GMP is a system of principles or guidelines to ensure that all products are manufactured and controlled in accordance with product quality standards and consistent in quality.
Learn about the GMP manufacturing process
GMP is a quality management system which:
– Ensure that the product is consistently produced and controlled, in particular addressing the risks of confusion and cross-contamination.
– Make sure that the manufacturer always produces the medicine in such a way that:
+ Meet high-quality standards
+ Is safe for users
Why should we apply GMP?
It is necessary to apply GMP for the following problems:
– Medicines are special goods related to human health. Therefore, if the drug is poor quality, it will cause many bad consequences.
– Drug quality is not dependent on test results according to standards but on manufacturing control (anti-confusion and cross-contamination), honesty and conscience of manufacturers.
– Drug quality is influenced by research, manufacture, marketing, distribution, administration and use.
– If not produced in accordance with GMP, many errors may be encountered and the product may be recalled. Detecting errors and handling recalled products will be very costly.
– GMP also helps to expand pharmaceutical export opportunities because countries around the world only allow the import and sale of pharmaceutical products manufactured according to WHO-GMP standards.
How to apply GMP?
To achieve the GMP target, it is necessary to apply in the following aspects:
1, Workshop, auxiliary system design
Workshops, production lines, and ancillary systems should be constructed in such a way that contamination from outside and cross-contamination are minimized or avoided.
Light, temperature, humidity, and ventilation should be designed and installed to suit the manufacture, storage, and operation of the equipment.
2, Equipment installation
Equipment requirements:
– Must be easy to clean and sanitize.
– Do not use asbestos materials (during filtration, packaging).
– The lubricants should not come into contact with the product
– The filter material should not release fibers into the solution
– Performance must be consistent
– The contact surface does not react or absorb any ingredients in the drug
– Equipment for sterile preparations must be sterilizable.
About installation:
– Arranging orderly and appropriately to avoid confusion and cross-contamination.
– Damaged equipment should be removed from the Production and Quality Control area. If it is not moved yet, it is necessary to clearly label that the machine is damaged to prevent inadvertent use in the production and production process.
3, Hygiene
– Use appropriate, standardized detergents.
– Avoid using compressed air, brushes, and brooms to clean facility and equipment.
– The cleaning of premises, equipment, and people must follow the SOPs that have been validated prior to issue and re-evaluated.
– After cleaning, a complete record must be filed in the batch record.
4, Manufacturing
– All operations in the Manufacturing Process must be in accordance with the specified process, in accordance with the production and marketing license.
– Material and product handling must be in accordance with SOP.
– When manufacturing different products, do not proceed with them simultaneously or consecutively in a room unless the impossibility of confusion and cross-contamination has been demonstrated.
– During the production process, all raw materials, semi-finished packaging, main machinery, and equipment must be labeled with the product name and batch number. In some cases, it is necessary to record the name of the product previously produced.
5, Quality check
– Check starting materials, intermediate products, semi-finished products, finished products.
– Review production batch records.
– Conduct Stability studies.
– Develop, validate and implement all quality control procedures, maintain reference samples of materials and products, label packaging containing materials and products, and participate in claims investigations related to product quality.
IMC is proud to be a pioneer factory applying GMP principles in researching and manufacturing leading ASEAN health and beauty products.