Sampling Booth (Downflow/RLAF) – Equipment Validation SOP

Standard Operating Procedure for Equipment Validation of Sampling Booth (Downflow/RLAF)

Purpose

The purpose of this SOP is to outline the validation process for the Sampling Booth (Downflow/RLAF) used in the raw material sampling process under containment in the production area.

Scope

This SOP applies to the validation of the Sampling Booth (Downflow/RLAF) utilized in the production/sampling area for Solid Dosage Forms (OSD). It encompasses all stages of validation including DQ, IQ, OQ, and PQ.

Definitions

  • DQ: Design Qualification
  • IQ: Installation Qualification
  • OQ: Operational Qualification
  • PQ: Performance Qualification
  • URS: User Requirements Specification

Roles

The following roles are involved in the validation process:

  • Validation Manager: Oversees the validation process and ensures compliance.
  • Quality Assurance: Reviews and approves validation documentation.
  • Technical Team: Conducts validation testing and documentation.

Lifecycle Procedure

The lifecycle of the validation process includes the following phases:

  1. Design Qualification (DQ)
  2. Installation Qualification (IQ)
  3. Operational Qualification (OQ)
  4. Performance Qualification (PQ)

GDP Controls

Good Documentation Practices (GDP) must be adhered to throughout the validation process, ensuring that all records are clear, accurate, and complete.

Acceptance Criteria Governance

Acceptance criteria shall be governed by the User Requirements Specification (URS) and in accordance with ISO 14644 Annex 15 standards, ensuring that the Sampling Booth meets the required performance standards for containment and air quality.

Calibration/PM Governance

Calibration and Preventive Maintenance (PM) shall be performed according to the manufacturer’s recommendations and internal policies to ensure the Sampling Booth operates within specified parameters.

See also  High Pressure Reactor / Hydrogenator – Traceability Matrix (URS ↔ Tests)

Change Control Triggers

Any significant changes to the Sampling Booth or its operating procedures shall trigger a change control process, requiring re-evaluation of the validation status.

Revalidation Triggers and Periodic Review

Revalidation shall occur every 12 months or upon significant changes to the equipment, processes, or regulatory requirements. Periodic reviews of validation documentation will be conducted annually.

Records/Attachments List

  • Validation Plan
  • User Requirements Specification (URS)
  • Installation Qualification (IQ) Protocol
  • Operational Qualification (OQ) Protocol
  • Performance Qualification (PQ) Protocol
  • Change Control Documentation
  • Calibration and PM Records

Also Check:

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