MMS Holdings Inc

Jennifer Perrin

Outsourcing activities in the pharmaceutical industry are common. It helps save on costs like resources, infrastructure, and overhead. When it comes to quality, outsourcing offers similar benefits. Small to mid-sized organizations can get expert guidance to make sure their quality management system (QMS) aligns with their current drug development phase. This helps them improve their QMS as they grow. Larger firms can use outsourcing to bridge any resource gaps or for specialized, short-term quality projects.

However, there are risks in outsourcing quality support. These include ensuring timely and high-quality deliverables, compliance with regulations, maintaining confidentiality, and lack of flexibility. To mitigate these risks, it’s crucial to set clear expectations with quality consultants before the project starts. It’s vital to note that even when outsourcing, the license holder remains responsible for their QMS. They will be accountable to any regulatory body, regardless of who manages the quality function. Therefore, organizations should thoroughly vet consultants to ensure they have the needed qualifications and training.

Here are some frequently outsourced quality functions in the pharmaceutical sector:

1. eQMS Administration: Outsourcing can benefit any sized organization that needs expertise in setting up and running the system. Smaller firms often lack in[1]house validation or quality experts for an eQMS setup. Consultants can handle most tasks remotely, from setting up the system to training users.

2. Document Management: Consultants can oversee this using your eQMS or other platforms like SharePoint®. It’s essential to ensure that electronic signature tools comply with regulations like 21 CFR Part 11.

3. Training: This is crucial to meet pharmaceutical industry regulations. Consultants can help set up training programs, ensuring employees understand regulations, procedures, and processes. They can also offer specialized regulatory training.

4. Batch Record Review: Essential for ensuring drug quality and safety, consultants offer an unbiased view, especially if in-house staff are deeply involved in processes.

5. Validation: Often outsourced, even by larger companies. While some validation activities might require on-site presence, tasks like computer system validation (CSV) can be remote.

6. Auditing: Remote auditing has grown popular recently. While cost[1]effective, the risks and benefits of remote auditing, especially for manufacturing sites and initial vendor qualifications, need consideration.

7. Remediation: External experts can offer fresh perspectives and process improvements.

Outsourcing quality-related functions goes beyond merely signing a contract. While many of these functions can be effectively outsourced, the ultimate responsibility for product quality and regulatory compliance always rests with the organization, whether it’s the sponsor or market authorization holder. This makes it imperative to select highly experienced and qualified consultants. Equally vital is ensuring these consultants undergo company-specific training, with proper documentation and maintenance of this training. This approach not only safeguards regulatory adherence but also leverages the efficiencies and expertise that outsourcing offers, reinforcing it as a sound and effective strategy.