Definition
It is the Korean standard for manufacturing business and sub dividion of medicines to comply with according to regulations of article 22 of pharmaceutical affairs law enforcement (application for industrial manufacturing business approval of medical supplies etc.) and called as the good manufacturing practice for Pharmaceutical Products in Korea (GMP)
Necessity
Medical supplies should secure 3 characteristics, efficiency, safety and stability. Since customers do not have the ability to check the characteristics of medicines, a manufacturer should secure the process to ensure quality at the level of business ethics and the government gives many preferential benefits to GMP facility business and encourages management & supervision and facilities.
Three indicators of GMP
- Minimization of artificial mistakes (confusion or fault)
- Prevention of contamination of medicine (microbial contamination, foreign substance contamination or cross contamination) and quality degradation
- Establishment of advanced quality assurance system
GMP cleanliness conditions
Clean area | Process | Cleanliness |
A | Manufacturing of injection, Collyrium, Aseptic jeomgol, Antibiotics, Hormone drug | NASA (Size) 100 ‾10,000 |
B | Manufacturing room, weighing room, Intermediate storage room of general medicine (Sugar-coated tablet, Capsule, Jeomgol, Liquid formulation, Liquid medicine) | 10,000 ‾ 100,000 |
C | Workers pathway, Packaging room, Raw material storing room, Dressing room | 10,000 (Over) |
- | HALL, Entrance, Hall plumbing | General district. |
Zoning according to GMP Cleanliness
EUGMP | KGMP | ISO CLASS | Corresponding workroom | Structure conditions | Number of ventilation | Management standards |
A | 100 | 4 | Raw material measurement of materials requiring aseptic manipulation, Prescription, Filling, Closed workroom(work board) filling of aseptic materials, Closed workroom | Clean Booth, Bench (installed in IB section), final HEPA filter, adjusting vertical or horizontal laminar flow humidity and temperature | Wind speed 0.55 m/s laminar approach | Maximum 1 falling bacteria/(9μm) or Maximum 1 floating bacteria/m³ aseptic clothes |
B | 1,000 | 5 | Washing room of aseptic material container, Semi products storing room, Direct packaging workroom | Clean room filter: installing Pre+ MED+ HEPA positive pressure, temperature humidity control only dressing room and preparation room (Pass box) | over 30 times/H | Maximum 5 falling bacteria (9μm) or maximum 20 floating bacteria/m³ aseptic clothes raw materials, outer sterilization bringing in of materials |
C | 10,000 | 6 | Sterile work management section of sterile materials of Storing room, Packaging room, Workroom except cleanliness 1, 2 sections (pretreatment room for herb medicine ) | Filter: installing Pre+ MED+ HEPA In case that dust is not generated : positive pressure In case that dust is generated : positive pressure | over 25 times/H | Maximum 20 falling bacteria (9μm) or maximum 20 floating bacteria/m³ aseptic clothes, Dressing, Cap, Mask, Washing |
D | 100,000 | 7 | Main measuring room, Prescription, Filing, Closed workroom of non-sterile materials, Entry room of sterile room (dressing room, preparation room) | Filter : Pre. | over 20 times/H | Dressing, washing raw materials : external cleaning of materials |
Application targets of base material medicine GMP (BGMP) are defined as follows.
WHO API GMP : pharmaceutical active substance · base material medicine
FDA Inspection Guide : active·inactive substances, inspecting when inactive raw material plant needs to be inspected
ICH API GMP : base material medicine for humans (synthesis / fermentation / extraction / cell culture API, API blood for clinical trials / API making plasma as raw material
※ Exceptions : vaccine, blood, plasma fraction, gene therapy API
Korea GMP : base material medicine (synthesis / fermentation / extraction etc. or materials produced by the combination of them and the things that become manufacturing materials of finished medicine) – major base material API
GMP cleanliness conditions
Manufacturing classification | Manufacturing process and GMP application process |
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Manufacturing classification | Manufacturing API starting material | API starting material is introduced to the manufacturing process | intermediate manufacture | Separate purification | Physical process packing |
Animal-derived API | Collecting organ, body fluid tissue | Cutting, mixing first process | Introducing API starting material into manufacturing process | Separate purification | Physical process packing |
Plant extract API | Plant collection | Cutting first extraction | Introducing API starting material into manufacturing process | Separate purification | Physical process packing |
API of herb medicine extract | Plant collection | First extraction after cutting | Re-extraction | Physical process packing | |
API of powder herb medicine | Plant collection, culture/harvest | Cutting, grinding | Physical process packing | ||
API of powder herb medicine | Establishment of Master Working cell bank | Maintenance & management of Working cell bank | Cell culture fermentation | Separate purification | Physical process packing |
API manufacturing by zymotechnics | Establishment of Cell bank | Maintenance & management of cell bank | Introducing cells into fermentation process | Separate purification | Physical process packing |
ICH-Q7A Regulations
Basic facilities / Equipment
- Designing separate section to minimize pollution
- Outfit room, shower room, bathroom
- Cold, hot water, detergent / soap, air Dryer / alcohol disinfection / disposable towels
- Manufacturing facilities – closed facilities if possible, when opening or in case of open type in case of pollution prevention measures closing system
- it can be be installed outdoors
- Support facilities – qualification and Monitoring are needed, water treatment process, validation
- Checking and marking each pipeline
- Important measuring instrument and testing instrument – using by correcting according to calibration plan
H.V.A.C system
- Penicillin·cephalosporin·sex hormone·cytotoxic materials
- Manufacturing facilities cooperation facilities – exclusive use (separate section) But, when inactivating any steroid, anti-cancer medicine and validating cleaning method, separating is not needed
- When persons / articles move from exclusive area to workplace, take measures to prevent pollution
- Not able to work in medicine manufacturing buildings where toxic non-medicine such as weedkiller·herbicide etc. are weighed, grinded, packaged