Tag: Production

Click now to hear from Jordan Elder, RCA’s Director of Regulatory Affairs, regarding the latest info on Quality System Regulation (QSR) regulations and FDA harmonization efforts:

 

 

When developing a quality management system (QMS), it is important to understand any pitfalls that could arise as well as understand what each notified body looks for in a compliant quality system. Recently, one of the US Food and Drug Administration’s (FDA’s) top medical device regulators said harmonizing the agency’s current Quality System Regulation with the International Organization for Standardization (ISO) 13485:2016 is a “high priority” setting a target date of December 2023 to finalize the rule.

 


Do you need ISO13485 compliance support? Talk to our Experts.


 

QMS Harmonization

 

Currently, the US Food and Drug Administration (FDA) does not enforce ISO’s 13458:2016 standards set in place for Quality Management Systems, but uses its own Quality System Regulation (QSR) guidelines that do include parts of the 13458 standards. But this is set to change for the better. The FDA has recently proposed plans to align its quality system requirements with ISO 13485:2016, creating a new regulation dubbed the Quality Management System Regulation (QMRS). This shift came four years after the agency first proposed the regulatory alignment.

 

Quality Management System

 

Manufacturers who already conform to the ISO standard should not see much change and this move should help create efficiencies for them in the long run. The FDA proposed the alinement by incorporating the 2016 edition of the international standard specific for medical device quality management systems ISO13485. Through this rulemaking, the FDA is also proposing additional requirements that help connect and align ISO13485 with existing requirements in the FD&C Act and its implementing regulations. This will include making conforming edits to 21 CFR Part 4 to clarify the device CGMP requirements for combination products as well.

 

Risk Management

 

The most noticeable difference between the current quality systems regulation and ISO13485 is that the risk management requirements are integrated throughout the aspects of the quality management system in ISO13485. This differs from 21 CFR 820, in that the only risk-specific requirement in the QS regulation is listed in §820.30(g), as it relates to risk analysis as a part of design validation.

 

These revisions are intended to supplant the existing ISO13485 requirements with the specifications of an international consensus standard for medical device manufacturers. The revisions are expected to reduce device manufacturers’ burdens, specifically aspects of compliance and recordkeeping through the harmonization of domestic and international requirements.

 

ISO Standard

 

With a membership of 168 national standards bodies, ISO is an independent, non-governmental international organization that brings together experts from around the world to share knowledge and develop voluntary, consensus-based, market-relevant International Standards that support innovation and provide solutions to global challenges.

 

Although the standers set by ISO are recognized by organizations around the world, ISO compliance itself isn’t a legal requirement, the standards naturally align with different regulations across the industries. ISO compliance means using ISO standards as guidelines for aligning your policies, processes, and operating procedures to adhere to the standard.

 

ISO 13485:2016

 

ISO 13485:2016 specifies requirements for medical devices quality management systems where an organization needs to demonstrate its ability to consistently meet customer and applicable regulatory requirements. This includes one or more stages of the product life cycle, including:

 

  • Design controls and development
  • Production and manufacturing
  • Storage and distribution
  • Installation
  • Servicing a medical device
  • Technical support

 

ISO13485:2016 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.

 

Are you ready for this Change? RCA can Help!

 

Regulatory Compliance Associates’® Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are Quality consulting Experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At RCA, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 15 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry experts and FDA veterans is fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation

 

About RCA’s Medical Device Consulting Services

 

iso13485The regulatory process surrounding the medical device industry involves strict adherence to pre/post-market compliance throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA’s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 industry experts — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs.

 

RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483s, import bans, or consent decrees. We offer expertise in a variety of medical fields, such

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates Inc.®, we offer a wide variety of services for medical device security to help ensure that your product is protected from cyber-attacks.

 

With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and/or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and industry experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation for an adverse event, Regulatory Compliance Associates can help.

 

Our network of over 500 FDA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response

 

Remediation Support

 

Regulatory Compliance Associates is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters, and Consent Decrees.

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our unique expertise and experience that makes partnering with Regulatory Compliance Associates a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP 

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates worldwide experience can help ensure a successful mix of people and products so your project is on time, on budget, and you’re never embroiled in a costly mistake.

 

Our 500 industry and FDA experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis, and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Product Complaints
  • Medical Information

 

About RCA

 

medical device consultantsRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for the resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Supply chain management is delicate — it only takes one “broken link” in the chain to significantly impact every aspect of a business’s operations. In a time when a pandemic is raging across the globe and wreaking havoc on manufacturing, maintaining an efficient, avoiding supply chain interruptions is more challenging than ever.

 

Pharmaceutical companies, medical device manufacturing, and a host of other industries are seeking ways to avoid costly interruptions by tightening their supply chains. In this post, we’ll offer some solutions your organization can consider implementing to prevent disruptions.

 


Need help Optimizing your Supply Chain?  Talk to our Experts →


 

Manufacturing Location

 

During the last century, businesses started looking to move their manufacturing operations to geographical areas where they could take advantage of lower labor costs. Companies in the U.S., for instance, began shifting production to Mexico, and eventually, India and Asia.

 

Logistics Management

 

While these plant relocations provided substantial cost savings for many years, several factors have conspired to reduce or eliminate the potential benefits. For example, COVID-19 has resulted in multiple plant closures and disrupted logistics management around the world. Growing political unrest in several nations is another contributing factor. It pays to periodically re-evaluate your global supply chain to determine whether it’s still cost-effective or increasing your risk of interruption.

 

Supply Chain Analytics

 

Supply chain interruptions

Are your manufacturing processes compatible with modern supply chain analytics and automation resources? As technology continues to improve, automation can provide a more practical and affordable alternative for a pharma company in many cases.

 

One of the most significant advantages of supply chain automation is the opportunity to integrate your systems with larger suppliers. By partnering with conglomerates that have access to numerous resources and advanced technologies, you’ll reduce the likelihood of a supply chain disruption within your operations.

 

Sourcing Opportunities

 

Relying on a single supplier or limited supplier base can leave you vulnerable if a problem occurs. Proactively seeking global supply chains that can replicate the services of your core suppliers can help you to make a fast, seamless shift if the need arises. It’s a reliable way to safeguard your company against disruptions resulting from unexpected shutdowns and similar issues.

 

Supply Chain Visibility

 

Too many big pharma companies lack end-to-end supply chain visibility. By gaining a better understanding of every aspect of your chain, you can anticipate where a breakdown is likely to occur and take the appropriate corrective measures. The process will also help you develop a contingency plan in case a disruption occurs.

 

Continuous Improvement

 

Even top pharmaceutical companies find it’s not always possible to avoid an interruption, even when leveraging manufacturing automation. When a disruption does occur, conduct a thorough supply chain audit to determine the cause. Use the information you obtain to prevent the situation from happening again. Make sure you document your response procedures based on pharmaceutical industry standards and make them a part of your future contingency plan.

 

About RCA®

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

As with many industries these days, pharmaceutical manufacturers are now reevaluating the structure of their manufacturing operations. A specific focus area is whether returning some or all production processes to American shores (inshoring) is a more practical and cost-effective alternative to the offshoring trend that’s been prevalent for several decades. 

 


Are you Considering In-Shoring your Pharmaceuticals?  Talk to our Experts →


 

Factors That Impact the Inshoring/Off-Shoring Decision

Examples of crucial considerations when in-shoring pharma include:

 

Manufacturing

If yours is like many pharma operations, you chose to outsource due to the lower production and labor costs available overseas. If it’s been a while since you’ve compared manufacturing abroad vs. at home, consider conducting a comprehensive cost analysis. You might be surprised to learn that you can now produce a pharma product in the U.S. more cheaply than before. In some cases, the costs are now nearly as low as in China.

 

Suppose your manufacturing cost analysis yields favorable results and you determine to move forward with in-shoring. The next step is to decide the type of manufacturing facility that makes the most sense for your operation. Specifically, you should determine whether a brownfield (existing) or greenfield (brand-new) site is the better option. 

 

Technology

inshoringIf you’re evaluating an existing structure, take a look at the current equipment and technology. Are they compatible with your projects’ demands? If not, can you make cost-effective upgrades or modifications to bring them up to speed? If these hurdles are prohibitive, building a greenfield facility will likely provide a more practical and affordable long-term solution. 

 

A greenfield site enables you to customize your manufacturing processes more effectively since you are building and equipping the facility from scratch. On the downside, the costs of a new building, compatible machinery, and hiring and training fresh personnel may not be affordable for some pharma operations. And constructing a new facility from the ground up takes time — a commodity that’s often in short supply in today’s ultra-competitive pharma industry. 

 

Supply Chain

Supply chain access is another vital factor when in-shoring pharma operations. Given that many of the raw materials and ingredients used to manufacture pharma products and medical devices come from outside the U.S., finding acceptable substitutes at home can pose a challenge. If you must import them, you’ll need to consider the added transportation and costs of these components.

 

You’ll also need to account for all applicable supply chain qualifications. For instance, if you’re partnering with new suppliers, you must ensure they meet your company’s unique qualification and quality criteria. Transportation concerns are another issue to evaluate. Will you be able to get the materials to your facility reliably on time to accommodate your production schedules? You’ll need to implement a qualified transportation system for certain essential ingredients and finished goods. 

 

Operations

From a business/operational perspective, consider how in-shoring pharma will impact your personnel. For instance, if you decide to move into an existing facility, determine if there will be sufficient space for your workers and any new equipment you add. Also, can the facility accommodate essential areas such as clean rooms, warehousing, waste treatment systems, and cold storage spaces?

 

If you’re relying on outdated technology systems, you’ll likely need to make upgrades to meet the changes in demand. Examples of systems that require careful evaluation include ERP, CAPA management, and eDoc, to name a few. 

 

About RCA

inshoringRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

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