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Pharmaceutical Industry Standard

Pharmaceutical manufacturing is a major industry worldwide, producing the medications and drugs people need for their health. Because pharmaceutical products are critical to well-being, the industry is highly regulated and has strict procedures to follow.
ISO certifications for pharmaceutical companies help them manage their operations while staying compliant.

About the Pharmaceutical Industry

The pharmaceutical industry discovers, develops and manufactures drugs and medications. Fields within this industry include researching new medications, working with chemicals to create drugs and following regulations from government agencies, such as the Food and Drug Administration (FDA) in the United States.
Major pharmaceutical products include drugs for:

  • Musculoskeletal disorders
  • Cardiovascular diseases
  • Bacterial, viral, fungal and parasitic infections
  • Oncology
  • Metabolic disorders
  • Central nervous system disorders
  • Respiratory diseases

Several trends drive growth in the pharmaceutical industry because they create a need for medication and drug treatments or otherwise help pharmaceutical companies. These trends include:

  • The prevalence of sedentary lifestyles and an aging population increasing chronic disease frequency
  • High pollution levels in urban areas contributing to conditions like asthma
  • Research and development (R&D) data services allowing clinical trial data to be used in trial simulations
  • New drugs facing low regulatory barriers in some countries

Challenges the Pharmaceutical Industry Faces

Pharmaceutical manufacturing entities often encounter these challenges in their operations:

  • Reduced R&D investments: Though many health conditions could benefit from new, more effective drug treatments, many pharmaceutical companies have reduced their investments in launching new pharmaceutical products. High failure rates, high drug development costs and low returns on investment discourage the pharmaceutical industry from product development.
  • Government and insurance company policies: Government regulations affect drug regulations, which can make new treatment launches slow and cumbersome. Insurance companies decide who the payer is and set reimbursement standards.
  • Consumer attitudes: Some consumers distrust medications and are more willing to try alternative therapies.
  • Drug affordability: Many medications are not affordable for patients due to their income or the price of the drug, even with health insurance coverage.

Related Standard

Benefits of ISO Certification for the Pharmaceutical Industry

ISO certifications for pharmaceutical manufacturing offer these benefits to your business:

  • Improved organizational performance: ISO certifications require the establishment of quality controls that will help your organization run more effectively. The certification process is an opportunity to analyze your business performance and identify improvements to aid efficiency.
  • Lower risk to employee safety: When your pharmaceutical manufacturing company complies with safety standards, you protect the health of employees involved in the manufacturing process.
  • Reduced energy costs: Working toward lower energy costs with ISO 50001 certification results in cost savings, and your business can direct these funds toward essential operations.
  • Compliance with federal and international regulations: Your business can meet pharmaceutical industry standards through ISO certification and the quality controls you implement.
  • Ensured quality standards: Pharmaceutical industry certifications promote the use of known best practices, so your business will manufacture safe and effective pharmaceutical products.
  • Better data protection: Companies in all industries are encouraged to have a comprehensive information security management system. Certifications like ISO 27001 ensure your information is protected so you can foster trust with your employees and customers.