General Notes on Validation

• Validation batches are saleable and
therefore will be used by patients.
True validation batches mimic routine
production in every detail. For example,
– Material handling methods of feeding a
tablet press may affect the processability.
– Batches should be ‘QC releasable’. We are
validating ‘acceptable’ processing and
product.
Note: Data from unacceptable batches may in special cases support
validation
• Sampling is frequently an issue in validation.
– Thus, think and plan ahead on specifics of the number
of samples, sample size, sampling location, method,
and handling and who will perform what activity
– Also, sample in the same way as development,
demonstration or prevalidation batches.
• Sampling strategy can be as important as process
development.
• Following protocols and procedures is another
frequent issue in validation.
– Consult the protocol and procedures frequently to be
sure they are being followed.
• Know your equipment, process parameters,
materials, tests and expected results.
• A robust process will allow some normal variation
in equipment operation, raw materials, and other
variables (e.g. environmental)
• Deviations and OOS (out-of-specification) results can jeopardize a
successful process validation.
• The development and production history can be helpful in
investigations.
• Conduct scientific and thorough investigations. Write clearly.
Implement corrective actions.
• Quality cannot be inspected or tested into the product; i.e. repeat
testing and resampling will not improve the quality.
• Quality comes through designing and proper controls of
manufacturing parameters (build quality into product).