ISO 22716 / GMP - Good Manufacturing Practices
GMP, the English abbreviation for Good Manufacturing Practices, is a standard developed to prevent or minimize risks arising from internal and external factors for products such as food, pharmaceuticals, and cosmetics that directly affect human health.
There is a perception that production refers only to the process of obtaining the product. However, GMP encompasses all processes from production to delivery to the consumer. It is important to note that it is a standard that also includes transportation, testing, storage, and packaging. The GMP certificate demonstrates that production is carried out according to specific standards and that consumers can safely use the products. It refers to certain standards that must be followed during the production of a product. GMP helps manufacturers produce safe, effective, and high-quality products for humans. It is applied in various industries such as pharmaceuticals, medical devices, food, and cosmetics. It ensures that products are processed, stored, and transported correctly during production.
The objectives of GMP include the following:
- Prevent the production of products that could be harmful to human health
- Ensure product quality and safety
- Provide repeatability and consistency in the production process
- Ensure proper labeling of products
- Prevent counterfeiting, theft, and other criminal activities
GMP compliance is regularly audited by national and international regulatory organizations. These audits aim to verify that manufacturers adhere to GMP standards and take all necessary steps to ensure the quality and safety of their products. In conclusion, GMP is an important set of standards that manufacturers must follow to ensure the quality, safety, and efficacy of their products.
What Are the Benefits of ISO 22716 GMP - Good Manufacturing Practices?
- GMP standards include quality control measures in the production process, which help improve product quality.
- They include strict procedures that help maintain consistency in the production process.
- They reduce errors and malfunctions during production, thereby increasing product quality.
- GMP protects consumer health by preventing the production of harmful products.
- GMP compliance helps build customer trust in the product and eliminates concerns about the quality and safety of the products.
- Ensures legal and regulatory compliance. It helps manufacturers meet their legal obligations by adhering to national and international regulations.
- Improves efficiency and profitability. GMP standards increase efficiency in the production process, reduce costs, and enhance profitability.
- Ensures workplace safety. Includes strict procedures for worker health and safety, preventing workplace accidents.
- Ensures business continuity. Supports uninterrupted operations during the production process.
- GMP prevents criminal activities such as counterfeiting and theft during the production process, protecting consumers.
Who Should Obtain the ISO 22716 Certificate?
The ISO 22716 certificate (GMP certificate) should be obtained by manufacturers of pharmaceuticals, food, cosmetics, medical devices, and biotechnological products, as well as all companies producing products in these industries. These companies are responsible for producing safe, effective, and high-quality products for humans. The GMP certificate covers all stages, from the production of products to their storage and distribution, and helps manufacturers comply with national and international regulations. GMP compliance is regularly audited by regulatory bodies, and conformity must be demonstrated during these audits. Therefore, any company producing products related to human health must obtain the GMP certificate to ensure compliance with GMP standards.
Which Product Groups Are Certified Under ISO 22716-GMP?
- Baby Products
- Personal Hygiene and Bath Products
- Eye Care and Makeup Products
- Fragrances and Deodorants
- Shaving Products
- Skin Care Products
- Depilatories
- Nail Products
- Oral Care Products
- Hair Care and Cleaning Products
- Hair Coloring Products
- Sun Protection Products
These product groups require GMP compliance as they are related to human health. The GMP certificate involves implementing quality control measures that cover all stages from production to storage and distribution and includes audits by regulatory bodies. Therefore, manufacturers of these products must obtain the GMP certificate to ensure compliance with GMP standards.
How to Obtain the GMP Certificate?
Companies wishing to obtain the GMP certificate must carry out the application process.
At EOScert, we meticulously complete your applications. After creating customized plans for your organization, we conduct inspections and evaluations through our accredited body. Based on this, your certification process is initiated.
Companies wishing to obtain the ISO 22716 (GMP) certificate must meet the standard requirements. Following the necessary steps, such as preparing documentation and creating records:
- During the initial assessment, areas of non-compliance are identified, and information is collected to examine the organization.
- During the audit phase, the collected information is confirmed. The ISO 22716 structure of the organization is inspected against standard requirements.
- During the completion of certification, any non-compliances identified during the audit are resolved, and if the report is completed appropriately, it is submitted to the certification committee for approval.
Where to Obtain the GMP Certificate?
The GMP certificate must be obtained from a certification body authorized to issue certificates in your sector or field of activity. Each sector has a specific EA/NACE code. At EOScert, we provide certification services to all sectors that prioritize quality under the ISO 22716 standard. You can contact us for all application processes and any questions you may have.