Standard Operating Procedures
in Pharmaceutical Industry.
Presented by:
Deepa Godhiya (14)
Rashmi Meher (06)
Ravi Khatpe
(31)
Ruchir Gandhi(29)
Table of contents
Introduction to SOP
SOP for receiving goods
SOP for Storage
5 S Program
SOP of Storage of finished
Products
SOP for dispatch of finished
products
Introduction to SOP
Written document or instruction detailing all
relevant steps and activities of a process or
procedure
Provides employees with a reference to
common business practices, activities, or tasks
New employees use an SOP to answer
questions without having to interrupt supervisors
to ask how an operation is performed
ISO 9001 essentially requires the determination
of processes (documented as standard operating
procedures) used in any manufacturing process
that could affect the quality of the product
SOP
For Receiving of:
Raw Materials
Printed Materials
Packaging components
Damaged goods
SOP: Describes procedures to receive
materials that will be stored in the warehouse
Objective: To receive the incoming raw
materials, printed materials, packaging
materials and damaged goods
Responsibility: Receiver, QC/QA, Product
Development Coordinator, Purchasing
Manager
Check the drivers slip to
ensure the company states
our company
Unload the shipment and
inspect the condition of the
shipment
Inspect all incoming trucks
STEP
3
STEP
2
STEP
1
SOP conditions
The receiver will-
Once QC has applied the QC approved
green stickers, store product in the
designated area
Complete the Receiving Log
Count the goods and compare the quantity, name,
and lot numbers to the information stated on the
shipping documents and company purchase order
(PO). Investigate any discrepancies.
Tag each skid with the product name and
BV code and notify the Supervisor and QA of
any issues
STEP
7
STEP
6
STEP
5
STEP
4
SOP for Receiving Raw
Materials
Place on
hold
labels on
the
skid/boxes
Pass the
PO with all
relevant
informatio
n to the
QC
departmen
t
QC will
take
sample as
per
sampling
procedure
for SOP of
New Raw
Material
Approval
QC willPlace a
QC
Approve
d
sticker
Tag the
product
with
necessary
details
Complet
e the
Receivi
ng Log
Material
deemed
unacceptabl
e will be
tagged by QC
as on hold
and should be
moved to the
QC hold area
Further
testing
would be
done by
QC/R&D
supervisor
and if the
material is
still out of
specifications,
it will be
tagged with
QC
Rejected
tags and
noted as
rejected in
the receiving
log
Purchasing
Manager will
contact the
supplier as to
the action
required for
the rejected
material i.e. to
be returned,
replaced or
destroyed
Purchasing
Manager
will
inform
the
Receiver
and QC
with the
status of
rejected
material.
QC will
record the
status of
raw
materials
on original
PO and
return the
original PO
back to
Purchasing
Manager
QC will file
the copy
of PO in
QC
Rejected
Material
binder
SOP for Receipt of Damaged
Goods
On receipt of a damaged shipment the
shipper/receiver will:
o Take a photo of the damaged product (camera in
supervisors office) and ensure the truck driver
signs the receiving document as evidence
o Notify QC
On being notified of a damaged shipment,
QC will:
o Inspect the damaged product and note the
damage on the PO
o Place the damaged product in sterile plastic bag
in QC Detention area, until notification is received
from the Purchasing Manager to return or destroy
o Label damaged product with all information:
name, lot#, quantity, report #, purchase order #
and date
o Attach the picture to the signed Purchase Order
and pass to the Purchasing Manager
On receipt of a PO with damaged product
the Purchasing Manager will:
o Instruct QC to save for suppliers inspection or
for disposal
o Contact the supplier for a claim
If product is to be disposed, follow SOP
Product Disposal.
SOP FOR STORAGE
1.Separate receiving and dispatch bays
2. Materials and products protected from weather
3. provide Area to clean incoming materials
4.Storage areas of sufficient capacity
5. categories of materials and products are Orderly storage
6.Separate and segregated areas: starting materials, packaging materials,
intermediates, bulk, finished products, quarantined, released, rejected, returned
and recalled products and materials
Design
1.Walls, floors, ceilings, ledges, drains, air supply, dust
extraction
2.Prevention of build-up of dirt and dust to avoid unnecessary
risks of contamination
3.Cleaning programme, appropriate cleaning, cleaning records
Effective cleaning and disinfection
4.Choice of materials and chemicals, validation
Drains prevent backflow
5.Protection from insects, birds, vermin and weather
from receipt of raw materials to dispatch of released product
Layout of area
Storage conditions
1.Appropriate temperature and relative humidity conditions within defined limits
Provided, controlled, monitored and recorded
2.Good storage conditions: clean, dry and appropriate lights
3.Quarantine area: clearly marked and access restricted
4.Separate sampling area is the norm: no risk for contamination or cross-contamination
5.Segregated areas for rejected, recalled and returned materials and products
6.Safe and secure areas for highly active, radioactive materials, narcotics and other
materials (risk of abuse, fire, explosion)
Packaging
1.Printed packaging materials
2.Critical to ensure correct labelling of products
3.Special attention to sampling of printed packaging materials
4.Special attention to safe and secure storage
Ensure compliance with specifications, prevent mix-ups
5 S Program
5S is a set of techniques providing a standard approach to housekeeping within
Lean .
It is often promoted as being far more than simply housekeeping and some of the
elements described below certainly have broader implications
The individual items within 5S are known as the "pillars" and are :
1. Sort
Sort is the identification of the most successful physical Organization of the workplace.
It is the series of steps by which we identify things which are being held in the
workplace when they shouldn't, or are being held in the wrong place.
2.
Set
Set is the series of steps by which the optimum organization identified in the first pillar
are put into place.
3.
Shine
Anglicised as Cleanliness but again the initial S can be retained in Shine, or Sweeping.
The principle here is that we are all happier and hence more productive in clean, bright
environments.
There is a more practical element in that if everything is clean it is immediately
ready for use.
4.
Standardization
This is well described as Standardized cleanup
the means by which we maintain the first three pillars
5.
Sustain
The final stage is that of Discipline.
to make people want to keep applying good practice in shop organization and
housekeeping.
Benefits of 5S Program
to reduce the amount of time wasted looking for misplaced tools, and
materials, and supplies
to make your work area clean and in order to unhide potential problems.
SOP for Storage of finished Products
1. PURPOSE
It is established to ensure the proper storage and handling
to prevent finished product from damage and deterioration.
2. SCOPE
2.1 It is applicable for storage and handling of all kinds of
finished product in FINISHED GOODS STORE.
3. RESPONSIBILTY
INCHARGE (Finished Goods Store)
Supervisor finished goods store
Helper
SOP for Storage of finished Products
4. PROCEDURE
Process of Storage and Handling
The finished products must be stored in the outer cartons
which is selected on basis of product type, pack size & life of
the product
The outer carton containing finished products must be
stacked in the following manner so that carton/product is
not damaged.
Outer Carton No.
Total No. of Outer Carton Stacked
Product must be stored separately as per end usage like
OTC, Rx, Hospital products & Veterinary
SOP for Storage of finished Products
Stocks of medicinal products should normally be segregated
into the following categories:
Medicinal Products for internal use
Medicinal Products for external use
Reagents
Refrigerated Items
Flammable
Sterile Topical Fluids
Baby milks
Controlled drugs
Store look-alike and sound-alike drugs separately.
SOP for Storage of finished Products
The product must bear its Name, Batch No., Batch Size, quantity, Mfg
date and Exp date on the outer carton.
During transportation of the finished product, it should be handled with
care to avoid breakage, damage, and leakage.
Stock rotation of all the batches must be maintained in the finished
good store according to the first in first out formula.
All the storage and handling must be carryout through authorized
persons under the supervision of finished good storekeeper.
Entry of unauthorized persons must be prohibited by the finished good
storekeeper.
The finished goods store should be neat and clean.
SOP for Storage of finished Products
All drugs, including samples, should be maintained separate
from non-medications in a locked cabinet or drug room
which is sufficiently secure to deny access to unauthorized
persons.
Place medication in to stock immediately upon receipt.
Stocks of medicines should be checked regularly (monthly)
to ensure that they are still within their expiry date and
remain fit for use.
SOP for Storage of finished Products
Store drugs in conditions required per labeling or other
official guidelines.
Maintain temperature between 59 degree and 86 degrees
Fahrenheit for non-refrigerated medications.
Where refrigeration is necessary use a Medications Only
refrigerator and maintain temperature between 36 degrees
and 46 degrees Fahrenheit.
Give every products digital code for cross reference which
denotes mfg dt, mfg site, exp dt
SOP for Storage of finished Products
On daily basis check, verify and document the proper temperature
All multiple-dose injectable medications should be initialed and have the
date of first entry recorded on the label.
Multiple dose vials remain potent until manufacturers date on the vial.
Each product SKUs must have code for easy storage and billing handling
SOP for Storage of finished Products
Products should be stored Batch wise and Product wise on raised platforms.
The storage should not hinder the cleaning and should have sufficient space
for movement of stocks and handling.
Products are to be stored in a manner that prevents damage due to excessive
vertical stacking heights as per Manufacturers Instructions and in no case
not to exceed eight stacks.
Storage should be done as per guidelines of insurance company for insure
products
Controlled drugs
a. Controlled drugs must be stored in accordance with controlled drugs
safe custody regulations. The room containing the controlled drugs
cabinet should be lockable and should not be accessible to clients.
b. The number of sets of keys and who holds them must be known at all
times. The medicines controller is responsible for the keys. The keys must
be kept separate from the cabinet.
c. The cabinet should only be opened by the medicines controller or by a
person authorized by them. The medicines controller remains ultimately
responsible.
d. The controlled drugs register should be stored in an appropriate
location outside the controlled rugs cabinet.
Standard Operating Procedures
for Dispatch of Finished Products
After completion of analysis by QC and Verification of batch
record by QA person, a finished Product shall be given for
dispatch.
Deliveries should be made only to customers appropriately
authorized or entitled to receive medicinal products.
For all supplies to an authorized person a document must be
enclosed to ascertain the :
a) date
b) name and
c) pharmaceutical form of the medicinal product,
d) batch number
e) quantity supplied;
f) name and address of the supplier,
g) name and delivery address of the consignee and
h) applicable transport and storage conditions.
Before Loading the material, check the following points:
Inspect the vehicle
Confirm the quantity & batch no. to be dispatched.
Prepare Excise invoice and make necessary entries in all
relevant documents.
Loading is to be done in presence of security person.
After completion of loading, handover the duplicate for
transporter copy to the Transporter.
One copy of each invoice shall be given to Accounts
Department and on security gate
Complete all necessary entries of dispatch in daily Stock
Account Register.
Customer verification must be performed prior to the
dispatch of products to such persons or entities.
The transport process should not affect the integrity and quality
of the
products and they should be transported in such a way
that:
a) Identification is not lost
b) They do not contaminate, and are not contaminated by,
other products or materials.
c) Adequate precautions are taken against spillage, breakage
or theft
d) They are secure and not subjected to unacceptable degrees
of heat, cold, light, moisture or other adverse influence, or
to attack by micro organisms or pests;
e) The products are secured so as to prevent unauthorised
possession;
f) The point of delivery must be consistent with the delivery
address on the waybill or delivery note or label.
For the deliveries of Specified Schedule 5 and/or Schedule 6
pharmaceutical products, requirements stipulated in Section
22A of the Medicines Act should be followed.
An invoice of the dispatched pharmaceutical products should
be prepared and should include at least the following
information:
a) Date of dispatch;
b) Name and address of the customer;
c) A description of the products including, e.g. name,
dosage form and strength (if applicable);
d) Quantity of the products, i.e. number of containers and
quantity per container;
e) Clearly identifying products requiring specialised
handling;
f) A unique number to allow identification of the delivery
order.
Delivery documentation should contain enough information
to enable traceability of the pharmaceutical product.
Thermolabile pharmaceutical products requiring controlled
temperature storage should be transported by appropriate or
specialized means.
Thank you !
