Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-001.00 Effective date: mm/dd/yyyy
Approved by:
20.1 PurPose
To provide a written procedure to be used as a guideline for type of validations, preparation of mas-
ter validation plan, preparation of validation protocol (installation qualification (IQ), operational
qualification (OQ), performance qualification (PQ) and process), and so on.
20.2
resPonsibilities
1. The QA manager will prepare and update the validation master plan and the validation
protocol, report write-up, and maintain the validation documents.
2. The validation team described in the validation master plan will be responsible for per-
forming the validation as per the approved protocol.
3. All departmental managers are responsible for system compliance.
4. The manufacturer or supplier of machines and instrument will be responsible for providing
the complete package of IQ and OQ for new equipment related to production, packaging,
utilities, and QC.
5. The validation team will be responsible for performing PQ.
20.3 background
Validation is a tool which gives assurance that the manufacturing equipment and process, when
operated within a given parameter, will produce the required results consistently. Distinct ongoing
benefits can be derived from an effective validation program in the form of increased reliability and
productivity, which can result in reduced testing and help avoid nonconformance cost.
20.4 validation team members
A validation team will be formed, one member each from QA, production or packaging, mainte-
nance, QC, and R&D (as per requirement) and members from other concerned departments desig-
nated by each departmental head.
20.5
Procedure
20.5.1
d efinitionS
1. Master plan: A comprehensive document describing all the applicable validation require-
ments for the facility, and providing a plan for meeting those requirements.
2. Validation: A systematic approach to gathering and analyzing sufficient data that will give
reasonable assurance, based upon scientific judgment, that a manufacturing process, when
operating within the specified parameters, will consistently produce product within prede-
termined specifications.
3. Qualification: Verification of the equipment/facility/heating ventilation and air-conditioning
(HVAC), and so on, including appropriate supporting systems, can be carried out according
to design and/or operating requirements.
4. Certification: A review and approval procedure carried out as a final step in the validation
program.
5. Types of validation
a .
Prospective: Analysis of process/equipment prior to use.
b.
Retrospective: Validation of a process for a product already in distribution, based on
accumulated production, testing and control data.
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