GMP-Logo-BlesstiaGMP stands for the international term “Good Manufacturing Practices” and a manufacturing plant is cGMP certified after passing 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 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:

Blesstia Lab ImagesThe 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: 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: 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.
Blesstia Lab EquipmentThe 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.

Blesstia Synthesis Homeopathic Medicine Bottles Group-01The 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.
BIOPHARMACEUTICALBelow are given some examples that convey the essential contribution of the GMP rules in the manufacturing of quality homeopathic medicines:
Homeopathic medicines are manufactured by sequential dilutions decimal or centesimal.

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.

Cleaning of manufacturing and weighing area.
Cleaning of the general areas of the premises.
Clothing, cleanness and hygiene of the personnel.
Disposal of the intermediate potentizations.
Line Clearance, Line Opening, Line Cleaning procedure.
Maintenance of punches and dies.
Manufacturing and bulk packing of inert excipients tablets.
Manufacturing and bulk packing of liquid homeopathic synthesis.
Manufacturing and Packaging of 30CH Homeopathic Liquid Potencies from 12CH.
Manufacturing and Packaging of 6CH homeopathic liquid potencies to 12CH.
Manufacturing of 12CH Homeopathic Liquid Potencies from 6CH.
Manufacturing of 1M homeopathic liquid potencies, from 200CH.
Manufacturing of 200CH Homeopathic Liquid Potencies from 30CH.
Manufacturing of 30CH Homeopathic Liquid Potencies from 12CH.
Manufacturing of a homeopathic liquid potency from a back to a final potency.
Manufacturing of inert excipients tablets.
Manufacturing, Filling and Packing of 200CH Homeopathic Liquid Potencies from 30CH.
Measurement of the differential pressure.
Monitoring and recording of the differential pressure.
Packaging of Homeopathic Liquid Preparations
Packaging of the inert excipients tablets.
Purified Water System Conductivity recording.
Recording of the Conductivity of the Purified Water System.
Recording of the temperature and humidity.
Repacking of inert excipient tablets.
Retail packing of the liquid homeopathic compounds preparations.
Sampling of Finished packed products.
Sanitisation of glass bottles and their caps.
Usage Cleaning and Maintenance of Finpipette Focus Pipette.
Usage Cleaning and Maintenance of Finpippete.
Usage Cleaning and Maintenance of Finpippete.
Usage Cleaning and Maintenance of Potentisation Machine.
Usage Cleaning and Maintenance of tablet press machine.
Usage Cleaning and Maintenance of the sterilizing oven.
Usage Cleaning and Maintenance of the Tablet Press Machine
Usage Cleaning and Maintenance of the Toppete Pipette.
Usage Cleaning and Maintenance of Toppete 100 pipette.
Usage, Cleaning and Maintenance of Tablet Press Machine.
Usage, Cleaning and Maintenance of the Counter Machine.
Usage, Cleaning and Maintenance of the Dispenser 10-100ml.
Usage, Cleaning and Maintenance of the Dispenser Calibrex 520, 1-5ml.
Usage, Cleaning and Maintenance of the Dispenser Optifix Basic 20.
Usage, Cleaning and Maintenance of the Dispenser Optifix Basic 5
Usage, Cleaning and Maintenance of the DY-050 Diamond Potentization machine.
Usage, Cleaning and Maintenance of the electronic metal detector machine.
Usage, Cleaning and Maintenance of the Fume Cabinet.
Usage, Cleaning and Maintenance of the Gilson pipette.
Usage, Cleaning and Maintenance of the Gilson pipette.
Usage, Cleaning and Maintenance of the Gilson Repetman.
Usage, Cleaning and Maintenance of the Gilson Repetman.
Usage, Cleaning and Maintenance of the Heat Sealer machine.
Usage, Cleaning and Maintenance of the HVAC system.
Usage, Cleaning and Maintenance of the Impregnator Equipment IMPRO-3000.
Usage, Cleaning and Maintenance of the Label Machine.
Usage, Cleaning and Maintenance of the Laminar Flow Cabinet.
Usage, Cleaning and Maintenance of the manual centrifugal device.(CL-13)
Usage, Cleaning and Maintenance of the Motic Microscope.
Usage, Cleaning and Maintenance of the Palson Vacuum Cleaner.
Usage, Cleaning and Maintenance of the pipette.
Usage, Cleaning and Maintenance of the Precision Balance.
Usage, Cleaning and Maintenance of the Precision Balance.
Usage, Cleaning and Maintenance of the Pressure Steam Sterilizer.
Usage, Cleaning and Maintenance of the Purified Water System.
Usage, Cleaning and Maintenance of the Refractometer HY-511.
Usage, Cleaning and Maintenance of the Tablet Four Tester.
Usage, Cleaning and Maintenance of the Thermometers.
Usage, Cleaning and Maintenance of the Thickness Tester.
Usage, Cleaning and Maintenance of the TOP-pipette 100.
Usage, Cleaning and Maintenance of the Water Conductivity Meter.
Using of the Liquid Potencies Balance label.
Cleaning of the Laboratory shoes.
Hazardous Chemical Substance Management
Pest Control.
The air ventilation system for the general areas.
Usage, Cleaning and Maintenance of the Electric Insects Traps.
Usage, cleaning and maintenance of the Hunan Kertone Water Purification System.
Retention Samples of Raw Materials and Finished Products.
Testing Requirements for Raw Materials, Packing Materials, Finished Goods.
Assign of Codes to Blesstia Products
Batch Documentation Checklist
Change Control System
Codes assigning to Blesstia Materials
Complaints and Defect Report Procedure.
Creation and Maintenance of Production Logbook.
Deviation Report System.
Disposal of products and materials
Documentation Rule for GMP documents.
Documents Management System.
Evaluating Batch Documents for Release for Sale from QP
GMP Audit Procedures.
Investigation Process for Quality Concern.
Job description for Key Personnel
Preparation Maintenance and Change of a Master Document.
Procedure for product Identification and Traceability.
Recall or Freeze Procedure.
Selection and Approval of a Vendor.
Stability Studies on Finished Products.
Verification of the electronic balances with standard weights.
Dispatch of Goods from Ready Products Warehouse.
Issuing Back liquid potencies from Ready products Warehouse to production for final Potentization.
Issuing Returning or Rejecting Materials.
Labeling of Blesstia Products.
Packing component requisition and reconciliation records
Quarantining, Sampling, Testing, Releasing of Raw Materials to production.
Sampling of components and printed materials.
Sampling of Raw Materials.
Starting materials-raw materials goods, inward procedure.
Transfer of Finished Goods to Quarantine and Ready Products Warehouse.
Transfer of Inert Excipients Ready Mixture from Warehouse Use to Weighing area
How to write training materials
Training of the Personnel.
Calibration and Maintenance Schedule.
Periodical Check of the Electrical installations, and preventive maintenance of the Plants.
Split Units Filters Maintenance.
Security of the Plants
Communication between members of the staff with memos.
Disease Report System.
Employment of New Personnel.
Entering and Movement of Visitors, Maintainers and Suppliers in the Laboratory.
Movement of personnel in the Laboratory.
Returning back to Job after sick-leave.
How to prepare a Design Qualification Protocol
Process Validation of the Purified Water System Production.
Revalidation Procedure.
Preparing and Sending of the order.
Material Purchasing Information Record
Replenishing Company’s Consumables