt of raw materials to the distribution of finished products) and involves record keeping, staff qualification and hygiene, cleaning, disinfection and sanitization, inspection of equipment and premises, process validation, complaint handling, and the need for food and/or products placed on the market to be supplied in safe conditions.
In order to truly comply with the guidelines, it is necessary to rely on certified and reliable sanitation systems. GMP is also called “cGMP”. The “c” stands for “current” and reminds manufacturers that they must employ up-to-date technologies and systems to comply with the regulation. Systems and equipment used years ago may not be up to today’s standards.
The role of companies like AMIL Care
For this, it is necessary to rely on companies such as AMIL Care. In fact, Medisystem supports and assists GMP in the field of sterilization and disinfection of controlled microbial load areas, in pharmaceutical production sites (mainly in BIO and vegetable productions), and in all those applications where there is the need to achieve a high environmental quality level (sporicidal activity).
The pharmaceutical industry environments are made up of a wide range of production departments, each of which has different characteristics depending on the type of possible contamination. Among these, we can mention the washing tunnel, the isolators, the laminar flow booths, the cleanrooms, the research laboratories, the animal enclosures, the logistics warehouses, etc.
Medisystem is particularly suitable for the sanitization needs of all these environments because it arises from the combination of cutting-edge technology and validated decontamination protocols, mainly in critical areas and on the main multi-resistant pathogens, even in points that are difficult to reach.
The combined action of micro-nebulization and hydrogen peroxide guarantees proven efficacy thanks to its sporicidal, micro bactericidal, fungicidal, and virucidal activity.
All of this is part of a standardized and traceable process. For information on sanitization in the pharmaceutical industry, do not hesitate to contact the AMIL Care staff.