See how the HPLC system passes the FDA inspection
HPLC is mainly used in QC laboratory control systems to detect raw materials, intermediates (semi-finished products), product content and/or impurities. It is now very popular, and it is one of the very high-frequency instruments in the FDA's cGMP certification or audit. Combine your own experience and share with your friends how to make the HPLC system pass the FDA inspection without any or only general defects.
The defects that are often detected by HPLC systems are mainly:
1. HPLC confirms that there are no items that are not reflected in the annual confirmation plan or that are not confirmed or made.
2. HPLC is not included in the company's instrument ledger.
3. There is no SOP or no use or maintenance record for the use and maintenance of HPLC, or the record is not suitable.
3. There are problems with the safety of HPLC system chromatographic data processing software.
4. There is no record of the use of the column.
5. The system suitability test was not performed or the method was not suitable.
6. There are defects in the management and use of liquid phase standards (control) or working standards.
The following analysis and measures are taken one by one:
1. For the newly purchased liquid chromatograph, there should be URS (can be completed together with the manufacturer); 3Q confirmation (IQ\OQ\PQ) should be performed after arrival, if the method used in the actual work is different from the manufacturer's method, You can also do IQ and OQ only, and then make PQ after making the inspection SOP. The FDA inspector does not approve the official metrology verification in China, so the 3Q confirmation of HPLC is mandatory and reconfirmed after expiration. The general HPLC3Q confirmation period is one year, while the HPLC mandatory verification period is 2 years.
2. Whether it is new or existing HPLC, it must be included in the company's QC equipment management.
3. There must be a confirmation plan and confirmation plan for each HPLC in the QC equipment annual confirmation plan. The HPLC confirmation protocol should be formulated in a detailed and reasonable manner. Here, the confirmation and verification are two completely different concepts, which cannot be confused or replaced by each other. FDA auditors are approved by HPLC.
4, HPLC should have used SOP, maintenance SOP, and have a corresponding use record, maintenance records. The difference we made was that there were no maintenance SOPs and records, or there were but implementations and records were not appropriate. For example, if a part of your HPLC is replaced, you should record the detailed operation of the replacement instead of just filling in the “replacedâ€. If key components are replaced, change management or even confirmation by HPLC is required. As for which are the key components, they are evaluated according to the risk.
5, HPLC rights management: the computer should be equipped with a power-on password, screen protection is also recommended to set a password. The chromatographic software used in domestic HPLC has very little usage authority management, so it is impossible to set the authority of the laboratory technician and the QC supervisor, so that the parameter setting and map of the HPLC may be accidentally deleted or changed. HPLC of well-known foreign brands has done a good job in this regard.
6. Audit trail function: FDA's cGMP requires chromatographic software to have audit trail function and use it during detection, which can prevent fraud by modifying the time of the computer. The domestic HPLC chromatographic software does not have an audit trail function, which is itself a defect and provides a possibility for fraud. Especially in the 3Q confirmation of analytical method verification and HPLC, the retention time and peak area reproducibility of the chromatogram of domestic HPLC are not good, and some maps and data cannot be used.
7. Integral parameters: For an analysis method, the integral parameters should be part of the analysis method and written in the method. For example, what is the peak width, what is the slope, and what is the minimum peak area. Once it is determined, it can no longer be changed, because if it is changed, it will affect the qualitative and quantitative, and the number and area of ​​the obtained peak or the final content will change. And the trend analysis and product quality review of your results and actual production operations and product quality are artificially misleading.
8. Calculation of results: Some chromatographic software can be used for calculation, or EXCEL for calculation, but sometimes the results obtained by computer or computer calculation are different, and even OOS, OOT. The reason is that the effective number of bits per data may be different, causing inconsistencies in the calculation process and the final result determination. The FDA inspector will calculate it according to the calculation formula, which should be taken seriously.
9. System Applicability: This must be done at the beginning of the test. Only when the system suitability test is passed can you prove that your HPLC can be put into the test. Otherwise, it is necessary to make appropriate adjustments to the flow equalization and re-do the system. Sex test. If the system suitability test fails, you should also find out if the hardware of the HPLC has failed.
10, the use of the column, every time to do, because the column is the core of separation, is the most important part of HPLC.
11. Preparation of reference solution and test solution: Usually, the reference substance and the test sample are weighed twice, and each sample is taken into 2 needles, and the result is calculated.
12, the use of standard products (control), work standards, must have a record of use, so that the account is consistent.
13. Relevant records of HPLC detection: such as the preparation record and batch number of the mobile phase, the account of the reagent used, the calibration of the analytical balance, the usage record, etc., and the relevant records must be complete.
The above content is for reference only by peers. If there is anything wrong, please correct me. Due to the limited personal level, the content of the summary will be incomplete, welcome friends to add, the friends will thank you.
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