Document Retention

Document Retention

Keeping track of data, development reports and other important documents for a given project for potential future need is always a concern for companies. Individuals working on a project may change; some will leave for other opportunities, and individual’s memories...
Manufacture, Retest and Expiry Date Revisited

Manufacture, Retest and Expiry Date Revisited

Several years ago, I wrote about the relationships among date of manufacture, in-process hold times and drug product expiration date. Since then, there have been some developments that are worth revisiting. The corresponding guidelines of EMA (The European Medicines...