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What is GMP Manufacturing and is it Required for Life Sciences

There’s an element of consumer trust when it comes to the consumption of food or medicine. Usually, consumers cannot detect if a drug they’ve purchased has been manufactured correctly, or if it contains what has been advertised. Without some form of government oversight, this can become a problem.

With that in mind, the U.S. Food and Drug Administration (FDA) has established Good Manufacturing Practice (GMP) rules for businesses in the food manufacturing and life sciences industries that help ensure consumer safety and confidence. Businesses in these industries need to understand GMP and what is required.

Read how Center for Breakthrough Medicines Implements a GMP Validated System

Understanding GMP Manufacturing

Good Manufacturing Practices are a set of standards for ensuring food and life sciences products are consistently produced and controlled according to quality standards set by the FDA. The intention of GMP is to minimize the risks involved with manufacturing in these industries that cannot be eliminated through the limited testing the FDA does on final products.

GMP manufacturing therefore is facility adherence to a set of basic quality assurance standards and processes set by the FDA. Some of the standards set by the FDA include building and facility conditions, equipment design and maintenance, employee practices, sanitation conditions, raw ingredient sourcing, maintaining strong production controls, and compliance around records and reports in case there are issues later with a given production batch.

GMP is Required for Life Sciences Manufacturing

Current GMP standards, known as cGMP, apply both to food and life sciences manufacturing intended for the U.S. market.

For food manufacturers, the FDA’s cGMP (food) covers the “methods, equipment, facilities, and controls for producing processed food” with the goal of ensuring that manufactured food is safe to eat.

For life science firms, the FDA’s cGMP (drug) requirements are mandated to assure “the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.”

Both food and life sciences manufacturers are required to follow the respective FDA GMP guidelines, and the FDA regularly audits manufacturers in these industries to ensure that GMP compliance is being followed. A failure to pass an FDA audit can lead to an FDA-mandated recall or seizure, as well as fines.

Certified vs. Compliant GMP

While cGMP compliance is required for manufacturers in the food and life sciences industries according to the FDA, GMP certification is not.

The difference between GMP certification and GMP compliance is solely based on verification of GMP standards. A manufacturing facility that passes an FDA audit is considered compliant, but the FDA does not certify or mandate GMP compliance at a manufacturing facility.

Still, there are advantages to a manufacturing facility getting GMP certification: It ensures a facility meets compliance requirements, serves as a mark of high standards for competitive advantage, and ensures that personnel are fully aware of GMP compliance requirements on an ongoing basis.

The process of GMP certification usually entails putting GMP processes in place, choosing a private auditing firm to conduct a GMP verification audit, correction of any areas of non-compliance, and then certification that the facility meets all applicable GMP standards.

Becoming GMP Compliant

The process of aligning manufacturing processes with GMP compliance typically takes between three and 12 months from start to completion. Getting there consists of six activities.

1. Establish 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.

2. Assess Quality
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.

3. Validate the System
Documentation of GMP processes and outcomes are 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.

4. Conduct Surprise Audits
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.

5. 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.

6. Train Around GMP 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, labelling, constant vigilance, Standard Operating Procedures, ways to minimize errors, etc. Ensure that guidelines and manuals are in place to assist with this process.

GMP Compliance Made Simple

Because GMP validation is a critical concern for food and life sciences manufactures, Navigator Business Solutions has developed prepackaged business software solutions based on SAP Business ByDesign ERP that come GMP pre-validated out of the box. While this by itself does not ensure GMP compliance, having GMP-compliant business systems out of the box can greatly reduce the time and expense needed for validation.

If you would like to learn more about how Navigator can help your company with GMP compliance, contact one of our consultants at (801) 642-0123 or by emailing us at info@nbs-us.com.

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