Interested to Buy Any Domain ? << Click Here >> for more details...
In pharmaceuticals formulation OOS applicable in Raw
Material(which is not manufacturing in the company. and
purchase by approved vendor)).Why?
- 1 Answers
- 9041 Views
- Orchid, I also Faced
- E-Mail Answers
Answer / b.suresh naidu
Yes OOS is applicable in Raw materials (which is not
manufacturing in the company and purchased by approved
vendor).
OOS may be due to assignable (or) non-assignable causes,
which may occur due to analytical error, manufacturing
error, _ _. To identify the root cause, investigation
should be done.
In a formulation unit, upon observation of OOS in any Raw
material, preliminary investigation/retesting to be done as
per ‘In-house OOS’ procedure (The procedure should be
clearly defined in ‘In-House OOS’ SOP). The OOS should be
informed to the Vendor on the day of the
observation/Confirmation. It is the responsibility of the
Vendor to do further investigation (Vendor should have
their OOS procedure for OOS investigation).
Upon completion of investigation, the Vendor should
inform the same to the respective Formulation unit with
necessary CAPA.
| Is This Answer Correct ? | 15 Yes | 0 No |
How can you prepare 0.05M Ammonium acetate volumetric solution?
Why using Holmium oxide in UV calibration
8 Answers Dr Reddys, Matrix, Nakoda Chemicals, Orchid,
what is the need of calulation of RRF of impurity in HPLC analysis?
Do you have experience with organic extractions or tissue digestions?
Why we use buffers Acetate for pH 4.5 & phosphate for 6.8 and not vice-versa?
Who discovered X-ray
2 Answers Huntsman Corporation,
How does GC did work?
why base line not start from zoro in GC Chromatograme.
What is normality
how do you established the RRF for unknown impurity
what is Hilic chromatography?
I have compare C2H2-air and C2H2-N2O flame AAS on determination calcium. Both use same range of std to plot calibration curve. (2-6ppm) When i measure the sample with phosphate, KCl and LaCl, C2H2-N2O flame give false positive result, around 0.5ppm. When i measure the sample with phosphste, KCl and EDTA. C2H2-N2O flame also give 0.5ppm false positive. But both above mentioned sample would not give false positive when measured by C2H2-air flame. What is the reason?
Organic Chemistry 
