Each
module below is a separate page which presents an overview for each topic.
The theory
or basic concept behind each issue is discussed along
with additional information to provide
examples of possible
implementations for each issue.
Process
Description
"State of
Control"
Baseline
Documentation
GMP
Flows
HVAC
Classifications
Gowning
Operations
GMP
Documentation
Procedures
Copyright 2004-08
cGMP
Compliance...the Toolbox...
|
Regulated Facilities
and
Processes
Engineering
Project
Management
Commissioning
Qualification
A lot
of the GMP world and compliance issues in general is just being familar with the
concepts
and ideas...and how it all actually gets
implemented...
Check out our training modules for a GMP primer...it is
intended to provide infromation
regarding the basics of GMP concepts
and requirments...please consult an industry
professional if you have
more in depth needs...
Commissioning- as per the ISPE
C&Q Guideline, commissioning is defined as follows:
"A well-planned,
documented, and managed engineering approach to the start-up and turnover
of facilities, systems, and equipment to the End-User that results in a
safe and functional
environment that meets established design
requirements and stakeholders expectations"
The Who, What, When, Where,
and Why of Commissioning...
Who- almost anybody, really...could be the
Owner's personnel, the construction contractor, or a
specialty
commissioning consultant...industry guidance suggests that one specific
indivdual be
given overall responsibility for the commissioning
program. Proper training of the personnel to
conduct the
commissioning effort is also critical. The more important part is who
should be
involved:
- Commissioning Leader
- Quality
Assurance Group *
- Validation Group *
- End User of system
- Project
Engineer
- Contractor
- Vendor
* = for Direct Impact
systems
What- as in what gets commissioned?...Building and utility
systems along with process
equipment...basic commissioning for
no-impact and indirect impact systems with full
commissioning with
enhanced documentation practices for direct impact systems that will be
subject to qualification procedures.
When- Commissioning typically
takes place after the physical completion of a system, (and
sometimes
after physical completion of related systems) and before system trun-over and
qualification...following a logical sequence becomes important
here.
Where- Commissioning can take in the field at the actual
installation site for stick-built and
installed systems, or in a
factory for pre-assembled, packaged type systems that can be tested
prior to shipping to the project site.
Why- to provide for an
orderly start-up and mostly to avoid costly and time-consuming efforts
during qualification which can result in under- qualification or
over-qulification of systems.
How- by following a lot of protcols and
checklists...and keeping careful documentation
Qualification- as per the ISPE,
qualification (a.k.a. validation) is defined as follows:
"Establishing
documented evidence which provides a high degree of assurance that a specific
process will consistently produce a product which meets it's
pre-determined specifications and
qulaity attributes"
The ISPE
C&Q Guideline...Read it, Live it, Love it...
All
Rights Reserved
Join us
as we examine the lighter side of GMP compliance, with some of our good friends
from
Fun E Pharm...and their earnest, if misguided, efforts to develop
a quality driven manufacturing
process, even if they are not really
sure what they are manufacturing...
The Fun E Pharm Manufacturing process
provides a farcical example used to communicate the
overall issues
involved...please make sure you bring your sense of humor...
Score
your projects Health- coming soon
Score your GMP Compliance- coming
soon
Review checklists- coming soon
Do's and Don'ts- coming
soon
Cost
prediction is always a critical part of a project, especially when dealing with
the costly
nature of the classified process spaces found in a
manufacturing facility. It is particularly
important to establish
an expected budget for project costs as early as possible.
A possible
method for determining a Rough Order of Magnitude (ROM) Opinion of Probable
Cost is outlined on it's own page- link here.
A Summary rolls
up the individual costs associated with the facility, equipment, and services
that may be found on a typical project.
An example project will
be developed to demonstrate how the model is intended to be used.
This is
a model...please consult with industry professionals for more information or
particular
details associated with your project.
