A) Assignment Brief Part A (20%): Scenario:

PHRM07022: You are the Lead Auditor and are tasked with performing a routine on-site audit of Jarden Pharmaceuticals. Jarden Pharmaceuticals are a sterile manufacturer of Epinephrine HCl, which is packaged in 4ml glass vials and supplied to your company, ATU Pharmaceuticals. Jarden Pharmaceuticals are based in Heidelberg, Germany. Jarden Pharmaceuticals were last audited by ATU Pharmaceuticals in June 2022. They are a supplier of Epinephrine HCl and also perform stability of epinephrine for ATU Pharmaceuticals for the last 15 years. Your contact at Jarden Pharmaceuticals is the Quality Director, Mr. A. Sequin. This is your first visit to Jarden Pharmaceuticals.

Points of information:

• In the last two (2) months, ATU Pharmaceuticals received 2 batches of Epinephrine HCl which were rejected by Quality Control at ATU Pharmaceuticals due to the presence of black specs in the liquid. Jarden Pharmaceuticals are tasked with performing an investigation and providing feedback to ATU Pharmaceuticals. No information received to date.
• There is a new Laboratory Manager and Quality Director at Jarden Pharmaceuticals in the last 6 months.

Actions:

1. Detail the audit preparation you would perform prior to the audit to ensure you are well-prepared before execution.
2. Prepare an audit agenda to perform a GMP compliance assessment of this sterile manufacturing facility and the associated quality systems. (Use Eudralex Vol 4 Part 1 and Annex 1 ‘Manufacture of Sterile Medicinal Products’ as an aid)

B) Assignment Brief Part B: Choose a piece of equipment which generates GxP data in your area of work or another area within your workplace. Complete the following tasks using the ‘APIC Practical Risk-Based Guide for Managing Data Integrity’ April 2022, as an aid and guidance.

a) Document the data lifecycle.