Good manufacturing practices are mainly considered as part of quality management. Good manufacturing practices, which are briefly defined as GMP, are formed by combining the initials of Good Manufacturing Practices in English. In particular, it means the production of products that directly concern the health of people, such as medicines, medical equipment, food and cosmetics, in safe environments and under favorable conditions. In other words, it is the set of principles that ensure that these products are manufactured in quality and condition suitable for their intended use. GMP applications include quality control as well as appropriate production. It is an application that requires to comply with the rules for cultivated and safe production.
Good production practices ensure uninterrupted production of products in line with market needs of manufacturers and under the control of quality standards. In order to achieve this, production processes must be clearly defined. These processes start with the entry of raw materials into the plant and continue until the finished product leaves the plant after production. It even guarantees the quality of the products during the distribution phase.
For a product to be of good quality, it must meet GMP standards with defined characteristics and analysis results. Therefore, the physical, chemical and biological properties of the products should be defined according to the determined numerical values, limitations and characteristics at every stage of the production processes.
In this respect, quality management system standards, quality assurance, quality control and good production practices are closely related. Quality management puts the company's quality policies above all. Quality assurance guarantees the implementation of these policies. Good manufacturing practices and GMP standard, as part of quality assurance, focus on untestable risks and accept quality as an integral part of the product. Quality control is concerned with materials, components and the product itself, as well as whether the production environment and facilities comply with the standards.
A well-designed and properly implemented quality assurance system is closely linked to the following factors in terms of product assurance:
- Good manufacturing practices (GMP)
- Quality control
- Quality risk management
What is GMP Good Manufacturing Practice System
ISO 2007 Cosmetic Good Manufacturing Practices System standard was published in 22716 by International Standards Organization. This standard covers cosmetics and personal care products. In the European Union, the Cosmetics Regulation was adopted and put into practice in 2010. In this way, in both the member states of the European Union and the candidate countries, the system of Good Manufacturing Practices in Cosmetics has been made compulsory for cosmetics producing enterprises.
Because it directly affects human health, cosmetic products must be produced under reliable conditions and in accordance with established standards. The GMP standard, which is designed to ensure the production of effective and reliable products, that is, the standard of good manufacturing practices, provides guidance on the production conditions of pharmaceuticals, food, medical devices and similar health products.
The ISO 22716 Cosmetic Good Manufacturing Practices System standard focuses on the GMP standard, which generally addresses pharmaceutical and food industry companies. In general, the GMP standard is the measurements and controls to ensure the quality of the products and to prevent possible defects. Production activities must comply with the GMP principles and follow the identified business processes.
The basic principles of the GMP Good Manufacturing Practice System standard can be listed as follows:
- Quality Management System standard must be established and applied before the enterprise
- Personnel and business structure should be revised for effective management
- The premises, buildings, machinery, equipment and materials of the entity must comply with the required standard
- Documentation work, such as workflows, workflow diagrams and application instructions, must be completed
- Raw material entry into the enterprise, its processing, storage of products and distribution principles should be determined
- Quality control and proficiency testing
- All documentation work must be approved and the authority and responsibility of the employees determined
- Customer complaints receiving, resolution and product recall systems must be installed
- Processes should be identified in order to investigate errors and take measures
- Procedures for storing samples, destroying problematic or returned products must be specified
- Internal and external audits of the enterprise should be ensured
What is the GMP Good Manufacturing Practices System in Turkey?
The Turkish Standards Institute started GMP Good Manufacturing Practices certification studies in 2012. Within the scope of these studies, it certifies the good production practices of the enterprises that make production in the cosmetic sector in our country and internationally on the basis of TS EN ISO 22716: 2008 Cosmetics - Good Manufacturing Practices - Guideline.
The TS EN ISO 22716 standard is a standard that seeks to prevent or minimize the possibility of contamination of products due to internal and external sources during production stages and includes the measures that enterprises will have to take for internal and external conditions. This standard is a range of techniques that ensure the quality of products and must be applied for all stages of production, such as raw materials, processing, product design, production, packaging, storage and distribution.
GMP Good Manufacturing Practices demonstrate the quality approach to production. It includes not only cosmetic companies, but also other companies operating in various sectors related to human health and tries to ensure that the production is reliable.
At the Turkish Standards Institute, the Chemical Sector Certification Department, affiliated to the Product Certification Center, issues the GMP Certificate for the following products:
· For cosmetic products produced and exported in our country
· For products that will be imported from abroad and placed on the market
What Does GMP Standard Gain for Firms
Compliance with hygienic conditions in production is the basic condition of both quality production and protection of human health. The GMP Good Manufacturing Practices System standard is also a quality approach in production and is designed to regulate the professional working conditions of employees in the production of food, pharmaceutical, cosmetic and medical equipment and to make reliable and effective production.
Firms that apply this standard in their enterprises and obtain GMP Good Manufacturing Practices Certificate give them significant advantages. Here are some of the benefits of this system for companies:
- Various contamination, confusion and errors are avoided in production activities
- Products are produced in a healthy way and presented to customers
- Competitive advantage in national and international markets
- Credibility is created in customers' company products
- Customers' future demands are met quickly
- Compliance with legal regulations
- Therefore, penal situations are prevented.
- Increases employee motivation and increases awareness of good production practices
- Company passes internal and external audits easily
- Company's reputation and reputation increases
Companies applying the GMP standard in their businesses may wish to obtain a GMP Good Manufacturing Practices Certificate by applying to an accredited certification body. For this, the certification body must first enter into a contract. A preliminary inspection is initiated via the documentation work that follows. If missing or errors are detected at this stage, the company is asked to be corrected. Then, field audits are carried out in the company's production facilities. Upon completion of all audit work, the auditors issue a report. If the certification body deems appropriate on the basis of this report, GMP issues a Good Manufacturing Practices System Certificate and delivers it to the firm.
our organization TÜRCERT Technical Control and Certification Inc.Is ready to help with any doubts about GMP Good Manufacturing Practices and certification efforts.