SOP for disposal of rejected primary and secondary packing materials

 Objective:
 To lay down a procedure for Disposal of rejected primary & secondary packing materials.

 Scope
 This SOP is applicable on procedure for Disposal of rejected primary & secondary packing
materials for Production dry powder Injection facility.
 Responsibility
 Officers or above – Production.
 Accountability
 Production Head.

 Abbreviations
 SOP : Standard Operating Procedure.
 WFI : Water for Injection.

 Procedure
 Disposal of Primary Packing Materials :-
 After completion of day’s work collect the rejected vials (Moulding defects, crack & broken vials)
in a separate poly bag.

 Count & checkthe collected vials & enter the quantity in Primary Packing Material Destruction
Record in Batch Production Record.
 Crushthe rejected vials and transfer the glass pieces in a poly bag.
 After completion of day’s work collect the rejected rubber stoppers (Shape defects, dirty rubber
stoppers) in a separate poly bag.

 Count & check the collected rubber stoppers & enter the quantity in Primary Packing Material
Destruction Record in Batch Production Record.
 After completion of day’s work collect the rejected aluminum seals (Shape defects, dirty & spot) in
a separate poly bag.
 Count & check the collected aluminum seals & enter the quantity in Primary Packing Material
Destruction Record in Batch Production Record.
 After verification of production supervisor / officer send the rejected vials, rubber stoppers and
aluminum seals to the scrap area for further destruction.

 Disposal of Secondary Packing Materials:

 After completion of day’s work collect the rejected secondary packing materials (Labels, unit
cartons, multi cartons, inserts (literature) & corrugated boxes) in separate poly bags.

 Count & check the rejected packing materials (Labels, cartons & corrugated boxes) & enter the
quantity in secondary Packing Material Destruction Record in Batch Production Record.
 Check that all the Printed Packing Material is torn after counting.
 Collect, count and check the rejected WFI ampoules and puncture them after checking. Record the
total quantity of rejected ampoules in the secondary packing material destruction record in Batch
Production Record.
 Collect, count & check the rejected corrugated boxes and torn them after checking. Record the total
quantity of rejected corrugated boxes in the Secondary Packing Material Destruction record in
Batch Production Record.
 After verification of production supervisor / officer send the rejected Labels, cartons, inserts,
corrugated boxes & ampoules to the scrap area for further destruction.
  Sendthe empty corrugated boxes of decartoned material, rejected rubber stereos and release paper
of label roll to the Scrap area for further destruction.
 Forms and Records (Annexures)
 Not Applicable
 Distribution
 Master copy – Quality Assurance
 Controlled copies- Quality Assurance, Production, Quality Control
 History
Date Revision Number Reason for Revision

– 00 New SOP

Sop on Rejection and Destruction Policy of Drug Products and its

Components
1.0 Objective

To establish the guidelines for destruction of drug products and its components.

Scope:

This sop shall be applicable for rejection, collecting, accounting & safe destruction of rejects, un-recoverable
and expired pharmaceutical products and its components at various stage in pharmaceuticals company.

Responsibilities:

QA / production / warehouse / personnel & administration officer or above shall be responsible for rejection,
destruction of rejected, unrecoverable and expired drug products & its components.

Accountability:

Head – QA shall be accountable for compliance of sop.

5.0 Abbreviations and Definitions:

SOP : Standard Operating Procedure; a document where step by step instructions are cited to serve as support
for methods or manners of fulfilling a function or functions reliably and consistently.

QA : Quality Assurance

ETP : Effluent Treatment Plant

NAOH : Sodium Hydroxide

QC : Quality Control

6.0 Procedure:

6.1 Rejection and destruction of packing material:

6.1.1 Destruction of the printed packing materials from the shop floor:

6.1.1.1 Following printed packing materials shall be subjected for destruction on the shop floor.

i. Wrong or smudged overprinting labels, cartons, catch covers and show boxes which are rejected while over
printing the batch details.

ii. Wrong or smudged overprinted labels, cartons, catch covers and show boxes that are rejected on packing
line.

6.1.1.2 Procedure for the destruction of paper / card board type of printed packing material from shop floor.

i. 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

ii. At the end of batch, the rejected printed packing materials shall be destroyed by shredding them off or
subjecting to shredding machine, if available in the presence of a Q.A. Officer.

iii. The torn rejected printed packing material shall be transferred to the scrap yard.

iv. 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 burning / shredding them at a safe
place.

v. This operation shall be carried out after taking approval from Q.A.

6.2 Procedure for the destruction of printed, plain aluminum / pvc foils, rejected ropp caps, measuring cups,
HDPE bottles, flip off seals glass bottles and vials from the shop floor:

6.3 Following packing materials shall be subjected for destruction on the shop floor.

i. Wrong or smudged overprinting foils which are rejected while over printing the batch details.

ii. 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.

6.3.1 The production officer shall make entries in BMR/BPR for accounting the rejeced packing material which
are to be destroyed.
6.3.2 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 Q.A. Officer.

6.3.3 The cut foil shall be transferred to the scrap yard.

6.3.4 The line rejected ropp caps, measuring cups, HDPE bottles, flip off seals glass bottles and vials shall be
destroyed by crushing / de-shaping them.

6.3.5 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.

6.4 Destruction of the printed packing materials from the warehouse

6.4.1 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.

6.4.2 If the material can not be salvaged and can not be reused, then it shall be destroyed by suitable destruction
procedure.

6.4.3 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.

6.4.4 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.

6.5 Procedure for destroying the printed packing materials from the warehouse:

6.5.1 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.

6.5.2 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.

6.5.3 If the printed material is destroyed by manual cutting, then after the distruction operation is over,
recording of the above shall be done.

6.5.4 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.

6.6 Disposal of rejected raw materials from the warehouse:

6.6.1 Disposal of the rejected raw materials on party’s account shall be done if the raw-material is rejected by
the quality control department. Then the party shall lift the material from quarantine.
6.6.2 Disposal of the rejected raw material on company’s account.

6.6.3 After taking approval as per annexure rejected raw materials, which are lying in raw material store, shall
be lifted for disposal.

6.6.4 Upon receiving the approval for the disposal, proper documentation / records shall be maintained.

6.6.5 Before destroying the active material, de-activate them using 2% NAOH solution.

6.7 Destruction of expired / recalled/ rejected products from the finished goods warehouse:

6.8 Reasons of rejections of finish good.

 Wrong overprinting of the batch details.

 Fail in finish good testing by Q.C.
 Recalled products in which corrective action and rework not possible.
 Not released for dispatch and rejected by Q.A. head.
6.8.1 Before destroying the expired / rejected / recalled drug material from finished goods store, approval shall
be taken from plant head and head – Q.A.

6.8.2 After receiving their approval, the finish goods are de-foiled / de-bottled / de-vials.

6.8.3 The de-foiled / de-bottled / de-vials drug products are then de-activated by treated with 2% NAOH
solution.

6.8.4 The treated material is then drained into ETP. The record for the same is maintained.

6.8.5 Packing materials destroy as per procedure and transfer in scrap yard.

6.9 Destruction of non-recoverable material generated during manufacturing:

6.10 Reasons for non recoverable rejection.

 Handling loss during manufacturing.

 Material found out of specification for example lump formation.
 Some kind of contamination or impurity observed.
6.10.1 The non-recoverable product (intermediate product) like; tablets, capsules, lubricated blend etc. Shall be
destroyed after de-activating with 2% NAOH solution.

7.0 List of Annexure / Formats:

Authorization For Destruction – Annexure – I

8.0 References (if any):

 SOP for collection and disposal of waste & rejected material from plant.
  SOP on destruction and disposal of media filled vials
 SOP for disposal of rejected primary and secondary packing materials.
 SOP on withdrawal, storage, observation & destruction of control / retention sample.
 SOP on inventory, storage issuing and destruction of rubber stereos
 Sop on handling rejected raw materials.
 Sop on rejected packaging material.
 Sop for handling of scrap.
8.0 Distribution
8.1 Master copy – Quality Assurance

8.2 Controlled copies- Quality Assurance, Personnel and Administration, Production-Oral and Ware house

9.0 History

Date Revision Number Reason for Revision

– – New SOP

Annexure – I

Authorization for Destruction

Product: Batch no.: Batch size:

1.0 Details of the material to be destroyed:

Materials Make Quantity

2.0 Reason for destruction :

3.0 Cost involved :

4.0 Detailed investigation report :

Investigated by:

5.0 Method of destruction :

Proposed by Approved by Authorized by

6.0 Destruction details :

Destroyed by Verified by
Checked by
Destruction of Finished goods
1.0 Purpose : To provide a documented procedure to establish the procedure for the

Authorization and destruction of expired finished goods in order to avoid misuse or mix up.

2.0 Objective : To provide a guideline on activities to be carried out on expired goods

Prior to and during destruction.

3.0 Scope : Destruction of finished good of ---pharmaceutical Ltd,

4.0 Responsibility :

· Production Dept

· Store Incharge.

· Quality Assurance
5.0 Procedure :

· To intimate destruction of expired Finished Product as per defined procedure.

· To supervise the destruction activity.

· To organize the destruction

· To prepare report regarding destruction.

· To keep record of the disposed expired finished goods.

· To check and ensure Excise formalities.

Ø Transfer expired finished goods to the scrap yard.

Ø Intimate the destruction of expired goods by filling Material Destruction

Approval form

Ø Get the approval from Q.A. Department.

Ø Get the authorization from General Manager.

Ø Destroy the expired goods in presence of QA person.

Ø After destruction send a copy of destruction note to Account Depts. For

Reconciliation.

Ø Finished products should be destroyed after 6 months from the date of expiry
of product.

Ø Check the Batch No. of products which are to be destroyed.

Ø Take out all expired / rejected finished goods in a separate polythene bag.

Ø Label the polythene bag as “Expired / Rejected” samples.

Ø Destroy the finished products as per defined procedure.

Ø Document the details of destruction and make the cross reference in the Finished

Goods register.

Ø Separate the product (primary packing) from its packing

Ø Product compactable with water Dissolved or suspend, contents of the product

in a container with water.

Ø Pass the suspended contents into drain and flush with sufficient water.

Ø Packing materials used in the product like – labels, cartons, leaflets should be

Passed through shredder.

Ø Jars should be passed through crusher.

Ø Collect the shredding in a polybag or a corrugated box and dispose the same

To GIDC dustbin.

MATERIAL DESTRUCTION FORM

To, Date:

The General Manager,

---- Established

We seek your authorization for destruction of the following products.

Sr. DESCRIPTION BATCH QUANTITY REASON FOR Q.A Signature

No. No. DESTRUCTION

Format No. F/ST/008

Waste disposal

Scrap: Materials like rejected foils, bottles, cans, and tins etc. which have a resale value.

• Generated at various stages of manufacturing

1)During compression encapsulation coating & packing stages.

2)In-process check.

3)Rejected printing packing materials.

4) From floor sweeping

5) Expired or damaged goods.

6) Excess sample in QC after test.
7) Product sample from R&D at development stage.

Trash: This material is to be discarded or disposed by suitable means and don’t have a resale value. E.g.
dust, unsalable materials

Types of wastes

A) On the Bases of State

1. Solid

2. Liquid

3. Gaseous

B) On the Base of Effect

1) Hazardous Waste

2) Bio hazardous Waste

3) Radioactive Hazardous Waste

C) WHO categories of health care waste

1. hazardous waste.
 2. A type of solid wastes that contain substantial or potential threats to public health or the
environment.
Must meet any of the following criteria: – Specifically listed as a hazardous waste by EPA

– Exhibits one or more of the characteristics of hazardous wastes (ignitability, corrosiveness, reactivity, and/or
toxicity) – Is generated by the treatment of

. Storage Requirements:
1)Containers must be in good condition
2)Containers must be compatible with waste
3)Containers must be handled in a manner to prevent leaks and spills
4) Containers must be inspected
5) Containers must be labeled “Hazardous Waste ”and / or list the contents of the container

Characteristic of Hazardous wastes Characteristic wastes are regulated becausethey exhibit certain
hazardous properties –

1. Ignitability,

2. Corrosivity,

3. Reactivity

4. Toxicity.

Some liquid pharmaceuticals can be diluted with water and flushed into the sewers in small quantities
without serious public health or environmental affect.Discharge to Sewer

WASTE PRODUCT DISPOSALPROCEDURE

1) Product disposal: Any product requiring disposal should initially be separated from its packaging if
appropriate. For example, any product to be disposed in an approved landfill site should not be left in
impermeable glass, plastic, or other containers which would significantly delay destruction. Ideally,
INCINERATION procedures have preference over LANDFILL ,where incineration is used, product in
plastic or other flammable packaging may not need.

2) Printed packaging disposal: The disposals of printed packaging components include labels, inserts, and
cartons possess no health risk. However, ineffective disposal, such as in the public landfill, can give rise to
public concern that product may be associated with the packaging. Such materials should preferably be
incinerated.

3) General trash and savage: Normal local services will be adequate for sewage and trash. However
internal procedures should be sufficiently rigorous and monitored, to ensure that product and the packaging
waste does not get intermixed. Containers used within the plant to accumulate waste materials should be
clearly marked to denote their designated use. CFR (Code of federal regulation) 211.50 states that
“Sewage, trash and other refuse in and from the building and immediate premises shall be disposed of in a
safe and sanitary manner

Provision shall be made for proper and safe storage of waste materials, awaiting disposal.• Hazardous
toxic substance and flammable materials shall be stored in suitably designed and segregated enclosed
areas in conformity with central and state legislation.5)The material is generally sold to scrap dealers.
Precautions should be taken before selling these materials to scrap dealer
41. e.g.; 1) Empty solvent containers should be free from residual solvent lying at bottom of drums. 2)
Rejected printed packaging materials (Labels, cartons, foils, etc) should be defaced, destroyed before
sending to scrap for storage and sale.
42. WHO guidelines: I. Provision should be made for proper and safe storage of waste materials
awaiting disposal. Toxic substance and flammable materials should be stored in suitably designed,
separate, enclosed cupboards as required national legislation. I. Waste materials should not allowed to
accumulate. It should be collected in suitable receptacles for removal to collection points outsides the
building & disposed off safely & in a sanitary manner at regular & frequent interval.
43. Records: Keep Longer Analytical Reports All data used in evaluation Training documentsKeep it
for at Least 3 Years for followings License applications (if applicable)o Licenses (if applicable)o Land
Disposal Restriction forms Inspection logos Recycled waste shipping papers Emergency Response
recordRECORDS:
44. Signature of the supernatants after completion of the destruction in records Safety precautions
taken while carrying out destruction must be included in the records. Quantities rejected and
destroyed must be recorded and reconciled in relevant batch documents. Date of destruction, name of
the product to be destroyed, type of destruction, place of destruction, cause of destruction should be
included in the relevant record. Records: Access Copy must be maintained at generator site Must be
available for inspection Paper or Electronic