1.0 Purpose
1.1 Handling scrap and disposal coming from any normal production run assumes great significance in
the pharmaceutical industry. Improper destruction procedures followed can lead to a problematic situation, if
such material finds its way into the wrong hands.
To lay down instructions for management of scrap generated in different departments of the Organization in
order to ensure correct handling & disposal.
2.0 Scope
2.1 It provides an overview for the generation of reject/scrap, its collection, and accounting,
recommends guidelines for dealing
with the rejects/scrap and its disposal thereof.
3.0 Responsibility
3.1 The responsibilities for dealing with scrap materials are Quality Assurance Department,
Warehouse Department & Administration Department for its final disposal in such a manner that it cannot
be misused.
a) Collection of
scrap from different department and transfer to scrap yard: Cleaning Supervisor and Production Cleaner
b) Periodic
inspection of scrap in the scrap yard: QA Officer
c) Final disposal
of scrap: Head of QA & Head of
Warehouse
d) Logistic
support: Administration Department
4.0 Abbreviations and Definitions
4.1 None
5.0 Materials and Equipment
5.1 None
6.0 Precaution / Health and Safety Considerations
6.1 None
7.0 Procedure
7.1 Collection
of Scrap/Reject:
7.1.1 Concern Officer
shall inform to Cleaning Supervisor to
collect the scrap.
7.1.2 Production/ Section Cleaner shall collect the scrap in presence of Production Officer / Production
Supervisor and keep specified
scrap in designated area of scrap yard.
7.1.3 Cleaning
Supervisor shall inform concerned Department In-Charge in case of any
discrepancy.
7.1.4 Ensure that
there is no spillage of scrap/reject on the floor or road during transfer.
7.2 Reject/Scrap
Generation:
7.2.1 The following rejects are generated at various stages of the manufacture of pharmaceutical products,
which should be systematically collected, accounted for, and disposed of, in a suitable manner to prevent
misuse.
7.2.1.1
Product rejects generated during
material processing and transfer operations
7.2.1.2 Product residues extracted into dust extraction system at various stages of manufacture or
leftover in various
processing equipment and machinery
7.2.1.3
Rejects generated during
compression, encapsulation, coating, filling, inspection stages
7.2.1.4 Rejects generated from in-process checks such as weight variation, volume checks, leak testing of
the strip, etc.
7.2.1.5
Reject generated during product
trial by Product Development Department
7.2.1.6 Excess or rejected printed packing materials coded or non-coded, like labels, leaflets, foils, tubes,
etc.
at the end of packing operation defaced/shredded
7.2.1.7
Rejects generated during batch
coding
7.2.1.8
Obsolete printed packing
materials in the stores defaced /shredded
7.2.1.9
Excess sample remaining with
Quality Control, after the testing is completed
7.2.1.10 Control samples in the custody of Quality Assurance & Product Development, after the
mandatory storage period
destroyed in the laboratory.
7.3 General
Principles:
7.3.1
There shall be written authorized procedures for:
7.3.1.1 Differentiating
recoverable residues from non-recoverable rejects.
7.3.1.2 Scrap which can be disposed of/sold on a commercial basis, and precautions to be taken thereof
e.g. defacing of labels on empty bulk containers, corrugated board, cartons (un-printed) etc.
7.3.2 There shall be written authorized procedures for handling destruction and disposal of all rejects
generated during
the production/handling of pharmaceutical products and printed packing components.
7.3.3 All rejects should be collected in suitable closed containers, labeled appropriately, and held in
secured
segregated space until taken for destruction.
7.3.4
Destruction must be carried out by authorized persons under the supervision of
a responsible person.
7.3.5 Quantities rejected and destroyed must be recorded and reconciled in the
relevant batch documents.
7.3.6
Rejected printed packing materials shall not be returned to suppliers.
7.3.7
Appropriate safety precautions must be taken while carrying out destruction.
7.3.8 Final disposal of residual solids/liquids shall be consistent with local regulatory requirements including
its effect on the environment.
7.4 Mode
of Destruction:
7.4.1 The following methods are recommended for carrying out the destruction of rejects generated during
the
manufacture/handling of pharmaceutical products.
|
Type of Rejection |
Method of Destruction |
|
Empty containers or drum of bulk materials |
Deface
the label before disposal |
|
Powder from dust extraction systems |
Slurry/solution
in water, or special solvents if necessary, incineration of solids |
|
Granules,
powder, tablets, capsules from manufacturing area |
Slurry/solution
in water, or special solvents if necessary, to be discharged in wastes stream
(drain), incineration of solids |
|
Granules, tablet, liquid in bottles |
De-seal
the pack, destroy the contents. Destroy the seal by crushing |
|
Liquid preparation |
Drain
into waste stream with/without special treatment (to destroy toxic waste) as
required |
|
Strip/blister pack including empty packs |
Tablets/capsules recovered (if permitted according to SOP) by de-foiling. Destroy rejected tablets/capsules Empty
strip/blister shredded |
|
Labeled bottles |
Remove
labels & destroy Destroy
the contents Crush
the container |
|
Printing
packing components (Label, Carton, Catch Cover, Insert, Foil, Master Carton
etc) |
Shredding and/or incineration |
|
Used Stereos |
Cutting/Shredding |
7.5 Inspection of Processed Scrap by Quality Assurance
before Final disposal:
7.5.1 Processed scrap should be kept in the scrap
yard for periodic Q.A. inspection.
7.5.2 Check and ensure that the identity of all printed /overprinted materials is destroyed by shredding them
into small pieces.
7.5.3 Check and ensure that the labels on all the
containers are correctly defaced.
7.5.4 After complying with all the above checks,
clear the scrap for final disposal after noting all entries.
7.6 Final disposal of scrap from Scrap
holding area to scrap yard:
7.6.1 After obtaining the Q.A. clearance, properly close the containers /poly bags holding the scrap on a
pallet in the
designated area.
7.6.2 Place the scrap separately based on the
following classification:
Ø Glass scrap
Ø Plastic scrap
Ø Paper scrap
Ø Blister /strip scrap
Ø PP cap scrap
7.6.3 Lock the scrap yard after keeping the scrap inside
7.7 Disposal of scrap from Scrap Yard:
7.7.1 Weigh each container of the scrap and enter the details of the item and update the register maintained
for the purpose.
7.7.2 Load each item into the vehicle. Ensure that the details are checked and countersigned by a security
officer and the representative of factory admin
respectively
7.7.3 Prepare gate pass mentioning all the items
being dispatched.
7.7.4 Counter check the details in the gate pass with the scrap yard register by the representative of
factory admin. If found correct allow the vehicle to pass.
8.0 Reference Document
8.1 In-house
9.0 Annexure
9.1 None
10.0 Revision History
|
Version No. |
Brief Reason for the Revision |
Effective Date |
Remarks |
|
01. |
New |
|
|
11.0 Training
11.1 Training is
required for all concern person of all departments trained by Head of Department
/ Head of Quality Assurance.
