Inside a GMP Tablet Manufacturing Facility — A Transparent Walkthrough

Table of Contents

1. Introduction – Transparency Builds Trust
2. Raw Material Management
3. Granulation – The Heart of Tablet Quality
4. Compression – Where Consistency Happens
5. Coating – Beyond Aesthetics
6. Final QA/QC
7. Packaging Line
8. What a World-Class Contract Manufacturer Should Demonstrate

1. Introduction – Transparency Builds Trust

In today’s competitive dietary supplement market, trust is the cornerstone of successful business relationships. For supplement brands seeking a reliable manufacturing partner, transparency is more important than ever. Especially when considering the critical nature of Good Manufacturing Practice (GMP) certification, overseas buyers are increasingly demanding visibility into the manufacturing processes behind the products they are sourcing.

Trust is built through understanding. When brands are looking for a trusted contract manufacturer for tablet production, the ability to “see inside” the factory, understand the processes, and know the quality controls in place is crucial for their decision-making. At Runxin Biotech, we believe in providing a transparent, detailed walkthrough of our GMP tablet manufacturing facility, showing exactly how we ensure the highest quality and consistency in every tablet we produce.

2. Raw Material Management

The foundation of every high-quality tablet begins with the raw materials. Our raw material management process is designed to ensure that only the best ingredients are used in tablet production. We adhere to strict GMP standards that ensure the authenticity, safety, and quality of all ingredients before they even enter our production lines.

Sample Retention System

At Runxin Biotech, we implement a sample retention system to ensure traceability and quality assurance for every batch of raw material received. This means that for every batch of raw material, we retain a sample that can be tested and analyzed if any issues arise down the line.

Batch Testing and In-Process Control

Before entering production, each raw material undergoes batch testing to check for potency, purity, and potential contaminants. Only materials that pass these rigorous tests are allowed into our production system. Additionally, in-process controls are used throughout the manufacturing process to monitor material consistency, minimizing risks of contamination or inconsistency in the final product.

Supplier Qualification and Audits

Choosing the right suppliers is crucial to maintaining the quality of our final product. We work only with qualified suppliers who adhere to GMP standards. We conduct supplier audits on a regular basis to ensure that our partners meet the highest quality standards. This ongoing evaluation guarantees that we use only the most reputable sources for our raw materials.

3. Granulation – The Heart of Tablet Quality

Granulation is a critical step in tablet manufacturing as it directly impacts the tablet’s quality. Granulation involves converting raw powder materials into granules, which are then compressed into tablets. There are two primary methods of granulation: wet granulation and dry granulation.

Wet vs Dry Granulation

Wet Granulation: This method uses a liquid binder to agglomerate the powder into granules, which improves flowability and compressibility. Wet granulation is typically used for ingredients that are difficult to compress or that require a controlled release of the active ingredient.

Dry Granulation: In dry granulation, the powder is compacted without the use of liquids. This method is suitable for heat-sensitive materials and helps preserve the integrity of delicate ingredients.

The Impact of Granulation on Tablet Properties

Granulation plays a significant role in determining the hardness, dissolution, and disintegration of the final tablet. The particle size and granule uniformity affect how the tablet breaks down in the body, which is critical for both effectiveness and safety. Runxin Biotech uses state-of-the-art equipment to control granule size, ensuring tablets have optimal hardness and dissolution rates.

4. Compression – Where Consistency Happens

Compression is the process by which granules are pressed into tablet form. Consistency during compression is crucial for ensuring that every tablet is uniform in weight, size, and active ingredient content.

Compression Machine Parameters

The compression machine is the heart of tablet consistency. We carefully adjust the machine’s parameters, such as pressure, speed, and feed rate, to ensure consistent tablet production. These parameters are continually monitored and adjusted to maintain quality standards.

Mold Selection

Choosing the correct mold is equally important. The size, shape, and design of the tablet mold affect both the functionality and aesthetic of the final product. At Runxin Biotech, we use high-precision molds that ensure uniformity and reduce the likelihood of defects.

Control of Pressure and Hardness

During the compression process, we monitor and control the compression pressure to ensure that the tablet has the desired hardness. Too much pressure can lead to tablets that are too brittle, while too little pressure results in tablets that are too soft and prone to breaking.

Common Defects and Their Resolution

Despite the best efforts, occasionally defects can arise, such as:

Cracks or Breakage: This typically occurs due to excess compression force or humidity fluctuations during storage.

Black Spots: These are often caused by contamination or improper cleaning of equipment.

Sticking or Punching: The granules can stick to the compression mold, which can be resolved by adjusting the lubricant used in the granulation process.

Our team is trained to quickly identify and resolve these defects, ensuring that each batch of tablets meets the highest standards.

5. Coating – Beyond Aesthetics

Tablet coating is not just for aesthetics—it’s a crucial part of the tablet’s effectiveness and stability. Coating protects the active ingredients, aids in controlled release, and improves the tablet’s appearance.

More Than Just a Pretty Coat

Stability: Coating helps protect sensitive ingredients from light, air, and moisture, preserving their potency and extending shelf life.

Taste Masking: Some active ingredients have an unpleasant taste, and a coating helps mask it, making the tablet more palatable for consumers.

Enteric Coating: For certain ingredients, such as those sensitive to stomach acid, an enteric coating ensures that the tablet passes through the stomach intact and dissolves only in the intestines, improving absorption.

Our advanced coating techniques ensure that every tablet has the perfect balance between functionality and aesthetics.

6. Final QA/QC

At Runxin Biotech, quality assurance doesn’t stop after compression. Our comprehensive final quality control (QA/QC) process ensures that every tablet meets the highest standards of safety, effectiveness, and consistency.

Key Quality Tests

Disintegration: We test how quickly a tablet dissolves in the body to ensure it will release the active ingredients at the right time and place.

Dissolution: The rate at which a tablet releases its active ingredients into the bloodstream is tested to ensure bioavailability.

Hardness: Tablets must have the correct hardness to withstand handling during transportation but still break down appropriately once ingested.

Friability: We test for friability, which ensures the tablet doesn’t break into pieces during handling.

Heavy Metal and Microbial Testing

To ensure product safety, we conduct rigorous testing for heavy metals, microbial contamination, and other potential pollutants. Only tablets that pass these critical tests are approved for packaging.

Stability Testing

To guarantee that the product maintains its efficacy and quality over time, we perform stability testing under various environmental conditions, ensuring that each batch meets the required shelf life.

7. Packaging Line

After the tablets pass QA/QC, they move to the packaging line, where they are carefully counted, sealed, and prepared for shipment. We use the latest technology to ensure that the packaging is secure and that the product is protected from contamination.

Counting Machine

The counting machine ensures that the correct number of tablets is placed in each bottle, minimizing the risk of human error.

Metal Detection

Our metal detection system scans every bottle for any metallic contaminants, ensuring the safety and integrity of the product.

Moisture Control

Moisture control systems are implemented to ensure that the tablets remain dry and unaffected by humidity during storage and transit.

8. What a World-Class Contract Manufacturer Should Demonstrate

When selecting a contract manufacturer, it’s essential to look for the following characteristics to ensure you’re working with a world-class facility:

Traceability

A world-class manufacturer offers complete traceability throughout the production process, ensuring that each batch of tablets can be traced back to the raw materials used.

Shipping Documentation

Reliable manufacturers provide batch documentation with every shipment, including product testing results, manufacturing dates, and certificates of analysis (COA), which demonstrate that the product meets the required specifications.

Timely Delivery

A professional contract manufacturer ensures consistent lead times and delivers products on schedule to meet market demand.

At Runxin Biotech, we pride ourselves on being a trusted partner in the supplement manufacturing industry. Our commitment to transparency, quality, and reliability ensures that every tablet we produce meets the highest standards. Whether you’re looking for a reliable GMP-certified manufacturer or just want to learn more about our process

For more insights into tablet manufacturing and how to bring your supplement formulas to life, contact Runxin Biotech today.