sop for online rejection in pharma

 

1.0 OBJECTIVE
1.1 The objective of this SOP is to define the procedure for online rejection.
2.0 SCOPE
2.1 This SOP is applicable for online rejection of raw material/packing material/finished goods during complete processing of any batch
3.0 RESPONSIBILITY
3.1 Officer-Quality Assurance – Prepare the SOP and follow-up the SOP accordingly.
3.2 Asst. Manager-Quality Assurance / Production -Provide the support to the implementation of SOP and maintained the records.
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance Department / Chief Executive Officer
5.0 REFERENCE(S)
5.1 Not Applicable

6.0 PROCEDURE
6.1 Online Rejection can be noted at any stage during processing of a product.
6.2 In case any abnormality or not suitability observed in the material (Raw material / Packing material) at any processing stage of a product, concerned departmental persons shall send request to QA department for issuance of Online Rejection Form.
6.3 QA department shall issue the Online Rejection Form to concerned department with numbering and recording in Online Rejection Note Register as mentioned in Format
6.4 Numbering system for Online Rejection Form shall be given as mentioned below:
OR/YYY/MM/ZZ/NNN
Where
OR – Online Rejection
/ – For Separation
YYY – Department Code
/ – For Separation
MM – Month
/ -For Separation
ZZ – Last two digit of current year in which rejection occur
/ – For Separation
NNN – Serial Number of online rejection
6.5 After receiving of Online Rejection Form from QA concerned department shall fill with all required information of form as mentioned in Format and give to IPQA person.
6.6 IPQA person shall inspect the rejections and if feels that material is not usable and need to be rejected, he shall give his comments in remarks with sign & date and send to Head QA for approval.
6.7 Head QA shall review and approve the form with sign and date and send to Chief Executive Officer for final authorization.
6.8 Chief Executive Officer shall review and give his comments in remark with sign & date.
6.9 If quantity of the rejection (only packing materials) is more than 2 % and less than 5 %, inform to purchase department to inform the supplier for taking corrective action.
6.10 If the quantity of rejection (only packing materials) is more than 5%, QA personal shall fill the Debit Note for Online Rejection as per Format and take approval of Head QA.
6.11 Head QA shall send the debit note to Chief Executive Officer for final authorization with sign & date.
6.12 After singing of Chief Executive Officer QA personnel shall makes two copies of this Debit Note one copy to be sent to purchase department and other to accounts department for their information.
6.13 If the quantity of rejection is very high, QA shall study the cause of rejection.
6.14 Based on study QA shall suggest the corrective action.
6.15 If any corrective measures required from the supplier, QA shall inform to purchase department for corrective actions.

7.0 ABBREVIATIONS

SOP : Standard Operating Procedure
QA : Quality Assurance
IPQA : In Process Quality Assurance
8.0 ANNEXURE

Annexure No.	Title of Annexure
Annexure-I	Online Rejection Note Register
Annexure-II	Online Rejection Note
Annexure-III	Debit Note for Online Rejection

Annexure-I

Annexure-II

 

Annexure-III