GMP (Good Manufacturing Practice) is a critical element in ensuring the quality, safety, and consistency of transdermal formulations. CD Formulation has made substantial investments in GMP-compliant production facilities, including pilot and commercial-scale workshops. Our facilities are equipped with state-of-the-art production equipment, operated by an experienced team, and adhere to a robust GMP quality system. These resources enable us to deliver high-quality, efficient, and reliable manufacturing solutions for both clinical and commercial needs, helping pharmaceutical companies and researchers accelerate their products to market.

Introduction to GMP Manufacturing for Transdermal Formulations

Good manufacturing practices (GMP) are a system that ensures the stable production of drugs by quality standards and quality control. The implementation of GMP aims to reduce risks that are impossible to remove through finished product inspection during the production process of drugs. GMP covers many parts of production. It includes good facility design and maintenance, equipment calibration, personnel training, and keeping batch records. It also ensures product identity, strength, purity, and quality testing. This ensures products are made in a clean, safe, and well-planned environment and meet quality standards. Drug manufacturers must follow GMP regulations to produce safe and effective drugs.

Our Tailored GMP Manufacturing Services

We have patented transdermal formulation technology and unique proprietary technology, including five R&D models (polymer material screening, penetration enhancer screening, optimal prescription screening, in vitro transdermal experimental model, etc.), the use of mature transdermal formulation and skin external use formulation R&D-industrialization complete system, High standard, high efficiency to provide transdermal patch, skin topical formulations before prescription research, pharmaceutical research, process research, pilot scale up and industrialization of the whole process services.

Pilot Scale-up of Transdermal Formulation

CD Formulation can be used for scale-up of a variety of transdermal formulations, including gel transdermal formulation, cream transdermal formulation, ointment transdermal formulation, spray transdermal formulation, transdermal patch, etc.

Commercial Manufacturing of Transdermal Formulation

The whole chain quality control system for CD Formulation is implemented, from raw material procurement, formulation design, and preparation to finished product testing. We choose top-quality raw materials that meet international standards. With precise formulation and process improvements, we ensure stable and efficient skin absorption of ingredients in transdermal patches. We also have advanced testing gear and a professional quality control team. We strictly test each batch of products to meet the toughest regulatory standards and customer needs.

GMP Production Facilities

To guarantee the production of all kinds of products, CD Formulation is equipped with the most advanced laboratories and facilities to provide quality assurance for your transdermal formulations.

• Solvent adhesive coating machine
• Solvent glue slitting machine
• Hydrogel coating and scuttling machine
• GMP analytical laboratory
• Individual air conditioning system
• Storage area for various storage conditions

Comprehensive Quality Control Testing

In addition to providing GMP manufacturing services, we also provide GMP-compliant analytical services, including but not limited to:

• Inspection of raw materials, intermediate products, and finished products.
• Appearance, identification, content, related substances, release, adhesion, microbial limits, and other key quality attributes.
• Finished product quality evaluation.

Advanced Detection and Analysis Capabilities

Fig.1 Fully automatic transdermal diffusion system.

• Appearance characterization
• Phase characterization
• Substance structure characterization
• Characterization of polycrystalline forms of active ingredients
• Characterization of rheological properties
• Characterization of quality stability

Specialized CDMO Services for Transdermal Formulations

• Microneedle technology transfer, amplification, pilot production
• Development, transfer and verification of production analysis methods for phase I and II clinical studies
• Release test, stability investigation, and influencing factors investigation
• Registration data submission, on-site inspection support

Why Choose CD Formulation for GMP Manufacturing?

• Efficient execution, experienced team
• International first-class production equipment
• Quality system by GMP
• Clean production environment
• Scientific process flow
• A full range of customized production services

As a dedicated CDMO specializing in transdermal formulation manufacturing, we have established a comprehensive cGMP production system. This system includes detailed process and operational procedures, rigorous quality control for raw and auxiliary materials, end-to-end production oversight, and meticulous quality inspections. We also prioritize cleanroom management, equipment calibration and maintenance, and ongoing personnel training and assessments. For customized GMP manufacturing solutions, please contact us, and our team will respond within three business days to address your requirements.