GMP Compliance: What Is the Challenge?

Beyond regulatory compliance, good manufacturing practice (GMP) compliance is a necessity for pharmaceutical manufacturers. GMP compliance guidelines ensure high-quality standards for manufacturing and control above and beyond the regulatory requirements of safety, quality, and efficacy. All top pharmaceutical manufacturers are encouraged to become GMP certified.

What Are GMP Pharma Rules? A brief look back into GMP compliance

GMP pharma rules were created in the United States in the early 1960s. The legal framework for GMP certification was related to recurrent manufacturing scandals affecting the health of drug product patients and users. By implementing the GMP compliance rules, pharmaceutical manufacturers of drug products should be able to bring safe and reliable medications to market, no matter the professional experience or the education of their employees.

What’s the Challenge of Reaching GMP Compliance?

As stated previously, GMP compliance is necessary for those who manufacture finished or active pharmaceutical ingredients (APIs) based on various national legislation. The applicable GMP certification rules are generally valid for one country based on their national laws. However, GMP rules are more or less internationally harmonized. For example, the ICH Q7 Guidelines representing the Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients being adopted by regulatory agencies in the USA, Japan, and the European Union (EU).

Even with defined harmonized guidelines in place, consistent GMP pharma compliance can still be a significant challenge for manufacturers. The challenge can be related to several reasons.

GMP Guideline Interpretations

Since GMP rules are often general and broad in how they are written, users have a difficult time understanding the meaning and implications of the guidelines. Some industry organizations offer “How to” documents to provide further explanations and guidance for daily practice.

National GMP Guidelines vs. International Guidelines

National GMP Guidelines are sometimes stricter or more lenient than international GMP guidelines. For example, the structure of the Chinese GMP regulations and the EU GMP Guide are different. When comparing requirements, this leaves room for interpretation. However, GMP compliance is always related to the marketing regulations and authorizations of the importing country. As such, GMP guidelines must be well understood by exporters. Compliance with their own national GMP rules may not be enough.

Cultural Differences in Understanding GMP Guidelines

Cultural backgrounds and understandings play a significant role in interpreting any form of guidelines. With several GMP rules being quite general, this leaves significant room for misunderstandings based on cultural differences or understanding of the people in the room.

Improving GMP Compliance Levels

Making improvements to the level of GMP compliance in an organization depends on support from all levels of a company. Internal audits by qualified independent auditors will ensure an organization is maintaining GMP certified levels. Results from these audits will determine what corrective and preventive actions (CAPs) need to take place. CAPs should be followed up with annual reviews with suitable GMP measures and means to manage ongoing efforts.

In addition, training for employees should be further developed to achieve the knowledge and understanding of GMPs. Organizations who constantly invest in maintaining and improving GMP compliance will successfully grow the GMP level when supported by all employees.

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