Golden rule #1 : Get the facility
design right from the start
Poor
planning on facility designed in food processing can effect to the failure on
maintain of product quality consistency. An example of mistake on facility design
is the movement intermediate products to another buildings for the next stage
of processing or storage of exposure final product adjacent to raw material that
potentially contamination. Before making any changes on facility, the company
should review the layout as a whole.
Golden rule #2
: validate prcesses
Process
validation defined as a documented proofing to provide assurance that specific process
will consistently produce the product as per specification or quality / safety requirement.
In
general, the process validation includes :
1
|
Qualification of installation,
testing (validation) is performed to ensure equipment installed properly.
|
2
|
Qualification of operational,
testing (validation) is performed to ensure equipment operated properly
|
3
|
Qualification of performance, testing
(validation) is performed to ensure the product produced to requirement
consistently.
|
Golden rule #3
: Write procedures and follow them
On
food industry, pharmaceutical, or medical equipment, the presence of critical
procedures must be available on-site to ensure performance of quality and safety controlled
consistently. The procedures should be clear, concise and logic.
Golden rule #4
: Identify who does what
Each
section of processing chain should clearly understand its task and
responsibilities to avoid misunderstanding and minimize the risk related to
product quality. Jobs description need to develop for each position to
determine job title, objective, task and authority and skills that must be
owned. The existence of gaps or overlap in authority should be avoided.
Golden rule #5
: Keep good records
The
accuracy of record management is one of success key on GMP implementation. In audit
process, a good record management will show that the established procedures
have been followed and can explain that the process is still under control. One
principle to remember is if a record of an activity can’t be proven, the
activity is considered never done.
Golden rule #6
: Train and develop staff
Training
activities should be conducted on all employees of production chains,
laboratory or other activities affecting to the product. The training includes
basic training such as understanding of GMP and implementation of GMP as well
as specific training related to their task.
One
thing to remember that training fulfillment requirement will be highlighted as
part of the system change control. For example if there any installation of a
new section of equipment it should be ensured that personnel understand to
operate it. We should keep controlling
that the training completed while validation and revise task change has been
taken. It also applies to procedures and work instruction.
Golden rule #7 : Practice
good hygiene
To
reduce the ris of product contamination, sanitation programs should be
available where it is needed. Development of sanitation programs is needed to
achieve hygiene standards that required for processing. For example, we must
have different cleaning standards for the products used in cinema compared to
the product to which blood is inserted..