Laboratory Investigation Of Aberrant Results in pharmaceuticals Part-2:
In the last part, we covered 2 points 1. Analyst responsibility and Awareness 2. Analytical record review.
In this part, we will cover another 3 points. i.e. 3. Analytical method verification 4. Sample integrity 5. Reference/Working Standards.
Analytical Method verification:
Check that the current version of the analytical method is available & the same was used for the analysis.
Crosscheck that the method is validated. And same is transferred to the quality control department and the method transfer was completed successfully.
If the method is new/recently revised/used the first time or less frequently used then a detailed review of the method should be performed.
If any special instruction/precaution is given in the method then check that it was followed properly.
Verify the sampling activity for compliance as per the standard operating procedure (SOP). If any deviation is observed that the standard procedure same shall be reviewed thoroughly.
Determine the time gap between the time of sampling till the time of analysis. Determine the effect of time of gap on the analysis result if any.
Determine whether the sample had any unusual or abnormal appearance from the previous samples.
Check the sample for homogeneity or any foreign material.
Verify the physical appearance of the sample for color, odor, crystalline/amorphous nature, etc.
Sample preparation & sample solution stability:
Review the analytical method and determine any deviation in the weighing & preparation of the sample. Check the compliance to the proper calculation and weighing of the sample and proper & accurate dilution of the solutions were done.
Review the stability of the sample solution mentioned in the standard analytical method. And same has been followed. Verify the usage of the sample solution within its solution stability.
Check the environmental conditions while sampling. Also, verify the storage conditions in the stores as well as in the laboratory.
Verify that the sample was properly stored since it was sampled to it was analyzed. Check for any chances of contamination during storage/sampling/analysis.
Check any special storage condition is mentioned & was followed for the storage of the sample.
Verify that the sample was stored in the specified container in the specified area.
Laboratory Glassware & Utensils:
Check the certified glassware was used for analysis. Appropriate laboratory glassware, specified in the standard analytical methods was used.
Verify that the glassware used was adequately cleaned and there were no chances of contamination.
The integrity of the standard:
Check that the correct & current lot of standard was used for the analysis. Crosscheck the usage log of standard against the raw data for correctness & transcription error.
Crosscheck the following points regarding the standard used,
- The expiry date of standard
- Expired or near expiry standard used
- Stability of the standard
- Storage of the standard
- Potency of the standard
- Any special instruction for usage of standard etc.
The appearance of the standard:
Physically verify the standard to confirm the absence of foreign contamination or suspect signs of deterioration.
For Example, Discoloration, change in physical characters, foreign odor, etc.
Preparation of Standard:
Crosscheck the data for the preparation of the standard. Check the reference standard used for the evaluation of the working standards. The lot is used for the preparation of standards & their purity.
Crosscheck the weighing & preparation of the standard as per the standard analytical procedure. And usage of standard solution within its stability.
Labeling of the standard:
Check the labeling of the standard & confirm that the correct potency/Purity is applied. The direction of use mentioned on the container is followed or not.
Determine the correction factor of any or moisture factor is applied or the standard has to be used on dried/anhydrous basis or as-is basis.
Also, determine that the standard had been stored as per the direction mentioned on the container label.
These are the 3 points of Laboratory Investigation Of Aberrant Results in pharmaceuticals and the remaining 4 points we will cover in the next part.
- Understand 14 ICH guidelines in short
- Handling of rejected batches
- What is form 482-483 and 484
- Electronic Code of Federal Regulation (E-CFR)
- Best Practices to avoid data integrity issues alcoa plus
- Interview Question and answer for Quality control
- Clinical Data Management Interview Questions And Answers
- Karl Fischer Titration Interview Question and Answer
- HPLC Interview Question and Answers
- Dissolution Interview Question and Answer
For interview preparation refer
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