FDA 稳定性指南问答草案2013年8月 FDA ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers
II. QUESTIONS AND ANSWERS B. Drug Master File
Q4: What is the Agency's position on using different lots of APIs and/or packaging materials? How many API lots should be used in the manufacture of finished product lots used to support the ANDA? 
A4: A minimum of two lots of the drug substance should be used to prepare the three primary batches of drug product. It is not necessary to use different lots of packaging material, except in cases where the packaging material could affect drug product performance and/or delivery. For nasal aerosols (meter-dose inhalers) and nasal sprays (meter-dose spray pumps), you should submit three different lots of drug substance.