Revalidation Procedure SOP

Standard Operating Procedure Title: Revalidation Procedure

Department Validation/Technical Services Document no VAL010
Prepared by:
Date:
Supersedes:
Checked by:
Date:
Date Issued:
Approved by:
Date:
Review Date:

Document Owner

Validation Manager

Affected Parties

All Validation, Laboratory and maintenance staffs involved in revalidation projects.

Purpose

To define the areas of responsibility and steps required in conducting Revalidation Studies on manufacturing equipment, processes and systems.

Scope

This procedure describes when revalidation is necessary on critical equipment /process/system and how to conduct revalidation on an annual basis or when a significant change of equipment /process/system has occurred.

Definition

Revalidation The act of (re) confirming that a validated process, e.g. a manufacturing or cleaning

process, continues to remain capable of achieving the intended results.
Requalification The act of (re) confirming that a va lidated system or piece of equipment remains

capable of achieving the intended results within planned regular intervals.
DR Deviation Report

Related Documents

Form370 Validation Discrepancy Form
Form375 Validation Project Log Form
VAL005 Validation – Concept and Procedure
VAL015 Method Validation Procedure
VAL020 Procedure for Cleaning Validation
QMS030 Preparation, Maintenance and Change Control of Master Documents
QMS035 Deviation Report System

EHS Statement

There is no particular EHS issue to follow this SOP.

Table of Contents

  1. Revalidation Categories 2
  2. Initiation 2

This is not an approved copy unless stamped in red File Location: Date Printed: Page 1 of 6

Standard Operating Procedure Title: Revalidation Procedure

3.1. In simplest sense, a change is one that may impact safety, purity, identity, effectiveness or quality of the product, for example:

  • Changes to Master processing instruction
  • Changes to raw material suppliers or components
  • Changes to formulation or batch proportion
  • Introduction of new equipment or utilities
  • After extensive preventative maintenance work

•Replacement of spare parts (different make) .

    1. Basic Steps during Revalidation
      1. Validation committee to determination of Revalidation qualification tests required and time frame done as part of Performance Qualification during initial validation.
      2. Validation team to Prepare and maintain Revalidation Master Plan
      3. Preparation and distribution of annual revalidation schedule
      4. Issue of revalidation protocols
      5. Coordination of preventative maintenance / recalibration / revalidation activities
      6. Consult the Change Request log for equipment/system of any changes conducted since the last validation/revalidation and include in the revalidation report.
      7. Validation Manager to Analyse the Change Request Log and determine if any additional revalidation tests required
      8. Update and/or Issue of Equipment Checklists and revalidation test protocols
      9. Conducting of revalidation qualification tests according to protocol, e.g. Chemical analysis of samples would be the responsibility of the Laboratory Manager.
      1. Validation committee to approve the revalidated equipment/systems for use by production after completion of revalidation studies when all acceptance criteria have been met. (Relevant Production Manager/Process Manager should be always notified.)
      2. Review and approval of completed revalidation qualification tests file.
    1. Revalidation Activities and Specific Responsibilities
      1. It is the responsibility of the validation manager to provide the annual revalidation schedule. This defines dates, activities and time frames when these activities are to be carried out in consultation with production schedules. When preparing the schedule, refer to the most recent past schedule and ensure timings are within one month from previous revalidation.
      2. Prior to the conducting of the revalidation tests as documented in the protocols, the

Validation staff has to asses the changes that have been conducted over the previous year and determine, in consultation with the Validation Manager, if any additional revalidation studies are required.

  1. The Validation staff is also responsible in coordinating with other departments to ensure that work is carried out according to schedules and actual studies follow the set protocols
  2. The Validation staff is also responsible in coordinating with other departments to ensure that work is carried out according to schedules and actual studies follow the set protocols.
  3. Following the preventative maintenance and calibration programme, a checklist for the equipment is to be filled out and a test run of the equipment/process/system is to be run by

This is not an approved copy unless stamped in red File Location: Date Printed: Page 3 of 6

Standard Operating Procedure Title: Revalidation Procedure

It is a document that summarises the overall test objectives, test functions performed

and an overall conclusion for a successful revalidation program. It is the document in the

Revalidation file that the Validation Committee reviews, approves and signs off.

11.3. Test Functions: This section is the main body of the file. It contains a series of test functions, which have been selected by the Validation Committee to be challenged during Revalidation. Each test protocol is made up with the following areas:

  • Process Description
  • Test Objectives
  • Acceptance Criteria
  • Method
  • Results
  • Conclusion
  • Attachments All raw data obtained from external calibrated measuring devices. Data is reviewed and recorded in the result section of the protocol. The results must agree with what is stated in

the acceptance criteria before proceeding to the next test function. (Note: The number of test functions will vary depending on the process.)

If a study is required to be repeated for any reason, it must be recorded on a Validation Discrepancy Form, and data from the failed study is to be filed in the Additional Information section.

This is not an approved copy unless stamped in red File Location: Date Printed: Page 5 of 6

Form370 Issue date:

Validation Discrepancy Form

(Ref. SOP VAL005, VAL010)

Project Name:
Project No:
Protocol No:

Discrepancy Description:

Sign: Date:

Change Request raised: Yes / No (if yes) Change Request No.:

Sign: Date:

File Location: Date Printed:

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