Audit Flashcards
What is the audit prework you’re going to do?
Eudra,
Previous audits
What auditing against – review
CA audit
Organogram
List of other products made in the facility
What are you going to look for with respect to QRM in place?
Senior management endorsement
Risk register and risk management process that monitors and reviews risks
Used in deviation, lab investigations, change control, validation etc
Use of quantitative tools
What are you going to pay special attention to when auditing an IMP factory
How managing cross contamination
How they manage updates to specifications, manufacturing formulae, processing and packaging instructions, comprehensive – are they updated promptly as likely to be changing
Are the manufacturing orders in writing and do they specify number of packs?
Are the orders precise enough to avoid any ambiguity? Are orders formally authorised and do they reference the Product Specification File and the relevant clinical trial protocol as appropriate?
Manufacturing instruction clarity inc number of units
IPCs for blinding. Defined critical parameters.
Equip’t qualification, sterilisation and swab analytical method validation
Media fill size big enough for small batches?
Blinding and randomisation controls
What would you look for if auditing a contract lab – PQS. Personnel, premises and documentation
GMP certificate & QA system – do they have QA department?
Self-inspection system?
QA agreements suppliers and customers?
Change control system?
SOP, LAM, logbook and specification management?
Raw data management
System traceability inc standards traceability
Training
Located away from production ?
Calibration procedures?
Equipment qualification
Maintenance system
When auditing at would you look for in a lab – think Production, QC, Outsourcing, complaints / recalls and self-inspection
Reagents, solutions and standards – how stored and expiry dates?
How is sampling managed?
OOS system and trending?
Is anything outsourced? How is chapter 7 reqts met both with contractor and contract giver?
What would you look for in utilities audit
Temp, pressure differentials, recirc?, airflow direction and laminar or turbulent
Qualification of system inc mapping and change controls
Test regime – smoke, particle etc
Calibration and work order history
Water system – passivation, welds, pipes and valves, qualification, feed water quality, monitoring regime, calibration and work order
What special things are you going to look for when auditing a packing operation
Purchasing from approved suppliers that have been audited
Integrity check and cleaning outside of the production area
Materials segregation and secure storage for packaging components
Release process for parts
IPCs and labels in BD. BD format
Maintenance and calibration
Line clearance and reconciliation
BD design
Sampling and self-inspection
What special things are you going to look for when auditing an aseptic facility
CCS
Training
EM processes
PUPSIT
Process simulations – batch size, people, results trend
Airflow monitoring and DPs
Zone rating and testing
Transport of sterile parts to line
Material transfer conditions – grade A maintained?
Air change rate
What are you going to ask to see before going for an audit
Previous audit report
External auditors report
Changes since last audit
GMP certificate
Deviations since last audit
Planned changes since last audit
Technical agreement
MA
What are you going look at during audit?
What you’re auditing for (eg part 2 for API)
P – PQS, PQR, Risk management process
P – Training and organisation
P – maintenance, upkeep, cleaning, validation
D – change control, things match MA, deviation, sops
P – equip qualification, calibration, trap points and cleaning
Q – sampling, IPCs, specs, tests vs MA
O – contracted out stuff, brokers
C – complaints process, recall process
S – Self inspection in place, in use? CAPA implemented?
