Protocol for process Validation

Protocol for process Validation

Protocol for process validation Contains a Title, Protocol Reference Number, Version, Objective, Scope, Manufacturing Formula, process description, Validation team, Critical process parameters, acceptance criteria, Sampling plan for analysis, sampling locations etc.

In Preparation of Protocol for process validation we also consider,

• The manufacturing Conditions, Including operating parameters, processing limit, and component input.
• The data to be collected and when and how it will be evaluated.
• Tests to be performed (In-process, release, Characterization) and acceptance criteria for each significant processing steps.
• The sampling plan, including sampling point, number of sample, and the frequency of sampling for each unit of operation and attribute. The Samples shall be adequate to provide sufficient statistical confidence of quality.

The Protocol for process validation contains following Clauses but not limited to,

• Objective
• Scope
• Responsibilities of validation team
• Product details
• Need of Validation
• Re-Validation Criteria
• Product Composition (RM & PM)
• Description Of The Equipment/ Instruments (In-process and QC)/ Utilities
• Process description (Flow Chart/ Manufacturing & Packing Process)
• Identification of Critical Control Parameters 
• Validation procedure
• Sampling Plan and acceptance criteria
• Product disposition and release criteria
• Stability Study

On the basis of Protocol for process validation a Checklist to be executed which contains

Details	Yes/ No/ NA
Approved change control Available for Validation campaign.
All the raw materials required for the validation campaign are available at site
All the required RMs are approved and released by quality for use.
Sufficient and satisfactory data available from the feasibility and trial batches to proceed for validation.
Manufacturing process identified
All the critical process parameters and their operating ranges identified.
Approved Batch Manufacturing record available.
Approved Process Validation Protocol Available.
Risk Assessment for Process validation completed.
Equipment to be used for validation execution in ready to use state with no overdue preventive maintenance.
All the equipment to be used for the validation batches are qualified.
All the utilities to be used for validation batches are qualified.
Approved Project validation master plan available.
Requirement for Cleaning validation assessed
Sampling plan defined and clear.
Required sampling aids are available.
Approved RM BOM available in TDS.
Approved MOM available in TDS.
Approved Product specifications available in TDS.
Analytical tech. transfer/Validation done.
All the Reference standards and testing methods available for testing of the validation batches.
All the required analytical instruments/ equipment are available and are qualified and calibrated for testing.
Is there any safety concern associated with the validation campaign?