Pharmaceutical Validation Study
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Client
Mid-size start up
Industry
Pharmaceutical
Business Challenge
Design a Pharmaceutical Validation Study that proves the SQUIPP of the drug product is maintained throughout the multinational manufacturing and distribution process given the multiple modes of transportation.
Validation Stufy Timeline
20 months
Background
Many medicinal products, intermediates, APIs, and diagnostic products require storage at specified temperatures in order to maintain product SQuIPP (safety, quality, identity, purity, potency). They are also regularly being shipped all over the world, therefore requiring temperature-controlled transportation, also referred to as “cold chain distribution”.
In 2005, PDA released Technical Report No. 39 on Cold Chain Guidance to provide the industry with the essential knowledge and practices needed to design and qualify a reliable cold chain shipping process. When designing the pharmaceutical validation study, it is important to keep in mind the principles of qualification for transport of temperature-sensitive items:
- Development of specifications, processes, systems, and components
- Written procedures
- Approved protocols and reports
- Justified test methods and acceptance criteria
- Qualification testing that challenges “anticipated extremes”
- Ongoing monitoring or periodic evaluation
- Change control
A Pharmaceutical Validation Study can be used to conduct qualification testing for shipping. The studies reflect actual transportation load conditions and configurations, and are executed seasonally (summer and winter) to capture “anticipated extremes”. There must be ample data, consistently generated over multiple shipments, to support that the shipping process is capable of maintaining product temperature within the required temperature range throughout transport and does not impact the product SQuIPP.
This data is captured by strategically placed temperature monitoring devices which monitor and record the drug product temperature and free air space temperature throughout shipment. After receipt and review of the temperature data following the shipments, it can be determined whether the cold chain shipping process designed is qualified for thermally-controlled transport.
Client Challenge
A pharmaceutical start-up, located in the USA, has a novel drug. They approach Regulatory Compliance Associates to design their shipping validation study given the complexity of their supply chain, manufacturing, and distribution process.
The challenge is to design a study that proves the SQuIPP of the drug product is maintained throughout the multi-national manufacturing and distribution process given the multiple modes of transportation and multiple handoffs between four different companies. The company has two API manufacturers, located in different parts of Europe, that they wish to qualify using both air and sea transportation between Europe and Canada. The finished drug product is to be manufactured in Canada by a different company and then shipped to the USA by either air or ground transportation for distribution by yet another company.
Approach
Based on the request of the client, this was not just one validation study, but multiple. Each API manufacturer needs to be qualified for each route using different modes of transportation, and each route needs to be challenged by “anticipated extremes”, which in this case is summer and winter temperatures.
There were a multitude of shipping configurations (# of drums, drum sizes, drum weights, # of pallets per container, types of containers, etc.) that differed by manufacturer, but in some cases also changed within the same manufacturer, that added complexity to this project. Additionally, any possible new challenges associated with international shipping practices had to be identified (languages, time zones, holidays, etc.). The critical parameters involved for each shipment were previously outlined by the client. These parameters include:
- Transportation (duration, modes, routes)
- Product Stability (temperature range established)
- Packaging (bulk or finished goods)
Based on this information, Regulatory Compliance Associates (RCA) was able to generate multiple shipping study protocols to fit the company’s needs. These protocols included representative transportation load configurations, defined packaging configurations, and calibrated temperature monitor positioning. Given the delicate nature of the API, lot samples were pulled and sent with each shipment to undergo chemical testing following shipment.
These pharmaceutical validation study data points were used as further evidence to illustrate that the SQuIPP of the API material was not impacted by the shipment. Because the client would not be at each CSP site to facilitate the validation shipments, it was imperative that the protocol provided clear instructions and diagrams (in the appropriate languages) to ensure temperature monitor placements and pallet configurations were accurate.
Given the complexity of the data collection, the pharma company also asked RCA to collect and analyze the shipping data. Multiple different companies were involved in manufacturing and distributing the finished product, therefore, the handoffs had to be effectively managed.
Each company involved was required to provide documentation to RCA illustrating their responsibilities outlined in the protocol had been followed. Given that the product is temperature-sensitive, a delayed or missed handoff puts the product at risk. It was RCA’s job to analyze the shipment documentation and temperature data to determine whether the validation passes and generate the final reports.
Results
The pharma company was able to provide sufficient data proving the drug product and drug product material was maintained within the established temperature range throughout the cold chain distribution by all modes of transport (land, sea, and air) during both winter and summer seasons. The data also illustrated the SQuIPP of the product was not impacted during the shipments. The thorough design of the study, combined with data tracking and analysis from RCA, enabled the company to prove this consistency over time.
With this milestone achieved, the company became attractive buyers, and has since become a wholly owned acquisition of a large pharmaceutical company.
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
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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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