SOP for Reprocessing of Capsules

OBJECTIVE

To lay down a procedure for reprocessing capsules.

SCOPE

This procedure applies to the production department in the Pharmaceutical Manufacturing Facilities of XYZ Limited.

RESPONSIBILITY

The production In-Charge is responsible for the execution of the procedure.

The pharmacist in-charge has to ensure compliance.

PROCEDURE

• Filled capsules that result at the optical inspection stage shall be reprocessed. If the number of rejected capsules is small, i.e. the total weight is less than 500 grams; the capsules are not worth reprocessing and are destroyed.

• The rejected capsules are collected in a polythene bag.
• The operator shall open the capsules and recover the powder into a plane-weighted polythene bag.
• This operation shall be done in a controlled environment of temperature and humidity 20-30°C and 40-70 % respectively.
• When all the capsules have been opened and the powder recovered, the empty shells shall be put in the trash can for waste disposal.
• The recovered powder is weighed and its quantity is recorded on the B.M.R.
• The powder may be handled as below:

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1. It may be filled on the machine and assigned the same batch number as the rejected capsules were having.
2. It may be blended with the next batch and filled.
3. Whichever procedure is followed, it should be clearly mentioned in the B.M.R.

• A full batch upon full analysis may fail to comply with any of the specifications calling for the need to reprocess it. A suitable procedure shall be decided in consultation with Q.C., Q.A and the pharmacist in-charge and full details should be recorded on the B.M.R.

ABBREVIATION

Q.A: Quality Assurance

SOP: Standard Operating Procedure

No. : Number

P.D: Production

Q.C: Quality Control

B.M.R: Batch manufacturing record

°C: Degree Celsius

% : Percentage

ANNEXURE

Nil

REVISION HISTORY

Nil

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