Good Chromatographic Practices (GCP)

What is Good Chromatographic Practices (cGCP) ?

As per WHO Guideline, “Good Chromatographic Practices (GCP) document provides information on good practices to be considered in the analysis of samples when chromatographic methods and systems are used. The principles should be applied in the analysis of, for example, raw materials, starting materials, intermediates, in-process materials and finished products.”

It is necessary to ensure that the data collected adheres to ALCOA+ principles due to the importance of the results obtained through chromatography. (i.e. attributable, legible, contemporaneous, original and accurate).

Good Chromatography Practices (GCP)

Good Chromatographic Practices (GCP) Consist of following but not to limited topics:

  1. Method Development:
    • Proper method development is essential to ensure accurate and precise results. It involves selecting the appropriate stationary and mobile phases, optimizing the gradient conditions, and selecting the appropriate detection method.
    • Method development should also take into consideration the properties of the sample being analysed, such as its solubility, stability, and concentration range.
    • Particular SOP should be followed for Method Development of Analytical Process.
    • HPLC chromatography or GC chromatography should be well developed.
  2. System Suitability Testing:
    • System suitability tests are performed to verify that the chromatographic system is working properly and that the separation is efficient and reliable.
    • The tests include parameters such as retention time, resolution, peak symmetry, and column efficiency.
    • These tests should be performed before the analysis of the samples to ensure that the results are accurate and reliable.
    • Ideally Pharmaceutical GMP procedure established the SST criteria for Product and Analysis wise and must be followed for Good Chromatographic Practices.
  3. Calibration:
    • Regular calibration of the chromatographic instruments (HPLC Calibration or GC Calibration) and HPLC detectors/GC Detectors is essential to ensure their accuracy and reliability.
    • Calibration involves the use of reference standards of known purity and concentration to determine the response of the instrument or detector.
    • The calibration data should be recorded and used to adjust the instrument or detector response to ensure accurate and reliable results.
    • SOP for Calibration should be followed.
    • Calibration criteria should be with the limit of Qualification range of Instruments.
  4. Sample Preparation:
    • Proper sample preparation is important to ensure that the results are representative of the sample being analyzed. Sample preparation may involve extraction, dilution, filtration, or other techniques depending on the nature of the sample.
    • It is important to ensure that the sample is properly prepared, and that any interferences or matrix effects are minimized.
    • Sample preparation should be well documented and validated as per Method Validation guideline of ICH Q2 (R1) Guidelines.
  5. Quality Control:
    • Quality control (QC) standards are used to verify the accuracy and precision of the method and to detect any changes or issues with the system.
    • QC standards should be run at regular intervals throughout the analysis to ensure that the method is working properly and that the results are accurate and reliable.
    • It is important to establish acceptance criteria for the QC standards and to monitor the results to ensure that they are within acceptable limits.
  6. Record Keeping:
    • Accurate and complete records should be kept of all experimental procedures and results, including method development, calibration, sample preparation, analysis, and data processing.
    • Records should be maintained in a format that is easily retrievable and should include information such as the date, time, analyst name, and any deviations from the established procedures.
    • Follow the Good Documentation Practices (cGDP).
  7. Training and Qualification:
    • Proper training and qualification of personnel involved in the analysis is essential to ensure that they follow the established procedures and guidelines.
    • Personnel should be trained in the proper use of the instruments and equipment, as well as the proper handling and preparation of samples.
    • Personnel should also be qualified based on their knowledge, skills, and experience to ensure that they can perform the analysis accurately and reliably.
  8. Qualification, Maintenance and Validation:
    • All stages of qualification should be accurately performed and it may include, user requirement specifications (URS), design qualification (DQ), factory acceptance test (FAT), site acceptance test (SAT), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).
    • Regular maintenance (Preventive Maintenance (PM)) and validation of the chromatographic equipment is essential to ensure that it is operating correctly and producing reliable results.
    • Maintenance may involve cleaning, lubrication, and replacement of parts, while validation may involve the use of reference standards or spike samples to verify the accuracy and precision of the method.
    • Preventive Maintenance should be performed by Trained personnel or Service engineer only.
    • It is important to establish a maintenance and validation schedule and to follow it regularly to ensure that the system is working properly.
  9. Peak Integration
    • Peak areas in chromatograms should be consistently and correctly integrated in a way that adheres to scientific principles.
    • Wherever feasible, HPLC and GC instruments should be connected to computerised chromatographic data acquisition and processing systems that can automatically and consistently apply integration parameters.
    • Unless otherwise justified scientifically, the same integration parameters should be applied to each peak in a sample collection or sample sequence.
  10. Access and Privileges & Audit Trails:
    • For the creation and deletion of user groups and users of the chromatographic system, there should be a standard operating procedure (SOP) showing the pertinent privileges assigned to each user.
    • Records must be kept securely as per 21CFR11 .
    • User organisations and users should be listed in a current database.
    • Users within each group should be well qualified for the assigned responsibilities and rights in the software.
    • Every process should be driven thought the Audit trails and it should be periodically checked and verified.
  11. Backup of Electronic Data & Data Management:
    • As a part of Good Chromatographic Practices, electronic data should be periodically backup by user and it should be checked against the physical copy.
    • Backup can be done by automatic or by manual procedure.
    • Audit Trails should be recorded for same.
    • Risk assessment for the Backup data and data management should be prepared in case of failure.

Good Chromatographic Practices (GCP) is now a day required tend in the cGMP and cGLP practices.

References:

  1. GOOD CHROMATOGRAPHY PRACTICES PDF (By WHO)

Read More:

Other Topics:

You cannot copy content of this page