Quality control (QC) is an essential part of the pharmaceutical manufacturing process to ensure

that capsule medications are safe, effective, and consistent. These medications come in two
main types: hard-shell and soft-shell capsules.

Here are the different aspects of quality control for capsule dosage forms:

In-process controls: These controls are performed throughout the manufacturing process to
identify and eliminate potential problems early on. They include:

Raw material testing: Raw materials, such as the drug substance, excipients, and capsule shells,
are tested for quality and purity before being used in production.
Manufacturing process monitoring: The manufacturing process is closely monitored to ensure that
all steps are performed correctly and consistently.
In-process testing: Samples of the capsules are taken at different stages of the manufacturing
process and tested for weight, uniformity, disintegration, and other parameters.
Finished product testing: Once the capsules are manufactured, they are tested again to ensure
that they meet all quality specifications. These tests include:

Physical tests: These tests evaluate the physical properties of the capsules, such as their weight,
size, appearance, and friability.
‫ صورة‬Capsule weight test‫يفتح الرابط في نافذة جديدة‬.

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Capsule weight test
Chemical tests: These tests assess the amount of drug substance in the capsules and ensure
that it meets the labeled potency.
‫ صورة‬Capsule chemical test‫يفتح الرابط في نافذة جديدة‬.
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Capsule chemical test
Dissolution testing: This test measures how quickly the drug substance dissolves from the
capsule. This is important for ensuring that the drug will be absorbed into the bloodstream.
‫ صورة‬Capsule dissolution test‫يفتح الرابط في نافذة جديدة‬.
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Capsule dissolution test
Microbiological testing: This test ensures that the capsules are free of contamination by
microorganisms.
Packaging and labeling: The capsules are then packaged and labeled according to strict
regulations. The packaging must protect the capsules from damage and contamination, and the
label must contain all the necessary information about the medication, such as the drug name,
dosage, and expiration date.

By following these quality control procedures, manufacturers can ensure that capsule
medications are safe, effective, and consistent for patients.