CELLPEPT LABS / QUALITY CONTROL
QUALITY YOU CAN VERIFY.
Quality control built around batch-specific analytical verification, physical traceability and defined product specifications.
IDENTITY — PURITY — CONTENT QUANTITY — ENDOTOXIN — HEAVY METALS — TRACEABILITY
BATCH-SPECIFIC ANALYSIS INDEPENDENT VERIFICATION PHYSICAL TRACEABILITY ANALYTICAL DOCUMENTATION
CELLPEPT LABS / QUALITY CONTROL
QUALITY YOU
CAN VERIFY.
Quality control built around batch-specific analytical verification, physical traceability and defined product specifications.
BUILD YOUR SPECIFICATION
01 IDENTITY 02 PURITY
03 CONTENT QUANTITY 04 ENDOTOXIN
05 HEAVY METALS 06 TRACEABILITY
BATCH-SPECIFIC ANALYSIS
INDEPENDENT VERIFICATION
PHYSICAL TRACEABILITY
ANALYTICAL DOCUMENTATION
CELLPEPT LABS / QUALITY CONTROL
QUALITY YOU CAN VERIFY.
Quality control built around batch-specific analytical verification, physical traceability and defined product specifications.
IDENTITY — PURITY — CONTENT QUANTITY — ENDOTOXIN — HEAVY METALS — TRACEABILITY
BATCH-SPECIFIC ANALYSIS INDEPENDENT VERIFICATION PHYSICAL TRACEABILITY ANALYTICAL DOCUMENTATION
CELLPEPT LABS / QUALITY CONTROL
QUALITY YOU
CAN VERIFY.
Quality control built around batch-specific analytical verification, physical traceability and defined product specifications.
BUILD YOUR SPECIFICATION
01 IDENTITY 02 PURITY
03 CONTENT QUANTITY 04 ENDOTOXIN
05 HEAVY METALS 06 TRACEABILITY
BATCH-SPECIFIC ANALYSIS
INDEPENDENT VERIFICATION
PHYSICAL TRACEABILITY
ANALYTICAL DOCUMENTATION
01 / QUALITY STANDARD
QUALITY DEFINED BY MEASUREMENT.
Every production specification can be connected to defined analytical requirements and batch-specific documentation.
DEFINED QUALITY PARAMETERS
*Where specified for the applicable product and production configuration.
01 / QUALITY STANDARD
QUALITY DEFINED BY MEASUREMENT.
Every production specification can be connected to defined analytical requirements and batch-specific documentation.
DEFINED QUALITY PARAMETERS
SPEC / 01
≥98.5%
MINIMUM PURITY SPECIFICATION*
98.5%
100%
SPEC / 02
±5%
TARGET FILL ACCURACY*
−5% ━━━━━━━━━━━ ● ━━━━━━━━━━━ +5%
0
VERIFY / BATCH
BATCH-SPECIFIC ANALYTICAL DOCUMENTATION
Analytical records connected to the applicable production batch.
BATCH ●──── ANALYSIS ●──── DOCUMENTATION
*Where specified for the applicable product and production configuration.
SPEC / 01
≥98.5%
MINIMUM PURITY SPECIFICATION*
98.5%
100%
SPEC / 02
±5%
TARGET FILL ACCURACY*
−5% ━━━━━━━━━━━ ● ━━━━━━━━━━━ +5%
0
VERIFY / BATCH
BATCH-SPECIFIC ANALYTICAL DOCUMENTATION
Analytical records connected to the applicable production batch.
BATCH ●──── ANALYSIS ●──── DOCUMENTATION
02 / IDENTITY & PURITY
VERIFY WHAT THE PRODUCT IS.
Identity and purity analysis provides analytical confirmation that the batch corresponds to the intended peptide specification.
01 / IDENTITY
CONFIRM THE INTENDED PEPTIDE
Analytical confirmation against the defined product specification.
02 / PURITY
MEASURE RELATIVE SAMPLE PURITY
Quantitative assessment of relative sample purity.
PRIMARY ANALYTICAL METHOD
HPLC ANALYSIS
Identity / relative sample purity
02 / IDENTITY & PURITY
VERIFY WHAT THE PRODUCT IS.
Identity and purity analysis provides analytical confirmation that the batch corresponds to the intended peptide specification.
01 / IDENTITY
CONFIRM THE INTENDED PEPTIDE
Analytical confirmation against the defined product specification.
02 / PURITY
MEASURE RELATIVE SAMPLE PURITY
Quantitative assessment of relative sample purity.
PRIMARY ANALYTICAL METHOD
HPLC ANALYSIS
Identity / relative sample purity
01 / PURITY
RELATIVE COMPOSITION
What proportion of the analyzed sample corresponds to the target compound?
DEFINED PURITY SPECIFICATION
≥98.5%*
02 / CONTENT QUANTITY
AMOUNT PRESENT
How much target compound is actually present in the analyzed sample?
TARGET FILL ACCURACY
±5%*
03 / CONTENT QUANTITY
PURITY ALONE IS NOT ENOUGH.
A highly pure sample does not automatically confirm how much peptide is present. Content quantity provides a separate measurement of the target compound within the analyzed sample.
01 / PURITY
RELATIVE COMPOSITION
What proportion of the analyzed sample corresponds to the target compound?
≥98.5%*
02 / CONTENT QUANTITY
AMOUNT PRESENT
How much target compound is actually present in the analyzed sample?
±5%*
COMPLETE CHARACTERIZATION
TWO MEASUREMENTS. ONE DEFINED PRODUCT.
PURITY + CONTENT QUANTITY = DEFINED PRODUCT SPECIFICATION
03 / CONTENT QUANTITY
PURITY ALONE IS NOT ENOUGH.
A highly pure sample does not automatically confirm how much peptide is present. Content quantity provides a separate measurement of the target compound within the analyzed sample.
COMPLETE CHARACTERIZATION
TWO MEASUREMENTS. ONE DEFINED PRODUCT.
Purity + Content Quantity = Defined Product Specification
*Where specified for the applicable product and production configuration.
04 / ENDOTOXIN
CONTROL BEYOND PURITY.
Purity testing and endotoxin screening measure different quality parameters. Where applicable, endotoxin screening forms part of the defined analytical scope for the production batch.
04 / ENDOTOXIN
CONTROL BEYOND PURITY.
Purity testing and endotoxin screening measure different quality parameters. Where applicable, endotoxin screening forms part of the defined analytical scope for the production batch.
05 / HEAVY METALS
SCREENING FOR ADDITIONAL QUALITY PARAMETERS.
Where applicable to the project specification, heavy metal screening can provide an additional analytical layer beyond identity, purity and content quantity.
05 / HEAVY METALS
SCREENING FOR ADDITIONAL QUALITY PARAMETERS.
Where applicable to the project specification, heavy metal screening can provide an additional analytical layer beyond identity, purity and content quantity.
06 / INDEPENDENT ANALYSIS
VERIFICATION BEYOND INTERNAL QC.
Independent analytical testing provides an additional verification layer separate from internal production controls.
06 / INDEPENDENT ANALYSIS
VERIFICATION BEYOND INTERNAL QC.
Independent analytical testing provides an additional verification layer separate from internal production controls.
01 / INTERNAL PRODUCTION CONTROL
02 / PRODUCTION BATCH
03 / INDEPENDENT ANALYTICAL VERIFICATION
04 / BATCH-SPECIFIC RESULTS
05 / THIRD-PARTY DOCUMENTATION
07 / PHYSICAL TRACEABILITY
THE BATCH ID STAYS WITH THE VIAL.
Laser-etched batch identification creates a permanent physical link between the vial and its corresponding production batch documentation.
LASER-ETCHED BATCH ID
Permanent identification directly on the metal vial cap.
07 / PHYSICAL TRACEABILITY
THE BATCH ID STAYS WITH THE VIAL.
Laser-etched batch identification creates a permanent physical link between the vial and its corresponding production batch documentation.
LASER-ETCHED BATCH ID
Permanent identification directly on the metal vial cap.
PHYSICAL VIAL → LASER-ETCHED BATCH ID → PRODUCTION BATCH → ANALYTICAL RECORD
LASER-ETCHED IDENTIFICATION / TAMPER-EVIDENT SEALS / ANTI-COUNTERFEIT MEASURES / BATCH TRACEABILITY
08 / DOCUMENTATION
FROM PHYSICAL VIAL TO ANALYTICAL RECORD.
Batch-specific identification connects the physical product to the analytical documentation associated with its production batch.
08 / DOCUMENTATION
FROM PHYSICAL VIAL TO ANALYTICAL RECORD.
Batch-specific identification connects the physical product to the analytical documentation associated with its production batch.
01 / PHYSICAL PRODUCT
02 / BATCH IDENTIFICATION
03 / ANALYTICAL TESTING
04 / BATCH DOCUMENTATION
IDENTITY & PURITY / CONTENT QUANTITY / ENDOTOXIN / HEAVY METALS / BATCH REFERENCE
09 / RELEASE CONTROL
QUALITY CONTROL IS A PROCESS.
Quality requirements should be defined before production and remain connected to the batch through analytical verification and documentation.
09 / RELEASE CONTROL
QUALITY CONTROL IS A PROCESS.
Quality requirements should be defined before production and remain connected to the batch through analytical verification and documentation.
01 / PRODUCT SPECIFICATION
02 / PRODUCTION BATCH
03 / ANALYTICAL TESTING
04 / RESULT REVIEW
05 / BATCH DOCUMENTATION
06 / RELEASE / DISTRIBUTION
10 / SPECIFICATION CONTROL
THE SPECIFICATION IS THE BENCHMARK.
Analytical results are meaningful when they are evaluated against defined project and product requirements.
10 / SPECIFICATION CONTROL
THE SPECIFICATION IS THE BENCHMARK.
Analytical results are meaningful when they are evaluated against defined project and product requirements.
01 / DEFINED SPECIFICATION
02 / ANALYTICAL RESULT
03 / REVIEW AGAINST REQUIREMENTS
04 / RELEASE DECISION
11 / QUALITY MATRIX
MULTIPLE CONTROLS. ONE BATCH RECORD.
QUALITY PARAMETER / PURPOSE / VERIFICATION
11 / QUALITY MATRIX
MULTIPLE CONTROLS. ONE BATCH RECORD.
QUALITY PARAMETER / PURPOSE / VERIFICATION
01 / IDENTITY
02 / PURITY
03 / CONTENT QUANTITY
04 / ENDOTOXIN
05 / HEAVY METALS
06 / BATCH IDENTITY
07 / DOCUMENTATION
01 / IDENTITY
02 / PURITY
03 / CONTENT QUANTITY
04 / ENDOTOXIN
05 / HEAVY METALS
06 / BATCH IDENTITY
07 / DOCUMENTATION
Confirm intended peptide
Assess relative sample purity
Measure target compound quantity
Screen applicable batch parameter
Screen applicable elemental contaminants
Connect physical vial to production batch
Connect analytical records to batch
Confirm intended peptide
Assess relative sample purity
Measure target compound quantity
Screen applicable batch parameter
Screen applicable elemental contaminants
Connect physical vial to production batch
Connect analytical records to batch
● ANALYTICAL TESTING
● HPLC ANALYSIS
● QUANTITATIVE ANALYSIS
● BATCH SCREENING
● ANALYTICAL SCREENING
● LASER-ETCHED IDENTIFICATION
● BATCH-SPECIFIC RECORDS
● ANALYTICAL TESTING
● HPLC ANALYSIS
● QUANTITATIVE ANALYSIS
● BATCH SCREENING
● ANALYTICAL SCREENING
● LASER-ETCHED IDENTIFICATION
● BATCH-SPECIFIC RECORDS
MULTIPLE CONTROLS → ONE CONNECTED BATCH RECORD
BUILD QUALITY INTO THE SPECIFICATION
DEFINE THE STANDARD BEFORE PRODUCTION BEGINS.
Configure product, analytical, packaging and production requirements as part of one project specification.
BUILD QUALITY INTO THE SPECIFICATION
DEFINE THE STANDARD BEFORE PRODUCTION BEGINS.
Configure product, analytical, packaging and production requirements as part of one project specification.
BUILD YOUR SPECIFICATION →