HACCP Consulting ServicesHACCP is a tool that was originally
developed for the seafood industry to determine potential hazards in your
production process that might critically effect the quality of your end
products. At the current time, HACCP is required for the food industry,
however, the FDA has made initial strides to require medical device
companies to comply with HACCP as well. It also looks like the
pharmaceutical industry will be next.
HACCP is a preventive, not reactive,
management tool used to assure that the manufacturing process addresses
all potential hazards of a product. HACCP is not a zero-risk system, but
it is designed to minimize the risk of potential hazards. Understanding,
proper implementation and monitoring can only be beneficial to your
company.
mdi Consultants provides the following
HACCP services:
Please click here to read
our article published in the Journal of cGMP Compliance - HACCP
Inspectional Approach for Medical Device Manufacturers
1. HACCP TRAINING:
WHAT IS HACCP?
HACCP is an acronym for Hazard Analysis and Critical
Control Points. When used properly, the HACCP approach of evaluating your
products and the production process could provide assurance that you have
determined the hazards associated with the product and its processes. You
will also have to determine the CRITICAL CONTROL POINTS, those points that
are used to either eliminates or reduces the Hazard and you have to define
how you would be controlling these points.
Our staff will provide in-house training on HACCP, what
it is, how it is to be used for your products and processes and most
importantly how to do a HACCP ANALYSIS and PLAN.
2.
HAZARD
ANALYSIS OF YOUR PRODUCT AND SYSTEM
mdi will work with your staff to prepare a flow chart of
your operations and to perform a Hazard Analysis of your products and
processes following the FDA guidelines for performing such analysis. Each
product and process will be evaluated as to their potential Hazard as it
relates to Biological, Chemical or Physical Hazard.
3.
DEFINING
CRITICAL CONTROL POINTS (CCP)
Working closely with your staff, we will assist in
identifying the CRITICAL CONTROL POINTS of the process as well as
establish the critical limits for preventive measures associated with each
CCP identified. We will then set up a program to monitor each CCP
(establish procedures for using monitoring results to adjust the process
and maintain control), establish corrective actions to be taken when a
critical limit deviation occurs and finally establish a record keeping
system.
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4.
HACCP IMPLEMENTATION
Once the HACCP PLAN has been established, our staff will
assist with the implementation of the plan to assure that it is fully
understood and can be implemented with minimum difficulty and confusion.
KISS is our motto (Keep It Simple Stupid). If not implemented properly,
the HACCP PLAN has no value and could be a potential liability.
5.
AUDITING THE HACCP PLAN
Once the plan has been implemented, our staff will
monitor the PLAN on a periodic basis to make sure that it is functioning
properly and being properly controlled and adhered to. We will make
recommendations of corrective actions to bring the PLAN into better
compliance.
6. INTERFACE
WITH THE FDA ON YOUR PLAN
If you are interested in working with the FDA on your
PLAN, our staff will provide an interface between your organization and
the FDA to assure that the PLAN is understood, address any FDA issues and
be available to meet with the FDA concerning any area that cannot be
rectified without a face-to-face meeting. Our staff's high level of
integrity is recognized by the Agency and we are able to understand and
work with the agency in a professional manner while still advocating your
needs and requirements.
7.
BE
AVAILABLE DURING FDA AUDITS OF YOUR HACCP PLAN
Once your PLAN has been accepted, the FDA will want to
audit the PLAN. Our staff will be available to be present during these
audits to assure correct interpretation, address any deficiencies
immediately, and to assure that the audit is fair and follows the FDA
guidelines.
Read
HACCP Article in Journal of cGMP Compliance
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