Cleaning validation with regard to protein residues;Reinigungsvalidierung unter besonderer berücksichtigung von proteinrückständen

Pharmazeutische Industrie

Volumn 67, Issue 11, 2005, Pages 1359-1365

  List, Wolfgang ^a,b   Müller, Judith ^a,b  

^a ZLB Behring GmbH   (Germany)

^b ZLB Behring GmbH   (Germany)

Author keywords

Plasma Produkte; Proteine; Reinigungsvalidierung, Akzeptanzkriterien; Rinse Proben; Swab Proben

Indexed keywords

PROTEIN;

ANALYTIC METHOD; ARTICLE; CLEANING; CONTAMINATION; DOCUMENTATION; PLASMA; PROTEIN ANALYSIS; PURIFICATION; SAMPLING; VALIDATION PROCESS;

EID: 29144468685     PISSN: 0031711X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (8)

1. FDA, Code of Federal Regulations (CFR), Title 21 Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General, Revision 2004
2. FDA, Code of Federal Regulations (CFR), Title 21 Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, Revision 2004
3. FDA, Guide to Inspections of Validation of Cleaning Processes (1993)
4. Pharmaceutical Inspection Conventions (PIC) / Pharmaceutical Inspection Co-operation Scheme, Recommendations on Validation Master Plan. Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation, PI 006-2 (2004)
5. PDA, Points to Consider for Cleaning Validation, J. Pharm. Sci. Technol., Technical Report No. 29, Supplement, Vol. 52, No. 6 (1998)
6. Betriebsverordnung für pharmazeutische Unternehmer (PharmBetrV) (1985)
7. European Commission, Annex 15 to the EU Guide to Good Manufacturing Practice, Qualification and validation (2001)
8. PDA, Cleaning and Cleaning Validation: A Biotechnology Perspective (1996)