GCLP Fundamentals
What is the primary purpose of GCLP?
To ensure laboratory processes produce reliable, reproducible, and auditable research data.
What document must exist for every laboratory staff member?
A personnel file (CV, training, competency).
What is the hierarchy of laboratory documentation?
Policies → SOPs → Work Instructions → Forms/Records.
What does QA stand for?
Quality Assurance.
What is a clinical trial?
Research to evaluate health interventions in humans.
Name one global expectation of GCLP-compliant laboratories.
Standardized procedures, documentation, QC, trained staff, etc.
What records must be maintained for all lab equipment?
Calibration, maintenance, repairs, corrective actions.
What is a chain of custody?
Documentation tracking specimen handling throughout its lifecycle.
Name one type of laboratory audit.
Internal, external, sponsor, regulatory.
What is One Health?
An approach linking human, animal, and environmental health.
Why are training expectations introduced at the beginning of a GCLP workshop?
To align participant expectations and guide learning.
Name two essential components of an SOP.
Purpose, scope, responsibilities, materials, procedure, references.
Name one key Lab Information System (LIS) security control.
Access control, passwords, audit trails.
Which global organization provides accreditation or regulatory oversight for labs?
WHO, FDA, ISO, EMA.
Why is mRNA technology important for global health security?
Allows rapid vaccine development and scalable manufacturing.
Name one international agency involved in GCLP guidance.
WHO, FDA, EMA, ISO.
Why are quality control samples run?
To monitor test performance accuracy and precision.
What is the purpose of an audit trail?
To track all changes made to data.
Name two possible consequences of GCLP noncompliance.
Invalid data, halted trials, loss of accreditation, legal sanctions.
Name one barrier to mRNA expansion in the Global South.
Infrastructure, cold-chain requirements, Itellectual Property (IP) restrictions, funding.
What is one difference between GLP and GCLP?
GLP = non-clinical research; GCLP = clinical research labs.
What is required when verifying a manufacturer’s performance specifications?
Precision, accuracy, reportable range, reference interval verification.
Name one common tool for securing laboratory data.
Encryption, VPNs, multifactor authentication, secure servers.
Why are quality indicators important?
They monitor performance and drive continuous improvement.
Give an example of a One Health success.
Rabies control programs, zoonotic disease surveillance, AMR containment, etc.