IMPORTANCE OF PROCESS VALIDATION IN FERMENTATION INDUSTRIES

Validation is a very important component in any manufacturing industries especially in the fermentation industries involved in the production of health care products and food products. In fact validation is one part of GMP and TQM and help in the HACCP requirements of the industries concerned. By carrying out the validation procedures we automatically ensure the standard, quality and consistency of products manufactured. As for the manufacturers it will ensure that their production are under optimum process control in terms of quality and efficiency and as for the consumers they are assured of receiving quality products that comply all the time.

When we talk about 'validation' in general, it simply means that it is a documentary evidence supporting or confirming that all equipments, processes are carried out
according to the set specifications or SOP. This means that that the equipments and the manufacturing processes are functioning as designed.

In reality, validation is a complex but schematic process that encompasses the whole process of manufacturing from A to Z.The validation studies carried out in the fermentation industries include analytical test, equipment, facility systems such as air, water, steam, process; manufacturing processes, cleaning, sterilization, sterile filling, lyophilization. In fact every step of the manufacturing process such as cleaning of glasswares, sterilization process and maintaining cultures has its own set of SOP to be complied Validation involves various stages of design and execution


In discussing validation procedures for a particular manufacturing or fermentation process we must first bear in mind that a manufacturing process are made up of various steps in the production which involve various components such as equipments,operators, material inputs and what ever. So before a proper process validation is carried out, the following components need to be qualified first:

Design qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
At each of these stage validation activities are carried out on the equipment and facilities

In the design qualification it is important to ask these questions:
1Have all components needed for the process been properly selected?
2Do all the components have adequate capacity to function for the intended purpose?
3 Will all the components selected adequately serve the operations or functions of another piece of EQ or operation?.

In the installation qualification it is important we ask the following:
1 Are all the relevant and proper proper information, instructions or written directives are carried out for all the identification information, location, utility requirements, and any safety features of EQ adequately provided?
2 Do these information provided verify that the item tally with the purchase specifications?

In the case of operational qualifications, the following questions need to be asked: 1 Do you need provide all information that all component of a system or of a piece of EQ operate as specified.
2 Do you have all the listings of SOPs for operation, maintenance and calibration?.
3 Do you define the specification and acceptance criteria Include information on EQ or system calibration, pre-operational activities, routine operations and their acceptance criteria?

For the performance Qualification, it is only carried out after both IQ and OQ have been completed, reviewed and approved. This stage describes the procedures for demonstrating that a system or piece of EQ can consistently perform and meet required specification under routine operation and, where appropriate, under worst case situations. At this stage it will include:
1 description of preliminary procedures required,
2detailed performance tests to be done,
3acceptance criteria and other supporting EQ used during qualification have been validated.

Now we will come to the validation of the process of manufacturing itself. We will define the process of manufacturing as a series of interrelated functions and activities using a variety of specified actions and EQ which is designed to produce a defined result. The process validation studies will involve the following activities or stages:
1 VALIDATING UNDER NORMAL OPERATING CONDITIONS
examine a process under normal operating conditions to prove that the process is in control
2 REVALIDATING STUDIES
which will be carried out if the process undergoes the following changes:
1 Any modification to the process
2 Anyproblems occurring in the existing process
3 If there are changes in the EQ or systems

The process validation procedures must be carried out scientifically so that the study does done should show consistency and reproducibility. These studies and usually involve:
1 Using validated EQ on the fully defined process
2 Studies carried out at least three times under established procedure
3 The process must successfully and consistently meet all acceptance criteria at all steps throughout the procedure. This must be shown to operate at least 3 times consecutively

In carrying out the validation of the process, studies must be carried to show the behaviour of the process is still acceptable under worst case scenario

The validation of the process must cover every step of the production process from A to Z such as cleaning, sanitization, fumigation, depyrogenation, sterilization, sterile filling, fermentation, bulk production, purification, inactivation, filling, capping, sealing and lyophilization

At each of the above steps detailed SOP must be carried out as required. These will normally involve various tests, analyses and experiments