, Quality Management Systems

Key Topics

  • Policies & SOPs
  • Alignment between corporate, sites and regulatory authorities
  • Redesign & optimization for sustainability and scalability
  • CAPA Change Control
  • Document Review
  • GMP Training
  • Quality Control
  • Culture assessment and execution of change plan
  • Organization Design
  • Validation
  • Site assessments & audit (internal and 3rd Party)
  • PAIs
  • Due Diligence
  • Qualification

Case Study

QMS Harmonization

Opportunity…

After a significant acquisition by a global Biopharmaceutical company, the client requested a turnkey approach to harmonize R&D quality standards and SOPs at the acquired sites, with corporate standards. Acquired sites to be harmonized were located on three continents: Europe, Asia, and South America.


Approach…
  • OQSIE structured the approach and resource plan.
  • Conducted a gap assessment of current site SOPs.
  • Prioritized gaps identified at the site level to manage “red, yellow, green” findings and avoid potential regulatory actions.
  • Implementation activities included revision of SOPs, and managing the revisions through the client change process to final approval and implementation.
  • Our Project Managers developed plans and drove harmonization activities at the various sites.
  • Our Subject Matter Experts on quality systems and aseptic manufacturing supported the revision and implementation of SOPs.
  • Our QPs helped to upskill local Quality leaders in batch disposition / release requirements.

Outcome…

The QMS Harmonization initiative was completed on-time & on-budget.

Case Study

Quality Culture Assessment

Opportunity…

A global Biopharmaceutical client requested a Quality Culture Assessment of its global vaccine franchise with sites in the U.S. and Europe.  


Approach…
  • OQSIE structured the approach and resource plan. 
  • A team of cross functional experts conducted the assessment, with expertise in human resources, regulatory, vaccine manufacturing and project management.
  • A single team was utilized to ensure consistency of approach at the five sites assessed.
  • Deployed multiple data gathering approaches, e.g., one-on-one interviews and group polling sessions.
  • Participants ranged from corporate and site leadership to shop floor supervisors and operators.
  • All information was kept confidential to facilitate open communication and input from all involved.
  • Findings were presented to the client’s sponsor group.
  • We facilitated the go-forward planning session with the leadership team, and delivered a short, mid, and long-term execution plans.

Outcome…

The assessment was executed on-time and on-budget. Our client implemented the plans we jointly developed, and reported extraordinary improvements in operational performance.

, Quality Management Systems
, Quality Management Systems

Project examples

For a global client, a Senior Project Manager developed and led execution of the initiative to expand their Quality Management System to integrate requirements for combination products.

Provided ex-FDA experts in GCP & BIMO for a global Biologics client to perform a gap assessment and lead remediation activity ahead of their PAI.

A Subject Matter Expert (SME) audited the Quality System of a pharmaceutical client’s transportation system.

Provided four Subject Matter Experts to develop the Quality Management System for a new aseptic manufacturing and packaging facility start-up.

Provided two cGMP training experts to develop and deliver training program for 170 new employees.

One SME developed and implemented the Supplier Quality Management program for a pharmaceutical client.

Two SMEs supported start-up of secondary packaging operation, developed SOPs for equipment validation and operational activities.

One SME oversaw SOP development for warehouse / distribution center operation.

One SME redesigned the global change control system for a large generics manufacturer.

**examples listed are representative, not an exhaustive list of projects OQSIE has supported**