OBJECTIVE:
To lay down the procedure for destruction and to have control over the destruction activity with appropriate review, authorization and labeling of the damaged, rejected, returned recalled and non moving Raw /Packing materials/Intermediate and Finished Products.
2.0
SCOPE:
This SOP is applicable to all the materials destroyed
after product changeover at -----------------------
3.0
RESPONSIBILITY:
3.1
Originating
Department designee / HOD responsible for initiating of destruction
requisition.
3.2
QA designee,
Manager QA- Loan license Party (If material belongs to loan license party) / QA-Third
party (If applicable) are responsible for complies of this SOP.
4.0
ACCOUNTABILITY:
HEAD – QA shall
be accountable for implementation and complies of this SOP.
5.0
PROCEDURE:
5.1
Destruction of packing material:
Destruction of the printed packing materials from the
shop floor:
5.1.1
Following
printed packing materials shall be subjected for destruction on the shop floor.
v Wrong or smudged overprinting labels, cartons, catch
covers and show boxes which are rejected while over printing the batch details
on packing line.
5.1.2
Procedure for
the destruction of paper / card board type of printed packing material from
shop floor.
v The packing supervisor shall make entries in the
register book as well as on the batch card for accounting the overprinting
packing materials which shall be destroyed.
v At the end of batch, the rejected printed packing
materials shall be destroyed by shredding them off or for incineration, if available
in the presence of a QA officer.
v The torn rejected printed packing material shall be
transferred to the scrap yard.
v The personnel & administration officer shall
ensure that these torn printed packing materials are taken outside the factory
premises at suitable interval and are further destroyed by incineration (burning)/
shredding them at a safe place.
v This operation shall be carried out after taking
approval from QA.
5.1.3
Any fresh
material if rejected due to printer’s mistake than the printer shall do the sorting
of packaging components. Sorted good and the rejected lots shall be destroyed.
5.1.4
If the
material cannot be salvaged and cannot be reused, then it shall be destroyed by
suitable destruction procedure.
5.1.5
The packing
material stores supervisor shall ensure to take in writing from the supplier
stating that the printed packing material shall be destroyed in his presence,
along with the name of the product, type of packing material, quantity, date
and the place where the printed packing material shall be destroyed.
5.1.6
In the event
of introduction of new type of material, all the old type of printed packing
materials shall be destroyed as above and recorded.
5.2
Procedure
for the destruction of printed, plain aluminum / PVC foils, rejected ROPP caps,
measuring cups, HDPE bottles, flip off seals and glass bottles from the shop
floor:
5.3
Following
packing materials shall be subjected for destruction on the shop floor.
v Wrong or smudged overprinting foils which are rejected
while over printing the batch details.
v De shaped or with other manufacturing and processing
defects in ROPP caps, measuring cups, HDPE bottles, flip off seals glass
bottles and vials that are rejected on packing line.
5.3.1
The
production officer shall make entries in BMR/BPR for accounting the rejected
packing material which are to be destroyed.
5.3.2
At the end of
the batch, the shift production supervisor shall ensure that the printed
aluminum and PVC for blister and strips shall be destroyed by cutting the roll
into pieces or subjecting it to shredding machine, if available carry out this
operation in the presence of a QA officer.
5.3.3
The cut foil
shall be transferred to the scrap yard.
5.3.4
The line
rejected ROPP caps, measuring cups,
HDPE bottles, flip off seals glass bottles and vials shall be destroyed
by crushing / de-shaping them.
5.3.5
Apart from
approvals from concerned production supervisor, it shall be the duty of the
security officer / guards to ensure that no intact / filled bottles / vials are
taken to the scrap yard.
5.4
Destruction
of the printed packing materials from the warehouse:
5.4.1
Any fresh
material if rejected due to printer’s mistake than the printer shall do the sorting
of packaging components. Sorted good and the rejected lots shall be destroyed.
5.4.2
If the
material cannot be salvaged and cannot be reused, then it shall be destroyed by
suitable destruction procedure.
5.4.3
The packing
material stores supervisor shall ensure to take in writing from the supplier
stating that the printed packing material shall be destroyed in his presence,
along with the name of the product, type of packing material, quantity, date
and the place where the printed packing material shall be destroyed.
5.4.4
In the event
of introduction of new type of material, all the old type of printed packing
materials shall be destroyed as above and recorded.
5.4.5
If the
printed packing material which is to be destroyed is a modvat item, then the
packing materials warehouse supervisor shall intimate the finished goods
warehouse supervisor for taking the permission for its destruction from the
excise department.
5.4.6
Destroy
the printed packing materials by subjecting it to shredding machine, if
available. in case the shredding machine is not available then the packing
materials destroy by manual cutting. Carry out this operation in presence of a
security personnel and intimate qa department for verification.
5.4.7
If the
printed material is destroyed by manual cutting, then after the distruction
operation is over, recording of the above shall be done.
5.4.8
If
large quantities of printed foils are rejected then these can be returned to
the supplier, for the printed matter erasing under non-returnable gate pass.
5.5
Destruction
of expired / recalled/ rejected products from
the finished goods warehouse:
5.5.1
Reasons of rejections of finish good.
v Wrong overprinting of the batch details.
v Fail in finish good testing by QC.
v Recalled products in which corrective action and
rework not possible.
v
Not released for
dispatch and rejected by QA head.
5.5.2
Before
destroying the expired / rejected / recalled drug material from finished goods
store, approval shall be taken from plant head and
head – QA.
5.5.3
After
receiving their approval, the finish goods are de-foiled / de-bottled /
de-vials.
5.5.4
The de-foiled
/ de-bottled / de-vials drug products are then de-activated by treated with 2% NaOH
solution.
5.5.5
The treated
material is then drained into ETP. The record for the same is maintained.
5.5.6
Packing
materials destroy as per procedure and transfer in scrap yard.
5.6
Destruction of non-recoverable material generated
during manufacturing:
5.6.1
Reasons for
non recoverable rejection.
v Handling loss during manufacturing.
v Material found out of specification for example lump
formation.
v Some kind of contamination or impurity observed.
5.6.2
The
non-recoverable product (intermediate product) like; tablets, capsules,
lubricated blend etc. Put in sufficient water to form slurry and put in line
connecting to ETP. In case of Betalactum and Cephalosporin Products, shall be
destroyed after de-activating with 2% NaOH solution and drain in line
connecting to ETP.
5.7
All the
materials, products, intermediates and finished products to be considered for destruction
shall be identified and labeled (with a Red destruction Status label), approved
and quarantined separately to avoid mix up.
5.8
As per the
requirement a material destruction form shall be initiated by the originating department
designee/Head to be addressed to QA department for Material Destruction as per
Format No.: F/QA-018-01.
5.9
After proper
reviewing with appropriate reasons and justification, HOD of QA will approve or
reject the same and send for final authorization in case of Loan License
Product/Third party if applicable.
5.10
Once the
destruction proposal is authorized, the materials / products under subject are
to be considered for destruction. The destruction procedure shall be carried
out.
5.11
Appropriate
precautions shall be taken while carrying out the destruction.
5.12
The post
destruction area / equipment / container shall be cleaned thoroughly.
5.13
Record of all
destructions with details shall be properly maintained in the material destruction
log format No F/QA-018-02.
5.14
Requisition
No. as per ( RR/20/001), where denoted by
DR-Destruction
Report denoted by
XX-Year
e.g. 18 for 2018
YYY-
Serial No. of three digits 001.
5.11 Acceptance
Criteria: Material should be
destroyed as per procedure.
5.12 Frequency: Whenever required.
6.0
LIST OF ANNEXURE AND FORMAT:
|
Sr. No. |
Title of Format |
Format No. |
|
01 |
Rejection
And Destruction
Authorization Form. |
F/ QA-018-01 |
|
02 |
Material
Rejection And Destruction log |
F/ QA-018-02 |
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 |
|
|
SOP |
Standard
operating procedure |
|
|
NA |
Not applicable |
|
|
QA |
Quality
assurance |
|
|
ROPP |
Round of
pilfer proof |
|
|
HOD |
Head Of
Department |
|
|
ETP |
Effluent treatment plant |
END
OF DOCUMENT
REPORT
NO_____________________ DATE: _______________________
Initiated
By /
(Sign
& Date): _________________________ Department_____________________
Product
Name: ________________________
Batch No.: _____________ Batch
Size: _____________
1.
MATERIAL STATUS: RM / PM / Intermediates / Engg. Batch / Trials/Finish Product
|
Material Name |
Batch. No. |
MFD.
BY |
Supplier |
GRN No. |
A.R.
No. |
Qty. Consumed |
Qty.
to be Destroyed |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.
Reason for Destruction:
3.
Value of Material (Cost): ____________
|
Stores In charge (If
Applicable) (Sign/Date):
________________________ |
Approved by: (QA Head/designee) |
|
Destruction carried out as per Method No.: |
|
|
Detailed Investigation
Report (If
Applicable):
|
|
|
CHECKED BY/ON (Initiating Dept.) |
|
|
VERIFIED BY/ON (QA Loan
Licensee/Third party if applicable) |
|
|
VERIFIED BY/ON Quality Assurance(Sign/Date):
|
|
|
Final Report Submitted to
QA by/on: (Sign & Date)
|
Verified by/on: __________________________ (QA Head /Designee) |
|
Sr. No. |
Material Name |
Batch. No. |
G.R.N. No./ A.R. No. |
Supplier |
Qty. Received |
Qty. Destroyed |
Destroyed by/on |
Approved by / on |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
No comments:
Post a Comment
Pharmaceutical guideline only