Restricted accessResearch articleFirst published online 1989-7
The Active Constituent: US and EEC Requirements for Documenting the Method of Preparation,Control of Starting Materials and Intermediates,Control of the Final Bulk Product,and Batch Analyses (Including Those from Toxicology and Clinical Studies) to Support Proposed Impurity Limits
Notice to applicants for marketing authorizations for proprietory medicinal products in the member states of the European Community. European Community; March 1988.
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Guideline for the format and content of the chemistry, manufacturing and controls section of an application. Rockville, MD: Center for Drugs and Biologics, FDA; February 1987.
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Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances. Rockville, MD: FDA; February 1987.
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Guideline for submitting samples and analytical data for methods validation. Rockville, MD: FDA; February 1987.
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21 Code of Federal Regulations ch. 1, 25.30. April 1, 1988: 204, 205.
