Virtual Quality Assurance
VIRTUAL QUALITY ASSURANCE
Over the past two decades, we have seen many pharmaceutical start-ups and virtual pharmaceutical and medical device companies looking for additional hands-on resources to fulfill mission critical roles that are by nature short in duration, or ebb and flow with the market at the time.
It is challenging to find experienced personnel who can work under those conditions who already have the experience and subject matter expertise. Time to market is critical, and often your market distinctive setting you apart from the competition. We fill that gap for you. You get the experience you need, when you need it, shortening your time to market.
Here is a partial list of some of the tasks that the Virtual QA can manage for you:
- Participate in FDA/Regulatory audits
- Manage change-control records
- Install Quality Agreements for clients and suppliers
- Audit raw material suppliers and contract manufacturers
- Trend raw material results for vendor qualification
- Set up document storage systems
- Create or revise SOPs
- Create or review Annual Product Reports
- Provide GMP training
- Review personnel qualifications and training records, Create and assemble training matrix.
- Create and Review Master Batch Records
- Create and review finished product and API specifications
- Create and review Test Methods
- Review finished product batch record, in-process testing, final release testing and related paperwork for first three batches in order to assure that CMO-QA is handling things in Client's best interest
- Label specification creation/review
- Review of CMO Investigations - nonconformances, deviations, customer complaints, OOS/OOT issues, yield variance, etc.
- Help with choosing sample and stability container-closure systems and packaging materials
- Review and approve stability protocols and stability data
- Review Raw material specifications including packaging materials
- Review and approve validation protocols and summary reports including equipment, utilities, process, computer, and cleaning validations
- Create or update Organizational Chart
Experience & Capabilities
FDA Compliance Consulting
FDA 483 / Warning Letter
Registration & Listing
- Nonclinical Development
Risk Based Assessment