Sometimes a slight manufacturing variance is acceptable. But sometimes it is not.
When it comes to the manufacture of life sciences devices or drugs, or the production of manufactured foods, precise methods and quality assurance is critically important. This is not just because drug manufacturing and food production require precise standards in ingredients, processes, and tracking for safety reasons, it also is because the U.S. Food and Drug Administration (FDA) requires it.
In order to ensure that life sciences and food manufacturers consistently produce products in accordance with quality standards, the FDA mandates specific Good Manufacturing Practices (GMP) that apply to all manufacturing facilities in these industries.
A manufacturing facility that meets these requirements is called GMP compliant. But since the FDA audits manufacturers against GMP standards but does not pre-validate compliance, a manufacturing facility also can be certified GMP compliant by third-party auditing firms. This certification helps with ensuring preparedness for an FDA GMP audit, and provides a level of assurance around compliance for partners and consumers.
What it Means to be GMP Compliant
GMP compliance means that a manufacturing facility meets specific industry-standard quality specifications in a number of areas that assure proper design, monitoring, and control of manufacturing processes and facilities.
Some of the areas that GMP addresses include:
- Building & facility conditions
- Equipment design and maintenance
- Employee practices
- Sanitation conditions
- Raw ingredient sourcing
- Maintaining strong production controls
- Records and reports
This formal system of controls specified by GMP, when put into practice at a manufacturing facility, helps protects against instances of contamination, materials mix-up, deviation, manufacturing failures, and other errors that can lead to safety issues.
The current GMP standards set by the FDA for a given industry, known as cGMP, were created with a balance between meeting quality standards and allowing manufacturers to innovate and individually decide how to implement cGMPs at a facility. In this way, cGMP is more about using scientifically sound design, processing methods and testing procedures to ensure reliable and safe final products.
How to Become GMP Compliant
There are six key steps for reaching GMP compliance. This process typically takes between three and 12 months to complete for a given manufacturing facility.
Build a GMP Quality Team
GMP compliance starts with a cross-functional team that will oversee the GMP adherence process. Select a high-efficiency employee from every department at the facility, including manufacturing, quality testing, storage, and distribution. These members of the team should review GMP requirements and thoroughly analyze the current capabilities and processes of the facility or facilities in question.
Assess Current Operations
An assessment of current manufacturing quality next should be conducted, including root cause identification of any deficiencies in current processes. The GMP quality team should then assess if these root causes might hinder GMP compliance, and appropriate remediation should be taken to correct these deficiencies.
Documentation of GMP processes and outcomes is essential for GMP compliance. The validation process is simply the documentation of the act of demonstrating that the instruments, processes, and activities used at the facility regularly lead to the expected results without significant variance. GMP requires process validation, cleaning and sanitation validation, computer system validation, and analytical method validation.
Test with Internal Auditing
Surprise internal audits help discover where GMP compliance is truly taking place—and where it is not. Thus, it is important to routinely conduct surprise audits of GMP compliance to spot and correct any variance that is unexpected. The results of these internal audits should be shared with employees within all departments related to the facility.
Monitor Ongoing Performance
In addition to internal audits, monitor instruments, equipment, processes and staff skills at regular and specific intervals for the assurance of ongoing GMP compliance. Frequently employees in production departments ignore a problem just because it is common. Ongoing monitoring will spot these issues.
Train for Compliance
Because GMP requirements touch on many areas of a manufacturer, bring awareness of GMP standards across the company and train employees on GMP needs such as record-keeping, sanitation, equipment handling, labeling, constant vigilance, Standard Operating Procedures, ways to minimize errors, etc. Ensure that guidelines and manuals are in place to assist with this process.
Pre-Validated Business Systems Make it Easy
The foundation for GMP compliance at a manufacturing facility is enterprise resource planning software (ERP) that oversees and standardizes operations across a manufacturer’s operations. This not only ensures standardized, reproducible operations and procedures necessary for GMP compliance, it also greatly assists with GMP validation through the ongoing tracking and monitoring of materials, processes, and procedures. It is nearly impossible to adhere to GMP specifications without an ERP in place.
As an SAP Gold Partner that has assisted more than 500 businesses with ERP implantation over the past 25 years, we understand what it takes to make a manufacturing facility GMP compliant. That’s why we’ve developed prepackaged industry solutions for the SAP Business ByDesign ERP platform that meet GMP compliance needs out of the box.
By using an ERP system that comes pre-validated for GMP compliance, manufacturers can greatly reduce the cost and headaches involved with bringing a facility up to GMP standards.
One manufacturer that has recently used our industry solution to reach a GMP-validation system is the Center for Breakthrough Medicines.
“With a validated and scalable ERP system, the company is advancing its vision to build the world’s largest cell and gene therapy manufacturing and testing facility and enable the rapid development and delivery of groundbreaking treatments for patients,” notes Peter Carbone, Chief Operating Officer for the company. “Navigator executed the work on time and on budget, and has proven to be an invaluable partner.”
So if your operations require GMP compliance, contact us for help with expediting the process. We can help guide your organization toward GMP compliance if you already have a modern ERP system in place, and assist with improving the speed of a GMP-compliant ERP systems rollout if you don’t.