Most teams can start moving routine compendial testing to a new GMP lab within a few weeks, once a quality agreement is signed and samples ship. Validated in-house methods take longer because they need a formal method transfer first. The fastest moves start with the tests that are holding up release and transfer the rest in planned waves.
If you’re reading this, an audit report probably landed on your desk with findings you didn’t expect. Maybe it was incomplete audit trails, results that were reprocessed without a documented reason, or out-of-specification investigations that never really looked past the bench. Now QA wants a new vendor, manufacturing wants to know whether next month’s release is at risk, and you’re the one who has to make both happen. For teams around Raleigh, Durham, and Research Triangle Park, the good news is that North Carolina has real options for GMP laboratory services close to home.
Are we still responsible for data our contract lab generated?
Yes. FDA’s 2016 guidance on quality agreements for contract manufacturing arrangements is clear that the owner of a product stays responsible for its quality, including work done by contract testing laboratories. Outsourcing the testing doesn’t outsource the accountability.
That is why the first step after a finding like this isn’t picking a new lab. It’s deciding what to do about the data you already have. Your QA team will usually need to assess which released lots relied on the questionable results, whether any of that testing should be repeated, and what the finding means for your own vendor qualification program. Document that assessment before you move anything, and keep it with the vendor file. An investigator who sees a vendor switch without a written risk assessment will ask why.
What should we look for in new GMP laboratory services so this doesn’t happen again?
Look at how the lab controls its data, not just what’s on its certificate wall. A lab can pass a sales call easily. Its data integrity practices are what show up in your next audit. FDA’s 2018 guidance on data integrity and compliance with drug CGMP expects data to be attributable, legible, contemporaneous, original, and accurate, and a good lab should be able to show you how its systems enforce that.
When you audit a candidate, ask to see:
- Audit trail review procedures for chromatography data systems, and evidence they’re followed
- How analysts’ access and permissions are controlled on instruments
- The SOP for out-of-specification investigations, and a redacted example
- A sample quality agreement and how the lab handles deviations that affect your results
- Recent FDA inspection history
Quality Chemical Laboratories publishes its quality assurance policy and is an FDA-inspected, cGMP compliant contract laboratory. All of its Wilmington facilities sit under one FDA registration, which keeps the paperwork simpler when your work touches more than one department.
Which tests can move right away, and which need a method transfer?
Compendial tests can usually move first. If a test follows a USP, EP, or JP monograph, the new lab verifies the method works for your material rather than revalidating it from scratch. Routine raw material testing and many microbiology tests fall into this group, which is why they’re often the first work to change labs.
Validated in-house methods are different. USP <1224> describes the main ways to move an analytical procedure to a new lab:
- Comparative testing: both labs test the same lots and results are compared against predefined acceptance criteria.
- Co-validation: the receiving lab takes part in validating the method.
- Revalidation or partial revalidation: the receiving lab repeats the validation parameters that could be affected by the move.
- Transfer waiver: justified in limited cases, such as when the receiving lab already runs a very similar procedure.
There’s a catch when the reason you’re leaving is data integrity. Comparative testing assumes the sending lab’s results are trustworthy. If they aren’t, revalidation at the new lab is often the cleaner path, even though it takes longer. QCL’s analytical development team handles method transfers, validation, and new method development in-house, with more than 100 HPLCs on site.
How do we keep releases and stability studies on schedule during the switch?
Sequence the move instead of doing it all at once. A practical order looks like this:
- Release-critical tests on lots that are already waiting
- Compendial raw material and microbiology testing
- Validated product methods, through formal transfer
- Ongoing stability studies, planned around existing pull points
Stability is the piece that needs the most planning. Moving a study mid-stream means deciding whether the remaining pulls stay with the original lab, move with a bridging comparison, or restart. That decision belongs in your change control, not in an email. QCL runs drug product analysis and stability studies in validated chambers with 24/7 monitoring, so studies can move into a controlled environment once you’ve settled the plan.
Communication matters just as much as sequence. At large multi-site labs, questions about your samples often go through an account manager first. QCL’s lab management works with clients scientist to scientist, so when a transfer result needs discussion, you’re talking with the person who ran it.
Does the new lab need to be close to our facility?
It doesn’t have to be, but distance helps more than people expect during a lab change. You’ll want to audit the lab in person, and you may want your own analysts on site during a method transfer. For Research Triangle teams, Wilmington is about a two-hour drive east on I-40, close enough for a same-day audit or a working visit. It also makes hand-delivering time-sensitive samples realistic when a courier schedule won’t work.
QCL has operated in Wilmington since 1998 and is listed in the North Carolina Biotechnology Center’s company directory alongside the state’s other life science firms. Its six-building campus covers raw materials, analytical development, stability, formulation, microbiology, impurity analysis, and organic synthesis, which means fewer vendors to qualify if your audit findings touched more than one type of testing. For a broader look at evaluating a development partner, see our guide on how to choose the right CDMO for your drug development program.
Common Questions About Switching GMP Labs
Do we have to retest lots that were already released? Not automatically. Your QA team assesses which lots relied on questionable data and decides, with documented justification, whether retesting or other action is needed.
Can we use the old lab’s validation data at the new lab? Sometimes, through a formal method transfer under a protocol both labs agree to. If the old lab’s data integrity is in question, partial or full revalidation at the new lab is usually the safer choice.
What paperwork comes before the first sample ships? At minimum, a signed quality agreement, a quote that defines the scope of testing, and your internal change control. Most teams also complete an audit or a documented vendor qualification first.
Quality Chemical Laboratories has provided GMP laboratory services to pharmaceutical and biopharmaceutical clients from its Wilmington, NC campus for more than 25 years. To scope a lab transfer, request a quote, contact the team, or call (910) 796-3441.