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What is GMP standard in pharmaceutical manufacturing

GMP stands for "Good Manufacturing Practice". This is a mandatory standard of a facility that manufactures, processes, and packs food, pharmaceuticals, etc., intending to ensure quality and safe products.

In 1969, when the World Health Assembly recommended the issuance of the first WHO Certification System for the Quality of Pharmaceutical Products in the International Marketplace in Resolution WHA22.50, the Council also concurrently approved GMP documents as part of the System. The draft amendments to the Certification System and the GMP document were unanimously adopted in Resolution WHA28.65 of 1975. Since then, the Certification System has been expanded to include certification for:

  • Veterinary drugs used for animals raised for meat;

  • starting materials used in the manufacture of pharmaceutical products, where such control is required by the laws of the exporting Member State and the importing Member State;

  • Safety and efficacy information (Resolution WHA41.18, 1988)

Good Manufacturing Practices for Pharmaceuticals GMP

To meet GMP standards, factories and production facilities need to fully meet the standards for building factories and workshops to ensure the quality of finished products.

In Vietnam, according to the decision of the Ministry of Health, the WHO GMP standard is a mandatory standard applied to all production facilities. GMP standards are also applied flexibly to suit each condition, size, and type of business

Scope of GMP application: personnel, factories, equipment, production hygiene, environmental sanitation, personal hygiene, production process, ...

GMP standards in production
GMP standards in production

Applying GMP standards in pharmaceutical production

HR requirements:

  • Arrange working positions to suit the capacity and qualifications of personnel,

  • Develop a strict health check process, especially for direct production workers

Requirements on design, construction, and installation of houses, workshops, and processing machinery and equipment:

  • Enterprises calculate factory construction location, processing equipment installation location

  • Type of factory building materials

Requirements to control factory hygiene and environment:

  • Incoming water treatment, output wastewater treatment

  • Handling of by-products and waste

  • Handling by-products, waste, etc.

Requirements for process control:

  • Develop regulations on processing methods

  • Develop procedures and work instructions

  • Ensure standards of ingredients and recipes

  • There are measures to monitor and inspect the production process

Requirements for control of the storage and distribution of products:

  • Ensuring quality and hygiene in drug production

  • Ensure that the finished product is not contaminated, affected by chemical, physical, or microbiological agents, and does not change quality when storing and transporting.

Benefits of investing in building a factory that meets GMP standards

  • GMP helps a lot for businesses. Producing quality products is a top priority of GMP standards. Quality products will meet the needs of consumers. Thereby gaining consumer confidence.

  • A good brand will gradually be built from there. A quality drug factory will make good and effective products. Good products will be what pulls users to your business.

  • Once the trust of customers has been gained, businesses will no longer need to worry about the consumption of products. Profits will then be formed. The business will come closer to success.

  • In addition, the factory meets GMP standards to help elevate the business position and make a difference compared to competitors. The GMP-certified factory is the foundation for developing communication activities to promote businesses as well as creating opportunities to reach international brands and export to foreign markets.

Some regulations in the design of pharmaceutical factories meeting GMP

  • Equipment should be located, designed, constructed, adjusted, and maintained by the operations to be performed to minimize the risk of errors and to permit effective cleaning and maintenance. fruit, to avoid cross-contamination, and accumulation of dust and dirt.

  • Equipment should be installed to minimize the risk of errors or contamination.

  • Fixed pipes should be labeled indicating the contents inside, and the flow direction.

  • All service piping and equipment should be appropriately marked, taking into account the irreplaceable connections or connections of hazardous gas or liquid passages.

  • Other measuring equipment of suitable range and accuracy for production and quality control operations.

  • Have a plan for comprehensive maintenance and cleaning of production machinery and equipment.

  • For the laboratory, the equipment and tools used are suitable for the test procedure to be performed.

  • Drying, washing, and cleaning equipment should be selected and used so as not to become a source of contamination.

  • Production machinery and equipment must not pose a hazard to the product, and parts of production machinery and equipment that come into contact with the product must not react, create additional substances or absorb substances to the extent possible. affect product quality.

  • Damaged machinery should be removed from the production area and inspected for quality or labeled as damaged if not shipped.

  • In case of using available equipment, or when opening machinery and equipment, care should be taken to minimize contamination.

  • Non-specialized machinery and equipment used in the production of various pharmaceutical products must be cleaned according to validated hygiene procedures to avoid contamination.

  • Store drawings of machinery and ancillary equipment systems.

Dossier of application for assessment and re-assessment of GMP certification

To be able to put factories and production facilities into operation, you need to prepare a full application for GMP Certificate according to the standards of the Ministry of Health, and must be approved. Profile components include:

  • Registration form for inspection/re-inspection “Good Manufacturing Practice” (Form No. 2/GMP).

  • Report on the changes of the establishment in the 2 years of implementing “Good Manufacturing Practices”.

  • Report on the establishment's activities for the past 2 years.

  • Report on overcoming shortcomings in the previous inspection report.

  • Brief report on training and training of the establishment in the past 2 years.

  • Report on self-inspection and assessment of the establishment in the latest batch (within 3 months) on the implementation of “Good Manufacturing Practices”.

Procedure to complete the application for GMP Certificate

  • Step 1: The establishment sends the application for GMP inspection to the Drug Administration of Vietnam - Ministry of Health

  • Step 2: The Drug Administration of Vietnam receives and appraises the application. Within 05 working days from the date of receipt of the dossier and the assessment fee as prescribed, the Drug Administration of Vietnam must notify the establishment of the status of the dossier if it is unsatisfactory or the inspection plan is not satisfactory.

  • Step 3: Within 20 working days from the date of notification of the inspection plan, the Ministry of Health must conduct a physical inspection at the facility.

  • Step 4: The competent authority must issue the GMP Certificate or notify the establishment of the official results within 05 working days from the date of completion of the inspection (satisfactory) or receiving the notification. base remediation.

For establishments that have not yet met the principle of "Good manufacturing practice", the establishment must take corrective action to correct the shortcomings. After self-inspection, the establishment will re-submit the application from the beginning.

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