Cleaning Validation Master Plan – Veterinary Biologicals

Sample Document

Table of Content:

  1. Introduction
  2. Purpose and Scope
  3. Responsibilities Matrix
  4. Rationale and General Principles

4.1          Rationale

4.2          General Principles

4.3          Cleaning Standard Operating Procedures or Operating Instructions

  1. Product Bracketing – Risk Based Approach

5.1          Selection of “Worst Case” – Product Bracketing Strategy

5.2          Potential Process Residues

  1. Assessment of Products
  2. Changes in Equipment or Usage
  3. Preparation and Approval of Protocols and Reports

8.1          Protocols should address the following:

8.2          The Validation Report should contain the following:

  1. Acceptance Criteria

9.1          Product and Detergent Residues

9.2          Priority, Schedules and Documentation

  1. Cleaning Strategies

10.1        Clean Hold Time

10.2        Dirty Hold Time

10.3        Campaign Cleaning

  1. Re – Validation
  2. Manual Cleaning Procedures – Monitoring
  3. Cleaning Validation Program – Required Documents Table
  4. Document History
  5. Related Documents
  6. References

APPENDIX

  1. Introduction
  2. Purpose and Scope
  3. New or Modified Product/Process Material
  4. New or Modified Product/Process Material
  5. New Equipment or New/Modified Equipment Train

Sample Content

Introduction

[Enter company name] manufactures and distributes a range of sterile and non-sterile, liquid, veterinary biological and pharmaceutical products from their sites [address].

The GMP facility has Code of Good Manufacturing Practice (cGMP) licenses with the [List all licenses].

This document aims to summarise the overall intentions and approach to the validation of the cleaning equipment and procedures involved in manufacture of sterile veterinary biologic products for [Enter company name].

It is intended to be a working document and will be periodically updated by site management responsible for the execution of validation.

Purpose and Scope

The Cleaning Master Validation Plan outlines the cleaning program and the associated cleaning validation strategies performed in the Biologics manufacturing area of the [Enter company name] facility. This document presents the methodology to achieve and demonstrate acceptable standards of cleanliness for equipment coming in contact with product or in-process material.

This document is intended for use as a guidance document for the development of specific plans or protocols for a given cleaning validation effort to be performed at in the Veterinary Biologics area. This document defines the expected methodology and rationales to be applied in those documents.

This cleaning validation master plan will discuss the following:

–              Scope of the plan including products and locations

–              Cleaning methods including systems and cleaning agents

–              Criteria to Establish for Cleaning SOPs

–              General Discussion of Cleaning Validation Evaluation and Testing

 

It will also discuss the Strategies, Approaches and Rationales used in cleaning validation including:

–              Worst Case, Bracketing Approach

–              Analysis and Acceptance Criteria

–              Clean and Dirty Hold Times

–              Evaluating Need for Cleaning Validation Studies

–              On-going Cleaning Validation Program

Rationale

Products manufactured in the biologicals/aseptic production facility can be contaminated by other products (cross contamination), by cleaning agents, by micro-organisms or by foreign matter. In a multipurpose facility the same (common) equipment may be used for many different products.

The objective of cleaning validation is to verify the effectiveness of the documented cleaning procedure for removal of product residues, degradation products, excipients and/or cleaning agents so that the analytical monitoring may be reduced to a minimum in the routine phase. In addition it is necessary to assess the risk of equipment usage associated with cross contamination of active ingredients.

Sample Document