FAQs regarding working standards in Pharma industry
Working standards refers to resources used for analysis regularly in the API, intermediates and other raw materials. The properties are matched in the lab with samples given by a client. The working standard qualification as per usp is also the basis of the standard operating procedure for testing.
Sourcing of working standards as per usp
It depends on the good quality of material of a consignment given in our laboratory. An analyst is assigned to check the LOD and least amount of impurity. The assay should have the highest potency from the stock available in the lab.
What if approval material is not in stock?
Then the consignment given is used as a working standard. Along with it, the routine analysis is done as per usp. The base material can be purchased from the vendor. The manufacturer can also share the WS with COA to proceed with the analysis.
What about solvent WS?
We use HPLC/GC, We ensure that only high purity chemicals are used. If any other source is taken, an authentication certificate is provided for it. Evaluation is done at the location itself. API specifications are taken by the lot and reference standards provided by the R & D department.
How do your R & D facilities operate?
Yes, this is an important and integral part of our services for working standard and reference standard. In the lab, the R &D department works on organic synthesis and analytical department works for qualifying materials depending on different needs.
How do organic synthesis work?
Depending on the needs at the plant lab, we provide the much needed reference standard and GRS. COA approvals also come with it.
What is the key role of the analyst in deploying working standards?
The samples are collected by the analyst and the team for WS preparations and procedure for the raw material. Two bags carry the quantity of the material. One is used for analysis and the other is kept for the final usage of WS. Some materials may be hygroscopic or sensitive to light. Due to these characteristics specific instructions are followed. The tests are carried out as per procedures. The WS code is procured from the QC. With this numbering the COA is prepared for WS.
These are the
main queries that explain how working
standard qualification as per usp work. We throw some more spotlight on the usp
which can further clarify how we conduct each project successfully.
Purposes of USP reference standards
They are usually conducted for assay only. They cannot be suitable for medical devices, drugs or even diagnostics. In the lab they can be applicable for testing and analysis. These are considered the primary standards unless they are calibrated and tested against the WHO standards.
SimSon Pharma works extensively with working standard and reference standard to help several companies who have the business of drug making. With our expertise, you can get all the assistance for your project needs.