In the pharmaceutical industry, change management is something every company deals with on a daily basis. A change and deviation management system (CMS) is a central part of the overall quality management system for drug product manufacture and is often referred to as the pharmaceutical quality system.
Typical major GMP deficiencies related to CMS include:
- Failure to evaluate FDA filing requirements; i.e., whether to file for a prior approval or changes being effected, or to report the change in the next annual report
- Failure to file changes with the FDA
- Failure to evaluate and / or justify whether equipment / system requalification is needed to support an equipment / system change, and whether process revalidation, stability studies, or equivalency studies are required to support a process and / or processing parameter change, iv) inadequate review and approval of the change by the quality control unit
- FDA expects the intimate involvement of the quality control unit in the change control review and approval process, and usually holds the quality control unit responsible for deficiencies regarding change control.
Regulatory Compliance Associates® can help you implement a CMS including the following as appropriate for the stage of the product lifecycle. Following is a representative, but not exclusive, list of reasons for change management:
- Changes to regulatory compliance with new standards
- Implementation of Cost Reduction Initiatives
- New Supplier Changes
- Upgrades to Aging Facilities
- Change Management to Address Complaints
About Regulatory Compliance Associates
Regulatory 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, 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 more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
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