What it means to be GMP-compliant

Goods Manufacturing Practices (GMP) compliance means that a manufacturing facility meets certain quality standards. These standards help to ensure that products are made safely and consistently. Get up to date and become GMP-compliant.

GMP covers many areas, including:

  • Building and facility conditions
  • Equipment design and maintenance
  • Employee practices
  • Sanitation conditions
  • Raw ingredient sourcing
  • Production controls
  • Records and reports

By following GMP standards, manufacturers can help to prevent contamination, mix-ups, and other errors. This helps to ensure that consumers receive safe and effective products.

How to Become GMP-Compliant

GMP compliance is a process that can take anywhere from three to twelve months to complete. Here are the six key steps involved:

Build a GMP Quality Team:

This team should be composed of employees from different departments, such as manufacturing, quality testing, storage, and distribution. The team will be responsible for overseeing the GMP compliance process and ensuring that all requirements are met.

Assess Current Operations:

The GMP quality team should conduct an assessment of the facility's current manufacturing quality to identify any areas for improvement. This assessment should include a root cause analysis of any deficiencies in current processes.

Validate Processes:

All GMP processes must be documented and validated. This means that the team must demonstrate that the instruments, processes, and activities used at the facility regularly lead to the expected results without significant variance.

Conduct Internal Audits:

Surprise internal audits should be conducted on a regular basis to ensure that GMP compliance is being maintained. The results of these audits should be shared with employees in all relevant departments.

Monitor Ongoing Performance:

Instruments, equipment, processes, and staff skills should be monitored at regular intervals to ensure ongoing GMP compliance.

Train Employees:

All employees should be trained on GMP requirements. This training should cover topics such as record-keeping, sanitation, equipment handling, labeling, and Standard Operating Procedures.

 

ERP Systems and GMP Compliance

Companies in the life sciences industry today need to deal with a complex business ecosystem, including R&D, safety, regulatory compliance, quality control, intellectual property management, testing, sales, and marketing. They also need to chart a strategy with advanced digital technologies like artificial intelligence, deal with new manufacturing processes and techniques, understand the fallout from healthcare industry reform, take on global competition, and shorten time to market.

Enterprise resource planning (ERP) software can help manufacturing facilities achieve GMP compliance by overseeing and standardizing operations across the organization. This ensures that all operations and procedures are conducted in a consistent and reproducible manner, which is essential for GMP compliance. ERP software also greatly assists with GMP validation through the ongoing tracking and monitoring of materials, processes, and procedures.

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