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SOP for De-Stripping and De-Blistering

OBJECTIVE
To provide a procedure for de-stripping and de-blistering of strip packed and blister packed dosage forms respectively.

SCOPE
The procedure applies to all the strip packs and blister packs of a batch that does not conform to specification.

RESPONSIBILITY
It is the responsibility of the operator to carry out activity as per this SOP.
The Packing supervisor shall ensure that the procedure is being followed.
The Production Manager / QA Manager shall give approval for commencing the activity.

PROCEDURE
  • The de-stripping activity shall be done on all the strip packed dosage forms of a batch that do not conform to specifications.
  • The de-stripping activity shall be done either on-line or off-line.
  • On-line de-stripping: De-stripping when the strip packing activity of a batch is in progress.
  • Off-line de-stripping: De-stripping when the strip packing activity of a batch is completed.
  • Wear the face mask, gloves and other protective gear before initiating the activity.
  • De-strip the tablets or capsules and collect in a separate clean polythene bag / drum.
  • The polythene bag / drum in which the de-stripped tablets or capsules are placed shall be appropriately labeled.
  • The damaged tablets or capsules during de-stripping should be retained in a separate labeled polythene bag for final yield reconciliation or reprocessing.
  • Send the de-stripped tablets or capsules for re-stripping.

NOTE: Same procedure shall apply for de-blistering of blister packed dosage form.

ABBREVIATIONS
SOP: Standard Operating Procedure.
QA: Quality Assurance.

REVISION HISTORY
Nil

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