Process Safety and Compliance for Pharmaceutical Manufacturers

Healthy Operations Through Custom Design, Process Innovation, and Compliance

The pharmaceutical industry is a high-stakes arena with the health and well-being of millions of people at stake. Ensuring that the drugs produced are safe and effective is essential. That’s why the US Food and Drug Administration (FDA) regulates the industry with standards and requirements all pharmaceutical manufacturers must meet.

Pharmaceutical companies must constantly address FDA standards, packaging requirements, quality control and assurance, safety standardization, and methodical design, approval, and development. With the help of custom machines and processes, pharmaceutical manufacturers can streamline operations and ensure they accomplish production and compliance needs efficiently and safely.

Ensuring Safety Standardization

Safety is a top consideration in pharmaceutical industry machine design, from the processing of potentially hazardous substances to applications including complex electrical machinery. Pharmaceutical manufacturers have significant requirements for safety standardization within their plant operations to meet mechanical and electrical occupational specifications. That’s important for the safety of their production employees and the environment and compliance with the US Occupational Health and Safety Administration (OSHA) and the Environmental Protection Agency (EPA). Our deep experience and expertise can ensure that your production line meets all safety and other specifications.

Quality Control and Assurance for Pharmaceutical Manufacturers

Quality control and assurance are critical for output consistency in the pharmaceutical industry. Manufacturers use quality assurance practices to define processes and manage quality across operations. At the product level, pharma producers apply quality control measures to identify and fix product defects, testing to ensure they meet all regulatory and consumer standards.

Streamlining Packaging Requirements

The FDA has specific packaging requirements for prescription and over-the-counter (OTC) drugs. They specify everything from what needs to be on the label to how it should be applied and how long it needs to last. That’s a lot of details, and most of the time, it needs to fit in a very small space, so pharmaceutical manufacturers need to be creative and precise in their packaging and labeling. Process and machine design experts like Alexander & Associates can help customize and innovate packaging and labeling for compliance, customer experience, and efficiency.

Methodical Design, Approval, and Development

With so much at stake for customers, employees, and the bottom line, pharmaceutical companies must take every precaution in designing and developing products and processes. That means methodical project management, from innovative prototyping, application integration, and testing to meticulous quality, safety, and approval protocols. With pros like us, you leave nothing to chance.

Learn How We Serve Pharmaceutical Manufacturers

Equipment design and integration needs for the pharmaceutical manufacturing industry are complex and require careful consideration of multiple factors. With our solutions, support, and services in prototyping efficiency and effectiveness, production line expansion to scale, proprietary application process protection, and regulatory expertise, prescription and OTC drug producers can stay ahead in this competitive industry.