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Process validation: Stage 3

 CONTINUED PROCESS VERIFICATION

Process Validation shall be performed in three stages as:

            Stage 1: Process design

            Stage 2: Process qualification

            Stage 3: Continued process verification

 

Stage 2 is already discussed.

Stage 3: Continued process verification:

  • Stage 3: Continued process verification shall be started immediately after completion of stage 2: process qualification.
  • This stage will help in evaluating the performance of the process, identifies problems and determines whether action must be taken to correct, anticipate, and prevent problems so that the process remains in control.
  • After completion of PPQ batches CQA and CPP data of all commercial batches including PPQ batches shall be trended in Minitab software.
  • Once the CPP and CQA data of 30 batches including PPQ batches are available, batches (from 31st batch onwards) shall be released as per control limits derived through Minitab software.

Collection of data and statistical evaluation

The values of CPPs and process yield from executed BMR and the value of CQAs from analytical reports.

In case of product is manufactured in more than one equipment then collection for CPP shall be done equipment specific.

For new drug product, start collecting the data from validation batches and for existing product (legacy product) collect data of last minimum 30 commercial released batches including validation.

The data collection for a given product shall be maintained in one file.

Following are the preconditions for calculating the control limit and trend the data.

    • Out of specification batch should not be considered. 
    • Minimum number of batches shall be not less than 30 irrespective to year and shelf life period. These 30 batches data shall include the recent validation batch data. 
    • For the product where intentional changes (such as CAPA) are introduced into the process and have the impact on product CPPs and CQAs in these cases the CPV shall be started immediately on availability of data of 30 batches since the change is implemented.

Batch release:

The data trending and review shall be done by a trained personnel.

Up to 30 batches, all commercial batches including PPQ batches shall be released as per OOT limits.

After completion of 30 batches (including PPQ batches), batches (from 31st batch onwards) shall be released as per control limits derived through Minitab software.

If the outcome of the statistical evaluation does not identify any out of trend for the CPPs and CQAs evaluated,  the batch shall be released by the QA.

If the outcome of CQAs statistical evaluation identifies an out of control limit, then QC reviewer shall initiate OOT as per plant OOT SOP and investigate.

If the outcome of CPPs statistical evaluation identifies an out of control limit then QA reviewer shall initiate deviation and investigate.

 

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