A stability program for the distribution of drug products

Pharmaceutical Technology

Volumn 28, Issue 7, 2004, Pages 68-73

  Lucas, Teresa I ^b   Bishara, Rafik H ^b   Seevers, Robert H ^a  

^a ELI LILLY AND COMPANY   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

DIESEL AND GAS TURBINE COMBINED POWER PLANTS; QUALITY CONTROL; STABILITY; THERMAL EFFECTS;

PRODUCT QUALITY; TEMPERATURE EXCURSIONS;

DRUG PRODUCTS;

ANALYTIC METHOD; DRUG MARKETING; DRUG PACKAGING; DRUG QUALITY; DRUG STABILITY; DRUG STORAGE; REVIEW; SHIPPING; TEMPERATURE;

EID: 3142618960     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (9)

1. FDA, "Draft Guidance for Industry, Stability Testing of Drug Substances and Drug Products" (FDA, Rockville, MD, June 1998), glossary.
2. International Conference on Harmonization (ICH), "Guidance for Industry, Q1A(R2): Stability Testing of New Drug Substances and Products," November 2003, http://www.fda.gov/cber/gdlns/ichstab.pdf.
3. General Information 〈1151〉, "Pharmaceutical Dosage Form," USP 27-NF22 (US Pharmacopeial Convention, Rockville, MD, 2004), pp. 2577-2578.
4. FDA, "Draft Guidance for Industry, Stability Testing of Drug Substances and Drug Products," June 1998, http://www.fda.gov/cber/gdlns/ stabdft.pdf.
5. General Notices (26), "Storage, Temperature, and Humidity," USP 27-NF 22 (US Pharmacopeial Convention, Rockville, MD, 2004), p. 10.
6. Committee for Proprietary Medicinal Products (CPMP), CPMP/QWP/ 609/96/Rev 1 (CPMP, London, UK, 3 April 2003).
7. Obtained through the Freedom of Information (FOI) Act, http://www.foiservices.com.
8. J. Taylor, "Good Shipping and Distribution Practices," paper presented at the United Kingdom Medicines and Healthcare Products Regulatory Agency, USP Packaging, Storage, and Distribution Open Conference, Washington, DC, 12-15 October 2003.
9. ICH, "Guidance for Industry, Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products," January 2003, http://www.fda.gov/cder/guidance/4985fnl.pdf.