Image of a GXP Laboratory
Image of a GXP Laboratory
By
ROBINSON A. WILLIAMS
Agilent Technologies
If GXP, data integrity, and reproducibility are of highest priority to a laboratory, it must routinely assess its Facilities, Methods or SOP’s, Personnel, Support system, Analytical Instruments, Microbiological Instruments, Standards and Materials and Laboratory Information Management Mechanism. The mirror image of a GXP laboratory should mimic the following minimum criteria and requirements as part of its construct.
1. Facility
· The laboratory operational areas should provide:
1. A workplace conducive, primarily, to personnel safety
2. A source for confidence in achieving and maintaining regulatory compliance
· Specific areas of concern that must be considered are:
1. Safety
2. Work space adequacy
3. Environmental monitoring
4. Preventive maintenance
5. Calibration
6. Microbiological suites
7. Biocontainment
8. Stability chambers
2. Methods/SOPs
These laboratory elements provide the guidance that is necessary to conduct a compliant operation.
· The elements may be those described or approved by the Local or Corporate Management and or mandated by the Federal agency.
1. Official
2. Non-Official
· Applicable procedures (Methods and SOPs) relevant to the lab requirements, system, or instrument orientation:
1. Validation — [process, cleaning, computers]
2. Instruments –[qualification]
3. Methods/SOPs – product related
4. System Suitability (as applicable)
5. Tech Transfer
6. Compliance is assured via spot checks & audits
3. Lab Personnel
To assure high performance, properly qualified and trained individuals are required to maintain the integrity of the lab operations.
· Basic area of emphasis – Training:
1. Local (site) and OJT
2. Academic
3. GXP & Par 11
4. Instrumentation
5. SOPs and methods
· Personnel Performance:
1. Initial demonstration of capability
1.1 Qualification to perform procedures
1.2 Ability to accurately generate reproducible data
2. Periodic performance proficiency evaluation
4. Support
To enable lab personnel to conduct efficient operations, proper basic equipment is needed.
· Equipment/Apparatus (General)
1. Autoclaves
2. Refrigerator
3. Incubators
4. Water-baths
5. Centrifuge
6. Desiccators
7. Drying ovens
8. De-ionized water system
9. Thermometer
10. Pipettes (manual & automatic)
11. Titrators (manual & automatic)
12. Recorders
13. Other as required
· Equipment (Sample Prep)
1. Blenders
2. Microwave for extraction/digestion (metals)
3. Analytical Balances
4. Certified Weights
5. Other as required
5. Analytical Instruments
Specifically designed or designated instrumentation will be required to conduct the various types of analytical testing.
· Chromatography
1. Gas (GC)
2. HPLC
3. Ion (IC)
4. Size Exclusion (SEC)
· Mass Spectrometer (MS)
· Interfaced MS units: GCMS, LCMS, MSMS
· Spectrophotometers
1. UV/Visible
2. Atomic absorption
3. Infrared (IR); Near IR; FTIR (Fourier Transform)
· NMR (Nuclear Magnetic Resonance)
· pH Meters
· TOC (Total Organic)
· Dissolution Units
· Polarizing Microscopes
· Chemistry Analyzers
· Auto-Analyzers
· Particle Size Analyzers
· Other as required
6. Microbiological Instruments
Specific instruments are necessary to conduct the specialized testing in the microbiological area.
· Plate Readers
· Microscopes
· Bacteria Identification Units
· Endotoxin (LAL) Units
7. Standards and Materials
Certain chemicals are needed to establish the veracity of the products being tested according to the prescribed methods and procedures.
· Standards
1. Compendial
2. Non-Compendial
· Bacterial Strains
· Laboratory Reagents
8. Laboratory Information Management System (LIMS)
A combination of software, hardware, and database tailored to a Laboratory to accept data, perform calculations and make lab information management easier.
· LIMS
1. Makes data retrieval easier
2. Enhances and accelerates lab operations and the dissemination of information
3. Reduces the large amount of quality assurance energy required in a paper system
· LIMS compliance must incorporate
1. Network Linkage/System Used
2. Instrument Systems
3. Software
4. Maintenance
5. Training
6. Validation Program
7. GXP and 21 CFR Part 11
Major decisions (public & private) are based on the outcome of analyses carried out in a cross spectrum of laboratories. Whether the data is used for monitoring, evaluating, or adjudication, it is paramount that the laboratories demonstrate data integrity and reliance in their operations.
Direct your comments and questions to robinson_williams@agilent.com
