SOP for Storage Procedure of In-Process Capsules

OBJECTIVE

To lay down a procedure for the storage of In-Process capsules.

SCOPE

This procedure applies to the production department in the Pharmaceutical Manufacturing Facilities Formulation division.

RESPONSIBILITY

The capsule-filling operator is responsible for the implementation of the process.

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

PROCEDURE

• The bulk quarantine area is demarcated for in-process capsules.
• The left-hand side is reserved for ‘UNDER TEST’ capsules and the right-hand side for ‘PASSED’ capsules, and these are clearly labeled as such.
• Each batch of the product should be physically segregated by a wooden partition from the other batch (es).
• Each product container should have an ‘IN-PROCESS’ label with the following information:

1. Product name.
2. Batch number.
3. Batch size.
4. Mfg. Date.
5. Exp. Date.
6. Gross weight, Tare weight, and Net weight.
7. Serial No. of the container.
8. Total No. of the containers for the batch.
9. Status of the capsules that is FILLED, INSPECTED/TO BE INSPECTED,
10. POLISHED/TO BE POLISHED.
11. Signature of supervisor.

ALSO READ: SOP for Issuance of Empty Capsule Shells

• The IN-PROCESS label should be affixed on the exterior of each container.
• The container should be stored on H.D.P.E pallets.
• The container should be placed in such a way that all the ‘IN-PROCESS’ labels are facing outwards.
• Once capsule filling is completed the operator should give intimation to Q.A. for sampling and should store the product in the ‘UNDER TEST’ zone.
• After removing samples from each container, Q.A. should affix an ‘UNDER TEST’ label below the ‘IN-PROCESS’ labels.
• Once the product is passed by Q.C., it should be transferred to the passed in-process capsule zone and Q.A. should remove it under the test label and affix a ‘PASSED’ label indicating product release for further processing.

• Q.C should authorize product passing by issuing a release to production staff through Q.A.
• On receiving the release slip from Q.A. the product may then be moved to the next stage of manufacturing.
• The rooms shall be maintained at a temperature between 20-30°C and Relative humidity of 40-70 %. The operators shall report any deviations outside these limits to the department in-charge.
• An operator assigned for the purpose shall record Day conditions of temperature and humidity At three times (9:00 A.M, 01:00 P.M and 5:00 P.M) as per annexure-1

ABBREVIATION

Q.A - Quality Assurance

BL - Beta-Lactam

SOP - Standard Operating Procedure

No. - Number

P.D - Production

Q.C - Quality Control

H.D.P.E - High-density polyethylene

ºC - Degree Celsius

% - Percentage

ANNEXURE

Annexure-1 - Temperature and relative humidity record

REVISION HISTORY

Nil

ALSO READ: SOP for Receipt and Storage of Raw Materials