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Qualification & Validation

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Based on the practical knowledge and ability accumulated through the years, sureAssist methodically initiates
the Execution through RA, and provide the document package (protocol and report) that DI (Data Integrity) is applied.

The term “Qualification” refers to proving and documenting that the machine and equipment is produced and installed as designed,
functions as intended, and thereby evidently obtains the product intended.
The term “Validation” refers verifying and documenting that a specific process, method, equipment or system consistently derives results that meet predetermined criteria.
* [Annex 1] Good Manufacturing Practices of Medicinal Products (Regulation on Safety of Pharmaceuticals, etc.)

Qualification & Validation Flowchart

“ Qualification ”

sureAssistconducts URS, SRA, DQ, FAT, SAT, IQ, OQ, PQ and RQ for GMP & GxP
manufacturing equipment and utilities.

“Design Qualification, DQ”

proves the planned design of the facility, system and equipment is suitable for the purpose of usage.

“Installation Qualification, I”

proves that the installation or reconfigured facility, system and equipment is in accordance with the recommendations of the manufacturer and/or the approved design.

“Operational Qualification, OQ”

proves that the installation or reconfigured facility, system and equipment is operating within the anticipated operating range as intended

“Performance Qualification, PQ”

proves that the system, facility can operate effectively and similarly based on the approved process methods and product specification.

“Requalification, RQ”

is an adequate routine assessment to confirm that the equipment, facility, utilities and system are maintained in accordance with the required status.

Qualification Procedure

  • Selection of Qualification Scope
  • Risk Assessment

    ·Evaluate the equipment’s potential risk and impact by deriving
    the CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)

    ·When conducting RQ, set the scope and items of Execution
    through Risk Assessment.

  • Qualification Protocol

    ·Write a protocol by selecting the items of Execution according
    to the scope and phase that is derived from the Risk
    Assessment

  • Execution

    ·Execute in accordance with the protocol prepared/reviewed/
    approved according to risk analysis

  • Qualification Report

    ·Qualified personnel record derived data after execution on
    the report.

    ·Suitability is determined after comparing the recorded data
    and pre-set acceptance criteria.

  • Finalized Qualification Report

“ Validation ”

sureAssistconducts URS, SRA, DQ, FAT, SAT, IQ, OQ, PQ and RQ for GMP & GxP
manufacturing equipment and utilities.

“Design Qualification, DQ”

proves the planned design of the facility, system and equipment is suitable for the purpose of usage.

“Installation Qualification, IQ”

proves that the installation or reconfigured facility, system and equipment is in accordance with the recommendations of the manufacturer and/or the approved design.

“Operational Qualification, OQ”

proves that the installation or reconfigured facility, system and equipment is operating within the anticipated operating range as intended

“Performance Qualification, PQ”

proves that the system, facility can operate effectively and similarly based on the approved process methods and product specification.

“Requalification, RQ”

is an adequate routine assessment to confirm that the equipment, facility, utilities and system are maintained in accordance with the required status.

* [Annex 1] Good Manufacturing Practices of Medicinal Products (Regulation on Safety of Pharmaceuticals, etc.)

Validation Procedure

  • Selection of Validation item and Scope
  • Risk Assessment

    ·Execute Process Risk Assessment in accordance with the
    guidelines of ICH Q9(Quality Risk Management)

  • Validation Protocol

    ·Reflect the Risk Assessment results when
    writing Validation Protocol (Process, Cleaning,
    Testing and Analysis, Computerized System,
    Transportation)

  • Execute Validation

    ·Clients will conduct manufacturing, cleaning, measuring
    and analyzing

    ·Provide support services when deviation occurs

  • Validation Report

    ·Draft the report based on the result of
    the execution

  • Finalized Validation Report