Regulatory issues with excipients

International Journal of Pharmaceutics

Volumn 187, Issue 2, 1999, Pages 273-276

  Robertson, Michael I ^a  

^a MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

Author keywords

Excipient functionality; Excipients; Legislation and guidelines; Marketing authorisations; Pharmacopoeias; Stability

Indexed keywords

EXCIPIENT;

ARTICLE; DRUG LEGISLATION; DRUG STABILITY;

DRUG STABILITY; EXCIPIENTS; LEGISLATION, DRUG;

EID: 0033527272     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0378-5173(99)00110-6     Document Type: Article

References (15)

1. Anon., 1997. Pharmeuropa 9 ICH Q3C: Impurities, Guideline for residual solvents, pp. 482-490.
2. Anon., 1998. Pharmeuropa 10 Excipients, p. 273.
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14. Robertson, M.I., 1996. Licensing considerations regarding the immediate packaging of pharmaceuticals for human use. In: Lockhart, H., Paine, F.A. (Eds.), Packaging of Pharmaceuticals and Healthcare Products. Blackie, London, pp. 68-97.
15. The International Pharmaceutical Excipients Council, 1995. Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients. Wayne, New Jersey, p. 103.