Good Manufacturing Practices – GMP

GMP

Blesstia is a pharmaceutical company holding a full cGMP certificate issued by the Health Ministry and published in the European Electronic Database EudraGMP, and it is one of the very few pharmaceutical companies worldwide that produces homeopathic raw materials possessing full GMP certification.

GMP includes all the factors involved in the manufacturing of medicines and can be concisely described as below:

The People

The people must be specially qualified for the specific job post they are assigned. There are eight distinct job posts with specific duties and authorities defined by the GMP in such a way that they coordinate functionally and operate hierarchically.

The staff members have to go through special medical tests before being employed which are to be repeated regularly. In case of a cold or illness, they are not permitted to enter the manufacturing plant; they follow special training courses and meet the required training standards on an ongoing basis; they work in pairs and sign all related documents in real time, so as to achieve double cross-checking. Subsequently, two more inspectors perform a triple-check on their work and complementary documents, in order to totally eliminate the risk of human error.

The Premises

The premises: Must demonstrate a special layout so that the personnel movement flows towards one direction only. The walls and ceilings must be painted with antibacterial dyes and floors must have antibacterial coatings. All areas are monitored and controlled for temperature and humidity and those classified under areas of sterile environment must retain positive air pressure. Premises must also have air ventilation which is monitored by special gauges calibrated regularly by a specialized service crew.

The Raw Materials

The raw materials: Even though they must be certified from the supplier, chemical and other tests have to be repeated prior to their use by the chemical analysis lab of the plant, so as to double-check and double-certify that these do not contain any chemicals, pesticides, heavy metals etc; must be stored in warehouses which have set specifications for fixed temperature and humidity conditions.

The Machinery

The machinery: Must be purchased from suppliers that comply with all the safety and quality specifications of the European Union.

After their installation, they are calibrated by authorized, certified and approved by the Health Ministry technicians, whereas calibration is performed systematically to attest their consistency in terms of performance and precision.

The Final Products

The final products: The GMP method and practices are structured in a way that ensures that the final products are completely protected from the risk of human error and meet all quality and safety standards. A set of sealed samples from each batch, are kept in a special locked area at the disposal of the Health Ministry inspectors in case of any type of investigation.

The most commonly used dilutions of homeopathic medicines are the 30 CH, 200 CH, 1000 CH and 10000 CH, that is the 30th, 200th, 1000th and 10000th centesimal dilution.

In order to be prepared the 30th dilution according to the HAHNEMANNIAN method, the initial pharmaceutical substance will be 30 times aspirated and dispensed with a precision pipette from one vial to the next.

In order to be prepared the 200th dilution according to the HAHNEMANNIAN method, the initial pharmaceutical substance will be 200 times aspirated and dispensed with a precision pipette from one vial to the next.

In order to be prepared the 1000th dilution according to the HAHNEMANNIAN method, the initial pharmaceutical substance will be 1000 times aspirated and dispensed with a precision pipette from one vial to the next.

In order to be prepared the 10000th dilution according to the HAHNEMANNIAN method, the initial pharmaceutical substance will be 10000 times aspirated and dispensed the precision pipette from one vial to the next.

If the entire above procedure is performed in an ordinary environment that is not clean and sterile as GMP requires, than floating particles, air pollutants and contaminants, bacteria and biologic material from the breath of the people in the area will be aspirated and dispensed by the pipette into the final solution 30, 200, 1000 or 10000 times. Therefore, the initial pharmaceutical substance will be contaminated 30, 200, 1000 or 10000 times and significantly divert from the strict regulations set by the European Homeopathic Pharmacopoeia.

The critical issue here is not the contamination, which is incompatible with the good manufacturing practices, but mainly the additional load of organic and inorganic materials which is added in each potentization. Consequently, the standardization in ppm of the initial solution is altered and what is potentized is not, for example, PULSATILLA but instead a new unknown material, with a different standardization.

Often, the new standardization of the initial substance due to the modification of its biologic nature, and also because of contamination, greatly diverts from the accepted limits, therefore the final medicine becomes unsuitable for use.

The preparation of homeopathic medicines in premises without steady temperature and humidity, results in volume and weight fluctuations of the solvent ethanol 96%vv. Great fluctuations can be noticed especially between warmer and cooler days, which means that the dilutions are not produced with the exactness and safety that the GMP regulations demand and ensure.

The diversions from the proper volume grows exponentially in the final homeopathic medicine since the error is repeated by 30, 200, 1000 or 10000 times.

The volume and weight measurements must be performed with precision scales and pipettes to ensure measuring accuracy of 1/1000 of the gram. When measurements are not made by regularly monitored and calibrated instruments, lead to great diversions from the correct figures, and the errors increase exponentially, especially in the preparation of homeopathic medicines where each error is repeated 30, 200, 1000 or 10000 times.

Once one becomes familiar with the GMP rules and comprehends them satisfactorily, he will be able to notice many more reasons that justify the necessity for applying GMP in the preparation of homeopathic medicines to ensure the high quality of the final product and safeguard public health.

The above brief description conveys the seriousness and safety guaranteed by the cGMP system which proudly offers with its products Blesstia LTD.

You may choose to utilize them to enrich and expand your own work.

We remain always at your disposal.

Below is a small indicative list of the Standard Operation Procedures (SOP) followed by Blesstia LTD.