Validation

Definitions: Action of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results

Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
=> Equipment validation
=> Facilities validation
=> HVAC system validation
=> Cleaning validation
=> Process Validation
=> Analytical method validation
=> Computer system validation

Similarly, the activity of qualifying systems and equipment is divided into a number of subsections including the following:
=> Design qualification (DQ)
=> Component qualification (CQ)
=> Installation qualification (IQ)
=> Operational qualification (OQ)
=> Performance qualification (PQ)

Design qualification (DQ)– Demonstrates that the proposed design (or the existing design for an off-the-shelf item) will satisfy all the requirements that are defined and detailed in the User Requirements Specification (URS). Satisfactory execution of the DQ is a mandatory requirement before construction (or procurement) of the new design can be authorised.
Installation qualification (IQ) – Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
Operational qualification (OQ) – Demonstrates that all facets of the process or equipment are operating correctly.
Performance qualification (PQ) – Demonstrates that the process or equipment performs as intended in a consistent manner over time.
Component qualification (CQ) – is a relatively new term developed in 2005. This term refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria. This could include packaging components such as folding cartons, shipping cases, labels or even phase change material. All of these components must have some type of random inspection to ensure that the third party manufacturer’s process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.

Scope of validation
=> Validation requires an appropriate and sufficient infrastructure including: organization, documentation, personnel and finances
=> Involvement of management and quality assurance personnel
=> Personnel with appropriate qualifications and experience
=> Extensive preparation and planning before validation is performed
=> A specific program for validation activities in place
=> Validation done in a structured way according to documentation including procedures and protocols.
=> Validation should be performed: for new premises, equipment, utilities and systems, and processes and procedures; at periodic intervals; and when major changes have been made.
=> Can periodic revalidation/requalification be substituted?
=> Validation in accordance with written protocols.
=> A written report on the outcome to be produced.
=> Validation over a period of time, e.g. at least three consecutive batches (full production scale) to demonstrate consistency. (Worst case situations should be considered.)

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