Quality System

In the pharmaceutical realm, precision is imperative. At Getwell, we prioritize unwavering quality, dedicating ourselves to a tailored Quality Management System for sterile drug production, ensuring compliance and patient well-being.

Ensuring Excellence: The Quality Management System at Getwell Pharma.

In the pharmaceutical industry, particularly in the production of sterile drugs, the implementation of a robust Quality Management System (QMS) is paramount to ensure safety, efficacy, and compliance with stringent regulatory standards. At Getwell, our commitment to delivering uncompromised quality drives the establishment and continual improvement of our QMS tailored specifically for the manufacturing of sterile drugs.

Foundations of our QMS

Regulatory Compliance

Our QMS is designed to adhere to the guidelines and regulations set forth by health authorities such as the FDA, EMA, and other relevant regulatory bodies. This compliance is not merely a checkbox but a fundamental aspect embedded in every stage of our operations.
Risk Management

Recognizing the critical nature of sterile drug production, our QMS places a strong emphasis on risk management. From raw material sourcing to the final product release, every step is meticulously evaluated and mitigated to minimize potential risks.
Document Control

A well-defined document control system is the backbone of our QMS. Standard Operating Procedures (SOPs), batch records, and protocols undergo rigorous scrutiny and are regularly updated to reflect the latest industry standards and best practices.
Ensuring Data Integrity

Our QMS places paramount importance on data integrity throughout the sterile drug production process. Cutting-edge information management systems ensure accuracy and security in critical data, from batch records to laboratory testing. Regular reviews and validations guarantee the authenticity of information, aligning with regulatory expectations and reinforcing our commitment to transparency and the delivery of safe, effective sterile drugs.

Process Control and Validation
Continuous Improvement
Training and Competence

Cleanroom Environment

Our QMS includes stringent controls over the cleanroom environment where sterile drugs are manufactured. Air quality, temperature, and humidity are continuously monitored and maintained at levels conducive to sterile production.

Equipment Validation

All equipment involved in the production process undergoes thorough validation to ensure its accuracy, precision, and reliability. This includes sterilization equipment, filling machines, and any other critical machinery

CAPA (Corrective and Preventive Actions)

The QMS incorporates a robust CAPA system. In the event of any deviation or non-conformance, immediate corrective actions are taken, and preventive measures are implemented to avoid recurrence.

Regular Audits

Internal and external audits are conducted regularly to assess the effectiveness of our QMS. This proactive approach allows us to identify areas for improvement and implement corrective measures promptly.

Employee Training

Our QMS places a strong emphasis on the training and competence of our personnel. Employees involved in sterile drug production undergo comprehensive training programs to ensure they are well-versed in the latest procedures and adhere to the highest standards of aseptic techniques.

In essence, our QMS is a dynamic framework that reflects our unwavering commitment to producing sterile drugs of the highest quality. It’s not just a set of procedures; it’s a culture of excellence ingrained in every member of our team, ensuring that every sterile drug that leaves our facility meets or exceeds the most stringent quality standards.

Quality System

Regulatory Compliance

Risk Management

Document Control

Ensuring Data Integrity