Malaysian KidneySPA comments...
of pharmaceutical products is required by the local governing body - The Ministry of Health Malaysia (KKM) to conform with stringent requirements laid down for the industry. As hemodialysis concentrates (HDC) are also produced by these manufacturers, therefore production of HDC also needs to conform with these strict and stringent requirements.
Lets start from the beginning, in order to set up a pharmaceutical manufacturing facility, a prospective company need to obtain numerous licenses from many government agencies. To fulfill all the requirements takes months if not years and numerous visits and inspection by the relevant authorities. A comprehensive manufacturing facility may cost tens of millions of Ringgit and over time, investment may exceed hundreds of millions of Ringgit.
To register a new pharmaceutical product too requires a heap of paperwork, time and expense. To register a new pharmaceutical product not in the local market may need clinical study and this will incur cost.
The company then has to decide which international pharmacopeia standard it wishes to follow, British Pharmacopeia (BPC), United States of America Pharmacopoeia (USPC) or the European Pharmacopeia (EUPC). Having decided on one, then all products manufacture must conform the pharmacopoeia standard requirements.
Raw material too are only source from reputable suppliers. These suppliers are audited from time to time by the company to ensure they comply with international standards. Only materials that are pharmaceutical grades and conform to the pharmaceutical standards are used. They are kept in a secured area in the manufacturing plant in order to ensure its safety link is maintained.
The production process is a tedious process of of make analysis after analysis to ensure that the electrolyte composition is within the range stipulated in the pharmaceutical standards. After the quality control officer is satisfied, then only will the HDC be bottled. Although it is a non sterile solution but steps are taken to minimised contamination. Manufacturers never reuse canisters but HD centre do.
The bottled HDC solutions is then quarantined for 10-14 days. Tests are done to ensure that the HDC solutions conform to the pharmceutical standards employed. After being satisfied, the quality assurance officer will sign off the batch for release.
The in-house laboratory used for testing of products produced is also accredited and accorded the latest ISO certification.
Most importantly, the production facility is audited by the National Bureau of Pharmaceutical Control of the KKM. Failing to pass their audit will result the shutting down of the whole production facility until the fault is resolved to their satisfaction.
As manufacturers have to comply with these stringent requirements to operate, do you think it is advisable to allow HD Centres to product their own HDC? Suppliers of Bicarbonate powders can only vouch the powder supplier IF mixed with the correct amount of water would give the stipulated concentration of electrolyte but would and could they vouch for what actually takes place during the mixing procedure?
HD centres do not have the laboratory facilities to monitor the HD concentrate solution while being mixed. Do they quarantine each a every batch before final testing and before being allow to be used. Do they have qualified personnel with the right qualification and equipement to carry out the task?
Lastly, I wish to revisit an open letter by the President of the Medico Legal Society of Malaysia which was posted on this blog on 29/10/2010.Read letter here Why have double standards!!! We should strived for the highest standard for the best outcome and well-being of the patients. Never compromised!!!
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