In-Process Quality Control Tests: Quality in the pharmaceutical industry has become a very important and sensitive issue. Since the world has gathered together to unite its practices, guides, and the launching of the Food and Drug Administration (FDA) current good manufacturing practices (cGMP) for the 21st century – there has been a growing awareness of the significance of the quality of the pharmaceutical products
The purposes of Quality control are to produce a perfect finished product by preventing or eliminating errors at every stage in production. Quality control is teamwork and we have to remember that quality must be built into a drug product during product and process design and it is influenced by the physical plant design, space, ventilation, cleanliness, and sanitation during routine production.
Process testing enables the easier identification of problems.
In-process quality control (IPQC) tests were important to remove problems from every stage in production and maintain the quality of the In-process product with standards as specified in the pharmacopeias.
In-Process Quality Control Tests (IPQC) are accurate and specific for testing of raw materials (RM) to the release of the finished dosage (FD) forms IPQC tests were performed in the production area.
If a defective product batch is identified, that can be corrected by rework. Whereas once that batch has been completed, this may not be possible.
Failure to meet IPC specifications indicates either those procedures were not followed or some factors were out of control. Standard operating procedures (SOPs) should be established in the pharmaceutical industry and followed that describe the IPQCs and tests:
1. Size and shape: The size and shape of the tablet can be dimensionally described monitored and controlled. It is determined by the tooling during the compression process.
2. Colour and odor: Many pharmaceutical tablets use color as a vital means of rapid identification and consumer acceptance. But it must be uniform within a single tablet, from tablet to tablet and from lot to lot. The presence of an odor in a batch of tablets could indicate a stability problem e.g. the characteristic odor of acetic acid in degrading aspirin tablets or could be characteristic of the drugs e.g. vitamins have a characteristic odor. Taste is important in consumer acceptance of chewable tablets.
3. Thickness: The thickness of a tablet is the only dimensional variable related to the process. The thickness of individual tablets may be measured by a micrometer. Other techniques involve placing 5 or 10 tablets in a holding tray, where their total thickness may be measured by a sliding caliper scale. Tablet thickness should be controlled within a ± 5 % variation of a standard. Thickness must be controlled to facilitate packaging. It is expressed in mm.
4. Unique identification markings: Pharmaceutical companies often use some type of unique markings on tablets in addition to color, for rapid identification of their product these markings utilize some form of embossing, engraving, or printing of the company name or symbol or a product code.
5. Moisture content of granules: Granules should possess sufficient strength to withstand normal handling and mixing processes without breaking down and producing large amounts of fine powder. On the other hand, some size reduction during compaction into tablets is desirable to expose the areas of clean surface necessary for optimum bonding to take place so moisture content is a very important factor for producing a good pharmaceutical product.
6. Assay: In a tablet, an active ingredient is present which is called an Active pharmaceutical ingredient. So to prepare the tablet assay has to be done by using a suitable analytical method to produce a good finished product
7. Uniformity of content: A physically sound tablet may not produce the desired effects. To evaluate a tablet’s potential for efficacy, the amount of drug per tablet needs to be monitored from tablet to tablet and batch to batch.
For this test according to BP using a suitable analytical method, determine the individual contents of the active substance(s) of 10 tablets taken at random.
The tablet complies with the test according to BP, if each content is between 85% and 115% of the average content. The tablet fails to comply with the test if more than one individual contents are outside these limits or if one individual content is outside the limits of 75% to 125% of the average content. If one individual content is outside the limits of 85% to 115%, but within the limits of 75% to 125%, determine the individual contents of another 20 tablets taken at random. The tablet complies with the test if not more than one of the individual contents of the 30 tablets is outside 85% to 115% of the average content and none is outside the limits of 75% to 125% of the average content.
8. Uniformity of mass: This test is applicable for uncoated and film-coated tablets. For this test according to BP weigh individually 20 tablets taken at random and determine the average mass. As per BP, the tablet complies with the test if not more than 2 of the individual masses deviate from the average mass by more than the percentage deviation and none deviates by more than twice that percentage.
9. Weight variation test: According to the USP weight variation test is run by weighting 20 tablets individually calculating the average weights and comparing the individual tablet weights to the average. The value of the weight variation test is expressed in percentage.
10. Content of Active Ingredients: For this test according to IP determine the amount of active ingredient(s) by the method described in the assay and calculate the amount of active ingredient(s) per tablet. The result lies within the range for the content of active ingredient(s) stated in the monograph.
11. Hardness Test: For this test one of the earliest testers was the Ketan tablet hardness tester, which is a type of the Monsanto hardness tester to evaluate tablet hardness tester. The tester consists of a barrel containing a compressible spring held between two plungers. The lower plunger is placed in contact with the tablet and zero reading is taken. The upper plunger is then forced against a spring by turning a threaded bolt until the tablet fractures. As the spring is compressed, a pointer rides along a gauge in the barrel to indicate the force. The force of fracture is recorded in kilogram.
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