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Testing & documentation

Lot-Level Documentation

A certificate is about a sample. Lot-level documentation is the join from that sample to a production run and to the container you can hold.

Therapept EditorialUpdated 12 September 20266 min readReviewed by Therapept Editorial

If the lot field is blank, reused across products, or belongs to a different date than the offer, you do not have lot-level documentation. You have a marketing asset that may be analytically true of something else.

The identifiers

  • Container lot.
  • Report lot.
  • Laboratory sample ID.
  • Report number / verification code.

Sources

  1. FDA — Analytical Procedures and Methods Validation

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