|
     
| |
The QED-QED definition of Inspection Compliance
Excellence (ICE) is:
"compliant facility + good
inspection management = successful outcome"
ICE is divided into short and long term
inspection preparation programmes. Depending on your current company situation
emphasis on which strategy to adopt will determine the most appropriate
programme mix.
QED-QED consultants
have helped to achieve many inspection successes for companies of varying sizes.
Direct
links
to
more
details
for
some
key
areas
of
interest
are
as
highlighted
in
the
diagram
below.
Inspection
Management
Achieving
regulatory inspection successes is dependent on having robust and compliant
systems, validated products/processes, trained personnel and a good inspection
management programme. QED-QED consultants have helped companies achieve
successful regulatory inspections. We have the skills and experience to support
you in the development of a good, sound inspection management programme
including some of the following elements:
 |
Inspection
strategy – long and short term |
|
Risk
assessment and gap analysis |
|
Core
team selection |
|
Back-room
control and logistics |
|
Planning,
preparation and monitoring |
|
Behavioural
training |
back to top
Internal
Audit Programme
An
Internal Audit programme is a cGMP requirement and most companies within the
pharmaceutical industry have such a programme in place. However, the management
of internal audit programmes often prove to be a challenge to many organisations
resulting in, typically, lack of follow-up and corrective actions not
implemented or fully completed. QED-QED consultants have extensive experience
and can assist in the development of new or improved existing internal audit
programmes through structured assessment and utilisation of proven techniques.
back to top
External
Audits
The
number of external audits received by companies within the industry varies but
without a doubt all companies host external audits at some time. External audits
can be from corporate, customer or partners and the aim of an external audit is
typically different to that of a regulatory inspection. As such, preparation for
external audits will vary depending on the reasons for such audits. QED-QED
consultants have led numerous external audits with successful outcomes with a
wide range of products and companies. We have the capabilities and skills to
develop audit strategies and programmes to ensure your audit successes.
back to top
Supplier
QA and Audits
Supplier
quality assurance is key to ensure material, components, and product supplies
are consistent and reliable. This is achieved through a sound Supplier QA
programme with built in alerts so that potential issues are prevented and
problems resolved effectively in the shortest time. At QED-QED, we have proven
track successes in achieving Supplier QA and we can support you in the
development of a sound programme.
Supplier
audits are typically performed either as part of initial supplier selection
process, or as part of the on-going Supplier QA programme. QED-QED
consultants have performed over 250 supplier/third party audits, specific
expertise include:
|
cGMP,
ISO, quality systems, “for cause”, regulatory dossier compliance, and
“mock” regulatory audits |
|
Raw
materials, drug substances, drug products, primary and secondary packaging
components |
|
Clinical
trial supplies manufacture and packaging |
|
Clinical
pharmacy and Phase I units |
|
Analytical,
Bioanalytical, and Microbiology Laboratories |
|
Animal
units |
|
Biotechnology,
cell banks |
back to top
Training
- Behavioural
The
outcome of an inspection not only depends on the compliance status of your
facility, or the technical knowledge of your people. The way people behave
during an inspection can have a very positive, or very negative, impact on the
outcome. QED-QED consultants can provide training for fronters, hosts, escorts,
and operational staff. We use role-play and case studies to cover typical
inspection scenarios such as dealing with difficult questions and coping with
multiple inspectors. We also explain typical inspector strategy and tactics and
how to deal with these different approaches.
back to top
|
A
distillation of pharmaceutical knowledge and experience
