PHARMACEUTICAL WAREHOUSING

CONTENT

1. Objective

2. Reason

3. Warehousing procedures

4. Premises

5. Storage Condition

6. Stock management

7. Documentation

8. Inventories

9. Reception of goods

10. Audit

1.OBJECTIVE

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

2. A suitable space is provided to raw material and packaging materials for manufacturer. this space is known as Warehouse.

3. It is a part of pharmaceutical company.

2.FOR WHAT?

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 goods.

2. Storage of ordered products .

3. Distribution of stocked products.

3.WAREHOUSING PROCEDURES

1. Quarantine of drug products before release by the quality control unit

2. Storage of the drug product under appropriate condition of temp.,humidity and light so that the identity strength,quality and purity of drug products are not affected.

4…PREMISES

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

It includes:

· Ancillary areas,

· Storage areas

· Weighing areas

· Production areas

· Quality control areas

· Sterile areas 6

· Storage areas

BASIC RULES FOR STORAGE

a. Systematic storage of the delivered goods.

b. Use of pallets.

c. Provision of shelves.

d. On shelves each product shall have one

e. specific place.

f. Prevention of collapses.

g. Controlled products stored in a locking

cabinet.

h. Flammable products stored in a separate well ventilated room.

i. Remove infested,damaged,or outdated goods immediately.

j. Suspect products shall be physically separated from other products in stock.

WHO GUIDELINES FOR STORAGE AREA

· Storage areas should be of sufficient capacity to allow orderly storage of the various categories of materials and products with proper separation and segregation.

· Receiving and dispatch bays should be separated and protect materials and products from the weather.

· Segregation should be provided for the storage of rejected, recalled, or returned materials or products

· Highly active and radioactive materials, narcotics, other dangerous drug and substances presenting special risks of abuse, or explosion should be stored in safe and secure areas.

· There should normally be a separate sampling area for starting materials

5…STORAGE CONDITION

A. TEMPERATURE

· Daily monitoring and recorded every hour.

· Temp. in warehouse must not exceed 25-300 C.

· Material that required stored in cool place should be stored in air condition rooms.

B. AIR

· All containers should be hermentically closed.

· Avoid prolonged unpackage material.

· Prefer original packaging to guaranteed airtigthtness and opacity.

· Premises should be ventilated.

C. LIGHT

· Many API should be stored in dark room.

· API should not be directly exposed to sunlight and not to be issued untill and unless it is required in manufacturing.

6…SHELF LIFE OF THE PRODUCT

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 preceeded by <USE BEFORE…>, then the first day of the stated 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 sorted by form to be destroyed in compliance with law and regulations.

7….ADDITIONAL GENERAL REQUIREMENT FOR WAREHOUSING

· Clean the premises with disinfectants.

· To clean the ground surface regularly.

· To clear the undergrowth from around the warehouse regularly. Smoking and eating must be forbidden in the

· premises.

· Faclility of locking doors and protective windows

· To provide extingushers to fight fires.

· To fight against pests.

· Adapted and functional lighting as well as generators ready to works. 16

8…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. 19

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.

9…DOCUMENTATION

Stock card

· 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 movements : incoming and outgoing products

· Know the theoretical stock level at any point in time

· Monitor the consumption of the different users

· Monitor expiry dates

· Assess losses by comparing the theoretical and real stocks

· Have data to plan subsequent orders. 22

STOCK CARD CHARACTERISTICS

Separate stockcard should be maintained for each consignment

· Exact description of the product

· Expiry date of the product

· Products movements:date;incoming quantities and origin ; outgoing quantities and destination; losses due to damaged products, broken flakes, outdated products, lost products

· Stock level after every movement

10…INVENTORIES

· Inventory makes it possible to check the expiry dates of all the pharmaceutical products.

· It is essential to make an inventory of the quantities that really are in stock (physical stock)

· The inventory should be conducted in a minimum time and the results should immediately be recorded to enable normal working to resume. 25

11…RECEPTION OF GOODS

Inspection of an order

· A separate rack should be provided to store approved raw and packaging materials. Materials that is awaiting for approval should be kept in “Quarantine area”.

· Quarantine materials should be labeled “Under Test” till it released by Quality control division.

· After receiving approval,it should be taken into stock.

First inspection

· Collect and check all the documents required for these transports

· Count the number of boxes on each pallet and check that it conforms to the number given by the supplier on the packing list.

· Check the condition of boxes : do some of them look to have been endamaged,opened.

· Check the special preservation conditions:cold chain 28

SECOND INSPECTION

· Secondly,the consignment must be checked in full by the medical team should be

· Check that the goods delivered do correspond to the invoice;

· Check that the quantities received match the quantities shown on the packing list.

· Check the conformity of each product: designation,quantity per packing unit,packaging,labeling,expiry date and product appearance(color change,precipitation etc)

12…THE WAREHOUSE STAFF

1) The responsible pharmacist

2) The warehouse keeper

3) The warehouse worker

4) The cleaner

5) The security guard

13… QUALITY ASSURANCE

SOPs

· 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, labeling and storage of products

· Computriazed stock managements

· Preprations of an orders for delivery

· Repacking or ordersf

· Returns of drugs

· Managemenets of outdated drugs

· Safety and clenlines of premises

14…AUDITS

Audits aim at assessing the activities and organization of the warehouse.

They aim at answering key questions such likes

· Have initially set of activities & quality objectives been reached?

· Are procedures correctly written respected,reviewed?

· Does the warehouse guarantee for safety standards? 33

REFERENCES

1. Good manufacturing Practices For Pharmaceutics, 4st edi.,Sidney Willing,130- 131.

2. PSF-CI PHARMACEUTICAL GUIDE; How better to manage pharmaceutical warehouses, March 2003,2-21,27-31.

3. Quality Assurance of Pharmaceuticals; GMP & Inspection;vol.-II.WHO Publication,Pharma book Syndicate;28-32.

4. SOP GUIDELINES,D.H. Shah, business Horizons, Pharmaceutical Publishers,2nd reprint edition,2004,410 34

Warehousing: Good warehousing practice, materials management