How to Stay Compliant in a Changing Pharma Regulatory Landscape


How to Stay Compliant in a Changing Pharma Regulatory Landscape

Compounding API

In 2012, contaminated medications from the New England Compounding Center (NECC) caused a meningitis outbreak, leading to tragedy when 64 patients were killed and 751 injured. Unsurprisingly, the pharmacy compounding industry has been under close scrutiny ever since. The FDA has now become the primary agency for regulating compounding pharmacies such as NECC.

Historically, compounding pharmacies operated in a grey zone of regulatory oversight with each state overseeing compliance. Now that both compounding operations and drug manufacturers are on a more level playing field under FDA oversight, virtually everyone across the drug industry supply chain is experiencing an uptick in regulatory scrutiny.

Industry Increasing Oversight

In the years since the NECC contamination, agencies around the world have dramatically increased oversight efforts, extending their reach up and down the supply chain. In fact, supply chains themselves are increasingly the focus of regulatory attention. To this end, the European Commission’s 2013 update to its Guidelines on Good Distribution Practice emphasizes global traceability and tight control of supply chains as a key factor in quality.

The U.S. took similar steps in 2013 with the Drug Supply Chain Security Act (DSCSA), which provided the FDA with the ability to enforce traceability. In 2018 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) followed suit, placing a priority on supply chain integrity.

Recent Regulatory Landscape:  FDA Warning Letters

More than 900 warning letters have been issued to drug makers by the FDA in the last ten years. In 2018 (the most recent fiscal year for which data is available), the most common grounds for FDA warning letters were:

  • Failure to control documents and recordsWarning Letters Issued by FDA
  • Failure to adequately investigate critical deviations and OOS results
  • Unauthorized access to electronic systems and data manipulation
  • Failure of the quality unit to ensure the critical deviations are investigated

These four types of violations happen repeatedly.

FDAnews reports:

“An FDAnews analysis of the FDA’s GMP inspection reports for the year shows that drugmakers continue to stumble at the same old hurdles.

Failure to document quality unit responsibilities and procedures was once again the top citation in the agency’s Form 483 reports. It’s been the top citation for over a decade — often by a wide margin.

This year, the agency logged 185 instances of the violation, 50 more times than the second most frequent GMP lapse, which was failure to thoroughly review unexplained discrepancies or batch/component failures to meet specifications.” (FDA’s Top GMP Inspection Findings for FY 2019)

Identifying the Right API & Pharma Services Suppliers

All of this increased regulatory activity should have pharma C-suites thinking ‘Supply Chain!’ and ‘Risk Mitigation!’ in big flashing warning lights. When vetting API suppliers, it’s critical to ensure they implement a rigorous quality focus.

Quality should be emphasized in terms of finished products, certainly – but also in how they approach & adapt to an ever-changing regulatory landscape. Minimizing a drugmaker’s regulatory & business risk exposure means paying attention to quality across the entirety of the supply chain.

Four Things You Need to Do to Stay Compliant
Implementing a suitable vendor qualification process to identify the right API sourcing providers can be complicated. Among the challenges, vetting vendor quality & compliance to minimize the chance of supply disruption can be resource-intensive – a challenge for smaller bio/pharma companies.

Here are four key fundamentals to building a strong quality program to minimize your supplier-related supply chain vulnerabilities and ensure ongoing regulatory compliance:

  • Follow a documented supplier selection process.
    We’ve found that sourcing and quality/regulatory groups are at their most effective when using a documented practice for supplier selection.Systems should be developed which capture technical and regulatory diligence in order to reduce supply risks and ensure compliance with GMPs.There are a number of parameters that are typically assessed during the initial evaluation of a supplier. These include: the quality management systems (QMS), process capacity, regulatory history, overall project cost, data integrity, and many facility-related factors (including EHS, training systems and more).Two of these parameters tend to weigh heavily on the minds of pharma companies – geographic proximity and price. And while both are – yes – important, they are by no means the most important.So what are the critical factors? If you care about your supply chain, you’ll pay particular attention to those parameters which best illustrate technical competence, regulatory compliance and product quality.
  • Perform periodic audits.
    In-house SOPs should mandate periodic audits of supplier operations. LGM audits each area of a supplier’s operations, for example, and provides recommended corrective/preventive actions to close significant gaps. Audits shouldn’t occur in a vacuum: a periodic review of the supplier’s audit performance overall is critical to evaluate trends. These longer-term reviews should also include any regulatory body inspections which have been performed.One key attribute you should evaluate is supplier capabilities, in order to determine if they match your evolving requirements. The number and types of molecules a supplier has produced are important indicators of manufacturing sophistication and supply chain diversity.
  • Systematize your procedures.
    LGM has established systematic procedures for customer complaints, investigations, and corrective actions. Complaints management is essential from a regulatory and compliance perspective, and an immediate, real-time response to urgent customer requests & returns is absolutely critical.We rely on our Quality unit’s extensive scientific and regulatory experience to assist with the collection of proper documentation and rationale to address complaints effectively and efficiently. Working with our clients and suppliers to identify root causes and suggest appropriate corrective actions to both, LGM Pharma ensures customers receive appropriate quality products.
  • Review and update quality systems to remain consistent with industry standards.
    Look for API manufacturers who maintain and update their quality systems as changes occur (or, in some cases, ahead of official guidance). We achieved this through evaluation of quality systems (including change control, training, document management, validated ERP, warehouse and equipment management) in order to ensure they meet current regulatory expectations and are at par with industry standards (if not better).

With regulatory attention increasingly shining on API manufacturers and other segments of the drug industry supply chain, consistent and robust supplier evaluation criteria are needed to ensure pharma supply chain reliability.

One increasingly popular trend in the pharma industry has been to leverage an API sourcing and procurement specialist firm. They often have a pre-qualified list of API manufacturers, have expert knowledge of global regulatory requirements, and will help ensure a smooth journey from concept to regulatory approval.

Interested in learning how LGM Pharma can help you identify the right suppliers for your pharma or biopharma drug project? Contact us today.

 

 

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