MANUFACTURING PROCESS AND FLOW CHART - TABLETS
A. OBTAINING RAW MATERIAL AND MATERIALS:
B. The raw material and other materials are purchased from recognized manufacturers of the nutritional supplement industry in the United States of America.
C. RECEIPT AND STORAGE OF RAW MATERIAL AND MATERIALS:
• The raw materials and supplies necessary in the manufacture of the product, are obtained from qualified suppliers, all raw materials and supplies must be accompanied by the corresponding analysis certificates that guarantee their quality and conditions for process.
• The main raw materials, in this case, the active ingredients, the other ingredients, and containers are received at the plant along with their analysis.
• They are identified and marked by assigning their label, codes according to their nature, physical characteristics and supplier according to the established format and protocol.
• Physical comparisons are made with standard materials that exist in the Quality Control Depaitment.
• Once the inputs have been fully identified and marked, they are stored in a quarantine ai·ea where all the physical standards for proper storage are available, pending the opinion of the Quality Control Department.
• The Quality Control Depaitment perfonns the checks with the analyzes presented by the supplier, corresponding to organoleptic analysis, identification, chemical analysis to determine the active substance and comparisons with the existing standard samples.
• If the tests yield satisfacto1y results, the order is extended to accept the material, otherwise if they do not meet the quality requirements they are returned by report to the supplier.
D. SELECTION AND WEIGHT OF COMPONENTS:
• The raw material is identified by means of its labels and is compared with the standard samples stored in the Quality Control Department, checking whether their physical characteristics ( color, smell, texture, taste, etc.).
• All materials to be used in the process, once identified, are marked and maintained in an area designated for this purpose before use. • The raw material already identified is weighed and separated according to the needs of the quantities to be produced and located in the area designated for production.
E. FORMULATION:
• The formulator prepares the batch manufacturing record (BMR) with the requested formula for the desired quantity to manufacture and send to the Manufacturing Manager for checking and producing.
F. DISPOSITION OF ELEMENTS INTERVENING IN THE PROCESS.
(Materials and supplies, personnel, machinery and equipment, process areas)
• Once the production requirement has been submitted to prepare the product, it is received by the Quality Control Department, which performs a thorough inspection of the area and the equipment in order to be able to declare the installation ready for the process, documenting the results of inspection according to established procedures.
• A copy of the production order arrives at the Quality Control Department. This checks to which master formula corresponds and assigns a lot number that will go through the entire production process including packaging and marketing.
• The quality control staff performs a thorough inspection of the area and the production equipment in order to be able to declare the installation ready for the process, documenting the results of the inspection according to the established procedures.
• Extends the order to bring supplies from the general store, the active ingredients, the other ingredients, and packaging which have been previously collated identified by assigning the lot number that will go through the entire production, packaging, and marketing process.
• In the batch register all the procedures to be followed in the production process will appear, as well as the corresponding specifications depending on the type of process.
G. ELABORATION PROCESS.
WEIGHTING AND MIXING:
The operator weighs each raw materials related to the batch manufacturing record. It is checked by the manufacturing Supervisor Each raw material is added into the blender, and they are mixed. The blend 1s placed m polyethylene drums and got it to the encapsulation room.
PRESS TABLET PROCESS:
To form a tablet, the granulated powder material must be metered into a cavity formed by two punches and a die, and then the punches must be pressed together with great force to fuse the material together.
A tablet is formed by the combined pressing action of two punches and a die. In the first step of a typical operation, the bottom punch is lowered in the die creating a cavity into which the granulated feedstock is fed. The exact depth of the lower punch can be precisely controlled to meter the amount of powder that fills the cavity. The excess is scraped from the top of the die, and the lower punch is drawn down and temporarily covered to prevent spillage.
Then, the upper punch is brought down into contact with the powder as the cover is removed.
The force of compression is delivered by high pressure compression rolls which fuse the granulated material together into a hard tablet. After compression, the lower punch is raised to eject the tablet.
H. QUALITY CONTROLS CARRIED OUT DURING THE MANUFACTURE PROCESS.
Controls carried out by the Quality Control Depaiiment to the product: Tablet gross weight control: In this control, the uniformity of the weight of the tablet is recorded, proceed as follows, it is taken at the beginning of the press tablet process and during the production and intervals of 30 minutes. For this test 25 tablets are used. Calculates the Average Weight (USP/NF <2091>).
General Appearance Control: For this control it is inspected at the beginning of the press tablet process and during production at 60-minute intervals. 100-200 tablets are used for this test.
Checking the size, shape, and color of the Tablet.
Disintegration Control: In this control it is inspected during production at 60-minute intervals.
For this test 6 tablets are used. Record the time of disintegration of tablets (:S30 minutes) (USP/NF <2040>).
Friability Control: In this control it is inspected after production, taking a sample of 10 whole tablets. The tablets should be carefully dedusted prior to testing. Accurately weigh the tablet sample and place the tablets in the drum. Rotate the drum 100 times and remove the tablets.
Remove any loose dust from the tablets as before, and accurately weigh. For this test 10 tablets are used. Record the friability of tablets (<1%) (USP/NF <1216>).
Hardness Control: In this control it is inspected one tablet during and after production. For this test the Hardness Tester is used. Record the hardness of the tablets (Kp) (USP/NF <1217>).
Thickness Control: In this control it is inspected one tablet during and after production. For this test the caliper is used. Record the thickness of the tablets (mm) (USP/NF <1217>).
I. QUALITY CONTROLS PERFORMED TO THE FINISHED PRODUCT
Controls canied out by the Quality Control Department to the product. The certificate of analysis is prepared.
• Once the order of the Quality Control Depmtment has been received, the finished product passes to the quarantine area, where the data reported by production are verified in terms of the process performed, batch registration and established procedures. A comparison is made regarding the presentation of the product, homogeneity of the tablets of the batch, and other aspects that guarantee a good quality of the finished product.
• Samples are sent to the laboratory for physicochemical and microbiological tests of the finished product. If the product meets all the characteristics and quality parameters established, it is ordered to go to the general store as a product suitable for distribution and marketing.
• The quality tests carried out, ce1tificates, analysis tests on raw materials and supplies, on the product in process and finished product carried out by the laboratory are maintained up to three years after the date of manufacture of the product.
J. PACKAGING PROCEDURE
• The finished tablets, after the final inspection of the press tablet process, are placed in polyethylene drums coated inside by a new polyvinyl bag. These drums are identified with the name of the product and its lot number, closed and taken to the bottling area where they are kept until the moment of counting and bottling. The tablets are packed in bottles containing 30 tablets each.
• The bottles are selected as per customer request. As a safety measure, a laminated liner is placed under the lid, which adheres to the edge of the bottle's mouth pe1manently when the thread of the lid is pressed by induction. • All data on the run to be performed are displayed on the run control board, including size and type of bottle, the size and type of cap, the product and number of the lot to be packaged, the number of bottles to be filled and the content of each bottle, among other information.
• The bottling line, consisting of counting / filling machines, accumulator tables, conductive belts, cappers, sealer, and labeller, is cleaned and checked by the personnel of the Depaitment of Bottling Control. Once the line is cleaned, it is inspected by a representative of the Quality Control Depmtment who authorizes the stait of the run.
• The representative of the Quality Control Department verifies the correspondence between the product, lot number, bottle and cap that is established in the packing order and the materials that will be used for the run, and once confirmed this, authorizes the start of operations.
• During the process of counting and filling the bottles, random samples are taken, but never less than 5% of the run to verify the number of tablets per bottle, the correction of the closure of the bottles, the presence of defective products or presence of foreign matter, security closures. Only the product that meets all the standards is approved for use.
• The finished bottles are packaged in cardboard boxes. The boxes are identified with one of the labels to be used on the bottles, attached to one of its sides. The number of bottles is marked under the label.
K. PRODUCT STORAGE
• The finished product is kept tightly covered and stored in a dry and cool place at a temperature not exceeding 30°C and Relative Humidity of 65%.
L. PRODUCT STABILITY TESTS
• The Quality Control Department perfo1ms product stability tests. These consisted of tests in accelerated conditions (temperature 40°C and relative humidity of 75%) and long-term condicitons (temperature 30°C and relative humidity of 65%) as environmental conditions similar to climatic zone IV. As a result of these tests, it was demonstrated that the product does not lose its qualities for a period of three years; therefore, it is proper to grant it a period of effectiveness for its active ingredients of 3 years from the date of manufacturing.
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