The “Good Manufacturing Practices Guidelines, 2009 Edition (GUI-0001)” require that each batch
must be identified by an individually numbered manufacturing batch document, each lot or batch of the
finished product shall be fully tested against the specification and retained samples for each lot or batch shall
be kept. Packaging of multiple lots of bulk finished drug product in a single packaging run with one lot
number should be done only in exceptional circumstances and should be well documented with appropriate
justification. The shortest expiry date of all the lots packaged must be indicated on the label. In case of a
product recall, the company must recall the entire lot comprising all the sub-lots.
