GMP

Under the standards of the Ministry of Food and Drug Safety, GMP is a minimum requirement, and it functions as a legal standard that businesses must meet.

Pharmaceutical GMP and medical device GMP share the common feature of being manufacturing and quality control standards, yet they differ in the governing statutes and management systems.

Pharmaceutical GMP operates under the "Pharmaceutical Affairs Act" and the "Rules on the Safety of Pharmaceuticals, etc.," and it centers on standards that scientifically verify product quality, such as the manufacturing process, test methods, and validation.

A distinctive feature is that detailed manufacturing and quality control standards are prescribed directly through the tables of the Rules.

Medical device GMP, by contrast, operates under the "Medical Devices Act" and is structured to assess the overall system management framework, including organization, documentation, processes, and post-management, centered on the quality management system (QMS).

A distinctive feature is that it operates in connection with the international standard ISO 13485.

The two systems use the same term, but the applicable standards and review methods differ, so a response suited to each regulatory framework is necessary.

Under Articles 31 and 34 of the "Pharmaceutical Affairs Act," anyone who intends to manufacture pharmaceuticals must establish manufacturing and quality control standards for the manufacturing site.

This applies not only to manufacturers of finished pharmaceuticals but also to manufacturers of active pharmaceutical ingredients, and stricter standards apply to high-risk pharmaceuticals such as sterile and ophthalmic preparations.

GMP standards also apply when pharmaceuticals are imported from abroad and distributed domestically.

An importer is responsible for managing and supervising whether the overseas manufacturing site meets GMP standards.

On-site investigation of overseas manufacturing sites and the collection of quality control data are therefore necessary requirements.

Under the "Medical Devices Act," anyone who intends to manufacture medical devices must satisfy the medical device GMP standards.

For Class 2 or higher medical devices in particular, GMP conformity assessment is a prerequisite for authorization or certification.

Medical device importers also have an obligation to confirm and maintain the GMP conformity of overseas manufacturing sites.

With recent changes to the system, on-site inspections of overseas manufacturing sites have been strengthened, and the scope of importers' responsibility tends to expand.

Products used in clinical trials must also meet a certain level of quality, so GMP standards apply to them as well.

Investigational pharmaceuticals administered directly to the human body, in particular, require control at the same or a similar level as general pharmaceuticals.

In principle, GMP is a mandatory provision that applies to all pharmaceuticals and medical devices, although in some cases its scope may be limited or relaxed.

For export-only products, certain standards may be relaxed because the products are not distributed domestically, but since they must meet the importing country's regulations, management at the GMP level is often required in practice.

For low-risk products such as Class 1 medical devices, certain procedures may be simplified, yet the basic manufacturing and quality control obligations still apply.

Reviews fall into the following types.

An initial review is the procedure through which a manufacturing site obtains GMP conformity assessment for the first time, and a change review follows when the manufacturing process or facilities later change.

Periodic reviews at set intervals confirm continued conformity.

The certificate of conformity is valid for three years in principle, and it must be renewed through a periodic review before that period expires.

Medical device GMP review assigns grades through an item-by-item assessment.

Medical device GMP review sorts items into Grades A, B, C, and D through an item-by-item assessment, and final conformity is decided under the review standards of the Ministry of Food and Drug Safety.

The final determination aggregates the assessment results for each item. Some items may require supplementation (B), and a finding of nonconformity follows where any item does not meet the standards (C).

Pharmaceutical GMP differs, however, in that the assessment centers on whether the process and quality control standards are met rather than on a separate grading system.

Where the GMP review results show that certain standards are not adequately met, the Ministry of Food and Drug Safety may require supplementation within a set period.

In that case, the business must submit improvement measures for the points raised, along with data that substantiate them.

When the supplementation procedure begins, a first supplementation period is granted, and additional supplementation may be required where the submitted data are inadequate.

Supplementation is judged mainly on whether the actual manufacturing and quality control system has been improved to conform to the standards.

In these situations, a finding of GMP nonconformity may be accompanied by administrative dispositions such as suspension of manufacturing operations or revocation of authorization.

The supplementation procedure is ultimately a process in which the conformity of the manufacturing and quality control system must be substantiated, and it leads directly to regulatory measures where this is not properly carried out.

Pharmaceutical GMP assessment proceeds as follows.

Rather than using a grading system as medical devices do, pharmaceutical GMP is judged as follows according to whether the standards are met.

Where the on-site investigation results reveal certain inadequate matters, supplementation may be required, and the business must submit improvement measures and substantiating data for those matters.

For a violation of medical device GMP standards, the following administrative dispositions may be imposed under Article 58 (1) of the Enforcement Rule of the Medical Devices Act.

For pharmaceuticals as well, a violation of GMP standards may bring parallel measures such as revocation of item authorization, suspension of manufacturing operations, and orders for recall and disposal under Article 76 of the Pharmaceutical Affairs Act.

Depending on the case, the matter may also raise issues of criminal liability, so caution is needed.

At the preparation stage, the key is to build the organization and documentation framework on a solid understanding of the manufacturing and quality control standards.

If the quality assurance and quality control functions are not separated and validation is not completed at this stage, the review process that follows may bring repeated requests for supplementation.

At the review response stage, the priority is to identify problems in advance through periodic review schedule management and internal inspections, and to respond promptly and accurately to the points raised.

The level of disposition may rise where the same violation recurs, so continuous management is necessary.

In risk management, the key is to control violation factors that can arise during routine operations, such as change control, record management, and consignment and entrustment management.

The Medical, Bio, and Healthcare Group of Daeryun LLC provides comprehensive legal services to prevent GMP-related legal risks and to strengthen regulatory response capabilities, drawing on an understanding of the pharmaceutical and medical device industry as a whole.

Through step-by-step, tailored advisory, it supports the stable operation of businesses so that they can respond effectively to complex GMP standards, review procedures, and the risk of administrative dispositions.

If you face difficulties with a related regulatory response or administrative disposition, you can obtain professional advisory tailored to your situation through Daeryun 🔗Consultation With a Medical Attorney.