Computer System Validation Lesson-1

What is Validation:-

Validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages.

Generation of Validation

“Validation is a concept that has been evolving continuously since its first formal appearance in United States in 1978. The concept of validation has expanded through the years to encompass a wide range of activities which should take place at the conclusion of product development and at the beginning of commercial production. Validation is confirmation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilled.”

Types of Validation:-

There are Four Type of Validation

1. Prospective Validation
2. Concurrent Validation
3. Retrospective Validation
4. Re-validation (Periodic and After Change)

Sub Category of Validation

·         Equipment validation

·         Facilities validation

·         HVAC system validation

·         Cleaning validation

·         Process Validation

·         Analytical method validation

·         Computer system validation

·         Packaging validation

·         Cold chain validation

Prospective Validation

It includes the division of the production process into separate steps, and the analysis of potentially critical points in the manufacturing process e.g. mixing times, or temperature.

Criteria of Validation

·         The facilities & equipment must be qualified

·         The operators running the validation batches must have an understanding of the process

·         The design and optimization must be completed

·         The pilot laboratory batches must be completed

·         Product stability information is available

·         At least one pilot batch has been completed which shows no significant deviations from the expected performance of the process.

         Concurrent Validation

Concurrent validation is carried out during normal production. It requires a full understanding of the process based on prospective work.

      Criteria of Validation

·                              o    pH Value

·                              o    Tablet Hardness

·                              o    Weight Variation

·                              o    Dissolution Time

·                              o    Content Uniformity

·                              o     Viscosity or Density

·                              o    Colour or Clarity

·                              o     Particle Size Distribution

·                              o      Average Unit Potency

Retrospective Validation

Retrospective validation is the analysis of accumulated results from past production batches manufactured under identical conditions to assess the consistency of a process.

It includes trend analysis on test results and a close examination of all recorded process deviations and their relevant investigation reports.

Criteria of Validation

o    Gather the numerical data from completed batch records

o    Organise this data in sequence i.e. Batch Manufacturing Date

o    Include the data for at least 20-40 batches, if the number is less than 20 include all of the data available

o    Lean the data by eliminating all of the non-critical numerical information

o    Subject this data to statistical evaluation

o    Analyse the state of control of the manufacturing process

o    Generate a report of all findings

Revalidation

Periodic revalidation offers the opportunity to check that the systems are still operating as originally validated and that no unintended changes have affected the process, system or piece of equipment and the end result.

Criteria of Validation

o    A change to a critical raw material involved with the drug make-up

o    A change or replacement of a critical piece of equipment

o    A change to the facility

o    A significant increase or decrease in batch size

o    Sequential products that that fail to meet product and process specifications

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