A critical approach to the evaluation of packaging components and the regulatory and scientific considerations in developing a testing strategy

American Pharmaceutical Review

Volumn 9, Issue 4, 2006, Pages

  Taborsky, C Jeanne ^a   Sheinin, Eric B ^c   Hunt, Desmond G ^b  

^a SciRegs International Inc

^b United States Pharmacopeia

^c NONE

Author keywords

[No Author keywords available]

Indexed keywords

BIOCOMPATIBILITY; CONTAINER; DRUG DOSAGE FORM; DRUG PACKAGING; FOOD AND DRUG ADMINISTRATION; MATERIALS TESTING; MEDICAL LITERATURE; REVIEW; RISK ASSESSMENT; STANDARD;

EID: 35348952045     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (21)

1. Federal Food, Drug, and Cosmetic Act § 501(a)(3).
2. 21 CFR § 211.84.
3. 21 CFR § 211.94.
4. FDA. Guidance for industry: container-closure systems for packaging human drugs and biologics - chemistry, manufacturing, and controls documentation. May 1999. Available at: www.fda.gov/cder/guidance/1714fnl.pdf. Accessed 17 August 2006.
5. 21 CFR § 174-178.
6. FDA. Changes to an approved NDA or ANDA. April 2004. Available at:www.fda.gov/OHRMS/DOCKETS/98fr/1999d-0529-gdl0003.pdf. Accessed 17 August 2006.
7. 21 CFR § 211.94(a) and (b).
8. USP. USP 29-NF 24. Rockville, MD: United States Pharmacopeial Convention, Inc.; 2006:2655-2664.
9. ICH. Quality guidelines. www.ich.org/cache/compo/276-254-1.html[click on Guidelines: Quality Toxics]. Accessed17 August 2006.
10. Coalition of Northeastern Governors. Available at: www.coneg.org. Accessed 17 August 2006.
11. ICH. Q6A. Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances. Available at: www.ich.org/LOB/media/MEDIA430.pdf. Accessed 17 August 2006.
12. ICH. Q3A(R1). Impurities in new drug substances. Available at:www.ich.org/LOB/media/MEDIA422.pdf. Accessed 17 August 2006.
13. ICH. Q3B(R1). Impurities in new drug products. Available at:www.ich.org/LOB/media/MEDIA421.pdf. Accessed 17 August 2006.
14. ICH. Q1A(R2). Stability testing of new drug substances and products. Available at: www.ich.org/LOB/media/MEDIA419.pdf. Accessed 17 August 2006.
15. USP. General Chapter Organic volatile impurities〈467〉. USP 29-NF 24. Rockville, MD: United States Pharmacopeial Convention, Inc.; 2006:2580-2590.
16. ICH. Q3C(R3). Impurities: guideline for residual solvents. Available at: www.ich.org/LOB/media/MEDIA423.pdf. Accessed 17 August 2006.
17. Section 201(j) of the Federal Food, Drug, and Cosmetic Act as Amended though 21 December 2000, U.S. Government Printing Office, Washington DC, 2001.
18. Ibid., Section 501(b).
19. USP. General Notices.Preservation, packaging, storage, and labeling. USP 29-NF 24. Rockville, MD: United States Pharmacopeial Convention, Inc.; 2006:9-10.
20. Marshall K, Foster TS, Carlin HS, Williams RL. Development of a compendial taxonomy and glossary for pharmaceutical dosage forms.Pharm Forum.29(5);2003:1742-1752.
21. ICH. Q2(R1). Validation of analytical procedures: text and methodology. Available at: www.ich.org/LOB/media/MEDIA417.pdf. Accessed 17 August 2006.