Validation and its Importance in Pharmaceuticals

Validation is a concept that has been develop gradually since its first formal appearance in United States in 1978. The concept of validation was first proposed by two Food and Drug Administration (FDA) officials, Ted Byers and Bud Loftus, in 1979 in USA, to improve the quality of pharmaceuticals. In 1996 GMP guidelines were published by WHO for the validation of manufacturing process

What is Validation :

Validation is the process of establishing documentary evidence of the consistency of any process or System & it is the collection and evaluation of data from the process design stage which establishes scientific evidence that a process is capable of consistently delivering quality product.

Why it is Important in pharmaceutical for any System or Process:

  • Regulatory  Requirement (GMP,FDA,MHRA,TGA & other regulatory agencies)
  • To confirm the process design as capable of reproducible commercial manufacturing & make the process better understood.
  • To identify Risk/Worst Case assessment.
  • To provide ongoing assurance that the process remains in a state of control during routine production through quality procedures and continuous improvement.
  • Quantitatively (quantity of something rather than its quality) determine the variability of a process and its control.
  • The variability within and between batches can be evaluated.
  • Safeguard and process against sources of variation which may not have been identified during the original process development.
  • The reason to optimize and validate pharmaceutical productions and supporting processes and cost reduction.
  • Decreases the chances of the product failure & assures the smooth running of the process.
  • Investigate the deviations if any from established process & Analytical parameters.
  • Result obtained in the validation helps to take decision for the manufacturer regarding repeat the batch manufacturing
  • Validation is legible through the documentation establishment and it guarantees a manufacturing process with assured product quality.
  • Deep study & understand the system & equipment are made possible due to validation.
  • What is Worst Case-It is a set of conditions encompassing upper and lower limits and circumstances, including those within standard operating procedures, which pose the greatest change of process or product failure when compared to the ideal conditions.

Different types of Validation in pharmaceuticals :

Water system, cleaning of equipment, manufacturing process, HVAC System, analytical method, computer system, water system and compressed air are related to system and process which are required.
All new system, equipment and process must be validated before routine manufacturing use.

Why Three consecutive batches taken for Validation :

What is Consecutive :  Consecutive comes from the Latin consecutus, meaning following closely with no gap or following one after another without interruption.

Why three batches to be taken for Process validation this is a common question which will come in everybody’s mind while executing or performing  the activity.

1.Actually neither FDA or nor any regulatory guidelines says about the maximum numbers of batches to be taken for validation. The number of batches to be taken under validation depends upon the risk involved in the manufacturing Critical process parameters & critical Quality Attribute so  depends upon that manufacturer have to choose the number of batches to be validated.

2.If we will consider less than two batches then the data will not be sufficient for evaluation of and to prove reproducibility of data  between batch to batch variation & if we consider more than three batches it can increase the time & cost of manufacturer which usually not preferred.

3.Generally if we will require quality in the First batch, then it is accidental (co-incidental), Second batch quality is regular & third batch quality is Validation or Confirmation.

4. Statistical evaluation cannot be done by considering two points, because two points always draw a straight line so minimum three points required for comparison of data.

5.Therefore for Process as well as for cleaning validation three consecutive batches are preferred by the manufacturer.

Conclusion :

Validation allows us to focus on our everyday business operations of making and selling quality products that also comply with regulatory requirements such as the FDA, Schedule M, GMP, USFDA, MHRA, WHO etc. The industry which has adopted a lifecycle approach to the product development, validation and modern risk analysis tools can control critical process parameters.


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