Template:LIMSpec/Batch and lot management

Regulation, Specification, or Guidance Requirement 21 CFR Part 58.105 (a) 21 CFR Part 211.80 21 CFR Part 225.102 21 CFR Part 226.102 ASTM E1578-18 E-4-1 EPA ERLN Laboratory Requirements 3.3 EPA ERLN Laboratory Requirements 4.10.1 OECD GLP Principles 6.2 11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria. 21 CFR Part 211.80 21 CFR Part 225.102 21 CFR Part 226.102 ASTM E1578-18 E-4-2 EPA ERLN Laboratory Requirements 4.10.1 11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system. 21 CFR Part 211.80 21 CFR Part 225.102 21 CFR Part 226.102 21 CFR Part 820.65 ASTM E1578-18 E-4-3 11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample. ASTM E1578-18 E-4-4 11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results. E.U. Annex 11-15 11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.