Virtual QA and Compliance Support for the Set Up and Management of Outsourced Activities
It is not surprising that the attraction towards the use of Outsourced Activities for Contract Manufacturing and associated services in the pharmaceutical industry remains strong once some of the benefits are understood. The decision to engage with Contract Manufacturer’s is getting easier over time due to the continued evolution and development of sophisticated technologies and increased industry knowledge base. Outsourcing also provides a mechanism for increasing efficiency and productivity while reducing cost, and, is therefore of interest to pharmaceutical companies.
Selection of an outsourced supplier is not just about evaluation of their capabilities, expertise, cost and satisfactory timelines. What is equally important but often overlooked, is the evaluation of the proposed supplier’s business strategy, core competencies and company culture. Any element of outsourced work is an extension of your company’s business, and as such, working with a partner who holds similar values is more important than you might realize in terms of long-term success.
But how can you demonstrate adequate compliance oversight for activities that are outsourced? This can be a challenging and daunting task especially with the increased globalization and accompanying complexity of the pharmaceutical supply chains. Specifically, for virtual organisations, a robust and effective Quality Management System and Supplier Management programme is critical, as well as monitoring its ongoing effectiveness and suitability through periodic GxP Audit and Quality Management review.
As part of the initial supplier evaluation process, you should be seeking answers from both the supplier and within your own company, as applicable, to the following questions:
- Does the existing Quality Management System (QMS) in your current company support adequate control and oversight of the outsourced activity?
- Do you have a process in place to ensure timely, accurate and comprehensive oversight on the contracted activities? If not, what would this look like?
- Are there adequate resources in place in your company with appropriate technical expertise to effectively analyze and understand technical issues that are incurred at the site of the CMO as they arise?
- Does the procurement team within your company understand the compliance checks that are required to be in place as part of the supplier onboarding process?
- Are there efficient lines of communication in place between compliance and procurement within your company and between the company and the supplier?
- Do you have a supplier performance monitoring programme in place and will the supplier agree to support and participate in this?
- Are the terms of the quality agreement achievable and acceptable to both parties?
- Does the supplier have an appropriate change management process in place that facilitates customer approval on all applicable changes?
- Will the supplier inform and involve the company upfront if a significant quality issue arises and how can this be ensured?
- Is the suppliers understanding of a critical issue the same as the company’s? Are definitions of Critical, Major and Minor aligned?
- Does the supplier have a process in place to ensure the keep abreast of industry changes, local and global compliance requirements?
The regulatory expectations around Outsourced Activities are made quite clear in various sections throughout Eudralex Volume 4. The full chapter on Outsourced Activities is contained at the following link: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/vol4-chap7_2012-06_en.pdf
PharmaLex has considerable experience in both the set up and operational support of quality and compliance services for different organisations which range from supporting a single element of the Quality System through to the outsourcing of the entire external Quality oversight of Manufacturing and Supply Chain activities. The ranges of services that PharmaLex support include, but are not limited to:
- Workshops to understand and identify compliance and regulatory requirements as a result of changing business models in the pharmaceutical supply chain
- Development of Quality Management Systems to support Wholesale Distribution Authorisation (WDA) and Marketing Authorisation Holder (MAH) activities
- Set up and implementation of CMO Onboarding processes
- Development of Quality Technical Agreements to support different business models
- Development of Supply Chain Maps to reflect physical and financial product flows
- Complaints, Recall and Product Quality Defects Management
- Staff augmentation (Qualified Person, Responsible Person, Quality Assurance Subject Matter Experts and Quality Assurance Operational staff)
- Vendor Management
- GxP Audits and Mock Inspections
Whether you are seeking the set up of virtual quality and compliance activities or are seeking to outsource the quality and compliance element(s) of your business our experienced experts are here for you. PharmaLex have built up a wealth of expertise over the years and have a proven record of the ability to deliver in line with their company tagline “Confidence beyond Compliance”. Why not get in touch to find out more on the range of services that we offer by connecting with us on +353 1 846 4742 or email us at email@example.com.