1. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency GMP Workshop Kuala Lumpur 14-16 Nov 2005 1 Prepared by : Mr. Haryanto Susilo - Indonesia Ms. Yupa Tiengthavaj - Thailand Mr. Vo Van Duc - Vietnam Approved by : GMP Cosmetic ASEAN Team SUPPLEMENTARY ASEAN GMP TRAINING MODULE WEIGHING PRINCIPLE

2. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency GMP Workshop Kuala Lumpur 14-16 Nov 2005 2  Weighing should be carried out - in defined areas - using calibrated equipment.  All weighing and measurement carried out should be - recorded - counter checked WEIGHING & MEASUREMENT

3. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency GMP Workshop Kuala Lumpur 14-16 Nov 2005 3  QC is responsible for sampling, testing, release and rejection materials..  The process of weighing or dispensing materials for production, should be done in accordance with an approved procedure.  Only designated persons, who are qualified and trained, should dispense materials for production.  Dispensing is a critical stage in the manufacturing process and should be properly controlled.  It is important that the correct material, and the correct quantity of material is dispensed (accurately weighed) for the product to be manufactured. WIGHING PRINCIPLES (1)

4. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency GMP Workshop Kuala Lumpur 14-16 Nov 2005 4  Weighing into a cleaned and labeled containers  Ensure that label container is not lost & reflect all relevant information  Second person who performs an independent check of the dispensing activity  Materials dispensed for a particular batch of product, should be kept together (e.g. on a pallet) and properly labeled to identify the product and batch it was weighed out for.  Evaluation on SOP for weighing to ensure that the dispensing activity complies with GMP requirements to prevent contamination, cross-contamination and mix-ups. WIGHING PRINCIPLES (2)

5. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency GMP Workshop Kuala Lumpur 14-16 Nov 2005 5  The area of weighing should be:  separated from activities of mixing, filling or warehouse  clean, dry, well maintained  only approved raw material and raw material with identification label should be allowed to be in this area.  separate area for clean and dirty weighing equipment.  The weighing device should be :  appropriate and well calibrated  clean ( balances, pails, scoops pumps etc )  Clean equipment should be well identified.  Production documents :  raw & packaging material request should use a dedicated documents. rvisor of production and warehouse  request and delivery of raw/packaging materials should be acknowledged by supervisor of production and warehouse WIGHING PROCESS (1)

6. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency GMP Workshop Kuala Lumpur 14-16 Nov 2005 6  Prior the weighing process  Check raw material name or raw material code  Presence of lot number and other information (safety etc )  Verify the quantity of raw materials to be weighed  Use appropriate weighing equipment ( balance, pails )  During weighing process :  Finished one batch before weighing another batches  Identification label on weighed raw materials should be put immediately after weighing  Weighing same raw materials for different batches should be avoided.  Provide dust collector for powder weighing  Put together raw materials for one batch in same pallet and put identification tags on it.  Avoid using “ intermediate container “ during weighing” WIGHING PRINCIPLES (2)

7. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency GMP Workshop Kuala Lumpur 14-16 Nov 2005 7  The weighing record :  weighing activities should follow a Standard Operating Procedure  weighing data should be recorded and kept, to be compiled in the batch records  weighing results should be counterchecked by different person before starting the mixing.  use of different lots of same raw material in one batch should be noted ( lot no, quantity of each lot )  Guidance for raw material weighing should be established: WIGHING PRINCIPLES (3)

8. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency GMP Workshop Kuala Lumpur 14-16 Nov 2005 8 WIGHING TAG

9. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency GMP Workshop Kuala Lumpur 14-16 Nov 2005 9