- Quality Agreements between suppliers and manufacturers should no longer be viewed as “nice to have,” but a “need to have,” as encouraged by the FDA.
- This document should include:
- Scope of responsibilities and roles; who is doing what?
- Change control process
- Contingency plan
- Quality Agreement (QA) Utilization. According to a survey of industry stakeholders, administered by Marken:
- 40% of respondents always use a QA
- 32% use a QA from time-to-time
- 41% use a standard corporate template
- Only 33% are aware that QAs are scrutinized by the FDA
- All Drug Products are considered to be temperature sensitive, including Controlled Room Temperature products. Some products are just more sensitive than others, but the same risks apply.
- GDPs are part of GMPs. In terms of commercial products, this position is becoming widely upheld by regulators. Moving forward, it seems likely that the same standard will soon apply to clinical trial materials
- “Good security happens every day at a detailed practitioner level,” not some high-level meaningless global standard. – Susan Griggs, Eli Lilly
- Reduce cargo crime by developing your own strategy, learning best practices from expert organizations and asking yourself the following:
- What do I have that is valuable?
- How do I currently secure it?
- Who would want it?
- How would they get it based on our current security protocol?
- What could I do differently to protect my cargo?
- Seven Deadly Sins of Security, by Barry Brandman
- Overreliance on safeguards that are cosmetic
- Inadequate employee background checks
- Making it too easy for dock personnel to work in collusion with truckers
- Being too reactive (get proactive)
- Not controlling truckers
- Failing to check the checkers
- Not making it conducive for concerned employees to voice their concerns
- Know who you are doing business with. Vet them, audit them, communicate with them. – Chuck Forsaith
- Improve the quality of your temperature controlled international shipments
- Develop quality agreements
- Utilize a shipment specification worksheet
- Analyze vendor metrics
- Improve knowledge
- Evaluate materials
Learn how BioC implemented takeaway #10 to yield a 99.7% excursion-free rateRead the Case Study
Global Manger, Business Development and Marketing at BioConvergence LLC
Lesli leads the business development and marketing groups at BioConvergence, with a focus on identifying marketplace trends and targeting new business opportunities for the organization. She has held a number of sales roles in her career including positions at Eli Lilly & Company and AstraZeneca. Lesli received her BS from Purdue University’s Krannert School of Management and her MA from The Chicago School of Professional Psychology.
Latest posts by Lesli Stasiek (see all)
- Top 10 from IQPC: Shipping 99.7% Excursion-free & More - October 8, 2013
- Top 5 Things to Expect from Your Contract Manufacturing Organization (CMO) - May 1, 2013