GUIDEGXP · PHARMA LAB
From instrument selection to reliable laboratory results.
Start with the instrument, workflow or measurement you need to manage. Pharma Lab organises laboratory work around six areas: instrumentation, microbiology, sample preparation, equipment, metrology and data.
Practical approach · Pathways by need · Lifecycle perspective
Find the right area for your instrument, measurement or activity.
PHARMA LAB DOMAINS
Identify the area that matches your need. Each domain connects the instrument to the activities, checks and decisions needed to use it in its intended context.
01 · INSTRUMENTATION
From requirements to troubleshooting: select, qualify and maintain analytical instruments for quality control.
HPLC and UHPLC; analytical qualification and reliability; GC and Headspace; spectroscopy and LC-MS; dissolution and physical testing; TOC and physicochemical analysis.
02 · MICROBIOLOGY
Connect methods, equipment, media and sample handling to assess the meaning of microbiological results.
Laboratory organisation; sterility testing and isolators; microbiological methods and technologies; media, strains and incubation; sampling and sample handling; equipment and result assurance.
03 · SAMPLE PREPARATION
Make pipetting, dispensing, weighing and preparation reproducible by controlling steps that can alter the sample before analysis.
Pipettes and pipetting technique; dispensing and automated handling; preparation, dilution and filtration; centrifugation and mixing; weighing and balance selection.
04 · EQUIPMENT
Define requirements, qualification and controls for support equipment and the storage of laboratory samples, reagents and materials.
Requirements and qualification; incubators; sample and reagent storage; chambers, mapping and alarms; thermal equipment and bench services; equipment lifecycle.
05 · METROLOGY
From calibration results to fitness for use: traceability, uncertainty, intermediate checks, certificates and out-of-tolerance instruments.
Strategy and fundamentals; instrument calibration; physical quantities; references and calibration lifecycle; quality, certificates and providers.
06 · DIGITAL LAB
Organise systems, instruments and records around laboratory work, from data acquisition to review and retention.
Architecture and system selection; chromatographic data; integration and sample workflow; assurance, access and compliance; retention, migration and support; suppliers and digitalisation roadmap.
FROM PROBLEM TO DECISION
What do you need to measure, prepare or demonstrate? Clarify the sample, instrument, expected result and responsibilities.
Separate requirements, qualification, calibration, checks and data management. Link each activity to the decision it needs to support.
Consider intended use, risk and the available documentation. For a specific need, describe your case to GuideGxP.
GUIDEGXP · EXPERT SUPPORT
Describe the instrument, activity, problem and support you are looking for. GuideGxP will review the request and, where appropriate, may connect you with a suitable specialist.
One contact point for Pharma Lab and Pharma Engineering. No purchase obligation.
PRACTICAL GMP TOOLS FOR PHARMA
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