Advantu Supports Biopharma

When Manufacturing and Supplier Quality Process Improvement is performed for biopharma – it is critically important to get it right…the first time.

Our biopharma RA/QA expertise helps you implement and advance your quality culture for biopharma.

We provide third-party objective analysis and corrective support you need – while your team stays focused on getting products built and shipped on time.

No more surprises!  Whether Biopharma, Pharma or Medical Devices – keep the quality of your products consistent while delivering them on an extremely reliable schedule.

Manufacturing and supplier quality process improvement is the solution to your customer satisfaction challenges.

Challenges teams face:

  • Lack of process knowledge
  • Inconsistency with documentation
  • Gaps in their QMS due to Silos within their Organization
  • Need to demonstrate equivalence with predicates
  • Not providing all of the expected testing
  • Lack of knowledge regarding differences between verification and validation
  • Underestimating risk management requirements
  • Incorrect formatting of required documentation
  • Incomplete or not-easy-to-understand QMS processes
  • Major disconnects between R&D and Contract Manufacturing 
  • Lack of thorough vendor/sub vendor agreements with Suppliers
  • Missing or incomplete Training Plan across the organization

Here is an example:

BioPharma (Q10 Pharmaceutical Quality System Guidance)

Per the FDA, this guidance extends quality systems responsibilities for drug makers to the activities they outsource. One particularly important clause states that contract givers “should be responsible for assessing the suitability and competence of the contract acceptor to carry out the work required.”

It also states that all responsibilities for quality-related activities between the two parties “should be specific in a written agreement.”

Beyond this, all drug manufacturers must ensure that any product they deliver to the market is neither adulterated nor misbranded due to the actions of a contracted facility, but rather due to the labeled drug manufacturer, because all companies (virtual or otherwise) are ultimately responsible for the products they deliver to the market.

Following a risk-based approach for supplier quality management is the formula for success – here are the key actions included:

  1. Conduct a comprehensive risk assessment
  2. Perform a supplier audit
  3. Monitor, document, and review supplier performance
  4. Establish appropriate written quality agreements

The Goal is to establish a complete and thorough, documented process.

  • Supplier Quality / Supplier Management Systems 
    • Purchasing & Supplier Quality Agreements
      • Supplier Evaluation
      • Supplier Monitoring (auditing)
      • Supplier Documentation
      • Supplier Communications
      • Supplier Quality Agreements
      • Supplier Quality Certification

Advantu’s FDA Process Experts are experienced performing Manufacturing and Supplier Quality Process Improvement

  • Our Process
    • GAP Analysis
    • Improvement Path Report
    • Implementation of Corrective Actions
    • Confirmation of Desired Goals Successfully Achieved

Our team can perform a Gap Analysis to identify and recommend QMS Process improvement areas, prioritize the improvement areas and develop short term, intermediate term and long term plan to ensure your QMS processes are clear, easy to understand and address “Common Sense Compliance”.

Is your company experiencing any of these issues? Contact the Advantu experts today!