Capsule Checkweigher – Equipment Validation SOP

Standard Operating Procedure for Equipment Validation of Capsule Checkweigher

Purpose

The purpose of this SOP is to outline the procedures for validating the Capsule Checkweigher used in the production of solid dosage forms, ensuring compliance with regulatory requirements and maintaining product quality.

Scope

This SOP applies to the validation of the Capsule Checkweigher utilized in the Production area for weight verification of capsules. It encompasses all phases of validation including DQ, IQ, OQ, and PQ.

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 protocol.
  • Quality Assurance: Ensures compliance with regulatory standards.
  • Production Personnel: Operate the Capsule Checkweigher and maintain records.

Lifecycle Procedure

  1. Design Qualification (DQ): Document user requirements and ensure equipment meets specifications.
  2. Installation Qualification (IQ): Verify that the Capsule Checkweigher is installed correctly and according to manufacturer specifications.
  3. Operational Qualification (OQ): Validate the operational parameters of the Capsule Checkweigher.
  4. Performance Qualification (PQ): Confirm that the equipment performs as intended during actual production conditions.

GDP Controls

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

Acceptance Criteria Governance

Acceptance criteria will be established in accordance with the User Requirements Specification (URS) and Annex 11 of the relevant guidelines, ensuring that all specifications are met during validation.

See also  Roller Compactor – Deviation Impact Assessment

Calibration/PM Governance

The Capsule Checkweigher must undergo periodic calibration and preventive maintenance as per the manufacturer’s recommendations and internal SOPs to ensure consistent performance.

Change Control Triggers

Any changes to the equipment, software, or processes that may impact the validation status must be documented and evaluated through the change control process.

Revalidation Triggers and Periodic Review

Revalidation is required every 12 months or whenever significant changes occur that may affect the equipment’s performance or compliance status.

Records/Attachments List

  • Validation Protocols
  • Calibration Records
  • Maintenance Logs
  • Change Control Documents
  • Training Records

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