SOP for process validation image



1.0       OBJECTIVE

To establish scientific documented evidence that process is consistent delivering the intended performance of the product.

2.0       SCOPE

This SOP shall applicable to all the new process developed in-house or transferred from other sites shall be validated prospectively and process step shall be evaluated to determine the critical factors and parameters that may affect the quality of the finished product.


3.1          QA department shall be responsible for:

3.1.1    Preparing the protocol and report as per the process requirements.

3.1.2      To verify that the process activities shall be performed as per protocol.

3.1.3      Sampling of the samples as per matrix attached to validation protocol.

3.1.4      To compile the data after completion of study.

3.1.5      Head QA responsible for pre and post approval of protocol and report.

3.2          QC department shall be responsible for:

3.2.1      To examine the validation samples.

3.2.2      To record the results of testing at different stage in report part.

3.2.3      Head QC shall be verifying the analytical results of samples.

3.2.4      Head QC shall be responsible for review the protocol & report.

3.3          Production department shall be responsible for:

3.3.1      To performs the activities as per BMR and protocol.

3.3.2      Head production shall be responsible for review the protocol & report.

4.0       PROCEDURE

4.1          A flow diagram should be constructed giving the steps of the process.

4.2          The pre requisites to perform validation shall be verified for their qualification prior to starting the process performance study. Like personal, premises, utilities, equipment, material management, calibration, Analytical method etc.

4.3          Process validation studies shall be conducted as per the pre-defined approved protocols.

                Protocol consists but not limited to:

  • Introduction
  • Objective
  • Scope
  • Responsibilities
  • Details of equipment/facilities
  • Time Schedule
  • Critical process parameters
  • Methodology to perform the operations
  • Sampling procedure and matrix
  • Specification of in process and finished product
  • Test to be conducted
  • Acceptance criteria
  • Training to the concern personnel.
  •  Deviation handling procedure.
  • Failure handling
  • Re-validation criteria
  • Evaluation of data and preparation of report.
  • Conclusion
  • Data sheets

4.4          Sampling of bulk, intermediate and finish product shall be done by QA representative using appropriate tools.

4.5          Sampling from the different stages shall be done as per diagram/ matrix attached in process validation protocol.

4.6          Samples of process validation shall be analyzed in quality control department as per validated analytical method.

4.7          Results of the test shall be attached to report part along with its raw data, Meta data.

4.8        If any deviation from procedure mentioned in protocol observed it shall be recorded in BMR and process validation protocol to ensure that, is there any requirement to change in critical process parameters or critical quality attributes. Or there is a requirement for a change in the design of the current process.

4.9          If all the results observed within specified limits. Continuous process verification shall be done for future batches by means of control charts, deviations, or non-compliance.

4.10       A conclusion shall be withdrawn on the basis of the study to declare process is competent enough to reproduce quality product.

4.9          QA officer shall be compiling all the data related to process qualification in the process validation report.

4.10        Trend of ongoing batches shall be monitored via analysis and controlled through control strategy.

5.0      Revalidation should be done after any change but not limited to:

5.1   Raw material /Packing material

5.2   Supplier

5.3   Process

5.4   Equipment

5.5   Utility (HVAC)

5.6 Technology.



SOP      :    Standard Operating Procedure

QA        :    Quality Assurance

Dept.   :    Department

HOD     :     Head of Department

QC         :     Quality Control

HVAC   :    Heat Ventilation and air conditioning system

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