식약처-질본, 백신 보관·수송관리 가이드라인 마련
1. 개요 ················································································ 1
1.1 배경 및 목적 ································································································ 1
1.2 범위 ·············································································································· 2
2. 용어의 정의 ·································································· 2
3. 제조·수입업체 및 도매상 백신 보관관리 ············ 4
3.1 보관업무 일반 ······························································································ 4
3.2 보관소 시설 ································································································ 5
3.3 보관소의 시설 및 환경관리 ···································································· 6
3.4 입고관리 ······································································································ 6
3.5 보관관리 ······································································································ 7
3.6 출고관리 ······································································································ 8
4. 제조·수입업체 및 도매상 백신 수송관리 ·········· 8
4.1 수송용기 및 장비 ························································································ 8
4.2 수송업무 ······································································································ 9
5. 의료기관 백신 보관관리 ·········································· 9
5.1 백신 접종기관 준비사항 ············································································ 9
5.2 백신 관리 담당자 지정 ············································································ 10
5.3 백신의 입고 및 재고 관리 ······································································ 11
5.4 백신 보관 및 취급 계획 수립 ································································ 13
5.5 백신 보관 장비(냉장고/냉동고) ······························································ 14
5.6 백신 보관 온도 기록 ················································································ 16
5.7 백신 보관 장비에서의 백신 배치 및 표시 ·········································· 18
5.8 백신 보관 장비의 유지 관리 ·································································· 20
5.9 백신 보관 장비의 사용 시 주의사항 ···················································· 21
5.10 백신 접종 시 주의사항 ········································································· 22
5.11 백신의 폐기 ··························································································· 23
5.12 백신 보관 시 응급상황이 발생한 경우 조치 ································· 23
5.13 기타 ··········································································································· 24
[참고 1] 국가예방접종업무 위탁 의료기관 자율점검표 ························ 25
[참고 2] 생물학적제제등 출하증명서 ························································ 26
1.1 배경 및 목적
백신의 경우, 생산·수입에서부터 유통, 보관 및 최종 사용에 이르기까지 적정 보관
온도를 항상 유지하는 것이 중요하다.
백신 콜드체인은 백신을 최적의 상태로 유지하여 유통시키기 위해 이용되는 온도
제어 환경으로 제조․수입업체에서부터 의료기관의 백신 투여시점까지 백신의
운반, 보관, 취급에 관련된 모든 설비와 절차를 포함한다. 백신의 제조·유통·사용
과정은 제조·수입업체가 백신을 생산·수입하여 냉장보관 장치에 보관 후
제조․수입업체에서 유통업체로 운반하고, 유통업체가 접종기관으로 운반하여
접종기관에서 입고․보관하였다가 환자에게 투여하는 것으로 종료된다. 콜드
체인에서 가장 중요한 점은 백신이 제조·수입업체에서 생산·수입되어 유통업체를
거쳐 접종기관에 이르기까지 적정온도를 유지하는 것이다(그림 1 참조).
백신 제조 및 수입과 관련된 세부사항은 「의약품 등의 안전에 관한 규칙」
[별표1] ‘의약품 제조 및 품질관리기준’, [별표3] ‘생물학적제제등 제조 및 품질
관리기준’ 및 [별표 6의2] ‘의약품등 수입관리 기준’에서 규정하고 있으며,
백신유통과 관련된 사항은 [별표6] ‘의약품 유통품질 관리기준’ 및 「생물학적
제제 등의 제조·판매관리 규칙」에 따라 시설 및 설비, 공급관리 등에 대해
상세히 규정하고 있다. 다만, 접종기관인 의료기관에서 백신의 보관, 취급에
관한 규정은 마련되어 있지 않으나, 백신의 품질관리를 위해서는 백신 보관,
취급에 적정성을 기하여야 한다.
적절한 백신의 보관·수송 및 취급절차를 포함한 올바른 백신 관리는 예방접종
사업의 토대라고 할 수 있다. 부적절한 보관·수송으로 인하여 역가가 떨어진
백신을 접종한 환자는 백신으로 예방할 수 있는 질환에 대하여 완벽하게 보호
되지 못할 수 있으며, 이로 인한 부적절하게 보관·수송된 백신 폐기관련 비용은
예산 낭비가 아닐 수 없다. 제조·수입업체, 도매상, 의료기관에서의 백신 보관·
수송 관리는 안전한 예방접종에 직접적인 영향을 주기 때문에 적정 온도유지 등
철저한 관리가 요구된다.
따라서 본 가이드라인에서는 백신을 생산·수입하는 제조·수입업체와 유통하는
도매상 및 예방접종을 실시하는 의료기관을 모두 포함하여 백신 보관, 수송,
입고, 사용 전 보관까지의 적절한 취급관리 중요성과 올바른 백신 보관·수송
관리에 대한 적절한 방향을 제시하고자 한다.