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.

What is column in chromatography?

0 Answers   Chembond Chemicals,

---

Why PH range from 0to14.

2 Answers   College School Exams Tests, Reddy Labs, Wings Customer Care,

---

why we measure PH of a solution in PH only why not POH ?

1 Answers   Stellence Pharm Science,

---

[3/30, 13:29] Manoj P Venkatpurwar: How hplc column selection according to structure? How mobile phase buffer selection on molecule structure?

0 Answers  

---

Why sulfuric acid is used in sulphated ash / residue on ignition test.

9 Answers   CS Pharmaceuticals, Dr Reddys, GVK, HPLC, Micro Labs, Samrudh, Watson Pharmaceuticals, Wings Customer Care,

---

what is principle of XRD?

3 Answers   Cipla,

---

How to calculate %w/w and %v/v of a component(or solvent)by NMR

1 Answers   ACME, Vimta Labs,

---

Is sonication essential in solubility testing of a drug substance?

6 Answers   Aurobindo,

---

what is mean by ambient temperature?

0 Answers  

---

What is the SOP for SOP

4 Answers   JBCPL,

---

What is differences between the Instrument and Equipment

2 Answers   Aurobindo,

---

In the gas chromatography what is used carrier gas and make up gas?

1 Answers  

---