Three Consecutive Batches for Validation in Pharmaceuticals : Pharmaceutical Guidelines

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Three Consecutive Batches for Validation in Pharmaceuticals

Know why three consecutive batches are taken for validation of manufacturing process and cleaning procedure instead of two or four?
This is a common concept to validate three consecutive batches in pharmaceuticals. In process validation, initial three batches are taken for validation. This is a basic question that concentrates everyone’s mind that why three batches are taken for validation?

Neither FDA nor any other regulation specifies the maximum number of batches to be considered as validation. The manufacturers have to choose the number of batches to be validated in this regard. 

Process Validation StagesThe number of batches to be taken under validation depends upon the risk involved in the process of manufacturing.

The less knowledge about the process requires the more statistical data to confirm the consistent performance. Consideration of validation batches fewer than three will require more statistical and scientific data to prove the consistency of process to meet quality standards.

FDA’s “Guidance for Industry on Process Validation: General Principles and Practices” provides the guideline for process validation, no longer consider the traditional three batch validation appropriate but also does not prescribe the number of batches to validate or suggests any other method to determine it.

Generally, it is considered if we get the desired quality in the first batch, it is accidental, second batch quality is regulator and quality in the third batch is Validation. When two batches are taken as validation the data will not be sufficient for evaluation and to prove reproducibility because statistical evaluation cannot be done on two points, it needs minimum three points because two points always draw a straight line.

Therefore, minimum three consecutive batches are evaluated for validation of manufacturing process and cleaning procedures. More than three batches may be taken in validation but it involves the cost and time and the companies don’t want to do so.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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8 comments: Post Yours! Read Comment Policy ▼

  1. Akhil BajajAugust 28, 2013

    There is another saying as well for the 3 batches. If one batch meets the quality requirement, it is an "Incidence", if two consecutive batches meet the quality requirement, it is "Coincidence". But, if three consecutive batches meet the quality requirement, it is "Consistent".

  2. SATYA PRAKASH SINGHSeptember 14, 2013

    Three batch are need because of the consider for quality and quantity is luck by chance , second is near by and third is consistant.

    Satya Singh

  3. For re validation studies how many batch can we perform. We already conducted three consecutive batches for our validation studies. Do we have to do it in three consecutive batches for our re validation

  4. If you have made any change in process then you have to re-validate the process. It shall be considered as a normal process validation with three batches.

  5. If the dry material is in two lots in intermediate (If blender is not available), how to take the Homogeneous sample for complete analysis.

    Someshwar rao.

  6. What controls required in a change control, if commercial batches proposed to take without completion of three consecutive validation batches.

  7. Where in the FDA regulation states that the same manufacturer API have to be used in the 3 process validation batches?

  8. If two batches are within the range, third batch is failed. What is further action to do?


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