- OBJECTIVE:
To lay down a procedure for Material Codification In Pharmaceutical.
- SCOPE:
This SOP is applicable for Material Codification In Pharmaceutical at {Company Name} {Company Location}.
- RESPONSIBILITY:
QA, QC, Production, F&D Warehouse Officer /Executive & Purchase – Follow the instruction as per procedure.
QA Sr. Executive – Review and technical correction of SOP.
QA Head –Training, approval & implementation of SOP.
- ACCOUNTABILITY:
Head Quality Assurance
- PROCEDURE:
- The materials shall be divided into Four types depending on the characteristic of the material,These types are as under:
- Raw Material: This includes all APIs & Excipients. The description of the material shall be as per the pharmacopoeia & those which are non-pharmacopoeial shall be described as per the trade name/In-house/generic name which is commonly used.
- Packaging Material: This includes all types of packaging materials used in the packing. For Example:-
Carton, BOPP Tape, Shipper. CRC Cap, & Labels.
- Finished Products: This includes final finished product.
- Miscellaneous Item: This includes miscellaneous item usedapart from product manufacturing,
- After receiving the request from concerned department as per Annexure-I, QA will issue the item code number to Raw material, Packing Material & Finished Products respectively and prepare a list of the item code as per Annexure-II.
- Material Code:
- The Material code for Raw Material, Packing Material & Finished Product shall be assigned a number with seven alphanumeric characters.
Material Code: RM/0001, PM/0001, FP/0001
Where,
The 1st two Characters indicate the material types.
For Example:-
For Raw material, the code shall be RM.
For Packaging material, the code shall be PM.
For Finished Product, the code shall be FP.
3rd Character is a Separator.
0001 indicates sequential Number.
- Material Code in the case of Miscellaneous Item shall be Assigned as M/0001
Where, M- Code for miscellaneous Items
- REFERENCES:
Not Applicable
- ANNEXURES:
| ANNEXURE No. | TITLE OF ANNEXURE |
| Annexure-I | Item code generation requisition for RM / PM / Finish Product / Miscellaneous Item |
| Annexure-II | Item code list for RM/ PM/Finished Product/ Miscellaneous Item |
- DISTRIBUTION:
| Control copy No. 1 | : | Head Quality Assurance |
| Control copy No. 2 | : | Head Quality Control |
| Control copy No. 3 | : | Head Production |
| Control copy No. 4 | : | Head Purchase |
| Control Copy No.5 | Head Warehouse | |
| Master Copy | : | Quality Assurance Department |
- ABBREVIATIONS:
| QA | : | Quality Assurance |
| SOP | : | Standard Operating Procedure |
| No. | : | Number |
| APIs | : | Active Pharmaceutical Ingradients |
| BOPP | : | Biaxially Oriented Polypropylene |
- REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To be written manual |
ANNEXURE-I
ITEM CODE GENERATION REQUISITION FOR RM / PM / FINISH PRODUCT / MISCELLANEOUS ITEM
ANNEXURE-II
ITEM CODE LIST FOR RM/ PM/FINISHED PRODUCT/ MISCELLANEOUS ITEM
Frequently Asked Questions?
Q: What is material codification in the pharmaceutical industry?
A: Material codification involves assigning unique codes to various pharmaceutical components for systematic identification and tracking purposes.
Q: Why is material codification important?
A: Material codification enhances inventory management, streamlines procurement, and ensures accurate tracking of raw materials, aiding in quality control and regulatory compliance.
Q: How is material codification implemented?
A: Pharmaceutical companies typically utilize standardized coding systems, such as barcodes or alphanumeric codes, to assign unique identifiers to each material, facilitating efficient inventory control and traceability.
Q: What benefits does material codification offer?
A: Material codification improves inventory accuracy, reduces errors, accelerates order processing, and enhances overall supply chain efficiency in the pharmaceutical sector.
