In the pharmaceutical industry, quality management preserves the integrity of products and minimizes the risk of impurities, contamination, improper handling, and recalls. These processes and policies guide a pharma company’s approach to managing production.

A quality management plan (QMP) formalizes this approach into a set of clear procedures that define who is responsible for each specific quality management task. The QMP follows the life cycles of projects and products to ensure everything stays on track and in compliance.

Below, we’ll outline the common challenges pharma companies face with quality management. In addition, we’ll review the components of a good quality management plan and how to implement them effectively.

Quality Management Challenges for Pharma Companies

When a pharma company fails to have a solid quality management plan in place, the company exposes itself to many risks. Ultimately, quality failures put the public at risk, which is a major reason why the industry is so heavily regulated. 

Some of the risks a quality management failure can cause include: Facing fines, shutdowns, and an inability to conduct pharmaceutical development, technical transfers, and commercial manufacturing.

Common quality management challenges for companies in this sector include:

• Detecting manufacturing errors
• Impurities and contamination
• Poorly-conducted and incomplete recalls
• Improper document control
• Lack of clear handling protocols
• Lack of internal auditing procedures
• Training issues and human error

In addition to these internal issues with quality management, a quality breach can lead to a loss of public trust and a severely damaged reputation. 

Components of an Effective Quality Management Plan

The best way to prevent negative outcomes is to have a strong quality management plan in place long before an issue ever arises. The Food and Drug Administration (FDA) recommends that all pharma companies create a quality management plan that includes four key elements known as the ICH Q10 core components.

4 Core Components of a QMP:

1. Process performance and product quality monitoring systems
2. Corrective and preventative actions (CAPAS)
3. Change management systems
4. Management review of process performance and product quality

A good quality management plan also addresses numerous key tasks that must be accomplished to prevent lapses in quality.

Key Tasks of an Effective QMP:

• Risk management
• Technical transfer planning
• Product recall/discontinuation plans
• Quality system audits
• Inspection readiness and training
• Regulatory compliance
• Adherence to current good manufacturing practices (CGMPs)
• Gap assessment and remediation
• Process optimization

When a pharma company can consistently accomplish the core components and key tasks described above, this is an indication of a good quality management plan. However, this type of high-quality QMP is difficult to accomplish without an expert-level quality management team.

Expert Execution With FlexPro

Many pharma companies work with quality management professionals to develop their QMPs and ensure they’re executed thoroughly, down to the last detail. FlexPro offers a wide range of world-class quality management services.

Work with FlexPro to manage tasks that require rigorous quality management like technical transfer planning, product recalls, auditing, and inspection readiness. We help pharma companies maintain FDA and EU pharmacovigilance, including gap assessment and remediation.

FlexPro can analyze your entire quality management plan and make recommendations for organizational optimization. This includes innovative outsourcing/manufacturing options that streamline your production and help your pharma company stay profitable. 

Schedule a 15-minute call today to discuss how we can help.