The Flow of Global GMP Regulatory Harmonization
As the biopharmaceutical market grows rapidly, GMP regulations across countries are quickly harmonizing around PIC/S (Pharmaceutical Inspection Co-operation Scheme). As of 2026, PIC/S has 56 member countries operating a mutual recognition system for GMP inspection results.
Since joining PIC/S in 2014, Korea has continuously elevated domestic GMP standards to international levels, and applying cGMP (current GMP) standards has become virtually mandatory for biopharmaceuticals.
Differences Between cGMP and Traditional KGMP
Traditional KGMP (Korean GMP)
cGMP (Current GMP)
SME Bio Company Response Strategy
1. Establish QRM System
The core of cGMP is risk-based approach. Systematic risk management using tools like FMEA and FTA according to ICH Q9 guidelines is required.
2. Ensure Data Integrity
The most cited finding in 2026 GMP inspections is data integrity. Apply ALCOA+ principles to all records.
3. Continuous Process Verification Program
Beyond traditional 3-batch validation, establish continuous process verification across all production stages. Statistical Process Control (SPC) is key.
4. PIC/S Inspection GAP Analysis
Conduct GAP analysis of current manufacturing facilities and quality systems against PIC/S GMP standards to proactively identify areas needing improvement.
Government Support
Contact KITIM
KITIM provides professional support for cGMP certification preparation, PIC/S inspection response, and quality system development. Contact us through [KITIM Contact](/contact).