For global pharmaceutical companies and their service providers today, ensuring and validating compliance is becoming more challenging.

Not only diverse global regulations but stringent enforcement require that manufacturers, CMOs and other service providers remain vigilant about ensuring current good manufacturing practices (cGMPs) for multiple technologies and dosage forms.

Successful management of a global QMS is vital to the success of any client focused business. The QMS must be fit for purpose in the worldwide market no matter where the product is being manufactured. Having a robust but adaptable system that can not only introduce changes to, but react to dynamic regulatory environments, can ensure business continuity, patient safety and client satisfaction.

A vigorous system of regulatory intelligence and analysis is needed to allow companies to be proactive in monitoring regulatory changes.

The process starts by scrutinizing every new piece of draft regulation, updated national requirements or monographs from regulators around the world, including the FDA, EMA, PIC/S, SFDA, and ANVISA. Any revised or newly introduced draft requirements must be assessed and compared to the company’s current global policies, and gaps noted.

At this point, one must determine any potential operational or technical resource requirements needed to comply with the new or proposed regulation, to enable feedback to the regulatory authority involved.

Appraising the draft guidance document facilitates the generation of specific changes to meet new requirements, so that modifications can be initiated immediately, or after the final guidance is formally issued, depending on the level of potential risk involved.

Each impact assessment can be debriefed to individual site quality leaders via collaboration/sharing forums, so that the entire company can be prepared for collective change implementation.

Once the new regulatory requirement takes effect, an in-depth review of the changes is needed from the initial drafted proposal, validating the relevance of the proposed change actions developed from the draft document. In this way, the company is ready to react and apply the necessary changes, ensuring complete compliance within the dictated regulatory implementation framework.

Don’t forget SOP’s
The work does not stop there.  As global policies are updated and local site leaders are trained on how to comply with them, it is also essential to ensure local compliance with Standard Operating Procedures (SOPs).

Validation of acceptance of such local changes is captured via a system-based Internal Audit Compliance Program (IACP). Extensive examination of procedures should be made during these routine system audits, demonstrating compliance but also sharing Best Practices across the company. Using this method also ensures that the client always sees one approach, as local procedures are harmonized with global policies, aligning the entire business with worldwide regulatory compliance.

Any such initiative should also drive compliance by assessing regulatory observation trends from the wider industry and from trends noted during customer audits. Focus must be given not only on the new requirements on the regulatory horizon, but where the company and industry need to improve in complying to current regulations.

Enabling Companies to be Proactive
Incorporating both a forward and inward looking approach, allows companies to be proative. Output from regulatory inspections and regulatory enforcement statistics can be made available for public viewing.

Your company’s compliance performance must be routinely compared to these regulatory trends, and must be considered during Management Review. However, don’t only look outward.  Always ensure that any observations received from regulatory agencies and clients are shared within your company as part of its ‘Inspection Readiness’ forum.

Global corrective and preventive action (CAPA) systems should be utilized to ensure that relevant observations are sufficiently addressed across the company network such that the regulators and clients do not see similar regulatory issues at different sites. The use of a global tracker system will support the company to identify and target network improvements based on the top trends and themes.

The final requirement for any integrated regulatory intelligence system is to assess the inspection-readiness of each site. Within a large and diverse global supply network, it is imperative to prioritize focus on where it is needed most. Catalent’s IACP initiative has led to development of a proprietary methodology for rating the functional performance of the quality system at each site (Figure). This system enables further evaluation during onsite internal audits. It uses a weighted risk score for almost 15 key performance indicators.

By focusing on what is important within the quality management system and trending performance, company sites can implement continuous improvement projects to reduce any perceived risk rating. Pharmaceutical company clients expect more group accountability and deliverables, and service providers must respond with agility. Having a strong and cohesive system in place to allow us to assess change, share experience, and determine risk, is critical.