Korean KGMP guideline in English
Any idea how many times we’ve been asked by our clients or subscribers whether an English version of the Korean KGMP guideline was available ?
Countless times !
Following our policy of transparency we’ve prepared a translation and reviewed several times to make sure that people familiar with other regulations such as European or US would understand it.
Inside different topics are covered such as:
- GMP inspection system
- GMP inspection method and procedure
- GMP inspection management plan
- Administrative matters
3 appendixes are included:
- Chart for Initial, Additional, Modification Inspection and Detailed Description
- Chart for Periodic Renewal Inspection and Detailed Description
- Overseas Travel Reimbursement Criteria for Regulatory Officials Travel Expense
One additional comment, the guideline is strictly identical to the original. However after September 16, 2013, compliance with KGMP requirements is not required for class 1 products anymore. To keep in mind…
Here is the link to the Korean KGMP guideline: