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Helping Improve the Manufacturing of Medicines in Cambodia
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| Cause and effect diagram for drug quality assurance: A document for GMP staff made by Kazuhiro Omata, a GMP specialist at the JPMA.
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The Japan Pharmaceutical Manufacturers Association (JPMA), Kanazawa University, and the Cambodian Ministry of Health have initiated a joint project to combat counterfeit medicines in Cambodia. Since it began last year, the JPMA has provided analytical instruments free-of-charge and also on-site guidance from technical and quality specialists, aiming to strengthen local quality control in Cambodia. In addition to improving the ability to detect counterfeits, the project has helped raise awareness of issues related to the quality of pharmaceuticals, including substandard registered products and problems with the national drug registration system.
The JPMA took the view that the medicine self-sufficiency ratio should be raised in order to promote the supply of safe medicine to patients in Cambodia, and therefore began offering GMP (Good Manufacturing Practice) training to Cambodian pharmaceutical manufacturers in 2008.
1. October 2008
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| An example of poor building conditions: a part of the ceiling in the manufacturing water room. A big space is open with the board peeled off, and the wiring is bare after a piece of electric apparatus has been removed.
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To gain a full understanding of the existing level of GMP in Cambodia, we visited seven major pharmaceutical companies around Phnom Penh and investigated the actual manufacturing practices in operation.
Through this one week investigation the following general conclusions could be drawn:
- Buildings, facilities and equipment in the factories are not kept in sufficiently good condition, and some of the buildings are too old.
- The local staff understand the importance of GMP, but in practice it can be difficult for them to implement.
- There are shortages of both equipment and instruments.
- All manufacturers recognize the importance of improving the level of GMP. It could reasonably be expected that most of the problems would be addressed through an increased understanding of GMP.
On the basis of these results we considered how the JPMA could best contribute to improving the level of GMP in Cambodia.
2. May 2009
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| A picture of the plant inspection and subsequent discussion conducted by Dr. OMATA (center), and staff at the Department of Health in Cambodia. (These ministry staff also learnt about how to conduct an inspection themselves, another benefit of the program.)
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We re-inspected five of the previously inspected seven manufacturers in detail and advised them on the points that could be improved. Working in cooperation, the manufacturers were each requested to draw up a plan for improvement and to implement this themselves.
The re-inspections allowed previous results to be confirmed, and in some areas improvements were found when compared with the previous results of the survey.
The main points of improvement suggested to each company were as follows:
- Education and training should be systematically facilitated.
- SOPs should be completed in full.
- The role of equipment and the meaning of each operation should be fully understood.
- Interception from the outside should be sufficient in terms of construction.
- Rules should be determined by common documentation, not by individuals.
- Packaging materials should be managed and checked.
- The way to correct the record should be properly.
- Lot number management of raw materials for drug formulations should be conducted in observance of the rule of first in-first out.
- The air-conditioning of the warehouse should be controlled so as to consider the quality of the raw material and the product.
- The amount of the raw materials should actually be weighed, not merely assumed based on the amount labeled in the manufacturing records.
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