Cold Chain Products handling in pharmaceuticals

1.0 OBJECTIVE 

1.1 To lay down a procedure for handling of cold chain products from the stage of dispensing to dispatch of the finished goods. 

2.0 SCOPE 

2.1 This procedure shall be applicable for all the cold chain products manufactured at XXX COMPANY. 

3.0 RESPONSIBILITY    

3.1  Chemist – QA 

3.2  Chemist – Production 

5.0 PROCEDURE 

5.1 Dispensing: 

5.1.1 The approved active pharmaceutical ingredient shall be stored at 2 – 8 ⁰C until use

5.1.2 Care shall be taken to ensure that the exposure time is minimum while handling the active pharmaceutical ingredient.

5.1.3 Dispensing shall be carried out just before or on the day of compounding.

5.1.4 The Dispensed active pharmaceutical ingredient shall be stored at 2 –8 ⁰C till the start of the compounding activity.

5.1.5 The remaining raw material shall be shifted immediately to the refrigerator at 2–8 ⁰C

5.1.6 Dispensing shall be carried out as per the instructions in the BPCR 

5.2 Compounding

5.2.1 The WFI used for compounding is collected in a SS316L jacketed vessel and allowed to attain a temperature as specified in the BPCR using chilled water circulation before compounding is started.

5.2.2 The temperature of WFI is checked and recorded during the stages of processing as per the BPCR.

5.2.3 The various stages of processing shall be as per the BPCR.

5.2.4 The bulk solution that is manufactured and filtered shall be stored at 2-8⁰C or at a temperature specified in the BPCR in the aseptic processing area under LAF.

5.2.5 The Bulk solution storage time shall be as per the BPCR. 

5.3 Filling

5.3.1 The temperature of bulk solution during the entire process of filling is maintained at 2 -8⁰C

5.3.2 In case of Off- line filtration the filling of the bulk solution is carried out on the same day of compounding to avoid the holding of filtered bulk for longer duration.

5.3.3 The filled containers are collected in crates, duly labelled with the details of Product name, Batch No and lot No and immediately transferred to walk in cooler till they are taken up for visual inspection.

5.4  Visual inspection

5.4.1 A single crate of the filled containers of the required batch to be inspected is taken out from the walk in cooler and transferred to packaging block. 

5.4.2 The filled containers are allowed to attain the room temperature (25⁰C) before carrying out the inspection. 

5.4.3 The containers are wiped to remove the moisture on the container before they are taken up for inspection. 

5.4.4 Inspection shall be carried out by validated operators as per the approved SOP.  

5.5 Labelling

5.5.1 The inspected good quantity shall be taken up for on line labelling and packing as per the requirement or transferred immediately to the walk in cooler and stored at 2 –8⁰C till they are taken up for further processing. 

5.6 Packing 

5.6.1 A single crate of the labelled container of the required batch to be packed is taken out from the walk in cooler and transferred to packaging block.

5.6.2 The labelled containers are allowed to attain the room temperature (25⁰C) before carrying out packing activities.

5.6.3 The initially removed labelled containers are packed and the finished product is immediately transferred to the walk in cooler before the next crate is taken up for packing.

5.6.4  The final packing of the finished product is carried out on the day of despatch where the final finished product is packed into EPS boxes using freezol bags (-20⁰C)

5.7 Dispatch

5.7.1 The finished goods are despatched in a temperature-controlled van to maintain the temperature of the product during transit.

6.0 ANNEXURES: NIL

7.0 CHANGE HISTORIY