Quality assurance is a vital process that helps ensure products meet a business's predetermined quality standards. Through this process, a company can improve the quality of its products and provide better satisfaction to its customers. On the other hand, quality control is a crucial component of process control that affects a company's quality management system. It helps detect errors due to different factors such as test system failure, adverse environmental conditions, or operator performance. Quality control provides essential information regarding test results' accuracy and reliability before patient results are reported.

In-process quality control automates all quality check processes, which helps drug manufacturers reduce effort, time, cost, and clutter. The process provides various test reports in a concise manner for a batch. These checks are carried out before the manufacturing process is completed. In-process quality control tests include Assay, Dissolution, Moisture content, Color, Weight, Surface condition, and Odor.

Assay is an investigative procedure that determines the existence and amount of a substance. This procedure checks its specificity with the pharmacopeial standards of quality, purity, and strength. The Dissolution test, on the other hand, checks the product's compatibility with the dissolution requirements by determining the rate at which the product dissolves in a defined medium and under defined conditions. Moisture content detection is also essential, as many pharmaceuticals contain water either in absorbed form or as hydrates, and its detection is necessary for concurrence with official standards.

Color, odor, surface condition, and weight are also checked during the quality control process. Homogeneity, intensity, and nature of the color should be documented. Odor can prevent distraction when handling similar suppositories and is a good symbol of batch precision. Surface condition monitors brilliance, dullness, mottling, cracks, dark regions, and holes. Suppositories are also weighed on automatic balance, ensuring that the molds are thoroughly filled, and any air bubble existence is removed. If the weight is too large or small, there are specific procedures to follow to ensure proper quality control standards.

Batch release requirements lay down the procedure for approval and release of the final product batch. The purpose of batch release requirements is to ensure that all products meet the predetermined quality standards before release. Overall, quality control is essential in pharmaceuticals to ensure that the products released to the market meet the proper quality standards set by the company and regulatory agencies.

In order to ensure quality and accuracy in production, it is imperative that batch manufacturing records and batch packaging documentation are reviewed and approved by the production officer, and subsequently reviewed by the head of production and quality assurance.

Various responsibilities lie with different officers and executives. The officer/executive in QA/production is accountable for reviewing the batch record for its integrity and precision. The head of production is responsible for reviewing the batch manufacturing record and batch packaging record for adequacy. Similarly, the head of QC/QM is tasked with reviewing analytical microbiology records for adequacy, while the QA (QC compliance) staff is responsible for reviewing analytical/microbiological data (in both hard and soft copy) alongside the COA.

Additionally, the plant head confirms the requisition in case of conditional transfer of product, while the head of QA is responsible for confirming and releasing the batch. They are also responsible for approving batches for limited transfer.

In order to test the quality of suppositories, there are two types of tests conducted: physical tests and chemical tests. There are six physical tests which are conducted, including visual observation, weight variation, melting point range, liquefaction test, mechanical strength/breaking test, and disintegration test. There are also two chemical tests, including assay/content uniformity and dissolution.

For the melting range test, the physical and saturation characteristics of each manufactured batch of suppositories are checked. This is done by observing the time taken by every suppository to melt when immersed in a consistent temperature of 37-degree water bath. The release rate is linked to the melting rate, and to ensure accurate measurement, the test must be performed using a non-destructive method.

There are various techniques for determining the melting behavior, including the U-tube method, drop point method, and open capillary method. The capillary tube method, which uses a U-shaped capillary tube to determine melting point, is particularly useful for controlling excipient and firmness for those suppositories containing soluble active ingredients, but is not advisable for suppositories with more powder content.

Different apparatus and parts are used for determining melting point depending on the method chosen. For example, the U-tube apparatus is used for suppositories, which have stirring water, a tube, rubber cover, and thermometer. The drop point apparatus, on the other hand, comprises a heating system, resistance sensor, sample, lamp, furnace, sample cup, photo resistor, and collector.

Overall, ensuring the accuracy and quality of production and testing procedures is crucial for safe and effective medical treatments.

Task: Rewrite the given text with better words and natural language while ensuring outcomes are in English.

B. The testing procedure includes the application of three suppositories to each individual.

C. Time the disintegration process of each suppository.

Acceptance Criteria:

The suppository should melt at the average body temperature of 37 degrees.

2. Hardness Test (Breaking Test):

This is the method used to assess the fragility and brittleness of the suppository. It is designed such that it measures the force which a suppository can bear without breaking.

The acceptable conclusion is a pressure of 1.8 to 2 kg. The purpose of the test is to verify that the suppository can be safely transported and delivered to the patient without breaking.

The following apparatus is used for the breaking test:

A. Place the suppository in the device.

- A double-wall chamber where the suppository is placed.

- Pump water at 37 degrees Celsius via the double wall.

- The suppository in the dry inner chamber support a disk with an attached rod.

- The other end of the rod has a disc where weights are applied.

B. Add 600 grams and allow it for 1 minute.

C. If not broken, add 200 grams every 2 minutes until the suppository is broken.

D. The weight at which the suppository crashes is the breaking point.

Calculations:

- Suppository hardness is assessed by weighing the weights together.

- If the suppository is broken before the last minute, the last weight is avoided.

- If the breaking point is reached within the first 20 seconds, the extra weight was not estimated.

- If the breaking point is reached within the second 20 seconds, half the extra weight was figured out.

- If the breaking point is reached within the third 20 seconds, then all the extra weight was estimated.

USP Monograph: (Indomethacin Suppository)

[INDO]

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Monograph: (Acetaminophen Suppository)

[Monograph 2]