The cGMP and GMP requirements are essential automatic capsule machine standards that all manufacturers in the pharmaceutical industry must adhere to. They play an integral role in quality control (QC) and performance validation procedures.

In this article, you will learn how the cGMP and GMP play a pivotal role in this industry.

To make it simple and easy to comprehend, this article will focus on two main aspects:

  • The role of cGMP/GMP in the pharmaceutical industry
  • Features of capsule fillers that meet the cGMP and GMP requirements

The Role of cGMP /GMP in Pharmaceutical Industry

The cGMP and GMP compliance are some of the key features of an encapsulator machine.

Good manufacturing practice

So, what exactly do they mean?

  • Follows a defined manufacturing process that can be validated where necessary for compliance and consistency.
  • Evaluates all aspects that may cause changes in the manufacturing process
  • Documents all manufacturing procedures concisely, including investigations on the deviations during the manufacturing process
  • Employs trained and qualified personnel to carry operation
  • Prevents any possible contamination
  • Has a system should for recalling encapsulators
  • Addresses all consumer complaints, assess causes of defects and adopts an appropriate cause of action.

In short, the cGMP/GMP regulations ensure capsule filler manufacturers adhere to high quality and verifiable procedures that guarantee safety and reliability.

Learn more about cGMP/GMP

1. Facts About the Current Good Manufacturing Practices (CGMPs) – FDA Website
2. Good Manufacturing Practice (GMP) Resources – ISPE Website
3. Information on Manufacturing and Quality – FDA Website

Now, let’s explore how automatic capsule machine standards affect products in the industry. In the next section, the main focus will be on:

Features of Capsule Fillers that are cGMP/GMP Compliant

It is a directive that every capsule filling machine should be cGMP/GMP compliant. Therefore, the design, fabrication and assembly process must not violate the above cGMP/GMP requirements.

Some of the key aspects of a cGMP/GMP compliant capsule filling machines include:

Capsule Filler Should be Easy to Clean and Maintain

The high level of hygiene is an integral part of the cGMP/GMP regulations. A machine that does not guarantee a hygienic capsule filling condition is deemed to be unsuitable for any manufacturing process.

It is for this reason that the entire structure of encapsulation machines is made from an SS 304 stainless steel. Stainless steel is strong, rustproof and easy to sterilize.
Moreover, it does not react with most filling material combinations. Click here to learn more about the properties of stainless steel.

Components of capsule filling machines made from stainless steel

Again, the dosing part is completely isolated from other section of the machine. That is, it is enclosed in a “cabin”, normally located in the upper section of the capsule filling machine.
Ideally, this eliminates any possibility of contaminating either the capsules or filler material.

Apart from this, another critical aspect in cGMP/GMP requirements is:

Better Dust Handling Features

When filling powders or a mixture of power and other materials, the procedure should be such that it minimizes the possibility of environmental pollution.

This is why cGMP/GMP requirements insist on superior dust handling capabilities.

Whether you opt for a semi-automatic or a fully automatic capsule filling machine, the equipment must have better dust handling features. These are crucial automatic capsule machine standards in the pharmaceutical industry.

An enclosed powder vacuum loading system

For instance, to ensure better powder dust handling process, the main turn table and dosing system are enclosed. This ensures the dust does not spread into the surrounding environment and mechanical components.

Also, the entire dosing system is enclosed in a “cabin” with polycarbonate sheet doors. This confines the tiniest dust particle within the cabin.

They are made from FDA Approved Material

FDA has strict manufacturing procedures to ensure every machine conforms to the cGMP/GMP regulations. The choice of material is one of the key aspects.

The entire structure of the capsule fillers must have only the FDA approved materials. Be it the dosing disc, capsule hopper, sealing material, turn table, conveyor systems or electrical components.

The Food Drug and Administration

All this insures the encapsulator operates without altering the key desired specifications of the final product.

Adopt Advanced Cleaning Procedures

Cleaning is an integral aspect of hygiene as stipulated in the cGMP/GMP requirements. In most machines, automating the cleaning process is an economical and a viable option.

You’ll find that the capsule filling machine manufacturers have put measures in place such as:

  • Enclosing the dosing disc and main turn table.
  • A vacuum cleaning station

All these automatic capsule machine standards help to reduce the frequency of cleaning the machine. Other critical aspects of a cGMP/GMP compliant capsule filling machine include:

  • Easy to use equipment; a reason for installing a fully integrated, automated system (SIEMENS PLC).
  • Safety measures such as interlocking systems
  • Accurate and precise system to ensure consistency throughout the capsule filling process.

Moreover, the encapsulating machine manufacturer must provide all documentations pertaining to a specific equipment. This is a requirement as per the cGMP/GMP regulations.

Conclusion

As you can see, the automatic capsule machine standards as stated in the FDA’s cGMP/GMP requirements, aim to ensure this equipment remains safe and reliable. The cGMP/GMP compliance is a strict quality inspection and validation process that guarantees consistency in the capsule filling process.