Validation and Qualification Status

밸리데이션 및 적격성 평가 현황표

√ Finished products (완제품)
Company : R.N. LABORATORIES PVT. LTD. Type of Product :
□ Raw material (원료의약품)

1. Validation Status (밸리데이션 현황)

1.1 Process Validation (공정 밸리데이션)
Material Name Document No. Approved Date
(물질명) (문서번호) (승인일자)
CHLORHEXIDINE GLUCONATE 20% SOLUTION

1.2 Cleaning Validation (세척 밸리데이션)

Material Name Document No. Approved Date

서식 SOP-K0702-001/F-04(19.10.01) page 1 of 3
 (물질명) (문서번호) (승인일자)
CHLORHEXIDINE GLUCONATE 20% SOLUTION

1.3 Method Validation (시험방법 밸리데이션)

Material Name Document No. Approved Date
(물질명) (문서번호) (승인일자)
CHLORHEXIDINE GLUCONATE 20% SOLUTION

2. Qualification Status (적격성 현황)

Facility Installation Qualification Operational Qualification Performance Qualification

서식 SOP-K0702-001/F-04(19.10.01) page 2 of 3
 Document No. Approved Date Document No. Approved Date Document No. Approved Date
(설비명)
(문서번호) (승인일자) (문서번호) (승인일자) (문서번호) (승인일자)

3. Computerized System Validation (컴퓨터화 시스템 밸리데이션)

Installation Qualification Operational Qualification Performance Qualification

Facility
(설비명) Document No. Approved Date Document No. Approved Date Document No. Approved Date
(문서번호) (승인일자) (문서번호) (승인일자) (문서번호) (승인일자)

Prepared by (작성자) : Signature / Date (서명 및 날짜) :

Approved by (승인자) : Signature / Date (서명 및 날짜) :

서식 SOP-K0702-001/F-04(19.10.01) page 3 of 3