• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Blog
  • News & Events
  • Videos
main-logo-small

Compliance Architects

Consulting Technology Outsourcing

  • About Us
    • Senior Staff
    • Why Us
    • Mission And Vision
    • Clients
    • Partners
    • Career Opportunities
  • Services
    • Inspection Readiness & Enforcement
      • FDA Inspection Readiness
      • Audits & Assessments
      • FDA Enforcement Response/Remediation
    • FDA Quality Consulting
      • Quality System & Compliance Turnarounds / Restructuring
      • Training / Coaching
      • Quality & Compliance Computer-Based Systems
      • External Supply Chain Compliance
      • Part 11 & Computer Systems Validation
      • Turnkey Quality Systems
    • Quality Assurance and Engineering
      • CRPN Quality Roadmap®
      • Quality Culture Assessment
      • Product Quality Consulting
      • Operational Efficiency/Compliance Effectiveness
      • Project/Program Management
    • Corporate Compliance and Litigation
      • Corporate Compliance Programs
      • Interactions With Department Of Justice And The Courts
    • FDA Regulatory Consultants
      • Product Development / Submissions / Commercialization
      • REMS (Risk Evaluation And Mitigation Strategies)
      • Mergers / Acquisitions / Licensing
    • Quality, Compliance, Regulatory & Operations’ Staffing
      • Staffing
      • Talent Management
      • Rapid Turnaround
  • Innovative Solutions
    • Writing for Compliance®
    • CRPN Quality Roadmap®
    • Quality Pulse®
    • IEEP
    • REMS
  • Success Stories
  • Industries
    • Biopharmaceuticals
    • Cannabis/CBD
    • Cell & Gene Therapies
    • Combination Products
    • Cosmetics
    • Dietary Supplements
    • Medical Devices and Diagnostics
    • Pharmaceuticals
  • Contact Us

I worked for a Chief Quality Officer a number of years ago who always had this response when our company was contemplating movement of a large volume of internal production to third parties:

“You can delegate your responsibilities
but you can never delegate your accountabilities.”

He was a wise man.

I have personally experienced the challenges of maintaining accountability for third party manufacturing in the Bio Pharma, Pharma and Consumer segments.  The complexities can be overwhelming.

The basis for an effective third-party supply relationship is framed out in two key documents: the Supply Agreement and the Quality Agreement.  Typically the Supply Agreement is managed between the Supply Chain teams in both organizations and the Quality Agreement is managed between the Quality teams in both organizations.  The Quality Agreement spells out the detailed Responsibilities and Accountabilities of each party as well as when either organization needs to be Consulted or Informed.  The Agreement may also identify which party is the final Decision-maker in specific circumstances.  Often I have seen a RACI/RACID document attached to the Quality Agreement delineating the R, A, D for each element of the Quality System as well as when either party needs to be Consulted and/or Informed.  Specific time-frames may be specified for certain key QA responsibilities.  For example, tPlanning - Third Party Manufacturing Quality Agreementshe QA Agreement may specify a timeframe of not more than 30 days for a Third Party Manufacturer to complete the manufacturing site investigation needed for a quality complaint investigation.

It can take weeks or months to complete the Quality Agreement and to obtain the required approval signatures.  I have seen more than one ISO Audit Report or Health Authority Audit Report in my 30+ years in industry citing the lack of a Quality Agreement between the company I was working for and a given Third Party Manufacturer.  When the audit closed, the team would often come forward stating that the Quality Agreement was “in draft” at the time of the audit.  When I would ask follow-on questions as to how long the Quality Agreement had been “in draft”, the timeframe provided was in some cases, months to years.

While getting the Quality Agreement signed can be a challenge,
the complexity of managing to the Quality Agreement is a much larger challenge.

For example, most Quality Agreements require notification of changes potentially impacting the product produced by the Third Party to be communicated to the company prior to implementation.  The reverse scenario is also true.  When the company responsible for developing and distributing the product makes changes to specifications or test methods, for example, the company must provide prior notification to the Third Party Manufacturer for implementation of the change.  Management of change — change control— is just one of the many QA Systems that must be executed between the two parties.  Other Quality System activities requiring information sharing, approvals, or decision-making include, but are not limited to:

  • creation of the Annual Product Review for drug products;
  • annual marketed product stability test results reporting;
  • test method validation and transfer;
  • deviation reports for non-conforming lots/batches;
  • CAPA;
  • quality complaint investigations; and, for devices,
  • design control documentation.

 

Executing the specifics of a Quality Agreement in a consistent,
robust manner is very, very complex. 

At worst, most Quality Agreements are approved, filed and never looked at until requested in an audit or until there is a significant quality issue impacting product supply which the companies must work together to resolve.

I have often seen the Quality Agreement implemented through a combination of “human-ware” and low tech software, aka e-mail.  Weekly conference calls held with a few company mid-level dedicated Quality staff and tens to hundreds of emails a week may be exchanged across multiple Third Party Manufacturing companies.  Any one of these emails might contain important or critical information in one to two sentences.  The opportunity for miscommunication leading to costly errors impacting product supply, patient/consumer product availability at the pharmacy or store shelf, and financial goals is very high.  At one time or another, I have observed or personally experienced all of these negative outcomes first hand.   Also, beyond the product, patient/consumer, and financial impacts is the lack of trust that builds up over time between the two parties and the individuals trying to collaborate across companies.

At best, I have seen lean, portal-based cloud-based software solutions between the companies that enable exchange of information, workflow approval of various document types, and shared metrics between highly-capable quality staff in each company.  In these instances, the business relationship between the company and the Third Party Manufacturer strengthens over time and the goal of having a strategic partner is achieved.  The financial and supply chain benefits of having a supply chain that fully leverages both internal and external capabilities is achieved.  Relationships are deepened between the contracting and partner companies.  Most importantly, the patient/consumer’s needs are met each and every time they experience the product.  “Product Quality” is an outcome and “compliance” is achieved through the creation of a robust, living Quality Agreement implemented through the use of lean, portal-based solutions by highly capable, empowered quality staff.

To read more about effective Third Party Management please see our White Paper on Third Party Supply Management:  Third Party Management White Paper.

To review a real life example of the use of lean, portal-based technical solution deployed between a company and its Third Party Manufacturers, please see our Case Study:   Annual Product Review Case Study.

If you would like to have further discussions on this, or other topics, please contact Teresa Gorecki at

Teresa.Gorecki@compliancearchitects.com or via mobile phone at +1-310-465-7285

Filed Under: Achieving Compliance, Quality Management & Assurance Tagged With: APR, cloud software, contractors, FDA regulatory compliance, outsourcing, quality agreements;, quality management systems, Quality Metrics, quality systems, supply chain, third party manufacturing

Primary Sidebar

Sign Up To Our Newsletter

You May Also Like

FDA Quality Agreements

What Should Companies Concentrate On When Partnering with CMOs and CDMOs?

The CDMO and CMO relationships and the whole kind of business dynamic is critically important to the life sciences space. And particularly now with what

How Does Compliance Architects® Help the Biopharmaceutical Industry Achieve Its Goals?

I think the fundamental principle for all regulated industry whether it be biopharmaceuticals, medical devices, is that scientific concepts do not result in products for
Biopharmaceutical risk

How Has Risk Changed for the Biopharmaceutical Industry in Light of Recent Events?

Risk is still an important issue, and the fundamental premise is that there is so much to do. The science is so complex. The regulatory

Footer

Compliance Architects®

  • Contact Us
  • (888) 734-9778
  • info@compliancearchitects.com

Quick Links

  • About Us
    • Senior Staff
    • Why Us
    • Mission And Vision
    • Clients
    • Partners
    • Career Opportunities
  • Services
    • Inspection Readiness & Enforcement
      • FDA Inspection Readiness
      • Audits & Assessments
      • FDA Enforcement Response/Remediation
    • FDA Quality Consulting
      • Quality System & Compliance Turnarounds / Restructuring
      • Training / Coaching
      • Quality & Compliance Computer-Based Systems
      • External Supply Chain Compliance
      • Part 11 & Computer Systems Validation
      • Turnkey Quality Systems
    • Quality Assurance and Engineering
      • CRPN Quality Roadmap®
      • Quality Culture Assessment
      • Product Quality Consulting
      • Operational Efficiency/Compliance Effectiveness
      • Project/Program Management
    • Corporate Compliance and Litigation
      • Corporate Compliance Programs
      • Interactions With Department Of Justice And The Courts
    • FDA Regulatory Consultants
      • Product Development / Submissions / Commercialization
      • REMS (Risk Evaluation And Mitigation Strategies)
      • Mergers / Acquisitions / Licensing
    • Quality, Compliance, Regulatory & Operations’ Staffing
      • Staffing
      • Talent Management
      • Rapid Turnaround
  • Innovative Solutions
    • Writing for Compliance®
    • CRPN Quality Roadmap®
    • Quality Pulse®
    • IEEP
    • REMS
  • Success Stories
  • Industries
    • Biopharmaceuticals
    • Cannabis/CBD
    • Cell & Gene Therapies
    • Combination Products
    • Cosmetics
    • Dietary Supplements
    • Medical Devices and Diagnostics
    • Pharmaceuticals
  • Contact Us

Our Services

  • Inspection Readiness & Enforcement
  • FDA Quality Consulting – Systems and Training
  • Quality Assurance and Engineering
  • Corporate Compliance and Litigation Services
  • FDA Regulatory Consultants – Due Diligence
  • Quality, Compliance, Regulatory & Operations’ Staffing Services

Proprietary Solutions

  • Writing for Compliance®
  • Quality Pulse®
  • CRPN Quality Roadmap®

© 2009-2022 Compliance Architects Holdings LLC – used by permission. All copyrights, trademarks and other intellectual property are the property of Compliance Architects Holdings LLC and are used by permission.

  • Debarment Certification Statement
  • Privacy Policy
  • Terms of Use

Contact Us Today