Complete IPQC Tests for Pharmaceutical Tablet Dosage Form

The assessment of tablet quality must be undertaken during the development phase of the product. During the product's design and assembly, it is imperative to establish the physical, chemical, and biological parameters necessary to ensure compliance with quality requirements and the setting of quality objectives.

The utilization of in-process quality control (IPQC) testing is crucial during production to guarantee the quality of the final product. These tests, conducted throughout the manufacturing process, enable the monitoring and adjustment of operations to ensure that the product aligns with specifications, ultimately resulting in tablets of excellent quality. The main aim of IPQC is to prevent or rectify errors at each stage of production, thus yielding an impeccable finished product.

Once the manufacturing process concludes, finished product quality control (FPQC) tests, in accordance with the specifications outlined in the pharmacopoeia, are performed on the pharmaceutical tablets. Such tests are instrumental in assessing whether the quality parameters fall within acceptable limits. The purpose of this study is to provide IPQC and FPQC testing for pharmaceutical tablets in accordance with the pharmacopoeia guidelines.

Rejected  in-process materials should be identified and controlled under a quarantine system designed to prevent their use in manufacturing

DEFINITION OF IPQC

IPQC stands for IN PROCESS QUALITY CONTROL .

These are checks that are carried out before the manufacturing process is completed. The function of of in-process controls is monitoring and if necessary adaption of the manufacturing process in order to comply with the specifications .this may include control of equipment and environment too. In-process materials should be tested for identity, strength, quality and purity as appropriate and approved or rejected by the quality control unit during the production process. Rejected  in-process materials should be identified and controlled under a quarantine system designed to prevent their use in manufacturing .Written procedure should be established and followed that describe the in-process controls and tests as specified

IPQC testing of pharmaceutical tablets was regulates by various physical parameters:

Size and Shape:

The tablet's size and configuration can be monitor and managed, an attribute verified by the device during the compression process.

Color and Odor: Many industries use color as an important method for quick identification and customer acceptance. But, this should be the same on the same floor, from floor to floor, from place to place. An odor coming from the medication stack may indicate an ongoing problem. E.g; Dissolved aspirin tablets produce an acetic acid odor characteristic of the drug. Vitamins have a unique smell. Taste is important to consumer acceptance of chewable tablets.

Thickness: The performance of the tablet is exclusively influenced by its thickness, which can be evaluated by observing the dimensions of its various layers through a microscope. An alternative approach involves incorporating 5 or 10 layers into the seating and potentially utilizing a sliding scale to ascertain the overall thickness.

Weight Variation Test: The USP weight change test is an analytical procedure in which 20 tablets are weighed individually to determine the average weight. The weight of each pill is compared to the average weight. The results of the weight change test are presented as percentages.

Hardness Test: A quick testing tool, the Ketane tablet hardness tester is used to assess tablet hardness, especially when using a variation of the Monsanto hardness tester. The device consists of a cylindrical container containing a compression spring placed between two pistons. When the bottom piston hits the ground, the first measurement is taken. The threaded bolt is pressed against the upper piston, causing the plate to break. As the spring is compressed, the pointer moves on a calibrated scale inside the container to show the force of application. The force required to break is expressed in kilograms.

Friability Test: Laboratory analysis of tablet friability requires the use of Roche friabilator. Take 20 tablets and put them in the machine, applying a rotation speed of 25 rpm for 4 minutes. The tablets are compressed and weighed again. The difference between the initial and final stresses is used to determine a percentage value that represents friability.

Disintegration Test: This test refers to check the time required for tablet disintegration.

QUALITY CONTROL EQUIPMENTS

• Friabilator

• Disintegration apparatus

• Hardness Tester

• Vernier Caliper

Course Eligibility :

Diploma Pharmacy Students

Bachelor of Pharmacy Students

Master of pharmacy Students

Pharmaceutical industry

Pharma Professionals

Benefits of course:

1. Learning of IPQC Tests

2. Tablet Dosage quality control

3. Hadling of Equipments

4. Theory & Practical demonstration

5. Certificate of completion