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.

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 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

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 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.

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 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

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 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

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