Case Study 2
Manufacturer of Rx Solid Dosage Pharmaceuticals
Issue: A medium-sized manufacturer of prescription solid dosage pharmaceuticals (tablets) had multiple 483 observations for deficiencies with its CAPA system, change control process and lacked a robust validation program.
Solution: IQA did a gap analysis audit to assess not only the deficient systems, but also to assess other systems, processes and programs that required remediation. The SOPs for the deficient systems were rewritten, training was completed and processes, products and API/Finished product testing were validated.