Pharmaceutical Packaging
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Client Size:
Global Medium Sized Company
Industry:
Pharmaceutical / Clinical Trials Supply
Project Timeline:
90 days + ad-hoc hours after submission
Business Challenge:
A Regulatory Compliance Associates client needed strategy and support with Pharma Licensing and Packaging & Labeling for a new greenfield facility.
Client Challenge
- An existing pharmaceutical client specializing in clinical trials supply was looking to launch a new packaging facility. The manufacturing operations team needed support with development plans and regulatory compliance.
- Requested Executive level consultant to validate entire packaging facility for FDA & EU compliance. Included in the validation plan were many different facets of production:
- Pharmaceutical packaging
- Labelling in pharmacy
- Pharmaceutical bottle
- Packaging for tablets
- Requested Executive level consultant to validate entire packaging facility for FDA & EU compliance. Included in the validation plan were many different facets of production:
RCA Approach
- Scope of work included two staff augmentation resources to begin the project.
- The first resource was a Quality Specialist consultant with experience in Risk Management & Quality Systems.
- The Quality Specialist became a valued liaison while operating across departments inside the organization
- Risk management tools were implemented in the following departments
- Sterilization
- Design Control
- Validation
- IT
- Training employees.
- Risk management tools were implemented in the following departments
- The Quality Specialist became a valued liaison while operating across departments inside the organization
- The second resource was a Quality Subject Matter Expert with executive experience.
- This type of high-level resource has the broadest based expertise able to effectively drive strategic discussions with corporate executives and business unit functional leaders.
- All types of medicine packaging
- Pharmaceutical packaging technology
- Pharmaceutical filling
- Pharmaceutical packaging solutions
- Drug packaging types
- Pharmaceutical primary packaging
- Pharmaceutical secondary packaging
- Pharmaceutical cold chain packaging
- Plastic pharmaceutical packaging
- Pharmaceutical labeling process
- Pharma label
- Pharma containers
- Drug carton
- Sustainable pharmaceutical packaging
- Pharmaceutical packaging machinery
- Blister packaging pharmacy
- Unit dose packaging pharmacy
- Pharmaceutical packaging technology
- All types of medicine packaging
- This type of high-level resource has the broadest based expertise able to effectively drive strategic discussions with corporate executives and business unit functional leaders.
- The first resource was a Quality Specialist consultant with experience in Risk Management & Quality Systems.
They also provide technical input and guidance from the perspective of many disciplines. After the implementation done by our Quality Specialist, this SME did the final validation of the plan and worked with the client on a “as needed” bases helping with any regulatory compliance issues.
Results
- RCA’s Quality Specialist worked collaboratively with the clients’ teams to valitate all training and SOP development. Enhancements for the new packaging facility included.
- Design Control team was trained extensively on risk management in packaging.
- Technology team improved their manufacturing automation through functionality that recognized the difference between “Printed Text Error” and “Packaging Component” deviations.
- This helped isolate the number of errors to a specific step in the package leaflet process.
- Assisted in identifying any gaps and/or opportunities with the firm’s plan.
- Supported with any FDA authority enquiries and other global scenarios impacting the firm’s US Operations.
- Implemented the secondary packaging and labelling protocols to match current licensing and marketing approval.
Conclusion
- At the end of this project, the Quality Subject Matter Expert with executive experience delivered a comprehensive readiness check for the facility.
- All the regulatory requirements
- Inspection readiness recommendations
- Process and production line validations
- SOP documentation and training qualifications
- The client was approved by both global regulatory bodies to successfully begin development of their new packaging facility.
About RCA’s Pharmaceutical Consulting Services
Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.
Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process.
Client Solutions
Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:
- Companies new to FDA, Health Canada or EU regulations and regulatory compliance
- Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
- Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
- Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans
Regulatory Affairs
Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.
As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.
- New Product Support
- Product Lifecycle
- Other Regulatory Services
- Combination Products
Compliance Assurance
The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.
- Assessments
- Audits
- Regulatory Agency Response
- Preparation and Training
- Inspection Readiness
- Data Integrity
Quality Assurance
Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.
- 21 CFR Part 11
- Data Integrity
- Manufacturing Support
- Facility Support
- Quality Metrics
Remediation Services
Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.
Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.
- Regulatory Action
- Regulatory Compliance
- Regulatory Enforcement
- Warning Letter
- 483 Observation
- Oversight Services
- Risk Management Plan
About Regulatory Compliance Associates
Regulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:
- Life Sciences
- Pharmaceutical
- Biologic & Biotechnology
- Sterile compounding
- Medical device
- Lab Testing
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, Health Canada, MHRA 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
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.
Commitment to Quality
Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.
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