compliance

 

Compliance Services

In FDA-regulated facilities (Pharmaceutical, Medical Device, Food & Beverage), compliance means implementing Quality programs and executing Validation activities to ensure that your manufacturing process is in control, produces repeatable results, and is secure.

The experienced professionals at JEA have worked with regulated facilities since the mid-1990’s to provide remediation and grass-roots validation deliverables. Our experts have previously teamed up with top QA and Validation programs at various companies, either as direct-hire employees, or as consulting partners. Our expertise covers the following areas of compliance:

  • Quality Program Development and Implementation
  • Current Good Manufacturing Practices 21 CFR Parts 210 and 211
  • Computer System Validation, 21 CFR Part 11
  • Medical Device Compliance, 21 CFR Part 820
  • Test Method Validation
  • Validation Program Execution
  • Validation Planning
  • Audit Preparedness
  • Hazard Analysis and Critical Control Points (HACCP)
  • Good Automated Manufacturing Practice (GAMP)

Do you need us?

The overall process of Validation is generally comprised of two steps: Commissioning and Qualification.

In a typical installation, some equipment will be commissioned, while others will be qualified. The distinction comes from risk assessments to determine the impact (direct, indirect, or none) of the equipment.

One example of a validated process is something as simple as the purification of drinking water. For millions of years, humans have been able to drink fresh water from a number of naturally occuring sources. However, modern manufacturing has given rise to the culture of bottled water. To ensure that your plant is producing pure, safe drinking water consistently across all shifts, the regulatory agencies expect that you have performed a thorough validation of your process and procedures.

Current Regulatory Environment

If your company produces food, beverage, pharmaceutical, or medical device consumer products, you know how important quality control can be. A single out of control incident can damage your brand’s good name in an instant.

Until recently, validation was generally the pervue of pharma and medical device plants. In January, 2011, however, the Food Safety Modernization Act was passed. This act was the result of several recent health scares propogated from less-than-stellar food processing environments. In a nutshell, it provides the FDA with increased authority to inspect and enforce food safety laws, includingmandatory recall authority.

What we offer

At JEA, we are validation experts, and will work with you whether you are being proactive in validating your new process, retroactive in testing an existing line, or have received notification from the FDA that your quality system needs some work.

JEA attends the annual Food Safety Summit, co-sponsored by the FDA and USDA. We also keep a close eye on regulatory trends by way of attending public meetings on rule changes. Moving forward, we expect to see increased quality control requirements for Food and Beverage plants. The bottom line is that the Food and Beverage industry is going to be required to be more proactive in demonstrating control over manufacturing processes, and reduce the need to be reactive when problems occur.

At JEA, we are experts at helping you design a quality system to do just that. We have contacts within the Federal and State regulation communities, and will work with you to ensure compliance at the appropriate level.

Compliance

Success Stories

Develop complete Validation Package for a Medical Device plant expansion in Puerto Rico

Perform Computer System Validation (CSV) for parenteral filling lines as part of $110 million grassroots project

Develop and deliver validation and technical training at several customer sites in both English and Spanish