Standard Operating Procedure

Title: Rework Procedure

______________________________________________________________________________________


File Location:

Date Printed : Page 1 of 12

Document Owner
Quality Assurance Manager
Affected Parties
All Quality Assurance Staffs and Operati on s Colleagues
Purpose
This SOP contains the steps to be followed when the Rework of an in -process or completed Finished Good

is required.

This SOP covers the following Reworks:
i In-

Process Manufactured Goods Rework . (Reworking of a complete or partial BP

N)
i Manufactured Finished Good Rework
i Specific in-process procedures
Scope

Responsibility for the procedures set out in this SOP is as follows :

Approval for Rework Quality Assurance
Scheduling Production Planner
Rework Protocol Preparation Operations or Quality Assurance
Rework Protocol Checking Operations
Rework Protocol Approval Quality Assurance
Creation of Rework BPN Production Planner
Returning Finished Goods to Production Warehouse Staff

Scope of Rework
In-Process Manufactured
Goods

(IPMG)
Re

inspection / Rework of In -Process Manufactured Good due to a possible

defect in all or part of the BPN . Batch number will not be changed .
Manufactured Finished
Goods

(MFG) Rework

Conversion of a product from one Batch Number to another .

Reinspection / Rework of Manufactured Finished Good due to a possible

defect in all or part of the BPN .
Rework of Product at

Contract Manufacturer .

Reinspection / Rework of Manufactured Finished Good due to a possible
defect in all or part of the BPN at an External Contrac

t Manufacture site.

Definition
QAM Quality Assurance Manager
IPMG In-Process Manufactured Goods
MFG Manufactured Finished Goods
IFG Imported Finished Goods
Department Quality Management Document no QMS-065

Prepared by:

Date:

Supersedes:

Checked by:

Date:

Date Issued:

Approved by:

Date:

Review Date:
Standard Operating Procedure
Title: Rework Procedure
______________________________________________________________________________________


File Location:

Date Printed : Page 3 of 12

1.3. Quality Assurance team must assess the Deviation Report and justify the defect category of

manufactured goods . QA Manager will review the product defect t ype and either reject the

batch or decide to rework of the full or part of the batch .

1.4. In the case of a critical product defect only the QA Manager can give approval for the

Rework. Critical product defects include defects that could potentially affect pr

oduct safety,
purity and efficacy

1.5.

For rework of Manufactured Finished Goods (MFG) where batch number will be
changed - Once approval for the Rework has been given the relevant Production team is to
inform the Production Planner to raise a Reworked Batch Pr

oduction Number (RBPN), which

will segregate the reworked part of the batch from the original batch . For a complete rework

there will be nothing left from the original batch . The numbering format of BPN and RBPN
will be same but the number must be kept dif

ferent. The original BPN and reworked RBPN

should be released separately by QA for sale after a successful rework has done . The

original Batch Production Number (BPN) and Reworked Batch Production Number (RBPN)

must be documented in the protocol . Both the original BPN and reworked RBPN batch

documents must be kept after rework, as both are GMP document .

1.6.

New Rework Batch Production Number (RBPN) does not need to be assigned for In-

Process Manufactured Goods (IPMG).

1.7. After a decision of the rework has been mad

e, QA has to raise a rework protocol according
to

section 3

of this SOP before any activity can commence .

1.8.

When the protocol is ready and approved , hand it over to Area Manager where the rework

will be carried out . QA Staff should ensure that protocol is ag

reed and understood, as it will

be a part of batch document .

1.9.

Production operator receives the protocol along with all other relevant forms , Visual Displays

and documents.

1.10. Production operator contacts the Warehouse to determine the location of the manufac tured

product, which is already kept in the Finished Goods storage location in the warehouse . The
storage type and the storage bin type of the manufactured goods can be found in the Goods

Booking Slip for the BPN.

1.11. Production operators print out a Goods Returns For Rework Form

(Form-

515) and fill up
the Production To Fill Up section of the form leaving the Warehouse To Fill Up section

blank. The form should have the information as follows :
i

Person requesting the goods return, name, sign and date.
i WIP or designated area of the process line where the rework will be carried out
i Product Code
i Product Description
i

Batch Production Number (BPN)
i Expiry Date
i Quantity to be returned
i Number of shippers
i Number of pallets
i Destination Storage type
i Destination Storage bin
i Shipper labels involved
Production operator has to sign the form and send to warehouse to arrange transfer of

goods.

1.12. Warehouse operator receives the form and pick up the requested stock from the source

storage bin . Warehouse operator has to fill up the warehouse section of the form before

sending the goods to be reworked , including source storage type and storage bins , number

of full shippers and partial shipper , Number of pallets.
Standard Operating Procedure
Title: Rework Procedure
______________________________________________________________________________________


File Location:

Date Printed : Page 5 of 12
i

Initial quantity of BPN received .
i

Final quantity of RBPN required .
i

Additional materials (components) required for the Rework.
i The location in which the Rework is to b

e done.
i

Procedure to be followed during the Rework .
i

Criteria for inspection/rejection of goods.

3.2. Protocol for In-Process Manufactured Goods TEM-125
The following information is to be provided in the request for Rework Protocol for an In -
Process Manufactur

ed Finished Good:
i

Why the Rework is being done.
i The related DR number
i

Batch Production Number (BPN) and Expiry date
i

Additional materials (components) required for the Rework.
i

Initial quantity received (excluding original sample qty)
i Final quantity produced.
i

The location in which the Rework is to be done .
i

Procedure to be followed during the Rework .
i

Criteria for inspection/rejection of goods.

3.3.

The Protocol must include :
i

Normal Line Clearance procedures.
i Exact processing details including where Rework was condu

cted, when work

was done and a record of all staff involved .
i

All component Code numbers and quantities required .
i

Reconciliation of product and all printed components .

3.4.

The Protocol follows the path of any batch document in Production . It is kept with all o ther

batch documents pertaining to the Rework Process Order . Protocol is to be forwarded

including the retention samples to QA for assessment .

4. Exception to Use of Rework Protocol

4.1.

Where a controlled form has been created for a specific repeated procedure , this form may
be used in place of a signed-

off Protocol Rework form (TEM-

115 or TEM-125).

4.2.

The procedure defined in this form is not to be changed without appropriate authorisation .

4.3. This form is to be signed -

off at the completion of the Protocol . All documentation relating to

the Protocol MUST be included with the Batch Documents .











Standard Operating Procedure
Title: Rework Procedure
______________________________________________________________________________________


File Location:

Date Printed : Page 7 of 12

6. Summery of Changes


End of Procedure


Version # Revision History
QMS-065 New
Form-555
Issue date:
Batch Documentation Checklist For Tablet Packing

(Ref. SOP QMS-

075; QMS-

085; QMS-

090)


File Location:

Date Printed : Page 11 of 12

Production is to compl

ete Sections 1 & 2

Quality Assurance Department is to complete Section 3

SECTION 1

PRODUCT NAME:

BPN:

CODE:

Tick appropriate boxes


Put a N/A against boxes which are NOT APPLICABLE

N/A


SECTION 2
The following manufacturing documents and samples must

accompany the checklist :
Production

Prod
Initial
QA
MI Sheets for all the process phases

Deviation Report Form (If any DR

raised)

Printed Material Sample Sheet /s

Bulk Tablet Sampling Form/s

(if applicable)

Line Clearance, Opening a

nd Cleaning Form/s

Finished Good Retention Samples


Material Transfer Order Form/s

Vacuum Leak Test - Hourly Form

Vacuum Leak Test - New Foil and PVC Roll Form

In-Process Check - Shipper Form

In-Process Check-Blister and Carton form

Batch Reconciliation Sheet for Tablet Packing


IBC Cleaning Tag/s


IBC Identification Label /s

Checkweigher Weight Record

(if applicable)

Pallet Booking Information



If any deviation raised write the DR Number /s:

(Attach the copy of de

viation report/s)


If any work-

order raised during the batch write the order number /s:



Name of authorised production

person (print name):

Signature of Authorised

production person:


Date: