Qualification of Raw Materials for Biopharmaceutical Use

BioPharm International

Volumn 17, Issue 2, 2004, Pages 28-41

  Shadle, Paula J ^a  

^a Shadle Consulting   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COMMERCIAL PHENOMENA; DRUG INDUSTRY; ENVIRONMENTAL SUSTAINABILITY; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; MATERIALS MANAGEMENT; PLANNING; QUALITY CONTROL; QUANTITATIVE ANALYSIS; REVIEW;

EID: 1242316346     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (22)

1. FDA. Current good manufacturing practices for finished pharmaceuticals. Code of Federal Regulations, Title 21, Part 211.80-94, 211.101, 211.184 as a mended 1 Apr 2003.
2. FDA. Quality system regulation. Code of Federal Regulations, Title 21, Part 820 revised 1 Apr 2003.
3. EMEA. Medicinal products for human and veterinary use. GMP Guide (Volume 4) 1998.
4. EMEA. Sampling of starting and packaging materials. GMP Guide (Volume 4) Annex 8 1999.
5. EMEA. Manufacture of investigational medicinal products. GMP Guide (Volume 4) Annex 13 revised 2003 Jul.
6. ICH. Good manufacturing practice for active pharmaceutical ingredients. Q7A.Geneva; 2000.
7. Del Tito BJ, Tremblay M, Shadle P. Qualification of raw materials for clinical biopharmaceutical manufacturing. BioPharm 1996;9(10).
8. Thereapeutic Goods Administration. TGA reminds Australians of the potential danger of Pan Pharmaceuticals [press release]. Woden, Australia: TGA;2003 Aug 24.
9. Lubiniecki AS, Shadle PJ. Raw material considerations. Dev. Biol. Standard 1997;91:65-72.
10. Dolecek G. Vendor audit and certification programs. Pharmaceutical Engineering 1997;17:24.
11. ICH. Specifications: test procedures and acceptance criteria for new drug substances and new drug products - chemical substances. Q6A.Geneva; 1999.
12. ICH. Specifications: test procedures and acceptance criteria for biotechnological/biological products. Q6B.Geneva; 1999.
13. ANSI/ASQC Z1.4-1993. Sampling procedures and tables for inspection by attributes. Milwaukee (WI): ASQC Quality Press.
14. Recent inspection findings. Excerpted from BioQuality: i2i Corporation. Idyllwild (CA);2001-2003.
15. FDA. FDA's electronic freedom of information reading room - warning letters and responses. Available from URL: http://www.fda.gov/foi/warning.htm.
16. ICH. Validation of analytical procedures: methodology.Q2B.Geneva; 1995.
17. USP. The United States pharmacopeia. 27th ed. Rockville (MD): United States Pharmacopeial Convention; 2004.
18. European Pharmacopeia Commission. European pharmacopeia. 5th ed. Strasbourg, France: The Commission; 2004.
19. EMEA. Note for guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products. London; 2001 May 31.
20. WHO. Guideline for sampling of pharmaceutical and related materials. Draft 2003. Avaliable from URL: http://www.who.int/medicines/organization/qsm/ ac tivities/qualityassurance/gmp/gmptwo.html.
21. CPMP. Note for guidance on viral validation. In: Commissions of the EC, rules governing medicinal products in the EC, Vol 3, Addendum 2. Luxembourg: Office for Official Publications of the EC; 1992.
22. Seely RJ, Wight HD, Fry HH, Rudge, Slaff, GF. and Rudge. Validation of chromatography resin useful life. BioPharm 1994;7(7).