Streamlining validation

Pharmaceutical Engineering

Volumn 18, Issue 1, 1998, Pages 8-24

  Atzor, M ^a   Blevins, E ^a   Cover, B ^a   Kelley, P ^a   McArthur, P ^a   Odegaard, D ^a   Sugerik, J ^a   Vasilevsky, M ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

DOCUMENTATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; NOMENCLATURE; PRACTICE GUIDELINE; QUALITY CONTROL; REVIEW; VALIDATION PROCESS;

EID: 0031885678     PISSN: 02738139     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (26)

1. CFR Parts 210 and 211. Current Good Manufacturing Practice: Proposed Amendment of Certain Requirements for Finished Pharmaceuticals; Proposed Rule. [Docket No. 95N -0362] Federal Register, May 3, 1996; 61:20103-20115.
2. Agalloco, James. Validation: An Unconventional Review and Reinvention, PDA Journal of Pharmaceutical Science and Technology. Vol. 49, No. 4 (July-Aug. 1995): 175-179.
3. Akers, J. Simplifying and Improving Process Validation. Journal of Parenteral Science and Technology. Vol. 47, No.6 (Nov.-Dec. 1993): 281-284.
4. Anisfeld, M.H. Validation: How Much Can the World Afford? Are We Getting Value for the Money? (Validation of Pharmaceuticals and Biopharmaceuticals). In: Proceedings, Second International PDA-Congress, Basel, Switzerland, 22-27 February 1993. Parenteral Drug Association, Inc., 1993: 191-198.
5. Bucholz, Steve. A Rapid Validation Approach, Biopharm (January 1997): 50-53
6. Fry, E.M. Comments Regarding FDA's Proposed Rule, 61 20103, May 3, 1996. PDA Letter. Vol. 32, No. 8 (Aug. 1996): 5-10.
7. Gold, D.H. PDA Journal of Pharmaceutical Science and Technology. Vol. 50, No. 1 (Jan.-Feb. 1996): 55-60.
8. Kieffer, R.G. PDA Journal of Pharmaceutical Science and Technology. Vol. 49, No. 5 (Sep.-Oct. 1995): 249-252.
9. McArthur, P. Controlling Validation Cost [slides for presentation]. GMP By the Sea, Newport, RI (Oct. 1996).
10. Sharp, J. Letter to the Editor. Journal of Parenteral Science and Technology. Vol. 47, No.1 (Jan.-Feb. 1993): 2-3.
11. Shepherd, R.E. FDA Inspections of Large Volume and Small Volume Parenteral Manufacturers. Bulletin of the Parenteral Drug Association. Vol. 30, No. 5 (Sept.-Oct. 1976): 209-213.
12. Stocker, A.T. Why Does Validation Cost So Much? And Take So Long? (and What You Can do about It). Journal of Validation Technology. Vol. 1, No. 1 (Oct.-Nov. 1994): 5-9.
13. Validation: How Much Can the World Afford? Are We Getting Value for the Money? Journal of Pharmaceutical Science and Technology. Vol. 48, No. 1 (Jan.-Feb. 1994): 45-48.
14. Shepherd R.E. FDA Inspections of Large Volume and Small Volume Parenteral Manufacturers. Bulletin of the Parenteral Drug Association.
15. Akers J. Simplifying and Improving Process Validation. Journal of Parenteral Science and Technology. 47:281-4.
16. Akers, Op, cit., 283.
17. Anisfeld M.H. Validation: How Much Can the World Afford? Are We Getting Value for the Money? Journal of Pharmaceutical Science and Technology. 48:45-48.
18. Anisfeld, Op. Cit., 45.
19. Shepherd R.E. Op. Cit., 209-213.
20. The Rules Governing Medicinal Products in the European Community, Vol. IV, Good Manufacturing Practice for Medicinal Products, January 1992. 2.5-2.7.
21. Santos P, Agalloco J.P. PDA Seminar on "Introduction to Process Validation", January 27-30, 1992, Lake Tahoe, NV, personal communication.
22. Agalloco J.P., Op. Cit., based on 176, and personal communication.
23. Bucholz, Steve. A Rapid Validation Approach, Biopharm, January 1997: 50-53
24. FDA, Loc. Cit.
25. Fry E.M. Comments regarding FDA's proposed rule, 6 20103, May 3, 1996. PDA Letter. 32:6
26. Fry E.M. Revising the CGMPs. PDA Letter. 32:2-3.