IMC – Learning about GMP in manufacturing facility

IMC - Learning about GMP in manufacturing facility

1. What is GMP?

According to WHO: GMP is a part of quality assurance, which helps to ensure that products are homogenous in quality and controlled by quality standards appropriate to their intended use as well as in accordance with the terms of marketing authorization.

GMP is a part of quality assurance that ensures that the drug is:

– Homogenous in quality

– Tested with quality standards appropriate to the purpose of use (national, organizational standards,…).

2. Why should GMP be applied in manufacture?

– Ensures that products are manufactured and controlled homogenously.

– Reduces risks that cannot be controlled by testing such as:

+ Cross-contamination

+ Mistake

– Ensure that the manufacturer always produces the drug in such a way that:

+ Meet high-quality standards

+ Is safe for users

– Good manufacture practice of drugs must be conducted because:

+ Medicines are special goods related to human health => Drug of poor quality will lead to many bad consequences.

+ At present, the quality control is still limited => The current testing will not ensure the quality of the drug

+ Drug quality does not depend on standard testing results but on production process control (prevent mistakes and cross-contamination), honesty, and conscience of manufacturers.

+ Drug quality is affected by research, production, marketing, distribution, management, and use.

+ Unless manufactured under GMP, there will be a high chance of errors, which cause product recall. It is very costly to detect defects and handle recalled products, even more than just developing and implementing GMP

+ GMP helps to expand pharmaceutical export opportunities because countries around the world only allow the import and sale of drugs manufactured according to WHO-GMP standards.

+ Poor quality drugs lead to distrust of medical service providers and customers.

3. How to apply GMP in manufacturing facility?

– The goal of good manufacturing practice is to produce medicinal products used for disease prevention, treatment, diagnosis and alteration of human physiological functions, which meets 3 standards:

+ Physically, chemically, biologically pure

+ Safe for users and the environment

+ Effective and economical in treatment

– To achieve the goal, it is necessary to pay attention to the contents of:

+ Facility design

+ Supporting system (water, air)

+ Equipment installation

+ Hygiene

+ Manufacturing area

+ Quality control


Facility design


– Workshops, lines, and production plants must be built in such an area as to minimize or avoid pollution from the surrounding environment or cross-contamination

– Light, temperature, humidity, and ventilation should be designed and installed to suit the production, storage, and operation of the equipment.

– The workshop must be sealed, not to be contaminated by air from the outside

– Workshops, lines, and production plants must be built in such areas to avoid causing pollution and affecting the surrounding environment.

Supporting system

– Install suitable airlock, differential pressure, air supply and exhaust system

– Minimize the risk of contamination due to untreated air recirculation

– HVAC air handling system should be designed and installed with suitable differential pressure and position

– The water treatment system must ensure to minimize microorganisms, maintain constant circulation and use in accordance with regulations

Equipment installation

– Requirements of equipment:

+ Must be easy to clean and scrub

+ Do not use asbestos materials (filter, packaging)

+ Lubricants must not make contact with the product

+ The filter material is must not release fibers into the solution

+ Performance must be consistent

+ The contact surface does not react or absorb any ingredient in the drug

– Installation

+ Arrange equipments in order to avoid pollution, mistake, should use closed equipment

+ Broken equipment must be moved out of the production area

+ Immobile closed equipment must be fixed to the floor

+ There must be safety measures attached

+ Must have anti-explosion measures when working with explosive materials

+ Electrostatic equipment or flammable solvent container must have ground wired



– Use appropriate detergents and disinfectants

– Avoid using compressed air, brushes, and brooms to clean the factory equipment

– Water used for rinsing equipment and containers must be suitable for each type

– Carry out cleaning of facility, equipment, and people according to pre-issued and re-evaluated SOPs.

– After cleaning, a complete record must be done in the production file

– Personal hygiene

+ Health Requirements

+ Hygienic habits: Do not eat, drink, chew bubble gum, smoke, brush hair … in the production area

+ Apply the right SOP for personal hygiene, clothes for workers at different levels of cleanliness

– Factory cleaning:

+ In general, there should be no sink in the sterile medicine production room,

+ Do not use ultraviolet light as a substitute for chemical disinfectants

+ Do not leave insecticides and pesticides in the production area

+ GMP specifies the level of particle pollution and limits the level of microbiological pollution for each clean grade

– Cleaning equipment:

+ After cleaning according to the SOP, the area must be checked by an inspector, who then signs, records and hangs a sign indicating cleaned equipment.

+ When cleaning, use a vacuum cleaner and wet towels to avoid pollution

+ There should be a separate area in the production line for cleaning


Manufacturing area

– All operations in the production process must comply with the specified process, manufacturing, and marketing license

– Material and product handling must be in accordance with SOP

– When manufacturing different products, do not manufacture both simultaneously or consecutively in the same room

– During the manufacturing process, all packaging materials containing semi-finished products, finished products, machinery, and equipment must be labeled.

– The entry and exit of the factory should be limited

– Non-medicinal products must not be produced in the same area or on the same equipment

– Pay attention during the production process to avoid contamination and cross-contamination



Quality control

– Check raw material, intermediate product, semi-finished product, the finished product

– Review batch record

– Conduct stability research

– Develop evaluation method and implement all quality control procedures, keep reference samples of materials and products labeled for packaging.