The Cycle of Good Manufacturing Practice are applicable to the manufacturing operations of medicines, cosmetics, medical products, food and drugs, in their final forms of sale to the public including large-scale processes in hospitals and the preparation of supplies for the use of clinical trials for the case of the drugs.
They are included within the concept of quality assurance and constitute the factor that ensures that the products are manufactured in a uniform and controlled manner, in accordance with the quality standards appropriate to the intended use of the products and in accordance with the required conditions. For its commercialization. The main objective of the regulations governing the GMP is to reduce the risks inherent in all pharmaceutical production.
Any integral guarantee system on the quality of pharmaceutical products should be based not only in a reliable system of procedures to authorize registration and marketing and in an independent analysis of the finished product, but also in the safety achieved through an independent inspection, that all manufacturing operations that are perform in accordance with accepted standards, commonly known as “Good Manufacturing Practices”.
The Good Manufacturing Practice (GMP) Standard is an administrative instrument by virtue of which the state undertakes, at the request of an interested party, to certify that:
- The sale or distribution of the product is authorized.
- The industrial facilities where the product is manufactured are subject to regular inspections to check if the manufacturer conforms to good manufacturing practices and quality inspection.
Thus it is necessary that the National Pharmaceutical Industry elaborate medicines, subject to BPM standards, which will facilitate the control and guarantee of the quality of the same; giving security and reliability for its use, administration, dispensing and dispensing to patient and health professionals.
In this article we will go into “Quality management in the pharmaceutical industry: philosophy and essential elements”, outlines the general concepts of quality assurance, as well as the main components or subsystems of the GMP, which are joint responsibilities of the main administration and administration of production and quality control. Between these include hygiene, checking, self-inspection, personnel, facilities, equipment, materials and documentation.
In the pharmaceutical industry in general, quality management is defined as the aspect of the administrative function that determines and implements the “quality policy”, ie the orientation and the general intentions of an organism with regard to quality, in the form as expressed and authorized by the higher authorities of said body.
The basic elements of quality management are:
- Appropriate infrastructure or “quality system” covering the structure, procedures, processes and resources;
- Systematic actions necessary to ensure sufficient confidence that the product (or service) satisfies certain quality conditions. The set of those actions it is called “quality assurance”.
Within an organization, quality assurance serves as an administrative tool. In contractual situations, quality assurance also serves to build confidence in the provider. In the manufacture and supply of pharmaceutical products, the terminology may vary. In particular, the expression “quality system” is rarely used, with “quality assurance” being thewhich generally encompasses elements such as organizational structure, procedures and processes.
The concepts of quality assurance, BPM and quality control constitute aspects of the quality management that relate to each other. They are described in this article in order to highlight its fundamental importance and its relation to the manufacture and control of pharmaceutical products.
Principle “Quality Assurance” is a very broad concept that encompasses all aspects that individually or collectively influence the quality of the product. Is the set of measures taken in order to ensure that pharmaceutical products are of high quality necessary for the use to which they are intended. Therefore, the quality assurance incorporates the BPM and other factors, including those that go beyond the scope of this guide, such as the design and production of the product.
The quality assurance system appropriate for the manufacture of products Pharmacists must ensure:
- That pharmaceutical products are designed and manufactured in such a way that take into account the requirements of the GMP and other related codes, such as Good Laboratory Practices (GLP) and the Appropriate Clinical Practice (PCA);
- That production and control operations are clearly specified in writing and that the requirements of the GMP be adopted;
- That managerial responsibilities are clearly specified in the work instructions;
- That the necessary measures are taken for the manufacture, provision, and use of material premium and suitable packaging;
- That all necessary controls of raw materials, products are carried out intermediate and bulk products, and other controls, calibrations, and checks during the processing;
- That the finished product is processed and controlled correctly and in accordance with the defined procedures;
- That pharmaceutical products are not sold or supplied before the authorized persons have certified that each batch of production has been manufactured and controlled in accordance with the established requirements by the authorities in charge of commercialization and with other regulations relevant to the production, control and issuance of pharmaceutical products;
- That adequate measures have been taken to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed, and subsequently managed in such a way that the quality is maintained throughout the period of activity of said products;
- That a self-inspection and / or quality audit procedure be established, through which the effectiveness and applicability of the guarantee system is regularly evaluated of quality.
The manufacturer must take responsibility for the quality of the products pharmaceutical companies to ensure that they are appropriate for the intended use, that they meet the necessary requirements to authorize its commercialization, and what is not risky for the patient due to its inadequate safety, quality or efficacy. The main administrative authorities are responsible for compliance with this quality objective, with the active participation and commitment of numerous departments to all levels within the company, suppliers and distributors.
In order to achieve the aforementioned qualitative objective, we must have a wide-ranging and correctly applied quality assurance system, which Incorporate Good Manufacturing Practices and quality control. It needs to be fully documented and that its effectiveness is controlled. All parts of the system of quality assurance must be attended by competent personnel, and it is necessary that adequate facilities, equipment and facilities are available.