Laboratories · GMP Laboratory Compliance
GMP Laboratory Compliance Consulting
The short answer
A GMP quality control laboratory is judged on laboratory controls: qualified instruments, validated methods, controlled reference standards, complete records and investigations that reach a conclusion. We work inside the laboratory to make those controls real at operating throughput.
Why this matters
- Laboratory controls are one of the most frequently cited cGMP systems, and findings there affect release decisions across the site.
- Invalidating an out-of-specification result without a scientifically supported laboratory cause is one of the highest-risk practices in a QC laboratory.
- Stability programs are easy to fall behind on and difficult to recover once pull points are missed.
Applicable regulations and standards
- 21 CFR 211 Subpart I
- Laboratory controls, including specifications, standards and test procedures.
- 21 CFR 211.192 / 211.194
- Investigation of discrepancies and complete laboratory records.
- FDA OOS Investigations Guidance
- Phase I and Phase II investigation structure and result invalidation expectations.
- USP General Chapters
- Method validation, verification and transfer expectations.
What our consultants actually do
- Assess the laboratory quality system: sample management, reference standards, reagents, equipment and documentation practice
- Rebuild OOS and OOT investigation procedures with a defensible Phase I laboratory assessment
- Review analytical method lifecycle: validation, verification, transfer and periodic re-evaluation
- Establish instrument qualification, calibration and preventive maintenance programs
- Improve stability program management, pull point control and trend evaluation
- Train analysts and reviewers using real records from your laboratory
Across the product lifecycle
01 / DEVELOP
Methods developed with the eventual validation and transfer in mind.
02 / SCALE
Laboratory capacity, instrumentation and staffing matched to batch volume.
03 / TRANSFER
Method transfer executed and documented before the receiving site releases.
04 / VALIDATE
Method validation and instrument qualification current and traceable.
05 / MANUFACTURE
Release and in-process testing with contemporaneous records.
06 / MAINTAIN
Stability trending, periodic method review and OOS trend analysis.
Problems we are usually called about
- Phase I investigations that assume laboratory error without evidence
- Retesting performed before a documented hypothesis exists
- Reference standard qualification and expiry not controlled
- Instrument qualification current but calibration performed outside the operating range used
- Stability pull points missed and recovered without an investigation
Typical deliverables
- Laboratory controls gap assessment
- OOS/OOT investigation procedure and investigator guidance
- Analytical method lifecycle status matrix
- Instrument qualification and calibration program design
- Stability program review and remediation plan
Frequently asked
- When can an OOS result be invalidated?
- Only when the laboratory investigation identifies and documents a scientifically supported assignable cause for the error. Absence of an identified cause does not permit invalidation, and the result must then be treated as valid pending full investigation.
- How many retests are appropriate?
- The number should be pre-defined in the procedure, based on a hypothesis being tested, and not open-ended. Testing until a passing result appears is the failure mode this rule exists to prevent.
- Do you support contract laboratories?
- Yes, both contract laboratories improving their own systems and sponsors qualifying and overseeing them.
References
More for laboratories
GLP and GMP laboratory compliance, data integrity and analytical operations.
- Data IntegrityLaboratory data integrity is a question of whether every reported result can be reconstructed from complete, attributable, contemporaneous records.
- GLP ComplianceGood Laboratory Practice under 21 CFR Part 58 governs nonclinical safety studies intended to support applications.
- Method ValidationMethod validation demonstrates that an analytical procedure is suitable for its intended purpose.
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