CONTENTS
- 1. GMP | Concept and legal basis
- - About Us
- - Pharmaceuticals and GMP
- 2. GMP | Target
- - Pharmaceutical
- - Drug Importers
- - Medical Device Manufacturer
- - Medical Device
- - Clinical Trial Medicine and Medical Device Manufacturer
- - Excludes or relief targets
- 3. GMP | Medical equipment GMP examination procedure and evaluation standards
- - Notice
- - Rating standards and ratings
- - Supplementation and follow-up
- 4. GMP | Pharmaceutical GMP examination and evaluation structure
- - Application
- - Hotel
- 5. GMP | Legal responsibility for violation
- - 담당자: Mr. Jerry Jiang
- - In the event of an accident
- 6. GMP | Response strategy
- - Recruitment
- - Copyright (c) 2015 DAEWOO. All Rights Reserved.
1. GMP | Concept and legal basis
GMP is an acronym for Good Manufacturing Practice.
Medicine and medical device manufacturing and quality control are divided into GMP and medical device GMP according to the laws and regulations.
Medicine Manufacturing and Quality Control Regulation on Quality Control (Purpose)
<> Article 34, Article 38. Paragraph 1, Rules regarding Safety of Drugs, etc. (hereinafter referred to as "Terms") Article 4, Paragraph 2, Article 30. Clause 1, Paragraph 9, Article 48. Issue 5 of Article 9 of the same Article, from the date of birth to the mortar Paragraph 2 of Article 48, Table 1 Issue 15.4, 1 2 3 4 5 6 7 8 9 10 Next Items that apply to the item permission must be submitted to the provisions of Article 48 of the Rules and the provisions of the Quality Control Standards for the manufacture and quality control standards according to Article 4 of the Rules Clause 1 of the Rules, Details and rules for the validity period of conformity clause 1, Table 1,2, The Company uses ‘cookies’ that frequently save and retrieve your information. A cookie is a very small text file that the server, used to operate the Company’s website, sends to your browser. The file is saved in the hard disk of your computer.
< style="color:black;">to the legal regulatory system for protecting the life and safety of the nationals "The rules regarding safety such as medicines", We are based on the principle of manufacturing and quality control of medical products.
About Us
According to the food's safety standards GMP is a legal basis for the minimum requirements. News /span>
Pharmaceuticals and GMP
GMP has a common point of manufacturing and quality control standards applied to both medicines and medical devices. News br>
Pharmaceutical GMP is operated according to the regulations regarding the safety of medicines and medicines, and manufacturing processes, Application This is the basis for scientific verification of product quality, such as Valley Daytion.
is characterized by a specific manufacturing and quality control standards. News br>
Semi-surface medical device GMP is operated according to “medical device law” and is organized around the quality management system (QMS), About Us Factory Tour It is composed of a way to assess overall system management system such as post-management.
is a feature that is linked to the ISO 13485 system, which is an international standard. News br>
If the two schemes use the same term, there is a difference in the application standard and the screening method, so it is necessary for each regulatory system. News /p>
2. GMP | Target
GMP is a duty that is imposed to manufacturing and importers in accordance with relevant laws and regulations.
The operators that correspond to regular requirements must comply with GMP standards. News In the case of br>
Pharmaceuticals, the manufacturer must comply with GMP standards for the manufacturing site, and the importer is responsible for managing the GMP conformity of overseas manufacturing sites. News /strong>
In the case of medical equipment, manufacturing and importers must meet GMP standards, and especially for more than a certain grade medical devices are subject to GMP compliance or certification.
Pharmaceutical
"Pharmaceuticals" Article 31 and 34 of the drug manufacturing needs to be manufactured and quality control standards for the manufactory. News /span>
This is not only a medical product but also a pharmaceutical product manufacturer of raw materials. a homogenizer, a more strict standard for high-risk medicines, etc. News /span>
Drug Importers
In case of importing drug products from abroad, the standard of GMP News /span>
The importer is responsible for management and control whether it meets the standards of overseas manufacturing GMP News /span>
Temporary investigation for overseas manufactory, quality control data is required. News /span>
Medical Device Manufacturer
A person who wants to manufacture medical devices according to the method of medical devices must meet the standard of medical devices GMP News /span>
specially 2 grade or more medical device case GMP functions as a prerequisite or certification.
Medical Device
Restaurant importers are also obliged to check whether or not to comply with overseas manufactory GMP News /span>
It’s a trend that expands the scope of the importer’s responsibility as it is strengthened by local authorities for overseas manufactory changes. News /span>
Clinical Trial Medicine and Medical Device Manufacturer
if it is a product used for trial, it is necessary to secure a regular quality level, so GMP standard is applied. News /span>
specially clinical trial medicines that are administered directly to the human body are the same or similar level of care is required< /span>
Excludes or relief targets
GMP is a pre-registration regulation that is applied to all medicines and medical devices, but in some cases, the coverage may be limited or cushioned. News /span>
• Some low risk medical devices (1st grade etc.)
In case of export-only products, there may be some standards in terms of domestic distribution, but it is necessary to meet the regulatory regulations of the import country, so substantially the management of GMP is often required. News /span>
In addition, low risk products such as grade 1 medical device can be simplified, but the basic manufacturing and quality control obligations still apply. News /span>
3. GMP | Medical equipment GMP examination procedure and evaluation standards
Total operating system is based on actual quality. News /span>
Notice
News /span>
The first company is the process to receive the product first GMP and if there is no change in the manufacturing process or facility.
Also, it is checked for continuous fit through regular trials every time. News /span>
The validity of the revision is in principle 3 years and it must be renewed through regular trials before the period expires.
Rating standards and ratings
장기 GMP News /span>
| class | The final decision is made by combining the evaluation result of each item, and the supplement (B) may be required in some items, and if there is no subject (C) that does not meet the criteria, the correction is made. News /span>
There are only differences in terms of the GMP is assessed based on the process and quality control standards than a separate grade system. News /span> |
Supplementation and follow-up
GMP If you have any inconveniences to some criteria, you may need supplements within a certain period of time. News /span>
In this case, the operator must submit the material that can prove this with the improvement of the intellectual property. News /span>
first first time of completion of completion of completion of completion of completion, and additional supplements may be required if the submitted material is poor.
Only supplements are based on whether the actual manufacturing and quality control system is improved to the standards. News /span>
The final complementary procedure is a process that should prove the conformity of the manufacturing and quality control system and it has a structure that leads to direct regulatory measures if it is not fulfilled properly. News /span>
المزيد
4. GMP | Pharmaceutical GMP examination and evaluation structure
Pharmaceuticals GMP shall not use evaluation systems such as A, B, C grades, and it shall be appropriate to meet the manufacturing and quality control standards according to the regulations of safety such as medicines. News br>
Pharmaceutical GMP evaluations are conducted through the actual inspection of food and medicine safety, and are conducted in a comprehensive manner to determine whether the facility, process and quality control system is suitable for all purposes. News /p>
Application
is done in the following ways: News /p>
▶ Manufacture process and test method validation
<>▶ Quality control (QC) and quality assurance (QA) system check News /p>
Hotel
Pharmaceutical GMP is not a grade system such as medical devices, Depending on whether or not meet the standard, it is judged as follows: News /p>
▶ If not meet the standard → GMP compulsory
The entire system is based on the core judgment whether the entire system is in compliance with the standards set forth in the statutes. News /p>
If there are some inevitable results, the supplement needs may be done, and the operators must submit improvements and evidences for that. News /p>
5. GMP | Legal responsibility for violation
GMP If you do not comply with the standard, the administration will be done and according to the degree of violation, the manufacture or import itself may be limited. News /span>
담당자: Mr. Jerry Jiang
In the event of an accident
medical equipment GMP In case of violation of the standard, the medical device laws and regulations may be made according to Article 58. News /span>
long content | 1차 breach | 2nd violation | In addition, it may lead to criminal liability problem, so it is necessary to be careful. News /span> |
المزيد
6. GMP | Response strategy
GMP is a system that pre-registers continuous quality control system.
The company must maintain the internal system that can meet the standards of flatness GMP News /span>
Recruitment
| In this step, we may require repeated supplements in the process of screening. News /span> Simple response phase is important to identify issues in advance through regular trial schedule management and internal inspection and respond quickly and accurately about intellectual property. If the same violation is repeated, the disposal may rise, so you need continuous management. News /span> Research Research Research < |
Copyright (c) 2015 DAEWOO. All Rights Reserved.
Major Medical·Bio·Healthcare Group is based on the understanding of the pharmaceutical and medical device industry GMP provides comprehensive legal services to prevent and strengthen regulatory compliance.
GMP standard and screening procedures, support stable operation of enterprises through step-by-step customized advice to effectively respond to real-time risk. News /span>
• Advised the strategy for reviewing and executing symptoms.
• • Manufacturing and import related regulatory review and internal management system construction advisory
<• Legal review of consignment contracts and quality control responsibility structures
If you are having difficulties with related regulatory response or administrative disposition issues 🔗Reservation for legal consultation with a medical lawyer for professional advice tailored to your specific situation Please receive it.
المزيد
