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FAQFrequently asked questions
Frequently asked questions
Answers to the questions we hear most about GMP, cleanrooms, validation and TAB. For anything else, send us a quote request.
GMP
Good Manufacturing Practice establishes quality standards for pharmaceutical manufacturing and control.
Cleanroom classification
Cleanliness classes based on airborne particle counts follow ISO 14644-1 (Class 1–9). Aseptic pharmaceutical manufacturing areas are managed separately under Grades A–D of EU GMP Annex 1 and the Korean MFDS aseptic pharmaceutical requirements, including in-operation and microbial criteria.
Validation
Documented verification that facilities and processes meet their design requirements. SAMYOUNG ENG performs installation and operational qualification (IQ, OQ) and TAB.
TAB
Testing, Adjusting and Balancing verifies and adjusts airflow and pressure differentials in HVAC systems.
Can renovation work be done while the facility is operating?
Whether renovation is feasible during operation needs to be checked for the specific site. Please send the facility use, current operating conditions and proposed work through the quotation inquiry.
What is the contract scope for construction and validation?
Alongside construction, our validation scope covers installation and operational qualification (IQ, OQ) and TAB. Please send the site-specific scope through the quotation inquiry.
Does HACCP construction alone give certification?
Facility construction satisfies part of the requirements for HACCP certification; construction alone does not grant it. Certification is granted through an audit by the certification body once the facility requirements together with hygiene management, records and operating standards are met.
How do ISO Class and GMP Grade differ?
ISO Class is a cleanliness classification based on airborne particle counts (ISO 14644-1, Class 1–9), while GMP Grades A–D apply to aseptic pharmaceutical manufacturing areas under EU GMP Annex 1 and the Korean MFDS and include in-operation and microbial criteria as well as particle counts. The same clean area can therefore be labelled with both an ISO Class and a GMP Grade.
What does the free preventive inspection cover, and when is it done?
We provide a free preventive inspection once a year before summer or winter, usually before summer, regardless of the defects liability period. Contact us to arrange the schedule.
What should I prepare to request a quotation?
Please share what you know about the site address, intended use, size (floor area, ceiling height and so on), required cleanliness and temperature/humidity, existing drawings or site photos, and preferred schedule.
Is there an inspection during the defects liability period?
We provide a free preventive inspection once a year before summer or winter, usually before summer, regardless of the defects liability period. Contact us to arrange the schedule.