PREPARED BY :- PARAS SHAH GUIDED BY :- MR.DHAVAL RATHOD M.PHARM SEM – 1 (Q.A.) SMT.R.D. GARDI B.PHARMACY COLLEGE

Objective A pharmaceutical warehouse for what ? Premises storage condition Shelf life of product General requiremet for warehousing Stock management Documantation Reception of good Warehouse staff Quality assurance Reference

Factory stores will invariably be receiving duly approved raw materials and packaging material from third party.

A suitable space is provided to rew material and packaging material for each contrac manufacturer. This space is known as warehouse.

To enable the fastest and cheapest transport of drug and medical equipment from suppliers to beneficiaries.

There are many three stages: (1)Purchase of pharmaceutical product (2)Storage of ordered products (3)Distribution of stocked products

PRINCIPLE: Premises must be located, designed, constructed ,adapted and maintained to suit the operations to be carried out.

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.

Where dust is generated e.g. – During sampling - weighing Mixing Processing operation Packaging of powder measure should be taken to avoid

cross contamination and facilitate cleaning.

Premises should be situated in an environment to protect the manufacturing process and minimum risk of causing any contamination of material or product.

Premises should be suitably designed and constructed .

Premises should be carefully maintained ,repair and maintenance operation do not present any hazardous to the quality of product.

Premises should be cleaned and where applicable disinfected acceding to detail written procedure and record should be maintained.

Electrical supply ,lighting ,temp., humidity an ventilation should be appropriate and they do not adversely affect pharmaceutical product and storage.

Premise should be designed to ensure the logical flow of material and personnel.

Systematic storage of the goods. Use of pallets Provision of shelves Prevention of collapses Control product stored in a locking

cabinet Flammable product stored in a

separate well ventilated room .

Storage area should be of sufficient capacity.

Storage condition Receiving area Receiving and dispatch by should be

separated and protect material and product from the weather.

Segregation should be provided for the storage of rejected and recalled or return material or product

Danger substance like radio active material , narcotic , and dangerous drug presenting risk so should be stored in safe and secure area.

Printed materials

Put the medicine in alphabetical order in each product family.

Place in front of each medicine label ,give the generic name (INN),dosage form and strength.

Store the medicines with the nearest expiration date first (first entry first out).

( A ) TEMPERATURE Daily monitoring and recorded every

hour. Temp in warehouse must exceed 25-30

C. Material that required stored cool place

should be stored in air condition rooms.

(B) AIR All containers should be hermetically

closed. Avoid prolonged unpackaged material . Prefer original packaging to guaranteed

airtigthtness and opacity. Premises should not be ventiled.

(C) LIGHT Many API should be stored in dark

room. API should not be directly exposed to

sunlight and not to be issued until and unless it is required in manufacturing.

A written sanitation program be in place indicating the frequency and method of cleaning the facility

Storage area should be cleaned and accumulated waste removed at regular intervals

A pest control program should be in place

Smoking ,eating and drinking should be permitted only in segregated area, and not in those area use for the storage and handling of final drug product

Spills involving drug product must be promptly cleaned-up and rendered safe in accordance with the relevant health and safety requirements for the product

Adequate toilet and changing facilities should be provided, and they should be segregated from the main storage and order assembly area

A Expiry Date The expiration date applies to a drug in

its original closed and undamaged package or container .

It must appear on the package and/or on the product.

If this date is preceded by <USE BEFORE …>,

then the first day of the started month shall be set.

B MANAGEMENT OF OUTDATED PRODUCTS

First, the expired products must be removed from the stock of the products. Stored in a locked area.

Secondly, these products are stored by form to be destroyed in compliance with law and regulations.

Clean the premises with disinfectants. To clean the ground surface regularly. To clean the undergrowth from around

the warehouse regularly. Smoking and eating must be

forbidden in the premises.

Facilities of locking doors and protective windows.

To provide extinguishers to fight fires. To fight against pastes. Adapted and functional lighting as well

as generator ready to works.

OBJECTIVES1. To ensure continuity of supplies2. To avoid over stocking

Stock management will set out to;1. Monitor stock levels2. Monitor consumption3. 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.

STOCK CARDDEFINATION :- It is a simple and efficient tool that

enables the management of a warehouse. A stock card should be created for each pharmaceutical product and regularly updated . They must be easily accessible.

It is necessary to Identify stock movement : incoming and outgoing

products Monitor the consumption of the different users. Monitor expiry dates Have data to plan subsequent orders.

Stock card characteristics separate stock card should be maintained

for each consignment exact description of the product expiry date of the product product movement ;date; incoming

quantity and origin; outgoing quantities ;losses due to damaged product broken flask ,lost product

Stock level after every movement.

Stock management with the help of computer for data

processing product movement will be recorded and

precaution should be taken Register of controlled products

Why do them it is essential to make an inventory of

the quantities that really are in stock. Inventory makes it possible to check

the expiry date of all the pharmaceutical products.

How to do them ? Inventory should made on regular basis

. The inventory should be conducted in a

minimum time.

Inspection Collect and check all the document

required for these transport. Count the number of boxes on each pallet Check the condition of boxes :damaged,

or opened . Check the special preservation condition Check the receive quantity Check the conformity of each product

The responsible pharmacist Warehouse keeper Warehouse worker The cleaner The security guard

Sops :-each warehouse will have to establish operating procedure they must be clearly defined for each stage activities

Direct purchase from raw material manufacturers Purchase via head quarters Reception local and imported orders Unpacking ,labeling and storage of products Computerized management Preparation of an orders for delivery Repackaging Return of drugs Safety and cleanliness of premises.

Good manufacturing practises for pharmaceutics,1st edition ,sidney H. willing,173-76.

PSF-CL PHARMACEUTICAL GUIDE; how better to manage pharmaceutical warehouse ,march 2003,3-21,27-31.

Quality assurance of pharmaceutical ;GMP & inspection;vol-ii.WHO publication ,Parma book syndicate ;28-32.

THANK YOU