Why Quality Control is Important in Parenteral Drugs Production

Parenteral drugs are sterile dosage forms intended for administering the drug through any other route apart from an oral route. The parenteral drug administration bypasses the gastrointestinal tract and liver and directly enters the systematic circulation. After the parenteral medication is prepared it is given for quality control process.

Quality control in parenteral drug production

Quality control in parenteral drug production involves sampling, testing, specification, documentation, and release procedures. It is important for a parenteral drug to pass the quality control tests for its sale. The areas in which parenteral quality control is done are incoming stocks, manufacturing and finishing products. The important tests for quality control in parenteral drug production are as follows:

1. Pyrogen testing

Pyrogen is a product produced by metabolism in microorganisms. A gram-negative bacterium gives the most potent pyrogens. After entering in the body, these pyrogens produce a sign of fever, chill, pain, nausea, vasoconstriction in 1 hour and headache. These pyrogens are heat stable, soluble, and are lipo saccharides of bacterial cell wall. To detect the presence of pyrogens in the parenteral medication two test are performed.

One is rabbit test in which the sample is injected into the rabbits. A temperature sensing probe is used to check the temperature under environmental conditions. If the temperature is not shown then the medication is said to be non-pyrogenic. Second is all test, an in-vitro test using pyrogen utilizing the gelling property of lysates. Positive results indicate the presence of endotoxin.

2. Sterility tests

It is the most important test for the Parenteral drug. This test is used to test the absence of all viable microorganisms. The test is performed by two techniques. First is direct transfer method, it is done by direct transfer into a test container to the culture medium.

The incubation is monitored for 14 days. Second is Membrane filtration technique, which is used for liquids, soluble, and powders of bacterial and fungal properties. The test is positive when no growth is seen stating no contamination of bacterial or microbial growth in the parenteral medications.

3. Particulate matter testing

The test is used to check whether the parenteral drugs are free from particulate matter and are clear when inspected. It is done in two ways. One is for the large volume parenteral drugs. It is a filtration by microscopical examination. Second is for small volume parenteral. For this, a light sensor is used that traps the liquid borne particles.

4. Leakage test

This test is done to test the package integrity. It is a viable test as it aims to check the ability of the product to keep contamination at bay. It is important for a parenteral drug to be checked for leakage as a discontinuity can allow the gas and particulate matter to pass through it and cause contamination.

Visual inspection is one of the ways to check for leakage. The second way is by bubble test. In this, the test package is submerged in liquids. A differential pressure is applied and the product is observed for bubbles. Third is vacuum ionization test. It is done for vials or sealed bottles. It is used majorly for online testing of the lyophilized products.


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