annex 4-2 Korean good manufacturing practices …

1 Enforcement Rule for Medicinal Product Safety, annex 4-2 " good manufacturing Practice for Investigational Medicinal Products" < >. Enforcement Rule for Medicinal Product Safety annex 4-2 " good manufacturing Practice for Investigational Medicinal Products". Korean good manufacturing PRACTICE REGULATION FOR. INVESTIGATIONAL MEDICINAL PRODUCTS. August 21, 2014. Note: This English version translated by gmpeye is not officially approved or endorsed by the Korean regulatory authority, the Ministry of Food and Drug Safety. ggm mppeeyyee 1. Enforcement Rule for Medicinal Product Safety, annex 4-2 " good manufacturing Practice for Investigational Medicinal Products" < >.

2 [ annex 4-2]. good manufacturing PRACTICE FOR INVESTIGATIONAL MEDICINAL PRODUCTS. (Article 24, Paragraph , Sub-paragraph 2 and Article 30, Paragraph , Sub-paragraph 9 of the Enforcement Rule for Medicinal Product Safety). 1. 1. Introduction Purpose The purpose of this Regulation is to specify good manufacturing , practice requirements, in order to assure quality, safety and , efficacy of investigational medicinal products under development . stage, to protect subjects participating in clinical trials and to assure the reliability of clinical data. 2. 2. Definitions . Terms used in this Regulation have the following meanings.

3 " (Order)" A. "Order" means an instructional document provided to an (Process), investigational medicinal product manufacturer by a (Package), (Ship) sponsor to process, package and ship a certain number of . units of investigational medicinal products for use in clinical trials.. " (Product Specification B. "Product Specification File" means a reference file File)" , , , containing or a list referring to files containing, all the information necessary to draft the detailed written instructions on processing, packaging, quality control ggm mppeeyyee 2. Enforcement Rule for Medicinal Product Safety, annex 4-2 " good manufacturing Practice for Investigational Medicinal Products" < >.

4 Testing, lot release and shipping of an investigational medicinal product.. " (Randomization Code)" C. "Randomization Code" means a list of identification codes created in a statistically appropriate manner, in which . treatment assigned to each subject from the randomization process is identified. 3. 3. General Principles . 1 A. A person who intends to manufacture an investigational , medicinal product should comply with "GMP for Medicinal 3, Products" in annex 1 as well as requirements in annex 3. 3 2, 3 3 for biological products, annex 3-2 for radiopharmaceuticals . , or annex 3-3 for medicinal gases.

5 However, if otherwise specified in this Regulation or if rationale appropriate for development stage of the investigational medicinal product . is provided, some requirements may not apply.. B. Specifications for investigational medicinal products , should be reinforced over development stages and various . kinds of changes should be documented and traceable.. 4 C. Prior to production of investigational medicinal products, , double-blinding, randomization and others as specified in good Clinical Practice Regulation in annex 4 and clinical . trial protocol should be sufficiently considered. 4.

6 4. Scope ggm mppeeyyee 3. Enforcement Rule for Medicinal Product Safety, annex 4-2 " good manufacturing Practice for Investigational Medicinal Products" < >. 34 This Regulation applies to investigational medicinal products , used in clinical trials under Article 34 of the Pharmaceutical Affairs Act. In addition, this Regulation applies to repackaging . or modification of commercially available medicinal products for the purpose of using them as comparators. 5. 5. Premise and Environment . , , , , A. If a sponsor intends to make another manufacturer perform all or some parts of production, quality control, , packaging, storage and shipping of investigational , medicinal products under contract, the sponsor should assess the manufacturer for manufacturing business.

7 License, compliance with GMP regulation and others in advance. In such instance, the manufacturer should establish and document production and quality control system for the investigational medicinal product.. B. Important facilities and equipment used in production and quality control of investigational medicinal products . should be calibrated and qualified.. , C. Toxicity, potency and others may not be fully understood , for investigational medicinal products. Therefore, for , multi-product manufacturing sites, measures for , prevention of cross-contamination, such as design of , equipment and premise, test methods and acceptance.

8 Limits to be used after cleaning and consideration of ggm mppeeyyee 4. Enforcement Rule for Medicinal Product Safety, annex 4-2 " good manufacturing Practice for Investigational Medicinal Products" < >. campaign working, should be developed. If necessary, toxicity of product, easiness of cleaning and removal, and other aspects should be assessed. 6. 6. Organization and Responsibilities . A. If the sponsor intends to use another manufacturer for all operations under contract, the sponsor should have a , person responsible for quality assurance of investigational 36 3 medicinal products, such as lot release.

9 This person . responsible for quality assurance should be a qualified person as prescribed in Article 36, Paragraph of the Pharmaceutical Affairs Act or a person having sufficient knowledge and experience in this Regulation.. ( ) B. The head of quality (assurance) unit belonging to the sponsor should revise the product specification file of section and make a decision of lot release under .. consideration of aspects as prescribed in section This requirement should equally apply to cases where some processing steps are contracted to another manufacturer.. C. Annual product quality review and critical material supplier assessment should be conducted within the limits.

10 Of the possible, under consideration of development stage of investigational medicinal products. 7. 7. Documentation and Specifications ggm mppeeyyee 5. Enforcement Rule for Medicinal Product Safety, annex 4-2 " good manufacturing Practice for Investigational Medicinal Products" < >. Specifications and Instructions . ( , 1 , , A. Specifications (for starting materials, primary packaging ), , materials, intermediates, drug substances and drug . , products), product master file, and processing and packaging instructions should be prepared given the . current development stage. However, if operations are not repeated, product master file and processing instructions may not be prepared.