Quality Assurance

Quality Assurance

Asymchem’s Quality Management System (QMS) is a robust and comprehensive framework designed to ensure our products meet the highest quality standards, whether for clinical phases or commercial production.

It covers all stages of production, from raw material procurement to final product distribution, guaranteeing compliance with regulatory requirements and industry best practices.

The QMS is focused on minimizing risks, enhancing product safety, and ensuring efficacy through well-defined processes for quality assurance, quality control, and continuous improvement. By fostering a strong culture of quality, Asymchem’s management team ensures that our QMS supports clients in delivering safe, effective, and high-quality medicines to patients.

Our Quality Assurance Team

Our team of dedicated quality professionals brings over an average of 25 years of experience in clinical and commercial GMP environments within the pharmaceutical industry.

In addition, we possess extensive expertise in overseeing outsourcing partnerships with CDMOs, which provides us with valuable insight into our clients' specific needs. With a combination of technical knowledge, integrity, and practical experience, we are well-equipped to support the quality of the GMP activities you entrust to us throughout the entire lifecycle of your projects.

Regulatory Guidelines

Exceeding Global Standards with Robust Quality Management and Compliance

As part of our commitment to the highest quality standards in all aspects of our operations, Asymchem has successfully implemented our Quality Policy and Management System, ensuring compliance with cGMP and ICH Q7/Q8/Q9/Q10/Q11, as well as 21CFR 211/210 guidelines. As a result, we meet or exceed regulatory requirements of the USFDA, the EU, the UK and other countries.

Data Integrity and Compliance

• Equipment, instrumentation and data is maintained in a cGMP state throughout the lifecycle
• Expertise in data integrity and data management including equipment data integrity risk assessments, data life cycle and ALCOA +
• Learning Management System to ensure colleagues are adequately trained
• Executing routine internal audits
• Experienced in external and regulatory inspections and audits

Quality Management System (QMS)

• Robust systems in place to ensure our products meet the highest quality standards
• Currently working with an external provider to implement a new electronic Quality Management, Document and Learning Management– COMING SOON – We are excited to be partnering with ZenQMS!

A flexible, all-in-one eQMS for Life Sciences & GxP-regulated companies

• Purpose-built for Life Sciences companies
• Validated for 21 CFR Pt.11/ Annex 11 and relevant GxP/ ISO requirements

Materials Management, Batch Release and Analytical Testing

• A customised validated Inventory Management System, managing movement, consumption and status of materials and products in our GMP facilities
• A holistic and comprehensive review process for disposition of batches to their intended use encompassing the principles of ICH Q7

Equipment and Computer System Validation

• A full system lifecycle process in place
• QA oversight of pre/post approval of all validation documentation throughout

Change Management, Deviations and Lab Investigations

• GMP compliant systems in place to ensure the GMP status of systems and processes are maintained throughout their lifecycle
• QA oversight throughout all changes, deviations and lab investigations

Quality Risk Management

• QA Quality Risk Management (QRM) Facilitators support risk assessment management for quality, safety, environmental and health related to material, building/facility/equipment, production, analytical testing, packaging and labelling
• Various Risk Management tools used to support the application of QRM