Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
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
STEP
3
STEP
2
STEP
1
SOP conditions
The receiver will-
STEP
7
STEP
6
STEP
5
STEP
4
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
shipper/receiver will:
o Take a photo of the damaged product (camera in
QC will:
o Inspect the damaged product and note the
damage on the PO
o Place the damaged product in sterile plastic bag
for disposal
o Contact the supplier for a claim
If product is to be disposed, follow SOP
Product Disposal.
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
Packaging
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
Sustain
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.
The product must bear its Name, Batch No., Batch Size, quantity, Mfg
date and Exp date on the outer carton.
storekeeper.
The finished goods store should be neat and clean.
to ensure that they are still within their expiry date and
remain fit for use.
official guidelines.
Maintain temperature between 59 degree and 86 degrees
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.
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.
Thank you !