Quality - Ilesol Pharmaceuticals

Quality

At Ilesol Pharmaceuticals LLC we are committed to excellence and integrity in every product we produce. Our dedication to quality is paramount, whether it’s for our cosmetic products line or our other products. We ensure that every product not only meets, but exceeds industry standards and regulations, guaranteeing safety, quality, and efficacy for our consumers.

We believe in continuous improvement and invest heavily in training our staff to handle complex quality control challenges. Ongoing training and improvement lead to better equipped staff to identify potential risks and implement preventative measures. This proactive approach to quality control can prevent costly recalls, legal issues, and damage to our and your brand reputation.

We monitor the quality system through internal audits, audits of certification companies and regulatory agencies.

In Ilesol Pharmaceuticals LLC all initial materials and packaging passes quality control and are approved for use in production. By controlling and supervising materials, packaging and production processes, we strive to reduce the risk of changes in final product quality to a minimum and provide customers with primarily quality and safety products.

To ensure full traceability, each batch of our products is meticulously documented through whole supply chain. This transparency allows us to rapidly address any issues that may arise from the production of finished products.

Continuous improvement and development begin with the detailed, analysis of our current processes. We use a combination of feedback loops involving customer insights, internal audits, and third-party evaluations to identify areas needing enhancement. This approach allows us to form the basis on which we build our future.

What international standards do we follow?

Our company operates according to the quality management system prescribed by the international standard HRN EN ISO 9001:2015. ISO 9001 is a globally recognized standard that sets out the criteria for a quality management system. It is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach, and continual improvement.

HRN EN ISO 22716:2008 Guidelines on Good Manufacturing Practices for cosmetics (GMP) provides guidelines for the production, control, storage, and shipment of cosmetic products. It focuses on ensuring product quality and safety for consumers through controlled manufacturing operations.

HRN EN ISO 22000:2018 is a globally recognized standard that sets out the requirements for a food safety management system (FSMS). It is designed to help organizations ensure that they can control food safety hazards and ensure that food is safe for consumption. ISO 22000 integrates the principles of the Hazard Analysis and Critical Control Point (HACCP) system with prerequisite programs and a quality management system framework, providing a cohesive approach to food safety that is recognized internationally.

OUR CERTIFICATES:

HRN EN ISO 9001:2015 Quality Management System
HRN EN ISO 22716:2008 Good Manufacturing Practices (GMP) for Cosmetics
HRN EN ISO 22000:2018 Food Safety Management System
Hazard Analysis Critical Control Points (HACCP) Management System

What are the benefits of implementing GMP standards?

Implementing of GMP requirements and standards offers numerous benefits to manufacturers, particularly those in the pharmaceutical, food, and cosmetic industries. GMPs are guidelines that provide a system of processes, procedures, and documentation to assure the product produced has the identity, strength, composition, quality, and purity that it is represented to possess.

The benefits of implementing GMP standards include:

Consistency: GMP ensures that products are consistently produced and controlled according to quality standards. It minimizes the risks involved in production that cannot be eliminated through testing the final product.
Quality Assurance: The guidelines cover all aspects of production; from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product.
Safety: By complying with GMP standards, manufacturers can assure their products are free from contamination and that they contain what the label claims, in the right concentrations.
Efficiency: GMP standards streamline production processes by reducing the errors and variability in production stages. This efficiency can lead to cost savings, as there are less waste, fewer recalls, and less rework.
Documentation and Traceability: GMP requires that all manufacturing processes are clearly defined, controlled, validated, and documented. This thorough documentation helps in the event of a product defect investigation or audit.
Legal Compliance: GMP compliance is legally enforced in many countries. Failure to comply can result in costly fines, product recalls, and reputational damage.
Market Requirements: Many markets demand adherence to GMP as a prerequisite for the importation and sale of products. Compliance can thus open larger markets and increase the potential for international business. Companies that are GMP certified can differentiate themselves from competitors, especially in markets where GMP is not mandatory.