Pharmaceutical Guidelines

Quality Assurance (QA) in the Pharmaceutical industry, is very essential for ensuring that Pharmaceutical Products are manufactured to a safe and consistent standard, and references with the guidelines, WHO, GMP are the main principles for pharmaceutical products.

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Wednesday 2 December 2020

Handling Of Online Rejected Materials




1.0              OBJECTIVE:

To lay down the procedure for handling of On-Line rejected materials.

2.0              SCOPE:

This SOP is applicable to all the On – Line Rejected Materials at -----------

3.0              RESPONSIBILITY:

3.1              Concern Operator, Production Officer/designee, is responsible for follow this SOP.

3.2              Production HOD responsible for complies of this SOP.

3.3              Concern IPQA/QA designee responsible for complies.


4.0              ACCOUNTABILITY:               

The accountability lies upon QA HOD and Plant Head for implementation and complies of this SOP.


5.0              PROCEDURE:

5.1              The Raw and Packing materials are rejected ON LINE due to some Problem.

5.2              Raw Materials may be rejected due to presence of Black Particles, hard particles, or any other foreign impurities.

5.3              Packing materials may be rejected due to any quality defects before start of packing activity.

5.4              Packing materials rejected ON line are as follows:

5.4.1        Foil rejection due to text matter printing problem, spots on foil, width problem,                          registration shifting, damaged core, pin hole, pocket problem, shade variation, machine setting problem, ink lifting and sealing problem etc.

5.4.2        Cartons/labels may be rejected due to printing problem, adhesive/pasting problem, registration shifting, and color variation.

5.4.3        Bottles/Caps may be rejected due to Improper sealing, Glass pieces in the bottles, mix up of two different size bottles, defective  neck height, foreign particles WAD layers variation  etc.

5.5              Fill the On Line Rejection format (Format No.: F/QA-020-01) with all details for such materials and send to Q.A department.

5.6              The Rejection Report shall be recorded in Online Rejection Log as per Format No.: F/QA-020-02 and a unique number is allotted to the Rejection Report. It is allotted as RR/XXYYY as per e.g. ( RR/20001), where denoted by RR-Rejection Report

XX-Year e.g. 18 for 2018

YYY- Serial No. of three digits 001

5.7              IPQA person shall check and verify the nature of rejection. Then QC will check the rejected material and mention action plan if required.

5.8              Decision to return the material to Stores or to use the material after sorting shall be taken Approval by QA Head/ designee.

5.9              After investigation and confirmation of rejection, QC will past the rejected label on the material.

5.10          Destroy the On Line rejected Packaging material as per SOP No.: SOP - QA- 018.

5.11          Raw material rejected On Line shall be either destroyed or sent back to the party.

6.0              LIST OF ANNEXURE AND FORMATS:

Sr. No.

Title of Format

Format No.

  1.  

On Line Rejection Form

F/QA-020-01

 

  1.  

On Line Rejection Log

F/QA-020-02

 

 

 

 

 

 

 

 

7.0              REFERENCES:

7.1              SOP-QA-001

7.2              F/QA-001-01

7.3              SOP-QA-014

8.0              REVISION HISTORY:         

Sr. No.

Date

Reason for Revision

Revision No

1.          

31/10/2018

New SOP

R0

2.          

31/10/2020

Schedule Revision

R1

           

9.0              ABBREVIATIONS:

Sr. No.

Abbreviations

Details

  1.  

SOP

Standard operating procedure

  1.  

NA

Not applicable

  1.  

QA

Quality assurance

 

 

 

 

 

 

 

 

 

 

END OF DOCUMENT

           

Report No.:_______________                                                                                           Date_______________

 

 

Initiated By (Sign/date):_________________                                                                          Department:_______________

Type of Material (Put the  tick mark):

        Raw                Packing                  Finish   

Product Name (if applicable):                                                                                           

Item Name:           

Batch No:

Manufacturer:  

Supplier:

A.R.No./Date:

Qty. Issued:

Challan No. / Date:

Qty. Received:

 

Reason for Rejection:

 

_________________________________________________________________________________________________

 

_________________________________________________________________________________________________

 

_________________________________________________________________________________________________

 

_________________________________________________________________________________________________

 

_________________________________________________________________________________________________

 

 

Checked By:

IPQA (Sign/Date):

 

Checked By:

QC (Sign/Date):

Remark:

________________________________________________________________________________________________

 

________________________________________________________________________________________________

 

________________________________________________________________________________________________

 

STATUS OF MATERIAL (Put the tick mark)

 

Returned to Stores:  

Used after sorting in coordination with QA:                           

APPROVED BY – QA HOD (Sign/Date):                                                     

Quantity Rejected: (Put the tick mark)

  As Such:                             After Sorting:

IF MATERIAL RECEIVED BACK BY – STORES

Received by (Sign/Date):

Remark:

 

IF MATERIAL RETURNED TO PARTY

Report No /date:

 

Stores In charge (Sign/Date):

IF MATERIAL DESTROYED BY – PRODUCTION

 

Destroyed by

production (Sign/Date):

(As per SOP No.: SOP-QA-018.)

 

 

QA (Sign/Date):

(In Presence Of QA Person )

CLOSE OUT DATE AFTER COMPLITION

 

Close Out By QA Head / Designee (Sign/Date):

 

Sr. No.

Rejection Req No.

Date

Item Name

Initiating Deptt.

On Line Rejection Initiated By (Sign /Date)

Qty.

Issued

Qty.

Rejected

 

Approved By

(Sign/

Date)

 

Action taken /Report No

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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