This document outlines a procedure for process validation. It establishes controls for validating processes important for product health, safety and quality. The scope includes storage, handling and use of packaging materials and filling of foil bags with wine intended for consumers. All production processes must be validated to ensure reliability and reproducibility. The procedure involves documenting process requirements, conducting testing and analysis, establishing process controls, and retaining validation records.
This document outlines a procedure for process validation. It establishes controls for validating processes important for product health, safety and quality. The scope includes storage, handling and use of packaging materials and filling of foil bags with wine intended for consumers. All production processes must be validated to ensure reliability and reproducibility. The procedure involves documenting process requirements, conducting testing and analysis, establishing process controls, and retaining validation records.
This document outlines a procedure for process validation. It establishes controls for validating processes important for product health, safety and quality. The scope includes storage, handling and use of packaging materials and filling of foil bags with wine intended for consumers. All production processes must be validated to ensure reliability and reproducibility. The procedure involves documenting process requirements, conducting testing and analysis, establishing process controls, and retaining validation records.
This document outlines a procedure for process validation. It establishes controls for validating processes important for product health, safety and quality. The scope includes storage, handling and use of packaging materials and filling of foil bags with wine intended for consumers. All production processes must be validated to ensure reliability and reproducibility. The procedure involves documenting process requirements, conducting testing and analysis, establishing process controls, and retaining validation records.
Download as DOC, PDF, TXT or read online from Scribd
Download as doc, pdf, or txt
You are on page 1/ 5
PROCEDURE FOR PROCESS VALIDATION
Approved by Signature Date
Managing Director
Amendment History Rev Description Date 00 New document for implementation
1 PURPOSE
This procedure will establish the controls required to validate processes
which are important for product compliance to health, safety and quality considerations.
2 SCOPE
This document is applicable to those phases of the process (and of product
development) where final health, safety and quality characteristics of the product can be influenced.
In particular, this procedure applies to:
Storage, handling and use of packaging materials Filling of foil bags with natural wine intended for the consumer market. Storage and dispatch of boxed foil bags with natural wine as content
3 RESPONSIBILITY
The management Representative must ensure that no process is used to
produce product, where the process itself was not validated
4 IMPLEMENTATION
The Management Representative implements this procedure through training
and validation work sessions
5 POLICY AND PROCEDURE
All production processes will be validated to assure its reliability and re- produce-ability.
A Product Development Checklist is used to document the phases of
development and to ensure sound communication of requirements between stakeholders.
DOC. NO. 0212 REVISION 01 Page 1 of 5
PROCEDURE FOR PROCESS VALIDATION
Validation- Confirmation, through the provision of objective evidence, that the
requirements for a specific intended use or application have been fulfilled
Verification- confirmation, through the provision of objective evidence, that
specified requirements have been fulfilled NOTE 1 The term “verified” is used to designate the corresponding status. NOTE 2 Confirmation can comprise activities such as — performing alternative calculations, — comparing a new design specification with a similar proven design specification, — undertaking tests and demonstrations, and — reviewing documents prior to issue.
Objective evidence - Data supporting the existence or verity of something
Process is defined as “set of interrelated or interacting activities which transforms
inputs into outputs”.
Requirement - Need or expectation that is stated, generally implied or obligatory.
Qualification process - to demonstrate the ability to fulfil specified requirements
NOTE 1 The term “qualified” is used to designate the corresponding status. NOTE 2 Qualification can concern persons, products, processes or systems
EXAMPLE Auditor qualifications, material qualification.
Approach to the Qualification (validation, industrialisation) of a Process:
INFORMAL APPROACH WITH HIGH RISK AND LITTLE ASSURANCE FROM PRODUCT DEFECTS
INPUT "PROCESS" OUTPUT
HUMAN
MACHINE PRODUCT IS MATERIAL NOT DEFECT FREE METHOD
MEASUREMENT BIG BANG ENVIRONMENT
FORMAL APPROACH WITH LOW RISK AND MORE ASSURANCE OF DEFECT-
FREE PRODUCTS
INPUT VALIDATED PROCESS OUTPUT
HUMAN
MACHINE EACH INPUT IS MATERIAL CONTROLLED PRODUCT IS (DETAIL) TO FIT THE DEFECT FREE METHOD END REQUIREMENT
MEASUREMENT
ENVIRONMENT
DOC. NO. 0212 REVISION 01 Page 2 of 5
PROCEDURE FOR PROCESS VALIDATION
Refer to background reading Process validation guidelines
Refer to the Flow Diagram of the procedure.
A Validation Checklist and Report is used to document the process of
validation and to provide objective evidence that this procedure is implemented and maintained.
5.1 SHORT DESCRIPTION of the process with critical steps highlighted
5.2 FINISHED PRODUCT SPECIFICATION – refer number if completed
5.3 PHYSICAL PROPERTIES AND CHEMICAL PROPERTIES – refer certificate of
conformance if received from supplier
5.4 DETAILS OF ANALYTICAL METHODS – refer method if current. Develop new if
not.
5.5 PRESENCE OR ABSENCE OF BARRIERS – state detail
5.6 OXIDATION ANALYSIS – Attach supplier record
5.7 SUPPLY: Supplier technical competence – Visit with supplier evaluation form Supplier HACCP – Attach copy Supplier quality and food safety systems – Include on evaluation report Certificates of analysis – attach or make reference
5.8 HACCP REVIEW :
refer HACCP review date and revision number Corrective Action on CCP’s - refer to HACCP study
5.9 NEW CONTROL LIMITS – establish limits from analysis or current proves parameters
5.10 IN PROCESS CONTROLS
Acceptance criteria – State new controls applicable to materials, equipment Additional testing to be carried out - refer to new test method
5.11SAMPLING PLAN – Describe method sampling
5.12 TIME FRAME – Restrictions in time
5.13 FAILURE MODE AND EFFECT ANALYSIS – refer FMEA record
Additional to a HACCP Review, the failure modes shall be identified, as well as their consequences. This analysis shall identify all possible product failures that could result from process failures. From this analysis, it must be possible to identify what measures need to be taken to prevent the risk of failures.
DOC. NO. 0212 REVISION 01 Page 3 of 5
PROCEDURE FOR PROCESS VALIDATION
5.14 TRACEABILITY ANALYSIS - List traceability of materials through the process.
Describe how traceability from destination back to source can be achieved and list records 5.15 PLANT AND EQUIPMENT IMPACT – Describe the impact. Refer to: Infrastructure Immediate production environment Pest control
5.16 COMPATIBILITY OF MATERIALS WITH EQUIPMENT
Tanks Filter Pumps Filler Printing
5.17 SAFETY OF PERSONNEL
5.18 PERSONNEL COMPETENCE
Training updated
5.19 QUALITY Testing methods updated QC equipment QC personnel Q Control plan updated
5.20 CLEANING VALIDATION
The objective of the cleaning validation is to verify the effectiveness of the cleaning procedure for removal of product residues, degradation products, preservatives, excipients and/or cleaning agents so that the analytical monitoring may be reduced to a minimum in the routine phase. In addition one needs to ensure there is no risk associated with cross-contamination of active ingredients
Refer to background reading on Cleaning Validation
Cross Contamination Dedicated surfaces New cleaning protocols updated Cleaning chemicals Test for cleaning effectiveness Cleaning equipment Cleaning instruction updated
5.21 TRANSPORT Transport of material inward Transport of product outward Storage of final product
5.22 DOCUMENTATION - updated
5.23 FORMAL RELEASE FOR OPERATIONAL TESTING
5.24 ANALYSE DATA
DOC. NO. 0212 REVISION 01 Page 4 of 5
PROCEDURE FOR PROCESS VALIDATION
6 RECORDS RETAINED When a process is validated, the Management Representative will retain all the following records for a period of 2 years and then destroy them: 5.1 Validation Checklist and Report and all associated reports, analysis, certificates, calculations, datasheet and printouts. 5.2 Product Development Checklist
