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의약품 용기 및 포장 적합성 평가 (MFDS)

가이드라인 [2019.9]

나. 침출물 분석

현재 모든 유기 및 무기화합물을 동시에 정성, 정량할 수 있는 분석 기술이나 분석 기술의 조합은 없다. 침출물에 존재하는 화학물을 여러 보완적인 분석기술을 사용하여 분석하여 침출물 프로파일을 생성하고, 평가한다. 침출물 분석의 목표는 현재 과학기술에 근거한 합리적인 수준에서, 안전성을 고려한 특정 수준 이상으로 의약품에 침출되어 존재하는 물질을 검출, 확인, 정량하는 것이다. 추출물에 대한 위해분석 결과에 따라 침출물 시험 여부를 결정할 수 있다. 침출물 분석을 위한 분석방법은 추출물 특성분석에 적용되는 기술과 동일하므로 이를 참고한다. 다만, 의약품 중 존재하는 첨가제가 탐색을 방해할 수 있기 때문에 일반적으로 탐색 분석은 침출물 분석에 사용하지 않는다.

EU GMP Annex 1

The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use

Annex 1

Manufacture of Sterile Medicinal Products

Single use systems (SUS)

8.131 SUS are those technologies used in manufacture of sterile products which are used as an alternative to reusable equipment. SUS can be individual components or made up of multiple components such as bags, filters, tubing, connectors, valves, storage bottles and sensors. Single use systems should be designed to reduce the need for manipulations and complexity of manual interventions.

8.132 There are some specific risks associated with SUS which should be assessed as part of the CCS. These risks include but are not limited to:

i. The interaction between the product and product contact surface (such as adsorption, or leachables and extractables).

ii. The fragile nature of the system compared with fixed reusable systems.

iii. The increase in the number and complexity of manual operations (including inspection and handling of the system) and connections made.

iv. The complexity of the assembly.

v. The performance of the pre- and post-use integrity testing for sterilising grade filters (see paragraph 8.87).

vi. The risk of holes and leakage.

vii. The potential for compromising the system at the point of opening the outer packaging.

viii. The risk of particle contamination.


8.136 The extractable and leachable profiles of the SUS and any impact on the quality of the product especially where the system is made from polymer-based materials should be evaluated. An assessment should be carried out for each component to evaluate the applicability of the extractable profile data. For components considered to be at high risk from leachables, including those that may absorb processed materials or those with extended material contact times, an assessment of leachable profile studies, including safety concerns, should be taken into consideration. If applying simulated processing conditions, these should accurately reflect the actual processing conditions and be based on a scientific rationale.