Standard Operating Procedure for Reporting of Raw Material and Working Standard Potency

1.0 Purpose:

To lay down a procedure for providing the Potency of Active Raw Material (API) to Warehouse Department before Dispensing.

2.0 Scope:

The scope of this procedure is applicable for providing the Potency of Active Raw Material (API) to Warehouse Department. It also provides the reporting procedure for Working Standard Potency.

3.0 Responsibility:

QC Personnel: To Analyze Active Raw Material (API), To Provide the Potency of the Active Raw Material (API) to Warehouse Department.

Head QC/ Designee: To Check the Potency of the Active Raw Material (API), To Monitor the Activity.

QA Personnel/ Warehouse personnel: To verify the Potency of the Active Raw Material (API).

4.0 Definitions:

5.0 Procedure:

5.1 The Active Raw Material (API) shall be analyzed as per the respective Specification.

5.2 Upon completion of the analysis, the Active Raw Material (API) shall be released and approved through LIMS.

5.3 The Certificate of Analysis (CoA) shall be printed after approval.

5.4 The actual value of potency, based on the Certificate of Analysis (CoA), shall be reported.

5.5 If the potency of the Active Raw Material (API) or Working Standard exceeds 100%, it shall be considered as 100% for calculation.

5.6 If the potency of the Active Raw Material (API) or Working Standard is less than 100%, it shall be used as is for calculation.

5.7 The above reporting procedure also applies to the Working Standard.

5.8 The LIMS configured CoA shall be prepared as per the respective SOP. This CoA shall include the Assay value on an as-is basis/dried basis/anhydrous basis and water/LOD test results.

5.9 If LIMS is under breakdown, details shall be provided to the Warehouse department as per the “Internal Correspondence Format for Reporting Potency”.

5.10 The Manager QC/Designee shall check the details in the “Internal Correspondence Format for Reporting Potency”.

5.11 A QA person shall verify the details in the “Internal Correspondence Format for Reporting Potency”, and subsequently, potency is verified by warehouse/IPQA persons.

5.12 A QC person shall also enter data (Assay/LOD/Water content, etc.) in SAP for potency calculation, and a QA person shall approve the potency in SAP through the applicable T code.

5.13 The “Master list for indicating drug product required ‘As is / Anhydrous / dried basis potency’” shall be reviewed during dispensing activity.

6.0 Acceptance Criteria:

As per respective Specification.

7.0 Frequency:

As and when required.

8.0 Format for recording:

8.1 Internal Correspondence Format for Reporting Potency.

Material Name
Control No.
Batch No.
Inspection Lot No.
Potency on as such basis
LOD / Water Content
Total Solvents
Potency on Dried Basis / Anhydrous Basis / Solvent Free Basis

Note:

– If the Raw materials have potency more than 100 %, it should be considered for calculation as 100 %.

– If Raw materials have potency less than 100 %, it should be considered for calculation as it is.

Calculation of Potency on Dried Basis / Anhydrous Basis/ solvent free basis:

= (Assay on as is basis X 100)/ (100-Water content or LOD)

Calculation of Potency on As is basis:

= [Assay on anhydrous or dried basis X (100-Water content or LOD + Solvent)]/ 100

In % for µg/mg = (µg/mg X 100)/ 1000

—	Prepared By (QC)	Checked By (QC)	Verified By ( Lab QA)	Verified By (Warehouse)	Verified By (QA)
Signature
Date
Department

8.2 Master list for indicating drug product required “As is/ Anhydrous/ dried basis potency.

Sr. No.	Name of material	Potency mentioned on CoA (As is basis / Dried basis/ anhydrous basis)	Potency required for dispensing of API As is basis / Dried basis/ anhydrous basis)	Remark

Prepared by		Checked by		Approved by
Date		Date		Date
Department	Quality control		Quality Control		Quality Assurance