Equipments in Pharmaceutical Manufacturing are required to of very good quality and Good Standards, by GMP guidelines, FDA regulations. Pharma Equipment’s Machineries are required to produce accurate results throughout the life span or predefined usage life span of that equipment for which it is going to be used in any Pharmaceutical manufacturing process.
Moreover, a detailed documentation is also required to be done for establishing documentary evidence that said equipment, machinery is giving results which comply with the desired or set parameters and yield product manufactured which in turn comply with set of standards.
In other words, Equipment Machinery are required to qualify for their intended use throughout their
usage life, not only that, the documentary evidence is required to generate to establish that the equipment, machinery is giving results complying set standards which is called Process Qualification Equipment Validation.
An equipment or machinery is validated for pharmaceutical manufacturing through a set of Activities as
follows.
1) URS (User Requirements Specification)
2) Designee Qualification
3) Factory acceptance test.
4) Site Acceptance test.
5) Installation Qualification.
6) Process qualification (Validation)
7) Cleaning Validation for equipment parts.
8) Computerized system validation.
9) Planned Revalidation.
User Requirement Specification (URS) is a document generated by end user or Pharma Manufacturer,
which provides guidelines for Pharmaceutical Equipment Machinery manufacturer it gives details of
specifications of Machine, or equipment which must be fulfilled by Pharma Machinery Equipment
manufacturer, complied, meet by the equipment in first place so as to qualify for the use in
manufacturing of pharmaceutical.
For an example.
URS mentions the speed at which a Pharmaceutical manufacturing equipment or machinery is required to be performed its intended activity. Its material of construction as per pharma guidelines it must be Stainless steel 316 Grade for all contact parts. Password protection for PLC and HMI. Sensors for critical operations.
Easy to clean and maintain, the manufacturer of spare parts may be different once can demand in URS spare parts of standard reputed company.
What is FAT (Factory acceptance test) how it is performed:
It is an activity which is undertaken by team of people, by Pharma Manufacturer who intend to use the equipment or machinery a team of people from his side which includes people from engineering, Quality Assurance , Production and Team of people from manufacturer of machinery which altogether inspects equipment, machine and its performance at equipment manufacturers workshop, before it is dispatched
to manufacturing unit from equipment manufacturer, A list of points are checked and verified which includes details in URS (User Requirement Specification) any other suitable point which may be required
by Pharma manufacturer is checked for availability in the machine or equipment.
After agreement of compliance of URS with new machine or equipment and its performance, Machine is delivered to Pharma Manufacturer for next stage, that is installation.
What is SAT (SITE acceptance test) how it is performed
In event the FAT is not feasible or Equipment is required to evaluated for its performance in accordance
with other equipment it is required to install at the Pharma Manufacturers Place, where again all the
test is performed to evaluate the equipment is running as per desired standards, delivers results as per
required in URS this is called as Site acceptance test. Documentation of Installation activity, and
qualification is done in event everything goes perfect, in a deviation occurs machine or equipment is
required to comply for the deviation, a due documentation must be done to identify the sequential
changes done in machine or equipment.
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