What is oos in pharma

Was the sample stored and transported as per the required packaging condition? Was there any sample mix-up during storage and handling. Was the sampling procedure followed feedback based on interrogation with concern person as per respective SOP?

Balance checked for its calibration. Instrument Calibration checked. Check as per respective SOP. Was the instrument working constantly as per requirement…? Sample preparation investigation. Was any abnormality observed in sample vial and syringe penetrates all the vials used in the run…? Were glassware and instrument used in analysis clean…? Was it checked whether the analyst performing multiple testing simultaneously which cause potential sample mix up?

How long has working standard bottle been in use in the lab? Was the standard weighed immediately or after reaching the room temperature…? Was the physical condition of the prepared solution and raw data of Volumetric Solution satisfactory?

Raw data and methodology review. Were there any deviations from the analytical test procedure? Was the dilution, weighing, titer values, and readings found satisfactory? Was the bracketing standard RSD as per the limits? Were the calculation and formula used correctly? Was any other test performed of the same sample? Chromatography review. What was the column type, serial no?

Mobile Phase liquid chromatography. Was any evidence of air bubbles in the mobile phase during use? Mobile Phase Gas chromatography.

Is the physical condition of the prepared solution and raw data of Volumetric Solution found adequate? Was the analyst trained for the analytical technique to perform a particular analysis? Have analysts generated other OOS using the same methodology for the same product and other products? Was the analyst training, qualification and performance record found satisfactory?

Training date:. Does this laboratory event indicate a repetitive type of event? Glassware checked for its accuracy i. Class A or Class B grade glassware used. Was previous batches trend data verify. However, you would much rather ensure the problem is identified, resolved, and learned from, rather than having it reoccur and cause greater consequences in future. Now that your sample has been labeled as OOS, an investigation is initiated to attempt to determine the cause. Every testing facility has its own system of handling OOS results.

In the first phase of the OOS investigation the laboratory will assess the initial data and determine if it was accurate. Did the analyst who tested the sample make any errors in the testing process? Were there any malfunctions with the testing instruments? Basically, this part of the investigation serves to eliminate laboratory, equipment, and analyst error from the list of potential root causes of the OOS result.

Within this phase, a review of the production may occur. Was there an inadequate amount of raw material used? Was there some sort of variation during the manufacturing process?

Was the product formulation lacking robustness? As mentioned before, every testing facility will have its own system for handling an OOS result. At Eagle, Phase I involves reviewing the test results and data to identify any laboratory errors. If there are none, we can presume the results are valid and the client has the option to investigate on their site. If laboratory errors are found, Eagle initiates a Phase II investigation, which also typically involves re-testing of the sample. In summary, when results are not meeting the criteria, investigation must take place in order to determine the root cause.

With so many factors to consider, every investigation must be carefully considered, unbiased, scientifically sound, and well-documented. Eagle consultants and scientists are helping compounding facilities implement successful quality systems. Our team has over years of combined experience in the FDA-regulated pharmaceutical industry and can provide guidance in establishing the systems and processes that will help facilities producing compounded medications meet and exceed regulatory expectations.

OOS investigations focus on determining the truth about that one value while OOT investigations focus on understanding non-random changes. Example: The specification limit for assay is: Case For a particular batch, the result obtained This is called OOS. Case-2 : The result obtained Although the results are well within the specifications, we should compare the result with the previous batches trend.

If we found the average value of the trend as Also see:. Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since