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How often should a third-party be quality-audited? - Coggle Diagram
How often should a third-party
be quality-audited?
COMPLIANCE
risk input
GMP status
by Health Authorities
outcome of recent regulatory inspections
-
quality certification
consistent with
required quality system and supplied market
Does TRAMS status cover below points?
commitment to i
nform in case of modification
(in QAA)
country
of manufacture : maturity of regulatory system to check compliance
recent company audits, including
- criticality ratings of findings
- timelines in addressing findings in a satisfactory way
- status of CAPAs
if available,
outcomes
of the third-party
site internal audit program
mother site visits
central quotation with QSTP alerts
major changes
identified since last audit
facility design
equipment
key GxP personnel
ownership
new product introduction to the site
number of previous batch refusals
number of complaints related to quality system
OPERATIONS PERFORMED
AT THE SITE TO BE AUDITED
and related factors
risk input
sterile
versus non sterile manufacturing
if sterile, aseptic filling process versus terminal sterilization
manufacturing process complexity
which may lead to variability of the final material
testing or sampling via
delegation
warehousing (storage areas)
distribution & transport
packaging & labeling
only information management
(orders, complaints)
at company,
no systematic QC test of each batch upon receipt
BUSINESS AVAILABILITY
risk input
Availability of third-party to deliver compliant materials or services,
and related factors
volume of products
manufactured or tested or stored...
still in line with projected changes in demand ?
site to be audited = single source
d
?
existing
licensed approved back-up sites
?
single source for company versus
widely available from many sources
material or service delivered
linked to strategic finished product
for the delivered markets
FACILITY
risk input
facility design
age, up-to-date, maintenance
equipment
maintenance, calibration
PRODUCT / PROCESS
risk input
for the site / operation
product complexity
(biologic versus well-defined small molecule)
formulation type
(ex intraveinous versus oral tablet)
patient safety
risk
(high potency actives, hormones, cephalosporins, allergens...)
powder blending
versus mixing a true solution
multi-product site
products in multiple profile classes?
compounds manufactured in the same areas?
using shared equipment?