Validation : As per Master validation Plan
Critical machines like liquid filling are revalidated for their performance Once a year.
Prospective validation is carried out for critical processes like Mixing, Equipment Cleaning, Bottle Washing, Fill Value Check at set frequency and set protocols.
Retrospective validation on process is carried out by comparing the analysis results for their higher and lower limits.
Cleaning procedures are validated for absence of previous products periodically. Method of evaluation is set on either 10 ppm or 1/1000 of dose of previous product.
Samples collected during filling of product as “In Process Checks” at various intervals are pooled together. They are analysed as per specifications and results are compared with set limits. Documents are checked for any critical or major deviation, complied with and finally Batch is released for Sale. Batches are retrospectively Validated.