1. Reasons for Amendment

This Partial Amendment is intended to reflect and harmonize relevant amendments to the Good Manufacturing Practice (GMP) of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), to which the Ministry of Food and Drug Safety is a member, into Korea’s Good Manufacturing Practice in an effort to strengthen the supply of good quality drugs and the export competitiveness of the country’s pharmaceutical industry, and to establish matters delegated from the amendment to the Rules on the Safety of Drugs, etc. (Ordinance of the Prime Minister No. 1835) (December 7, 2022) and necessary for their implementation, such as specific formulations for drug products subject to the certification of GMP compliance, procedures and methods. 

2. Major Provisions

A. Define specific formulations for drug products subject to the certification of GMP compliance (newly insert Article 3-2) 

Define specific formulations for drug products subject to the certification of GMP compliance (including the modified certification of GMP compliance) by considering the characteristics of processes (sterile or non-sterile or biologic), materials, and formulations.

B. Prepare specific procedures and methods for the certification of GMP compliance (newly insert Article 3-3)

Define procedures and methods related to inspection and supplementation during the certification of GMP compliance (including the modified certification of GMP compliance). 

C. Amend details about GMP for sterile drug products (Table 1)

Reflect relevant amendments to the GMP of the PIC/S into Korea’s regulations by establishing contamination control strategies through quality risk control and preparing management standards for the latest sterile manufacturing facilities and technologies to advance the quality assurance system for sterile drug products.

D. Update details about GMP for biologics (Table 2)

Delete provisions related to advanced biopharmaceuticals as details about GMP for advanced biopharmaceuticals are proposed. 

E. Prepare details about GMP for advanced biopharmaceuticals (Table 2-2) 

Reflect relevant amendments to the GMP of the PIC/S into Korea’s regulations by establishing GMP for advanced biopharmaceuticals considering their characteristics, separate from the existing GMP for biologics.