WORK FLOW RELABELLING

- Ask is there new medicines to relabel from suppliers( Busitile, Serolf, Focused), send a mail. If
there is a new supplier ask for their licence and make a contract
- They deliver or we pick up medicines. With an air-conditioned car. Check the “Delivery Note”
and count the boxes. When delivered put the boxes in room( Quarantine).
- If we don’t have appropriate labels they deliver it to us
- Control the room with AC and keep the temperature according to the medicine instructions(
usually between 15-25 C)
- Check the HOBOs if they have enough charge, if they are under 30% than replace the battery
- Take the GRN ( Goods received numbers) book and give GRN to new medicine (blue-black
book)
- Take Batch number book and give a batch number to new medicine (black book)
- Make sure packaging room is clean and clean it before repackaging
- Fill the Cleaning Log Book
- During the repackaging fill the Packing Log Book
- Also take and fill the Ambient Condition Book No. 3
- Make sure there are hair nets, gowns and hand cleaning gel available
- We fill up the Goods received Checking Report paper( from the Standard forms arch file)
- Fill up the Material Requisition Form( Standard Form arch file)
- Also fill up Checking Report For Incoming Medicinal Products For Repackaging( Standard
Forms ach file)
- Checking Report for Repackaged Medicinal Products( Standard form)
- Do the Document Checklist For Medicinal Products for Contract Repackaging
- When repackaging is finished make sure you clean area, check time and read the HOBOS and
file them
- Fill the paper Batch Release Certificate for Medicinal Products for Contract Repackaging
- From the computer Validation Batch file PRINT and FILL UP next papers:
1. Pre manufacturing line clearance
2. Batch record (affix the label)
3. Operators and In-process check
4. Outer package labelling
5. Post manufacturing line clearance
6. Quality control records (2 papers)
- Take the photos of one sample of relabelled medicine
- Fill up the BATCH RELEASE CERTIFICATE FOR MEDICINAL PRODUCTS FOR CONTRACT
REPACKAGING
- All the papers GIVE TO QP to sign them! All papers must be signed by QP and Production
manager!!!
- Make the INVOICE
- When everything is ready and signed we call the contract giver and tell them to pick up
medicines or we deliver it
- Togethter with medicines we give them Batch Release certificate they sign it and we get a
copy and give them invoice or send it by mail