Tablet Checkweigher (Inline) – Equipment Validation SOP

Standard Operating Procedure for the Validation of Inline Tablet Checkweigher

Purpose

This SOP provides the framework for the validation of the Inline Tablet Checkweigher to ensure accurate weight verification in the production of solid dosage forms.

Scope

This procedure applies to the validation of the Inline Tablet Checkweigher used in the Production/Compression area for weight verification of solid dosage forms.

Definitions

  • DQ: Design Qualification
  • IQ: Installation Qualification
  • OQ: Operational Qualification
  • PQ: Performance Qualification
  • CSV: Computerized System Validation
  • URS: User Requirements Specification

Roles

  • Validation Team: Responsible for executing the validation process.
  • Quality Assurance: Ensures compliance with regulatory requirements.
  • Production Personnel: Operate the equipment and provide necessary input during validation.

Lifecycle Procedure

  1. Preparation of User Requirements Specification (URS).
  2. Completion of Design Qualification (DQ).
  3. Installation Qualification (IQ) execution and documentation.
  4. Operational Qualification (OQ) execution and documentation.
  5. Performance Qualification (PQ) execution and documentation.
  6. Review and approval of validation documentation.

GDP Controls

Ensure Good Documentation Practices (GDP) are followed throughout the validation process, including proper record-keeping and version control of all documents.

Acceptance Criteria Governance

Acceptance criteria will be governed by the User Requirements Specification (URS) and in accordance with Annex 11 of the applicable regulations.

Calibration/PM Governance

The Inline Tablet Checkweigher must undergo scheduled calibration and preventive maintenance (PM) as per the manufacturer’s recommendations and internal procedures.

Change Control Triggers

Any significant change to the equipment, software, or process that may impact the validation status will trigger a change control process.

See also  Hammer Mill – Equipment Validation SOP

Revalidation Triggers and Periodic Review

Revalidation is required every 12 months or when changes occur that may impact the equipment’s performance or compliance.

Records/Attachments List

  • User Requirements Specification (URS)
  • Validation Protocols (DQ/IQ/OQ/PQ)
  • Calibration Certificates
  • Change Control Records
  • Periodic Review Reports

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