GMP Facilities (Pharma · Cosmetics · Food)

New GMP plant constructionNew GMP plant construction

New GMP plant construction

New GMP (Good Manufacturing Practice) plant construction creates clean production facilities with strict environmental standards for high-quality, safe products such as pharmaceuticals and medical devices.

New GMP construction prevents product contamination and quality deterioration and establishes production environments that meet international standards.

GMP extensions and remodelingGMP extensions and remodeling

GMP extensions and remodeling

GMP plant extensions and remodeling expand and improve existing structures and systems to increase cleanliness, production capacity and efficiency.

GMP extensions and remodeling expand existing cleanrooms and systems to improve quality and productivity and accommodate new product groups and increased output.

GMP cleanroomsGMP cleanrooms

GMP cleanrooms

Cleanrooms that meet GMP standards prevent contamination, cross-contamination and quality deterioration, helping provide consumers with safe products of consistent quality.

GMP cleanrooms minimise product contamination by strictly controlling airborne particles, microorganisms, temperature, humidity and pressure.

Systematic management of personnel, material and equipment access and work procedures maintains aseptic and clean environments.

• Product quality and safety: preventing microbial and foreign-matter contamination protects sensitive products such as pharmaceuticals and medical devices.
• Compliance with international standards and regulations: manufacturing environments can meet domestic and international requirements such as FDA and ISO 13485.
• Consistent production: systematic control of temperature, humidity, pressure and other variables maintains consistent quality.

Cleanroom gradesCleanroom grades

Cleanroom grades

Sterile medicinal product facilities are divided into four grades, A, B, C and D, each with its own airborne particle and microbial limits. The values below are taken verbatim from Annex 1 (sterile medicinal products) of the Korean MFDS GMP regulation and EU GMP Annex 1 (2022). Grades A–D are a sterile-medicines standard; the Korean medical device GMP and HACCP regulations do not set these grade limits.

• Particle limits: maximum total particles per m³ during environmental monitoring (cumulative, at or above the size shown). Grade D in-operation limits are not predetermined; the manufacturer sets them from risk assessment and routine data. The ≥5µm value of 29 is a monitoring limit; for classification (qualification) no ≥5µm limit is specified for Grade A (at rest and in operation) or Grade B at rest (classification including 5µm particles may be considered where the contamination control strategy or historical trends indicate it).
• Microbial action limits: settle plates of 90mm diameter exposed for up to 4 hours. Any growth in Grade A is investigated.
• Airflow and pressure (guidance values): unidirectional airflow in Grade A of 0.36–0.54m/s at the working position; at least 10Pa between adjacent rooms of different grades. Neither source sets air-change rates by grade.
• Clothing: Grades A and B sterilised suit, sterile mask, goggles and gloves; Grade C single or two-piece trouser suit gathered at the wrists with a high neck; Grade D general protective suit with hair and beards covered; disinfected shoes or overshoes in Grades C and D.
• Sources: MFDS Regulation on Good Manufacturing Practice for Medicinal Products (Notice 2024-87), Annex 1, sections 4, 4.2, 7, 8.2, 9.3 and 9.4 (in force for sterile finished products from 28 Dec 2025 and sterile APIs from 28 Dec 2026); EU GMP Annex 1 (2022), sections 4.4, 4.14, 4.30, 7.13 and Tables 1, 2, 4, 5 and 6.

HACCP cleanroomsHACCP cleanrooms

HACCP cleanrooms

HACCP cleanrooms are hygienic spaces designed and operated to minimise contamination risks and maintain a clean production environment under HACCP principles.

They ensure the safety and quality of sensitive products such as food and are essential for hygiene compliance and consumer trust.

HACCP cleanrooms apply to food manufacturing and processing, meat, dairy and seafood processing, catering facilities and restaurants.

• Source: MFDS HACCP Standards for Food and Livestock Products (Notice 2026-60, in force 11 Aug 2026), Annex 1 prerequisite programmes I.A.3, I.B.15, 17 and 18, and I.G.50.
• HACCP can improve safety, hygiene and confidence in product quality, meet domestic/international hygiene and quality certifications such as HACCP and ISO 22000 and legal requirements, and improve efficiency while reducing contamination and defects.

BCR cleanroomsBCR cleanrooms

BCR cleanrooms

Biological cleanrooms strictly control temperature, humidity and pressure to defined standards while effectively managing airborne microorganisms and biological particles.

BCRs focus on microbial as well as particle contamination, mainly in pharmaceuticals, food, hospitals and laboratories where aseptic environments are essential.

Grades A–D apply to sterile medicinal product manufacturing (see the GMP cleanroom grade table). Cleanliness requirements for food, hospital and laboratory facilities follow each field's own rules and process risks.