HPLC Method Equivalence between USP and EP

#1
I make a product that complies with USP/BP/JP/IP/ and EP. Is there any way I could use only one HPLC method (Say USP) and still claim EP/Bp/IP etc?
 
Elsmar Forum Sponsor

Ajit Basrur

Staff member
Admin
#2
You must comply with the individual monographs to comply the USP, BP, EP and other requirements.

Have you done any comparison between those methods to see what the differences are?
 
Thread starter Similar threads Forum Replies Date
O HPLC Impurity Method Transfer help needed Document Control Systems, Procedures, Forms and Templates 4
F Reintegration of Peaks on Chemstar for HPLC Miscellaneous Environmental Standards and EMS Related Discussions 1
S Statistics in Check/Replicate Analysis - HPLC Assay (Sample Duplicates) Statistical Analysis Tools, Techniques and SPC 1
J IQ, OQ and PQ for HPLC-UV or Liquid Chromatography-Mass Spectrometry (LC-MS) system General Measurement Device and Calibration Topics 1
R How to calculate and apply Measurement Uncertainty in Chemical Analysis - HPLC, GC Measurement Uncertainty (MU) 8
R What's the cause of tailing factor in High Performance Liquid Chromatography (HPLC)? General Measurement Device and Calibration Topics 6
Q Sampling method for Distributor verification activities EU Medical Device Regulations 1
D Test Method Validation Qualification and Validation (including 21 CFR Part 11) 4
C Correct Calibration Method for Dial Depth Gage General Measurement Device and Calibration Topics 6
E Mentor for Test Method Validation (TMV) Design and Development of Products and Processes 2
earl62 IATF 16949 Clause 9.1.1.1 - What is the batch conformance to specification method? IATF 16949 - Automotive Quality Systems Standard 3
A Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
S What is the best method to bond urethane foam to urethane foam? Manufacturing and Related Processes 4
R BS EN 12060:1998 - Zinc and zinc alloys Method of sampling Specifications Manufacturing and Related Processes 4
M Test method validation - Is MSA (MSA1, MSA2, MSA3 and linearity) a good solution? Medical Device and FDA Regulations and Standards News 1
Pau Calvo How to motivate colleagues to use 8D method or similar Quality Manager and Management Related Issues 37
M Proper method to test flow of a regulator Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
V Minitab GRR crossed Xbar and r method macro needed Using Minitab Software 9
R Please share your method used for PEMS Validation IEC 62304 - Medical Device Software Life Cycle Processes 5
S AS9100D PEAR - Examples for organization's method for determining process results? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Y Post Market Surveillance Indicators and Analysis method EU Medical Device Regulations 1
silentmonkey Seeking efficient method to manage install base data Manufacturing and Related Processes 0
D 4M (Man, machine, method, materials) Management Manufacturing and Related Processes 3
Ron Rompen Measurement Method Challenge - Measure feature #91 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
C FDA on changing acceptance criteria re: analytical method validation US Food and Drug Administration (FDA) 1
M Issuing NCR for improper method statement submissions Internal Auditing 10
F Irradiation Sterilization Validation Maximum Dose - VDmax 25 method (ISO 11137) EU Medical Device Regulations 2
I "Method" vs "Process" - Differences Document Control Systems, Procedures, Forms and Templates 33
P Test Method Validation for Tensile Strength Tester Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
C ICP versus AA: How to determine appropriate specification for assay method verification Qualification and Validation (including 21 CFR Part 11) 1
I Flatness - Rectangular part using the three jack method Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
B AS9102 Supplier Flow Down Method AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
M Control Method correspondence between PFMEA and CP FMEA and Control Plans 8
qualprod Qualitative or Quantitative? Risk method evaluation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Ron Rompen Dual level holes - Measurement method suggestions wanted General Measurement Device and Calibration Topics 9
D Sampling method that is representative of the devices supplied by that distributor EU Medical Device Regulations 5
P Production Line Pump Cleaning Validation Method Question Qualification and Validation (including 21 CFR Part 11) 0
A Risks related to Method Validation and Stability Studies Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
qualprod ISO 9001 Risk control method - What could be the better way to control risks? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Ron Rompen Ford Method - Position Capability with MMC Modifier Capability, Accuracy and Stability - Processes, Machines, etc. 14
J Inspection method for T10 Hex driver General Measurement Device and Calibration Topics 13
qualprod ISO 9001:2015 - Right method to address clause 6.1? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S Stakeholder analysis Method Six Sigma 1
T ER Checklist - Method(s) of conformity EU Medical Device Regulations 1
T ISO 17025 Method Verification - One sided “F” test or two sided “F” test ISO 17025 related Discussions 1
B Dosimeter Calibration Method General Measurement Device and Calibration Topics 5
A Test method for presence or absence of hexavalent chromium on a metal coating RoHS, REACH, ELV, IMDS and Restricted Substances 4
S Response Surface Method to create design matrix in Minitab Using Minitab Software 5
T Method to assess Measurement System of a Continuous Process Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
S Test Method Validation or MSA for Batch Manufacturing Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1

Similar threads

Top Bottom