Process validation protocol
A written plan stating how validation will be conducted, including test parameters, product characteristics, production and packaging equipment, and decision points on what constitutes acceptable test results.
The process validation protocol is defined as the experimental plan that design thoroughly the validation programmed.
Protocol of the Process validation consists of the following
Contents of Process Validation Protocol
- Approval Signatures
- Overview
- Responsibilities
- Background
- Validation Approach
- Equipment List
- Product details
- Manufacturing Location
- Unit Formula and Batch Calculation
- Process Flow Chart
- Manufacturing Procedure
- Proposed Requirements
- Methodology
- Result recording and evaluation
- Preparation of Report
- Handling of Deviations
- Change management
- Reference documents
Protocol Approval:
It is same as equipment validation protocol
Overview: The overview of protocol consists of critical processing stage during the manufacturing and sampling at different stage for assurance of the reproducibility and reparability.
Objective :The objective of the Protocol is to provide the methodology to validate the manufacturing process .
Scope : The scope of this Protocol is limited to for which validation what is it process and for which market it shall be incused where the validation is performed
Responsibilities : The various department what is there responsibilities is must be defined in the protocol.
Background:
When the process validation is performed there is clearly mention about for which market it is applicable and what is the back up data for that validation is available is defined.
Validation Approach: the validation approach consists of the following
The selected validation approach for which type of validation.
Three batches for each strength proposed for validation study using different API lots, to assess the process parameters and quality attributes of the product.
It includes the division of the manufacturing process into unit operations, and the analysis of sample from potentially critical points in the manufacturing process.
Study will be carried out in which these steps and critical points are simulated and the effect on the process is assessed.
The study may include upper and lower processing conditions that will be encountered normally in the routine production operations (in case of oral section).
This study may include worst case conditions but not necessarily simulate the failure range of the product processing conditions (in case of oral section).
The steps of Validation methodology and acceptance criteria for each step are described in the following sections.
EQUIPMENT & SOP LIST: The equipment which are used during the validation are defined and there SOP is defined.
PRODUCT DETAILS: The product details consists of Product Name, Generic Name, Formulation Design, Category: Storage & Environmental Conditions
Protocol No. for process validation should be written in format PR/PV/AA/ CC/DD and report No. should be written in format RP/PV/AA/ CC/DD.PRT refers to protocol ,PV refers to Process validation, AA refers to study done , CC refers Protocol no. DD refers to revision no. of the protocol. Revision No. of the protocol go through the proper change control procedure refer SOP on change control procedure SOP. For details of Protocol No. SOP on document numbering.
Unit Formula And Batch Calculation:
The unit formulation of the batch and per dose calculation and API calculation is defined in protocol.
Process Flow Chart : The manufacturing process must be defined in flow chart.
Manufacturing Procedure :The manufacturing procedure is mention in the protocol.
Sampling Plan :In this section sampling plan should be defined .Under this section qty. test description shall be defined.
Methodology:
What are the critical steps during the validation stage, Critical processing steps, Control variables, Sampling plan, Test Parameters, Acceptance Criteria are mention in this section.
Result Recording and Evaluation:
Record all the observation and results as per the Monitoring Methodology given in the After completion of recording all the relevant data a final conclusion shall be drawn to assure all the data collected supports that the all the batches thus produced meets the pre-defined specifications and quality attributes. There by consistent quality of the commercial batch production is assured.
Preparation of report:
Upon successful execution of process validation batches a consolidated report shall be prepared. This shall include summary of all the intended activities define in the protocol, results of each test performed at different unit operational stages, details of instruments / equipment’s used during the process validation activity, intended environmental monitoring data, resolution of deviation if any, conclusion of process validation activity. Appropriate yield at manufacturing and packaging stage shall be defined and shall form a base line for commercial batches.
Handling of Deviations:
Any deviations / critical changes to the approved protocol during the execution of process validation shall be handled as per handling of deviation procedure. Details of deviation shall be documented in the report with details such as, description of deviation, reason / cause, corrective and preventive action, and status of the deviation.
All the deviations shall be closed or resolution shall be specified prior to release of product for intended purpose.
Change management:
Any changes to specified process during post validation period with respect to key process parameters, key raw material & packaging components, critical quality attributes of the product, equipment’s, and facility related changes shall be handled as per applicable change control procedure.
Reference documents: what are the reference documents are used for the validation activity and test procedure are used must be kept in reference document
Validation Status Label
Validation status label affix on the equipment.
References (If any):
- SOP on SOPs
- SOP on document numbering.
- SOP on Change Control Procedure.
Reason for revision:
- Not Applicable.
Abbreviation:
- IQ : Installation Qualification
- OQ : Operational Qualification
- PQ : Performance Qualification
- BET : Bacterial Endotoxin test
- PV : Process Validation
- r.t : With respect to