GMP 소식

의약품 소량포장단위 공급에 대한 규정

제1조(목적) 이 규정은 「약사법」 제38조 및 제42조,「의약품 등의 안전에 관한 규칙」제48조 및 제60조의 규정에 의하여 의약품의 제조판매 품목허가를 받거나 제조판매 품목신고를 한 자(이하 “의약품의 품목허가를 받은 자”라 한다)․수입자가 제조․수입하는 의약품 중 낱알모음포장 등 소량포장단위로 공급하여야 하는 대상 및 공급방법 등을 정하는 것을 그 목적으로 한다.

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의약품 바코드 또는 전자태그(RFID tag) 표시 대상 등에 관한 기준

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Contract Manufacturing Arrangements for Drugs:
Quality Agreements

This guidance describes our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy. This guidance applies to the commercial manufacturing of Active Pharmaceutical Ingredients (APIs or drug substances, or their intermediates), finished drug products, combination products, and biological drug products. For the purposes of this guidance, the term “manufacturing” includes processing, packing, holding, labeling operations, testing, and operations of the Quality Unit.

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Expiration Dating and Stability
Testing of Solid Oral Dosage Form
Drugs Containing Iron

I. INTRODUCTION
This guidance describes how manufacturers and packagers affected by the final rule that published
in the Federal Register (62 FR 2218) on January 15, 1997, requiring label warning statements and
unit-dose packaging for solid oral drug products that contain 30 milligrams (mg) or more of iron
per dosage unit, may meet stability and expiration dating requirements.
II. BACKGROUND
The Federal Food, Drug, and Cosmetic Act requires that manufacturers establish controls for the
manufacture, processing, packing, and holding of drug products to ensure their safety, identity,
strength, quality, and purity (§ 501(a)(2)(B)). Requirements for these controls, also known as
current good manufacturing practices (CGMPs), are established and monitored by the FDA.

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