SCOPUS 정보 검색 플랫폼

Pharmaceutical Technology

Volumn 24, Issue 10, 2000, Pages 160-168

Establishing scientifically justified acceptance criteria for the cleaning validation of APIs

(1) LeBlanc, D A a

a STERIS Corporation (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG RESIDUE;

CALCULATION; CLEANING; DOSE CALCULATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; GOOD MANUFACTURING PRACTICE; MAXIMUM PERMISSIBLE DOSE; PURIFICATION; QUALITY CONTROL; REVIEW; VALIDATION PROCESS;

EID: 0033752226 PISSN: 01478087 EISSN: None Source Type: Journal
DOI: None Document Type: Review

Times cited : (16)

References (9)

1
- 0003548168
- Division of Investigations, Office of Regional Operations, Office of Regulatory Affairs, July
- (1993) Guide to Inspections of Validation of Cleaning Processes

2
- 0001820755
- Determining cleaning validation acceptance limits for pharmaceutical manufacturing operations
- (1993) Pharm. Technol. , vol.17 , Issue.4 , pp. 54-60
- Fourman, G.L.¹ Mullen, M.V.²

3
- 7844220598
- Establishing scientifically justified acceptance criteria for cleaning validation of finished drug products
- (1998) Pharm. Technol. , vol.22 , Issue.10 , pp. 136-148
- LeBlanc, D.A.¹

4
- 0007273431
- Setting Acceptance Criteria
- Validated Cleaning Technologies for Pharmaceutical Manufacturing (Interpharm Press, Englewood, CO)
- (2000) , pp. 135-150
- LeBlanc, D.A.¹

5
- 0030762870
- PhRMA guidelines for the validation of cleaning procedures for bulk pharmaceutical chemicals
- (1997) Pharm. Technol. , vol.21 , Issue.9 , pp. 56-73

6
- 0007267093
- 7 October
- (1999) Impurities in New Drug Substances

7
- 0002294155
- Cleaning validation: An overall perspective
- (1994) Pharm. Technol. , vol.18 , Issue.4 , pp. 60-73
- Jenkins, K.M.¹ Vanderweilen, A.J.²

8
- 0031980941
- Rinse sampling for cleaning validation studies
- (1998) Pharm. Technol. , vol.22 , Issue.5 , pp. 66-74
- LeBlanc, D.A.¹

9
- 0004064095
- 19 July
- (2000) Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.