When you source pharmaceutical packaging machines, especially in China, many suppliers claim that their machines are in compliance with GMP and cGMP. But does it really fit GMP and cGMP? And what does GMP exactly mean? How can we discern it when selecting the packaging machines?

When we talk about GMP—Good Manufacturing Practice—it’s really about trust.
Every tablet, capsule, or bottle of medicine you see on the shelf carries with it a promise: that it’s safe, consistent, and exactly what the label says. GMP makes this promise come true.

GMP History Background

But this promise came at a cost.

In 1937, a new “elixir” appeared in the United States.

It was a sweet liquid version of sulfanilamide—easy to swallow, especially for children. Parents trusted it, doctors prescribed it, and pharmacies sold it nationwide.

But within weeks, tragedy struck. Patients, many of them children, began dying. The culprit? The manufacturer had used diethylene glycol—a toxic solvent also found in antifreeze—as the base of the medicine. No safety tests were done beforehand. The result: 107 lives lost in a matter of months.

This disaster shocked the nation. It became painfully clear that testing the final product was not enough—the entire process of making medicine needed strict control.

In response, the U.S. government passed the 1938 Federal Food, Drug, and Cosmetic Act, giving the FDA authority to oversee drug safety. A few decades later, after other tragedies like the thalidomide disaster in Europe, the U.S. introduced the Kefauver–Harris Amendments of 1962, which legally required pharmaceutical production to follow current Good Manufacturing Practice (cGMP).

From then on, GMP was no longer just a guideline—it became the global language of quality, gradually adopted by Europe, Japan, China, and recognized under WHO standards.

How cGMP Compliance of Pharmaceutical Packaging Machines Is Verified in China

In China, the National Medical Products Administration (NMPA) enforces cGMP inspections on pharmaceutical and health-care packaging equipment. The goal is to ensure that machinery used in drug production meets international quality and safety standards.

1. In What Way?

Routine Inspections: Planned evaluations carried out regularly to confirm ongoing compliance.

Unannounced “Flight” Inspections: Surprise audits without prior notice, designed to uncover hidden risks and test the manufacturer’s real compliance level.

2. Inspection Focuses on What?

Cleanroom & Contamination Control: Whether the equipment design prevents cross-contamination and supports cleanroom integration. Such as whether the drive system, normally with lubrication oil, is built separated with the output part.

Material & Structure: Verification that contact parts use compliant materials (e.g., 316L stainless steel), proper sealing, and corrosion-resistant structures.If the factory uses ordinary stainless steel or even painted metal in contact parts, rust and contamination would be inevitable, thus not complying with cGMP.

Quality Management System: Existence of SOPs, validation documents, batch records, and proper change-control procedures.

Packaging Integrity: Machines must ensure that tablets, capsules, or liquids are sealed without leakage. Especially for liquid filling capsules, it’s better to find one with its own sealing formula.

Automation & Traceability: Increasingly, inspectors also check for automation, electronic records, and traceability features that align with modern cGMP.

Buyer’s Own Flight Check

Regulatory inspections in China—both routine and unannounced—give us a clear picture of how strictly cGMP is enforced. But as a buyer, you can’t always wait for an official report. After all, once the machine arrives in your factory, the responsibility for compliance and product safety ultimately rests with you.

That’s why, beyond relying on government inspections, it is equally important to make your own checklist when evaluating equipment suppliers. From the choice of materials and manufacturing technique, to the structural design of the machine, to the supplier’s certifications and track record—these are practical indicators that help you judge whether a manufacturer truly meets cGMP standards before you commit to a purchase.

In the following sections, I will illustrate how to select cGMP-compliant equipment by taking five major categories of pharmaceutical packaging machines as examples. If you are looking for guidance in this area, the next part is just for you.

How to Judge a Tablet Press for cGMP Compliance

A tablet pressing machine is used to compress powders into solid tablets of uniform size and weight. It plays a critical role in pharmaceutical, nutraceutical, and food manufacturing, ensuring precise, high-quality tablet production. Ensuring that equipment meets cGMP standards is crucial to producing pharmaceuticals that are safe for consumption, effective, and free from contamination. When evaluating a tablet press, it's essential to look beyond just its mechanical capabilities. A cGMP-compliant tablet press must meet stringent requirements for material selection, hygiene standards, ease of cleaning, and operational consistency.

Materials

It is quite important to make sure that all contacts parts, which includes hoppers and (don’t forget the) dies, are made of 316L stainless steel. Attention, not just 316, but 316L. The "L" stands for "low carbon," with a maximum carbon content of 0.03%. This lower carbon content improves its corrosion resistance and reduces the risk of carbide precipitation, making it ideal for welding and applications requiring high levels of durability and resistance to corrosion.

For instance, high-acidic ingredients such as Vitamin C tablets indeed require the use of materials with strong corrosion resistance, such as 316L stainless steel, during the production process. Otherwise, it will react with ordinary metals such as 304 stainless steel or carbon steel, leading to metal corrosion or contamination of the active ingredients in the tablets, which can affect the quality and stability of the pharmaceutical product.

Tablet pressing machine from   Packing are all built with 316L stainless steel or even materials with higher standards contact parts.The turret is made of high-strength 2Cr13 stainless steel, with the upper and lower structures made of tin-mixed QT600, and the surface hardness exceeds HRC53, ensuring higher hygiene standards. The press rollers are made of alloy tool steel, with hardness exceeding that of the molds. Additionally, the press rollers are treated with a sealing process to prevent dust from entering the roller, ensuring that the roller will not wear out even after long-time use, saving you from being interrupted during your peak season.

In case the factory lies to you, ask them for their material certificates. Trust me, dependable sellers will be happy to provide all of these.

Manufacturing Technique

• ♦ Welding Technique

The quality of welding is crucial to the durability and functionality of the tablet press. Weld points must be smooth and even, free from burrs and dead corners. A reliable manufacturer should be able to provide welding process certification to ensure that all welds meet industry standards and can withstand long-term use in production.

All Rich Packing machines normally feature infinite electronic polishing, creating mirror-smooth contact surfaces that prevent powder adhesion and make cleaning effortless—perfectly aligned with cGMP standards.

♦ Polishing Treatment

The surfaces that come into contact with the powder must undergo mirror polishing (Ra ≤ 0.8 μm) to prevent residue buildup and microbial growth. This high-quality finish ensures that powders do not adhere to the surface, reducing the risk of contamination and making cleaning easier. Dependable manufacturers will issue polishing reports to confirm that the polishing treatment meets the required specifications.

Reliable manufacturers will always provide documentation for their welding, polishing, and sealing techniques, ensuring that every component is built to perform under the highest standards of cleanliness and efficiency.

Equipment Structure

♦ Modular and Easy-to-Clean Design

A cGMP-compliant tablet press must adopt a modular structure that allows for quick disassembly and easy cleaning. The design eliminates hidden corners and ensures there are no “dead spots” where powder can accumulate, reducing the risk of secondary contamination. This not only simplifies daily maintenance but also guarantees long-term operational efficiency.

♦ Sealing Performance

Both the turret and the feeding section are designed with excellent sealing performance, preventing any powder from leaking during high-speed production. The tablet compression chamber is fully enclosed with transparent organic glass, isolating the product from the external environment while allowing operators to monitor the process in real time. Additionally, the machine is equipped with special oil- and dust-proof seals to further protect the working environment and the product.

♦ Cross-Contamination Prevention

The internal material flow channels are engineered to ensure that each workstation is completely independent, preventing cross-contamination between different processes. The lubrication system is positioned at the bottom of the machine, avoiding any possibility of lubricant entering the die cavity and contaminating the tablets. Furthermore, the system is equipped with an automatic solid-liquid lubrication unit, which supplies oil at fixed times and in precise amounts. This prevents excess lubricant from seeping into the molds and ensures that the tablets remain pure and uncontaminated.

♦ Safety Protection

Safety is a critical requirement under cGMP compliance. The equipment is therefore fitted with safety doors, emergency stop devices, and automatic monitoring systems for compression pressure and tablet weight. These features not only protect the operator but also safeguard the machine, ensuring reliable and consistent performance throughout production.

How to Judge a Capsule Filling Machine for cGMP Compliance

Materials

For a capsule filling machine, the choice of materials quite similar to that of a tablet press. All parts in contact with the product—such as the dosing disk, filling rods, mold bores, and capsule hopper—must be made of 316L stainless steel or other pharmaceutical-grade materials. A material certificate should always be provided to prove corrosion resistance, non-toxicity, and ease of cleaning.

In our capsule filling machines, all contact parts are manufactured from 316 stainless steel, while the rejection unit is built with 7000-series aerospace-grade aluminum for strength and precision. Since capsule mold bores require extremely high accuracy, substandard materials can easily lead to wear, deformation, and inconsistent dosing. Under high-speed friction, if the hardness is insufficient, metal shavings may be produced, causing serious contamination of the finished ules.

Depending on the material characteristics, certain components can also be upgraded with Teflon coatings. This helps prevent sticking, die-locking, and moisture absorption issues, ensuring smoother operation and higher yield.

Manufacturing Technique

♦ Groove Cam

The cam system is the heart of any capsule filling machine, controlling capsule separation, dosing, and locking with precision. Its stability and accuracy directly affect production efficiency, reliability, and product quality. Among different designs, the internal groove cam offers smoother motion, lower noise, and better protection against contamination, making it ideal for pharmaceutical applications.

Our machine is equipped with an internal groove cam manufactured by CNC one-piece forming technology. This seamless design eliminates joints and gaps, ensuring high precision, durability, and easy cleaning. By preventing powder build-up and lubricant leakage, it not only extends machine lifespan but also ensures full compliance with international cGMP standards.

♦ Precision Machining

Accuracy is the foundation of cGMP compliance in capsule filling. Key parts such as the dosing disk and compression rods must undergo high-precision machining to guarantee uniform powder filling. cGMP also requires strict documentation of weight variation validation, ensuring that every capsule meets dosage accuracy. Our capsule filling machines adopt a German Zeiss 3-second optical indexing head, with the indexing shaft finished in a single machining process. This advanced design delivers filling accuracy with an error margin of ≤3%, setting a new benchmark in precision.

♦ Surface Polishing

All product-contact parts must be polished to a surface roughness of Ra ≤ 0.8 μm. This prevents powder residue, reduces microbial growth, and fully meets cleaning validation requirements. Just like our tablet press, components of oour capsule filling machine such as filling rods, upper and lower mold bores, and dosing disks also undergo continuous electronic polishing treatment, which significantly improves powder flow between workstations. This effectively solves common challenges like stickiness, die-locking, caking, and moisture absorption during production.

♦ Concentric Precision

Concentric precision is a key manufacturing requirement for capsule filling machines. Only with perfect alignment between the capsule body and cap can stable separation, accurate dosing, and reliable locking be achieved. High-accuracy machining of the turret, indexing system, and cam ensures smooth operation at high speeds, reduces rejection rates, and meets strict cGMP standards.

Equipment Structure

♦ Lubrication Isolation

Lubrication isolation is a key principle under cGMP. Lubricating oil must never come into contact with the powder or capsule shells. For this reason, components such as bearings and cams are designed with sealed systems or oil-free technology (self-lubricating bearings), completely eliminating the risk of cross-contamination.

♦ Dust Control and Powder Removal

Capsule filling inevitably generates dust during operation, and without proper control this can lead to contamination of both the product and the production environment. A cGMP-compliant design must therefore be equipped with a vacuum dust extraction system and a powder recovery unit. These features ensure that the workspace remains clean, while also allowing excess powder to be efficiently collected and reused, maximizing yield and protecting the integrity of the finished capsules.

Our exclusive positive air blowing keeps dust away from the bearings, ensuring clean, stable, and long-lasting performance—technology you’ll only find with us

♦ Sealing Performance

Sealing design is vital for both equipment stability and cGMP compliance. Our patent-certified capsule filling machine turret adopts an exclusive dual-seal system on key shafts: NBR nitrile rubber prevents lubricant leakage, while imported SIL silicone seals block powder ingress. This dual protection eliminates capsule jams and ensures long-term, trouble-free operation.

♦ Ease of Cleaning

To meet cleaning validation requirements, the structure of the capsule filling machine must be modular and easy to disassemble. Components can be removed quickly, allowing for thorough cleaning between batches. Our machines adopt a low-platform, you can reach everywhere easily without dead corners. 

♦ Automatic Detection and Rejection

cGMP also emphasizes traceability of production data. That’s why our machines are equipped with automatic detection and rejection systems that identify defective capsules, including empty shells and incorrect weights. These defective capsules are automatically rejected and recorded, providing a complete data log for every batch. This ensures full traceability and compliance with cGMP data integrity requirements, giving manufacturers confidence in both product quality and regulatory adherence.

How to Judge a Blister Packing Machine for cGMP Compliance

Nowadays, the most common types on the market are flat-plate and roller-type blister machines, but in terms of cGMP compliance, the points requiring attention are largely the same. The material requirements are omitted here, as they are similar to those of the other machines mentioned above.

Manufacturing Technique

♦ Precision Heating and Sealing

One of the key factors is whether the heating and sealing process is precise and consistent, as this directly impacts blister quality and contamination risk. Conventional machines often rely on single-zone heating with limited control, leading to uneven film softening, material sticking, or unstable sealing.

We apply a PID multi-zone linear heating system with Teflon-coated heating plates. This achieves uniform heat distribution, prevents sticking, improves energy efficiency, and extends the service life of heating plates to over 8 years. It ensures consistently strong and reproducible seals, as required by cGMP.

♦ High-Strength Forming Process

cGMP also requires forming processes to be strong and consistent, ensuring cavities are uniform and protective of the product. Many blister machines rely on single-shaft forming structures, which may result in uneven pressure distribution and less defined cavities, especially at higher speeds.

Our design adopts a double-shaft, double-cam forming press with up to 11 tons (110 kN) of pressure. This ensures blister cavities are uniformly shaped, stable at high speed, and highly durable, fully protecting product integrity and aligning with cGMP’s emphasis on consistency and quality.

♦ Surface and Bearing Technology

It is equally important to examine how the machine prevents secondary contamination from lubricants or wear during operation. Traditional heat-sealing rollers often require regular lubrication. Over time, this can risk oil leakage, causing secondary contamination.

Our machine uses high-temperature sealed bearings that are maintenance-free for life. This eliminates lubrication needs, avoids contamination risks, and ensures long-term hygienic operation in compliance with cGMP.

♦ Process Control and Validation

cGMP demands that all manufacturing steps be controlled, reproducible, and verifiable. In older designs, forming, sealing, and punching are mechanically linked, which makes precise synchronization difficult and limits reproducibility.

Each process in our machine—heating, forming, sealing, punching—is servo-driven and digitally controlled. This guarantees accuracy, reproducibility, and full data traceability, fulfilling cGMP’s requirement for validated and verifiable processes.

Equipment Structure Design

♦ Modular and Enclosed Design

To check cGMP compliance, look at whether the machine adopts modular, enclosed zones that prevent cross-contamination. Conventional blister machines often integrate multiple stations with limited partitioning, making cleaning more difficult and increasing the risk of cross-contamination. Safety protections for operators are sometimes minimal, leaving open moving parts exposed.

Our machines adopt a modular, zone-separated design, with transparent protective covers for forming, sealing, punching, and feeding areas. These covers not only provide full visibility for monitoring production but also protect operators from accidental contact with moving parts, greatly reducing the risk of injury. At the same time, the enclosed zones ensure strict isolation in compliance with cGMP cleanroom standards.

♦ Quick Cleaning and Changeover

Another cGMP criterion is how easily molds and parts can be removed for cleaning and validation. Older models usually require tools and lengthy downtime to replace molds or change packaging material, making cleaning less efficient.

We use drawer-style mold slots and quick-connect PVC platforms, enabling complete mold replacement or material change in minutes. This tool-free, fast-disassembly design minimizes downtime and ensures effective batch-to-batch cleaning validation.

♦ Dust and Contamination Control

cGMP requires effective systems to control dust and prevent contamination during packaging. Many machines rely on simple air extraction or partial dust covers, which are not always effective in high-speed production.

Our blister machines feature a dedicated dust removal system, with optional multi-stage dedusting and antistatic functions. In addition, high-temperature sealed bearings in the heat-sealing rollers eliminate the need for lubrication, preventing secondary contamination.

♦ Integrated Monitoring and Rejection

Finally, cGMP compliance depends on whether the equipment can detect defects and reject non-conforming products automatically. Many conventional machines lack full inspection, relying only on operator checks, which increases the risk of undetected defects.

Our machines include a comprehensive monitoring and rejection system: cameras detect missing tablets, broken pieces, color or size variations, while defective blisters are automatically rejected. Real-time monitoring of temperature, pressure, and material flow ensures data traceability, meeting cGMP validation and documentation requirements.

How to Judge a Tablet Counting Machine for cGMP Compliance

Materials

Other than gummy counting machines, which require Teflon or PTFE upgrades, the material requirements for other counting machines are largely the same as those for tablet presses.

When handling fragile products such as gelatin or HPMC soft gels, Rich Packing machines integrate Teflon-coated channels or food-grade engineering plastics to reduce friction and eliminate static.

Equipment Structure Design

Since the manufacturing techniques are largely the same as those used in other machines, we will focus directly on the structural design aspects. The structural design of the counting machine has been carefully engineered to ensure accuracy, reliability, and compliance with cGMP requirements:

♦ Patented Feeding Mechanism

The unique flap-type distribution system fills bottles smoothly without damaging tablets or capsules, protecting product integrity and appearance.

♦ Safety and Wiring Design

Nice counting machines like ours are equipped with a fully enclosed motor cover with ventilation holes, ensuring both safe operation and effective heat dissipation. All electrical cables and air pipes are neatly embedded within the machine’s frame, with integrated wiring ducts that keep the structure clean, organized, and secure. This design not only improves operator safety but also enhances the machine’s overall appearance in compliance with cGMP standards.

♦ Multi-Stage Vibration Separation

Special vibration design separates irregular, sticky, or oversized products effectively, guaranteeing smooth material flow and consistent counting.

♦ Modular, Tool-Free Disassembly

Key components can be quickly removed without tools, simplifying cleaning and changeover, and reducing the risk of cross-contamination between batches.

♦ Dust Collection System

An integrated dust box captures particles during operation, minimizing environmental pollution and ensuring a clean working area that fully supports cGMP standards.

♦ Automatic Detection

In line with cGMP data integrity requirements, modern counting machines must do more than just count. Rich Packing counters are equipped with automatic rejection systems for empty capsules, broken tablets, or foreign bodies. The machine records every detection and rejection event, generating batch data logs for full traceability. This ensures product quality is not only consistent but also auditable for regulatory inspections.

How to Judge a Cartoning Machine for cGMP Compliance

Equipment Structure Design

♦ Integrated Monitoring and Rejection

To check cGMP compliance, see if the machine can automatically detect and reject defective packaging. Conventional machines often rely on manual checks, meaning missing leaflets, misaligned products, or empty cartons may not be detected in time.

Our machines feature a dual-stage photoelectric detection system. From leaflet insertion to product positioning and final closing, each step is monitored. If there is no carton, the machine stops automatically; no leaflet, no loading; product misalignment, alarm and stop. This ensures 100% verification and compliance with cGMP validation requirements.

♦ Carton Forming and Pushing System

cGMP also requires packaging processes to be stable, safe, and efficient at high speed. Older machines may use single-point carton opening systems, which are less stable for larger cartons and may cause collisions or deformation.

We adopt a rotary double planetary wheel opening system with dual preforming units, guaranteeing stable carton forming even for larger boxes. In addition, our rear 22-head continuous pushing system not only improves throughput but also leaves a wide operating platform, making operation and maintenance safer and more convenient.

♦ Component Quality and Reliability

Another aspect to evaluate is whether the machine uses durable and reliable components that ensure stable operation. Many machines use locally sourced or generic components, which may shorten service life and reduce reliability in long production runs.

Our cartoners are equipped with internationally recognized components for motors, sensors, inverters, and pneumatic systems. This guarantees stable performance, reduces unexpected downtime, and enables continuous 24-hour operation, supporting GMP’s demand for reliability and consistency.

♦ Folding and Coding Precision

cGMP requires clear, traceable instructions and product identification for every package. Some cartoners lack reliable leaflet folding systems or produce unclear coding, which compromises traceability. Our machines integrate a stable leaflet folding mechanism supporting 1–4 folds, ensuring instruction leaflets are accurately prepared. The roller-type coding system produces clear, fast batch codes, with optional inkjet or laser marking to fully meet cGMP traceability requirements.

♦ Safety and Protection

cGMP also emphasizes operator safety and equipment protection in abnormal conditions. Some machines provide only basic safety covers, with limited overload protection for the drive system. Our cartoners include overload protection on both the main drive and leaflet folding unit, as well as air pressure and vacuum fault shutdown functions. This prevents equipment damage, protects operators, and ensures compliance with GMP’s emphasis on safety.

Other Auxiliary Inspection Methods

In addition to the professional evaluation criteria outlined above, several auxiliary inspection methods can also be used to assess whether a supplier truly meets cGMP standards. These include reviewing the company’s qualification certificates, checking which clients they have previously cooperated with, verifying whether key components are sourced from reputable brands, evaluating whether the workshop follows 6S management standards, and considering the overall strength of the after-sales service team. Together, these supplementary checks provide a more comprehensive view of the supplier’s reliability and compliance.

Conclusion

In summary, whether it is a tablet press, capsule filling machine, counting machine, blister packaging machine, or cartoning machine, cGMP compliance is built upon the same foundation: hygienic materials, precise manufacturing techniques, and well-designed equipment structures. Each machine type, however, also carries its own unique requirements—from the concentric precision of capsule fillers, to the dust-proof accuracy of counting machines, to the modular quick-change design of blister and cartoning systems. By understanding these key factors, manufacturers can not only ensure regulatory compliance, but also achieve higher efficiency, lower risk of cross-contamination, and more reliable production quality. Rich Packing designs every machine with these principles at its core, delivering solutions that help our partners meet cGMP standards with confidence. Ultimately, choosing Rich Packing equipment is not just about passing audits—it is about safeguarding product integrity, protecting patients, and strengthening trust in pharmaceutical manufacturing.