Validation Program Assessment and Pharmaceutical cGMP Compliance

As implied by the name, validation is the process which verifies whether defined quality and compliance standards are being met by a product in the real-time environment. The evidence obtained through this process is then documented in a structured manner, making it available for review and cross-verification when needed.

The importance of the validation process cannot be stressed enough in sectors that are heavily regulated by the FDA and other authorities. It’s especially crucial for the pharmaceutical and biotech industry, since the end products impact public health and safety, and any deviations in quality can have life and death repercussions.

A validation program in drug or pharma equipment manufacturing basically ascertains the company’s claim that the product is meeting cGMP (current Good Manufacturing Practice) guidelines for pharmaceuticals, as laid down by the relevant regulatory bodies.

Validation Process in Pharmaceuticals

In the pharma industry, the validation process is implemented across the complete product development life cycle, to ensure adherence to good manufacturing practices and maintain pharmaceutical quality:

  • Beginning right from the research and development stage, this program runs parallel to each stage, be it conceptualization, design development, testing or product rollout. It runs hand in hand with the project management process.
  • Various studies may be initiated at each step to further cross-verify the authenticity of the claims being made.
  • A series of systematic documentation is prepared towards the validation done at each step for future reference.
  • Documentation usually contains the observations, pointing out the deficiencies that may be existing in the system and outline a suggested course correction (if required).
  • Considering that pharma manufacturing standards are quite stringent, validation acts as a sentinel to monitor any shortfalls that may have occurred.

The advantage of implementing a validation program at each stage of the product’s life cycle is that any rectification required can be done at each step before the final rollout, to avoid the pitfalls of product recall or lawsuits.

Types of Validation

The validation program for pharmaceuticals typically includes one or more of the following types of validation:

  • Prospective Validation
    This type of validation is usually applied to new products which are going to be launched. It involves running checks and balances of the development procedure before the product is commercially launched. The process is run through both during and after the clinical trials conducted for it.
  • Concurrent Validation
    This method of validation is applied to drugs which are already in commercial production. It evaluates the critical stages in the production process to ensure that they are meeting the defined standards which have been laid out. A structured documentary proof is created in this method, to create evidence of the existence of best practices that are being followed to meet quality standards. In a sense, this method is part of the quality assurance process.
  • Retrospective Validation
    As the name suggests, this method evaluates products on a retrospective basis and is applied to products which are stable and have already been in the market for a certain period of time. It involves a statistical study of batch-wise historical data from the production lifecycle. This method of validation is usually undertaken when financial limitations do not permit prospective validation.
  • What is Validated during the Validation Program?
    Validation is implemented across all possible processes and stages in a pharmaceutical manufacturing setup. It ranges from evaluating various aspects like:

    • Raw materials
    • Personnel
    • Facilities for manufacturing
    • Equipment used in production
    • Packaging and distribution systems
    • Automated processes and automated equipment
    • HVAC (Heating, ventilation and air conditioning) systems
    • Waste management equipment and programs

    Validation is a time-tested tool in the process of implementing quality assurance. In addition to ascertaining adherence to cGMP guidelines for pharmaceuticals, it also helps in cost optimization related to the monitoring and testing of products. It ensures that regular efficiency of the process is maintained, for delivering consistent quality.

    RS Calibration can assist you with planning and implementing programs for all your validation, calibration and qualification needs. If you operate in the realm of the healthcare industry, get in touch with us to discuss your specific requirements or concerns, and our experienced professionals will be glad to help!

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