Overview on good warehouse practice

SUBMITTED TO

Dr. Babasaheb Ambedkar Technological University Lonere, Raigad,

Maharahstra
Submitted By
Mr. Sainath Mahadev Hirave
Under the Guidance of
Miss. Mali Sunayana Mallappa (M. Pharm)
Assistant Professor

Department Of Quality Assurance

Sahyadri College of Pharmacy, Methwade, Sangola.

CERTIFICATE

Certificate

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This is to Certify that the Project Work Entitled by “Qualification of manufacturing
equipment of tablet compression machine is record work done by Mr. Sainath Mahadev
Hirave studying in B-Pharm Final Year, at Sahyadri College of Pharmacy, Methwade under
the supervision of Miss. Mali Sunayana Mallappa during the year 2023-24. I also certify
that the project represents independent work done by the candidate.

Place: Methwade
Date :

Supervisor
Miss. Mali S. M.
Assistant Professor
Department of Quality
Assurance

CERTIFICATE

Certificate

2
This is to certify that the project work entited Certificate on “Qualification of
manufacturing equipment of tablet compression machine” is a record of project
work done by Mr. Sainath Mahadev Hirave Department of Quality
Assurance, Sahyadri College of Pharmacy Methwade, under the guidance Miss.
Mali Sunayana Mallappa, Department of Quality Assurance, Sahyadri College
of Pharmacy, Methwade, in partial fulfillment of the DOMAIN NO. 10:
QUALITY CONTROL AND QUALITY ASSURANCE IN
PHARMACEUTICALS for the award of Bachelor of Pharmacy, under Dr.
Babasaheb Ambedkar Technological University Lonere, Raigad.

Place : Methwade
Date :

Principal
Dr.Patil Manojkumar
Sesharao
Sahyadri Collage Of Pharmacy,
Methwade

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 DECLARATION
DECLARATION

I hereby declare that the dissertation entitled ‘‘Qualification of manufacturing

equipment of tablet compression machine ’’ Submitted by me for the award of
Bachelor of Pharmacy, Dr. Babasaheb Ambedkar TechnologicalUniversity,
Lonere Raigad, is the result of my original and independent work at Department
of Quality Assurance, Sahyadri College of Pharmacy, Methwade during the year
of 2022-23 under the supervision of Miss. Mali Sunayana Mallappa Assistant
Professor, Department of Quality Assurance, Sahyadri College of Pharmacy,
Methwade. The project work or any part thereof has not formed the basis for the
award of any degree or any other similar title of this or any other University,
previously.

Place: Methwade
Date :

Mr. Sainath
Mahadev Hirave

ACKNOWLEDGEMENT

Acknowledgement
Success is the progressive realization of worthy goal. Many able people fail to achieve
anything worthwhile because they have not been properly guided. Success of any project

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depends solely on support, guidance and encouragement received from the guide and well
wishers.
I am extremely grateful to the guide Miss. Mali Sunayana Mallappa, Assistant
Professor,Department of Quality Assurance, for her critical comments, guidance, support,
constant encouragement and timely valuable suggestions which were very much helpful for
me in completing and bringing out this research work. It is a pleasant duty to express my
sincere grateful thanks to Dr. Patil Manojkumar Sesharao Sir (Principal Sahyadri college of
Pharmacy, Methwade.) for his help, encouragement and for making available infrastructural
facilities and equipments at the institute for the research work.
I feel short of words to express thanks to President Dr. Dilipkumar Ingawale Sir (President,
Shikshan and Krushi Vikas Pratishthan, Medshingi’s) for their kind moral support to make
this work possible. I am greatly thankful to respected Miss. Mali S. M. Providing her much of
the guidance and encouragements at all stages and timely valuable suggestions which were
very much helpful for me in completing and bringing out this research work and study at
Sahyadri college of Pharmacy, Methwade.

I am also thankful to my teacher Mr. Kale S.S.sir. Mr. Tomboli A. M. Sir. Mr. Jokar S. P. sir.
Mr. More S. M. sir. Mr. Garande B.B. sir, Mr. Mali A. D. sir, Dr. Tamboli N.A. Madam, Miss.
Awatade S.S. Madam, Miss. Adat P.M. Madam, Miss. Kale S.R. Madam, Miss. Kadam R.K.
Madam, Miss. Pawar S.M. Madam, Miss. Anekar V.P. Madam For their help and suggestions
throughout my course and also thankful to all teaching staff, Sahyadri college of pharmacy,
Methwade.
I owe my warm and humble thanks to our junior for their immense help throughout the work.
The completion of this dissertation is not only my dreams but also the dreams of respected
father Mr. Hirave M.V. and mother Miss. Hirave R.M. who have taken lots of pain for me in
completion of higher studies.
Finally my salute to Sahyadri college of Pharmacy, Methwade, that inspired me a lot
todevelop myself with best of my abilities and qualities.

Mr. Sainath Mahadev Hirave

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 CONTENTS

CONTENTS

1. introduction

2. Purpose

3. Various areas of ware housing

4. Design

5. General guidelines

6. Good warehousing practice

7. Rules for warehousing

8. Characters of good warehouse

9. Warehouse staff

10. Storage of material/products

11. Stock management

12. Quality assurance (sops)

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  Maintaining proper storage condition for pharmaceutical products and paramedical is
vital to ensure their quality, safety and efficacy.
 Factory stores will invariably be receiving duly approved raw materials and
packaging materials from third party.
 A suitable space is provided to raw material , handling of raw & packaging materials
required for manufacturing, including packaging of pharmaceuticals. This space is
known as Warehouse.
 It is a part of pharmaceutical company.
 For what purpose ?:
 To enable the fastest and cheapest transport of drugs and medical equipment from
suppliers to beneficiaries.
There are mainly 3 stages:
1. Purchase of pharmaceutical products.
2. Storage of ordered products.
3. Distribution of stocked products.

 VARIOUS AREAS OF WARE HOUSING :-

 RECEVING AREA:- includes initial inspection, cleaning & weight checking.
 SAMPLING AREA:- with adequate facilities to prevent cross contamination.
 STORAGE AREA:- including specific storage like air condition rooms, cold rooms,
hazardous chemical storage room.
 REJECTED MATERIALS:-Destroyed or retested unsuitable.
 DISPENSING AREA:-with adequate facilities to preclude cross contamination
during dispensing.

Design:

 Principle : Premises must be located, designed, constructed, adapted, and maintained

to suit the operations to be carried out.

DIAGRAM FOR THE LAMOUT OF THE PHARMACEUTICAL WAREHOUSE

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Pharmaceutical warehouse

General:

 The layout and design of premises must aim to minimize the risk of errors and
permit effective cleaning and maintenance in order to avoid cross-contamination,
build-up of dust or dirt, and, in general, any adverse effect on the quality of products..
 Where dust is generated (e.g. during sampling, weighing, mixing and processing
operations, packaging of powder), measures should be taken to avoid cross-
contamination and facilitate cleaning.
 Premises should be situated in an environment in which the minimum risk of any
contamination of materials or products.
 Premises used for the manufacture of finished products should be suitably designed
and constructed to facilitate good sanitation.

 Premises should be carefully maintained, and it should be ensured that repair and
maintenance operations do not causes any hazard to the quality of products.
 Premises should be cleaned and, where applicable, disinfected according to detailed
written procedures. Records should be maintained.
 Electrical supply, lighting, temperature, humidity and ventilation should be
appropriate and such that they do not adversely affect, directly or indirectly, either the
pharmaceutical products during their manufacture and storage, or the accurate
functioning of equipment.

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  Premises should be designed and equipped so as to afford maximum protection
against the entry of insects, birds or other animals. There should be a standard
procedure to prevent from rodent and pest control.
 Premises should be designed to ensure the logical flow of materials and personnel.

Zone: Clean Zone: Packaging Zone: Controlled

 Arrival of goods, Entrance for visitors, Entrance for forkers, shipment of goodsì
 Example of material and people flow
 GENERAL GUIDE LINES :-
 Materials received against specific supply devices
 Each such consignment have written documents (delivery Chelan)
 All materials received by responsible persons materials to be checked for cleanliness
& package integrity
 Damaged container separated & reporting immediately
 Check for proper container labeling
 i.e status of materials UNDER TEST,
 A Waiting for APPROVAL .

GOOD WAREHOUSING PRACTICE :-

 Factory Stock which should be received with proper documents detailing the names of
product ,the batch number ,the number of units of final packs of each batch ,the date
of dispatch and the quality control status of the batches.
 The stock control system must be such that only passed batches of products are issued
for distribution. Stocks should be stored, product wise to enable quick identification
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 and control of stock movement .Stocks should therefore be racked and stored in a
manner that earlier stocks are more early accessible than the later ones.
 The picking and assembling areas should be so arranged as to minimize the distance
travelled by warehouse operators. Picking stocks should be located on shelves at
convenient heights and with proper labels which clearly identify the products.

 Assembled products should be checked for accuracy of quantities and identities of

products ordered. Batch details should be recorded in relevant documents.
 Finished product should be packed in the containers and dispatched for the
transportation.
 The unit product packs should be not contaminated by other products. Vehicles which
carry the final packaged stocks of products should be so selected that-
1) They are clear, dry and sufficiently protected from rain and other weather factors.
2) They are free from infestation .
3) They do not give off strong odours which may contaminate the products .
4) They are suitable to withstand the weight of the load they carry .

RULES FOR WAREHOUSING :-

 Systematic storage of the delivered goods.

 Use air circulation & protection against rodents .
 Keeping a space at least 50cm between the rows of pellets walls .
 Providing each products have only one specific place.
 On shelves clear labelling of products should be there .
 Adequate space should be provided for each goods .
 Provide separate stoke card for each products.
 All boxes in stock should be closed .
 Flammable products should stored in separate place.

CHARACTERS OF GOOD WAREHOUSE :-

 Properly cleaned.
 Good preservation of drugs & equipment.
 Provide safety for staff & stocked goods.
 Control of air, light ,humidity & temperature.
 Products to be purchased according to needs.
 Order the destruction of unsuitable products.
 Promote rational use of pharmaceutical products.

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  The warehouse staff:1.The responsible pharmacist
 His duties
 Good management of the stock of the warehouse.
 Good preservation of drugs and equipment. Safety of stored goods.
 The warehouse keeper
 His duties
 Reception of supplies.
 Storage of stocks of goods.
 Recording of every IN and OUT movement of the products in the stock card.
 Issue of products during manufacturing.

 The warehouse worker

 His duties
 Handling operations includes the carrying and moving of goods which are intended
for storage, shipment and sale.
 The warehouse staff helps in receives and issue goods and maintain inventory.
 The cleaner
 His duty
 Ensure cleanliness of premises and equipment.
 5.The security guard
 His duty
 He is responsible for ensuring supervision and security of the warehouse .

STORAGE OF RAW & PACKAGING MATERIALS :-

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  Storage condition- special storage area with controlled temperature , humidity &
stored off from the floor.

 bottles, vials, ampoules, tins, tubes should be stored in a manner that they do not
 contaminated by extraneous matter . printed packaging material also stored properly .
 Printed materials such as labels , printed films / foils /laminates, cartons should kept
in storage cupboards.
 preventing mix up of printed & non printed materials .
 Physical segregation of printed & labelled containers should be made .
 Special precautions is needed for the storage of packaging labelling controlled
products.
 Appropriate storage condition to be provided ( air conditioning, aluminium foil)

HANDLING & ISSUE – RAW MATERIALS :-

 Attention to be made for -prevent cross contamination ,health of personnel handling

materials ,containers should be closed properly ,materials that support microbial
growth are handled carefully. Eg.Agar. materials issued only against authorized
person .
 Personnel protective devices like gloves, facemasks etc. should be used to avoid
health hazards. Adequate dust extraction system should be provided to suck away fine
dust as to prevent cross-contamination.
HANDLING & ISSUE: PACKAGING MATERIALS :-

 Packaging materials issued to production only against packaging materials order.

 Care should made to check for only right packaging materials to be issued.
 Unlike raw materials , exact quantity of packaging materials to be issued.
 Unused packaging materials returned to the warehouse & will accompanied by
authorized documents .

WARE HOUSING OF FINISHED PRODUCTS :-

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For avoiding deterioration, spoilage or breakage

 requirements:-
 safe , orderly & dispatch of all products -cold storage area have temperature
monitoring & recording devices -racking & shelving system should have good
mechanical strength .
 Procedure:-stock received from factory with proper documentation (name, batch
number, date of dispatch)
 Finished products which are under test" must be quarantined
 & segregated from passed stocks”
 Stock should be stored product wise to enable quick identification & controlled stock
movement
 Store rotation should be on first in ,first out basis.

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QUARANTINE MATERIALS

WARE HOUSING OF RETURNED GOODS :-

 Stocks should be carry out only consultation with quality controlled manager.
 Returned goods must be isolated on receipt ,clearly identified & records regarding
reason for the return .
 Qc manager should examine whether these goods are reprocessed or destroyed.
 Reprocessing of returned should be done according the instruction of Qc manager.

SANITATION:-

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  Written sanitation programmes should be available. These should include validated
cleaning procedures for premises and equipment, a quality standard for water,
instructions for hygiene when manufacturing and handling goods, and instructions
relating to the health, hygienic practices, and clothing of personnel and the disposal
procedures for waste materials and unusable residues.
 Eating, smoking, and unhygienic practices should not be permitted in manufacturing
areas.
 There shall be written procedures for use of suitable rodenticides, insecticides,
fungicides, fumigating agents and cleaning and sanitizing agents.
 cleaning procedure to be followed, including equipment and materials .

MAINTANANCE :-

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  Any building used in the manufacture, processing, packing, or holding of a drug
product shall be maintained in a good state of repair.
 Deterioration of buildings not only presents a poor image of the facility, it can also
impact on product quality.
 Cracks and holes in walls, floors, or ceilings can provide access for insects, rodents,
birds, dirt, or microorganisms.
 They can also hinder cleaning and sanitation, thereby increasing the potential for
cross contamination or microbial multiplication.
 Floor cracks can also become a safety hazard for people or even dislodge materials
from trucks.
 The ingress of water from roof leaks can cause significant damage to materials and
equipment, give rise to electrical failures and fires and result in damage to the basic
structure of the building.
 Additionally, holes in the roof or near the tops of buildings provide ready access to
birds, which may then be encouraged to nest within the building.

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STOCK MANAGEMENT:-
Objectives:-

 To ensure continuity of supplies. To avoid over stocking.

 Stock management will set out to; monitor stock levels monitor consumption
anticipate delivery time for order activation.
 Issuing of material:-
 store should issue raw and packaging materials on the basis of FIFO(first come first
out) basis. Entry and exit of every consignment of materials should be entered on the
stock card.
 Issuing of materials should do on the basis of raw and packaging materials required
in manufacturing process. while issuing hazardous and explosive materials, the
operation should be supervised to prevent any mistake.

Quality Assurance (SOPs) :-

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  Each warehouses will have to establish operating procedures.
 They must be clearly defined for each stage activities.
 Direct purchase from raw materials manufactures.
 Purchase via Head quarters.
 Reception of local and imported orders.
 Unpacking, labelling and storage of products.
 Computerized stock managements.
 Preparations of an orders for delivery.
 Returns of drugs.
 Managements of Expired drugs.
 Safety and cleanliness of premises.

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REFERENCES :-

Sidney H. Willing ,Good manufacturing Practices For Pharmaceutics , 1st edition,, page
no:173-76.
DR.MGR , Ananth Vannemsetty , Tinu Thomas ,Consise text book of QC & Q.A , ,Page no:
222 – 231.
Available on who.int (Surfing on 19-11-11).
Also available in revised schedule-M (Surfing on 19-11-11).
https://images.app.goo.gl/2PpBrV3QqnHLP2Cr6
https://images.app.goo.gl/TZ6Rm2d7DRr3wVxA9
https://images.app.goo.gl/FYp1ToqaxLk4eh8D6
https://images.app.goo.gl/oZbh7FzkSz6geJep9
https://images.app.goo.gl/A1u2epegnrgAfHsGA
https://images.app.goo.gl/AAHzzqKfc9GK2TnK9

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