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SOP for Storage Procedure of In-Process Capsules

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

SCOPE 
This procedure applies for production department in Pharmaceutical Manufacturing Facilities Formulation division. 

RESPONSIBILITY 
The capsule filling operator is responsible for implementation of the process. 
The Beta-Lactam In-Charge is responsible for the execution of the procedure. 

PROCEDURE 
  • 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: 
             Product name. 
             Batch number. 
             Batch size. 
             Mfg. Date. 
             Exp. Date. 
             Gross weight, Tare weight, and Net weight. 
             Serial No. of the container. 
             Total No. of the containers for the batch. 
             Status of the capsules that is FILLED, INSPECTED/TO BE INSPECTED, 
             POLISHED/TO BE POLISHED. 
             Signature of supervisor. 
  • 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’ labels below the ‘IN-PROCESS’ labels. 
  • Once product is passed by Q.C, it should be transferred to passed in-process capsule zone and Q.A should remove under test label and affixed ‘PASSED’ label indicating product release for further processing. 
  • Q.C should authorized product passing by issuing 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 temperature between 20-30°C and Relative humidity 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(s) 
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 poly ethylene 
ºC - Degree Celsius 
% - Percentage

ANNEXURE(s) 
Annexure-1  -  Temperature and relative humidity record 

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