GMP,
VMP, GEP, C&Q, Quality...all good stuff...we talk about it almost every
day...
But we had the same questions you do...how does all of this fit
together???
There didn't ever seem to be a good explanation...so we
decided to take a shot at it...
here's what we came up with...
Copyright 2004-08
This
Site- GMP Compliance Basis (GMP CB) is
intended to be an on-line "Knowledge Center"
addressing the integrated
documentation of Project requirements and GMP compliance for
engineering, procurement, construction, commissioning, qualification, and
process validation
phases of capital engineering products in the
pharmaceutical and biotechnology markets.
The OS
Diagram- GMP CB has developed an Operating
System to document a systematic
approach and explanation of GMP
compliant execution of projects that are subject to
regulation by the
FDA.
GMP CB believes that this approach represents an overall view of
a complex group of issues.
Share the
Knowledge- We deal with these issues every day
in our project work...
Capital project execution programs in the pharmbio
industry require a significant level of
expertise in order to
succeed...
We all benefit from sharing our thoughts and experiences in this
area.
Feedback- We welcome your
thoughts and reactions to the information you see here as well
as your
own views on this subject...
Make sure you visit our blog!!!
The
About GMP
CB page contains a basic description of
this effort and our overall approach
and intentions.
The
Explanation contains a basic
description of how the GMP CB Operating System works.
The Industry
Links section contains links to various
websites, blogs organizations, information
, etc. that are specific to
the pharmaceutical and biotechnology design industry.
The
GMP CB
Blog is our discussion and news blog
relating to design, engineering, project
management, and validation
issues.
The Future section is a listing of
developments for the site which are underway or planned.
The
Contact GMP
CB button will contains our e-mail
address.
The Take our Industry Survey section contains links to current
users surveys.
Operating System approach...
Explanation...
Tools...
Tips...
Other fun stuff...
cGMP
Compliance...an integrated view...
|
ISPE
COP
The C+Q COP currently
has
over
1650 members...
Join now for
access to
virtual discussion and
chat features for C+Q
topics...
Regulated Facilities
and
Processes
Engineering
Project
Management
Commissioning
Qualification
An
Online Knowledge Center for information and
discussion of a fully
integrated approach to
Engineering, Project Management,
Commissioning,
and Qualification and GMP Documentation for the
Pharmaceutical and Biotechnology industries...
and
Thanks in advance for spending some time here...
Hopefully you will leave
feeling the time was well spent...
and maybe even stop back from time to
time...
See our latest updates below...
How does all this
work???
|
The
ISPE C&Q Guideline- this document is the basic
reference for this system...a great
document, the question remains as
to why the suggestions and approaches are not
implemented, along with
some of the other specifics about how the various documents relate
and
interface.
Project Life-cycle
approach- Let's look at the overall
life-cycle of a project in three phases...
basically the system looks at
the following:
- Engineering- this effort establishes both the
requirements and the documents which
specify items which conform to
these requirements.
- Construction- The physical installation of the
items that constitute the project
scope.
- Validation- This phase results in documented
evidence that a system performs as
designed.
Matrix
Approach- Each of the three phases can be
considered separately for each group of
systems that can be found in
the scope of a captial project, as follows:
- Facilities- the
systems that physically house the process.
- Equipment- the
systems directly associated with the manufacturing
process.
- Utilities- the
systems that support both the facility and the equipment associated with
the process
operations.
Step by
Step- Each phase is broken down into the
individual steps required for the complete
process... the intent is to
provide a description of how each step relates to the other steps and
the entire process
- Engineering begins
with the definition of project requirements, goes
through several
design phases separated by three
individual design
review efforts, and a system
impact assessment, all as prescribed by
the C&Q Guideline. This
methodology is
followed for Facilities, Equipment, and Utilities,
again, exactly as prescribed by the
Guide.
- Construction consists
of two separate functions to deal with
submittals and
documentation and the main effort
of the physical construction of the
capital project.
This phase needs
to differentiate between systems
and facilties being commissioned
and those being
qualified.
- Validation consists of
4 separate
phases which include commissioning, qualification
consisting of IQ, OQ, and PQ,
followed by process validation, and
on into ongoing
operations.
The overall approach for
each effort is differentiated based whether or not the system in
question is to be commisisoned only or both commissioned and qualified.
A basic
explanation and other details...
|
All
Rights Reserved
GMP Operating
System Diagram
|
The
full diagram coveres the life
cycle of a project and outlines what
activities take place in each project
phase...this makes the full
diagram
quite large when created with html
code...
accordingly, the diagram is broken
down into three
separate diagrams
based on the flow of
information;
Engineering...provides info
to...
Construction...provides info to...
Qualification...
Click
on each diagram above for the detailed view of
each phase which has
more information available
specific to each section...
Hire
Nicole Bernshaw GMP
Proofreader
Resume
E-mail
|
ICH Standards
Site
The ICH publishes the
guidelines you're looking
for...
Fun E
Pharm…
Brought to you
by
BFPC
(Big Fat Pharm
Co)
Spending $800
million
dollars...
and 10 years
like it
was our job…
|
The
real life fictional action drama documentary mini-series that
dares to
show us the pudgy underbelly of the Life Sciences industry…
Update...The Overall View of
the OS Diagram has been revised to include relationships for
GMP
Documentation, including Commissioning Master Plan and Qualification Master Plan
to
the overall project life cycle...
Look for additional updates
soon regarding the flow of information for these documents...
Industry
Employment Opportunities
|
New
Story Line!!!- watch a bunch of summer interns
show FEP how
C+Q issues are supposed to be
addressed...
Endless Summer...
