Scenario Questions

Unanswered Scenario - The Purchasing Manager comes to see you as he can get a particular active substance much cheaper if the solvent is changed for the final crystallisation stage. What do you say? What would you need to consider?

Active Substance Audit Related Questions

You have to audit two API suppliers. Do you spend the same time on each site? What information would you base your decision on?

Typically, how much time would you spend auditing an API site

Going to audit a chemical API manufacturer. What key things would you look for?

Explain the level of facilities you would expect to see for bulk non-sterile manufacture?

Active Substance Manufacture

Sterile AS manufacturer – What manufacturing conditions should they have for the final (bulk) product. What guidance is applicable?

For a non sterile bulk actives manufacturer - What are the controls on the final purification of crystals?

For a non sterile bulk actives manufacturer – Blending of sub batches of a mother liquor into one big batch, any issues?

A new manufacturing method is being introduced for a bulk active material. As a user of this bulk active in your finished products, what licence changes do you make?

Are there any particular APIs where a manufacturing process change might give you cause for concern? Why?

What issues might you need to be careful of for a bulk biotech product from E.coli? How would you minimise this?

Describe the manufacture of an antibiotic raw material and associated quality issues.