You are developing a Standard Operating Procedure (SOP) for…

You are developing a Standard Operating Procedure (SOP) for the handling of product complaints relating to marketed medicines.List the key aspects that should be addressed in the procedure section of the SOP according to PIC/S GMP requirements relating to the receipt of the complaint and documentation thereof.

A pharmaceutical manufacturer outsources microbiological tes…

A pharmaceutical manufacturer outsources microbiological testing of finished products to an external laboratory. No technical agreement is available describing responsibilities for sample handling, testing, investigations, or data reporting. According to GMP principles, what is the primary concern?