Good Manufacturing Practices
GMP stands for the international term “Good Manufacturing Practices” and a manufacturing plant is cGMP certified after succeding in strict inspections by the Health Ministry, according to the international set standards.
Blesstia is a pharmaceutical company holding a full cGMP certificate issued by the Health Ministry as well as Ministry of Agriculture, as published in the European Electronic Database EudraGMDP, and it is one of the few pharmaceutical companies worldwide that produces homeopathic starting materials while possessing full GMP certification.
GMP covers all factors involved in the manufacturing of medicinal products and can be concisely described as follows:
The people must be specially qualified for the work position they are assigned. There are eight distinct work positions with specific duties and responsibilities defined by the GMP in such a way that they are functionally coordinated and operate hierarchically.
The staff members have to go through special medical tests before employment which are to be repeated regularly. In case of a cold or illness, they are not permitted to enter the manufacturing plant; the staff follows special training courses and meets the required training standards on an ongoing basis; the staff members work in pairs and complete all relevant documents in real time, so as to achieve double cross-checking. Subsequently, the supervisor performs a third check on their work and documentation, so as to eliminate the risk for human error.
The premises: Must demonstrate a special layout so that the personnel movement flows towards one direction. The walls and ceilings must be coated with antibacterial dyes and floors must have antibacterial coatings. All areas are monitored and controlled for temperature and humidity and those classified under the 'cleanroom environment' category, must retain positive air pressure. Premises must also have air ventilation which is monitored by gauges calibrated regularly by specialized service crew.
The Raw materials: Even though they are already certified by the supplier, quality tests have to be repeated upon receipt and prior to their use, conducted by the quality control laboratory of the company, so as to double-check and double-certify that the said materials are not contaminated and that they comply to their specifications. All materials must be stored in areas with controlled environmental conditions.
The Equipment: Must be purchased from certified suppliers that comply with the safety and quality specifications of the European Union.
After their installation they are qualified and calibrated by certified technicians, whereas their performance and precision are regularly monitored and requalified so as to ensure consistency.
The Products: The GMP methods and practices are structured in such a way that ensures that the final products are protected from the risk of human error and meet all quality and safety standards. Product samples from each batch are kept in assigned areas, being at the disposal of the Health Ministry inspectors in case of investigation.
The following few examples convey the essential contribution of the GMP guidelines in the production of quality homeopathic medicines:
Homeopathic medicines are manufactured by a procedure involving sequential dilutions (decimal or centesimal) and succussions (i.e. vigorous shakings), called 'Potentization'.
The most commonly used dilutions (or so called 'potencies') of homeopathic medicines are the 30 CH, 200 CH, 1000 CH and 10000 CH, that is, the 30th, 200th, 1000th and 10000th centesimal dilution respectively.
In order to prepare the 30CH dilution according to the HAHNEMANNIAN potentization method, a series of successive dilutions and succussions of the pharmaceutically active substance must be executed 30 times, in a ratio of 1:100 - where 1% is the active substance and 99% is the diluent purified water or ethanol. For the transfer of the materials from one vial to the next, pipettes and dispensers are utilized so as to ensure the precision of the measurements.
In order to be prepared the 200CH dilution according to the HAHNEMANNIAN potentization method, the series of successive dilutions and succussions of the pharmaceutically active substance must be executed 200 times, in the manner described above.
In order to be prepared the 1000CH (or 1M) dilution according to the HAHNEMANNIAN potentization method, the series of successive dilutions and succussions of the pharmaceutically active substance must be executed 1000 times, in the manner described above.
In order to be prepared the 10000th (or 10M) dilution according to the HAHNEMANNIAN potentization method, the series of successive dilutions and succussions of the pharmaceutically active substance must be executed 10000 times, in the manner described above.
If the entire potentization procedure described above, is performed in an ordinary environment that it doesn't conform to the GMP cleanliness standards, then floating particles, air pollutants and contaminants, as well as bacteria and biologic material generated from the environment or people in the area, will be aspirated and dispensed by into the final solution 30, 200, 1000 or 10000 times. Therefore, the product and materials will be contaminated 30, 200, 1000 or 10000 times and significantly divert from the quality requirements set by the Homeopathic Pharmacopoeias.
The critical issue in this case is not the contamination per se, which is by itself incompatible with the good manufacturing practices, but most importantly the additional load of organic and inorganic material added in each potentization step. Consequently, the standardization in ppm of the dilution is succesively altered and what is potentized is not, for example, the pure PULSATILLA substance but a new unknown material instead, with different standardization.
Often, the new standardization of the substance due to the modification of its biologic nature but also because of its contamination, greatly diverts from the acceptable limits, and therefore the final product becomes unsuitable for use.
The preparation of homeopathic medicines in premises without controlled temperature and humidity conditions, results in volume and weight fluctuations of the diluent Ethanol. Substantial fluctuations can be noticed especially between warmer and cooler days, which leads to dilutions not produced with the precision and safety that the GMP guidelines demand.
The volume and weight measurements must be performed with calibrated precision scales and pipettes so as to ensure accuracy of measurements. When measurements are not made by regularly monitored and calibrated instruments, substantial diversions from the reference figures might occur; the diversions from the proper volume grows exponentially in the final homeopathic product, since the error is repeated by 30, 200, 1000 or 10000 times.
Once one becomes familiar with the GMP guidelines, they will be able to detect many more reasons that justify the necessity for applying the GMP in the preparation of homeopathic medicines in order to ensure the high quality of the final product and safeguard public health.
The above brief description conveys the safety guaranteed by the cGMP system which BLESSTIA LTD proudly abides by.