GMP Good Manufacturing Practices
What is GMP (Good Manufacturing Practices)?
Good Manufacturing Practices (GMP) is the name given to all the procedures and principles that bring various protective measures and standards in the production stages of products such as medicines, cosmetics, food, medical devices, etc.
Good Manufacturing Practices were put into practice in the European Union in 2010. In our country, the Turkish Standards Institute (TSE) published the TS EN ISO 22716:2013 Cosmetics – Good Manufacturing Practices (GMP) – Guide on Good Manufacturing Practices in 2013. Companies that meet the requirements of this standard can apply for a GMP Certificate.
Why GMP Certificate ?
Hygienic conditions must be provided in the production of products that directly affect human health. Ensuring hygienic conditions and carrying out production under these conditions is achieved through the application of GMP (Good Manufacturing Practices).
GMP is a set of rules that must be followed in order for a product to be effective and safe, starting from raw materials and packaging materials until it reaches the consumer. The aim of GMP is zero error, and the goal is to ensure continuous quality.
The production conditions of products that directly affect human health (food, medicine, medical devices, etc.) must meet GMP rules. In order for production to be carried out, it is essential that GMP rules are met.
Hygienic conditions must be provided in the production of products that directly affect human health. Ensuring hygienic conditions and carrying out production under these conditions is achieved through the application of GMP (Good Manufacturing Practices).
GMP is a set of rules that must be followed in order for a product to be effective and safe, starting from raw materials and packaging materials until it reaches the consumer. The aim of GMP is zero error, and the goal is to ensure continuous quality.
The production conditions of products that directly affect human health (food, medicine, medical devices, etc.) must meet GMP rules.
The rules for the provision of GMP production is essential.
What are the GMP Basic Principles?
- Quality management
- Personnel and organization
- Building, hardware, equipment and materials
- Documentation
- Raw product input, product processing, storage and distribution
- Quality control and proficiency testing
- Approval and authorization of all transactions
- Complaints and recall
- Investigation of errors, the use of products manufactured after clinical follow-up
- Storage of samples is problematic, disposal of returned products
- Internal and external audit.
What are GMP Rules?
- Details of work to be done to decide the production(product types, controls, approvals)
- To be done write everything, (standard application methods ( standard operating procedures=SOP’ s), equipment, laboratories, etc.)
- Everything that is written to do (Training, qualification, process control)
- Doing summer prove they do(records, audits)
- Corrective action, continuous improvement, fix errors and improving the quality( operations, ask around and get results)
What are the Obligations of GMP?
- Prior to the commencement of any work that is attempted should be taken to ensure correct and in accordance with the instructions.
- These instructions every time , without missing absolutely nothing should be followed.
- The correct use of material must be provided.
- Use the right equipment to ensure they are clean and are needed.
- Must be taken to prevent contamination and mix.
- Label against processing defects should be exercised at all times.
- Always meticulously and should work correctly.
- Everything was clean and tidy, including the employees should be kept.
- Always errors, mistakes and bad events, and one should be prepared for these should be reported immediately.
- Checks must be sure about the accuracy of the reports and maintained.
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