Good Warehousing Practice

Good Warehousing Practice

1. Premises

2. Security

3. Temperature and humidity control

4. Equipment

5. Personnel

6. Sanitation

7. Receipt of incoming goods

 8. Warehousing of FG (Finished Goods) and Dispatch of FG

9. Packing for transportation

10. Transport

 

PREMISES:

·        Premises should be of suitable size and construction to facilitate cleaning, maintenance and orderly, segregated storage.

·        Storage areas must be designed to provide adequate Ventilation, Temperature, Sanitation, Humidity, Space, Equipment, security conditions.

·        Each material should be stored separate from other materials to avoid the risk of cross contamination.

·        Incoming materials should be Quarantine until approved by the responsible person.

·        A segregated area must be provided for returned, recalled and rejected goods prior to a decision on further action.

·        A secure, segregated area must be provided for the storage of controlled drugs

SECURITY:

·        Storage areas should be provided with security to prevent theft or unauthorised entry.

·        Maintain a control of who may enter the facilities.

·        Establish system for controlling access to the facility (including all entrances and exits)

TEMPERATURE AND HUMIDITY CONTROL:

·        All materials must be stored at appropriate conditions as stated on the label of the material.

·        The temperature of all storage areas should be regularly monitored.

·        Controlled temperature storage areas should be equipped with recorders and devices which indicate when the specific temperature range has not been maintained.

·        A written procedure must specify the action to be taken when this occurs.

·        Control should be adequate to ensure that all parts of the storage area are kept within the specified temperature range

·        Should always have a backup system in case main system fails

·        The humidity of all storage areas should be regularly monitored and recorded.

·        If the product specification require a specific humidity, a written procedure must specify the action to be taken when the specified humidity range has not been maintained

·        Establish a normal operating baseline of humidity if no specific value is required

·        Records of temperature and humidity in all storage areas should be reviewed and retained by a designated responsible person

EQUIPMENT:

·        There should be a planned preventative maintenance programme in place (i.e. RLAF, AHU etc.)

·        Recording and control equipment should be verified & calibrated in intervals by appropriate methods (i.e. Electronic Balances, Thermo hygrometer, RLAF, AHU, Dynamic pass box)

Thermal Hygrometer

Reverse Laminar Air Flow Bench

Dynamic Passbox

Palate

·        Alarm set-points should be checked on periodic intervals

·        A computerised system (SAP) used for stock control/distribution should be validated.

PERSONNEL:

·        The organisation chart should be in place.

·        There should be a sufficient number of staff.

·        There should be clearly defined job description.

·        Personnel should be trained in relation to good storage and distribution practice and to the duties assigned to them.

·        The current records of training should be in place.

·        The trainers should have established and approved qualification.

·        ORGANIZATION CHART (STORES)

¾   Head Stores

¾   Deputy Manager Stores

¾   Sr. Executive Stores

¾   Executive Stores Assistant

¾   Stores Manager Stores

SANITATION:

·        A written sanitation program should be in place indicating the frequency and method of cleaning the facility (i.e. Area cleaning SOP)

·        A pest control program should be in place .

·        Smoking, eating and drinking should be permitted only in segregated areas, and not in those areas used for the storage and handling of final drug products

·        Material spill must be promptly cleaned-up in accordance with the relevant health and safety requirements for materials.

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

RECEIPT OF INCOMING GOODS:

·        It should be carried out according to approved adequate SOP.

·        Visually examine delivery documents of the consignment (i.e. delivery challan, LR Copy, excise invoice,COA etc.)

·        The documents should be essentially consist of following information (Name of material, Name of manufacturer, batch no, manufacturing date, expiry date, qty. etc.) ü

·        Visually examine physical condition & verification of consignment for damage.

·        Cross verify container labels with documents, Batchwise segregation reject product if damage or otherwise unfit for use

·        If any discrepancies is observed in documents, material packing, vehicle condition, then warehouse officer should bring notice this to head warehouse.

WAREHOUSING & DISPATCH OF FG:

·        It should be carried out according to approved adequate SOP:

·        Storage area should be maintained or designed to ensure good storage practice

·        Finished product shippers should be kept on pallets batchwise in defined high stacking to avoid fails down

·        Stores area should be suitably secured and of sufficient capacity to allow for the safe storage & handling.

·         Storage area should be clean & dry and maintained within acceptable temperature limit

·         Record should be maintained of storage conditioned, Records of temperature monitoring data should be available for review

·        Prepare adequate shipping package to protect any damage of goods, seal pack and provide relevant identification.

PACKING FOR TRANSPORTATION

·        Products should be packed in such a way that the identification of the product is not lost, the product does not contaminate and is not contaminated by other products or materials

·        Adequate precautions are taken against breakage.

·        Products requiring controlled temperature storage should be provided with insulated packs.

·        There should be in place documented evidence that the insulated packs ensured adequate transport conditions with regards to: product quantity, ambient temperature, maximum delivery time.  

TRANSPORT:

·        Products should be transported in such a way that the safety, identity, strength, quality of the product is not lost

·        The product is not contaminated by other products or materials.

·        Adequate precautions are taken against breakage.

·        The product and its package are not subjected to unacceptable degrees of heat, cold, light, moisture or other adverse influences nor to attack by micro-organisms or pests ü

·        Drug products requiring controlled temperature storage by appropriate specialised means or should be packed with adequate insulation 16 STAC Academy

·        TRANSPORT Documents should be provided to cover all shipments. These document should include as minimum: name of the product, quantity of the product, special storage and handling instructions.

RECORDS:

Following records should be in place: 

¾   Receiving material (delivery challan, invoice, check list)

¾   Issuing material (BMR/BPR issuance copy) 

¾   FG (receiving packing list, outgoing invoice, delivery challan, ARE1 copy with authorised signature)

¾   Training

¾   Monitoring temperature and humidity

¾   Cleaning operation

¾   Pest control

¾   Calibration

¾   Preventative maintenance

¾   Recall

¾   Complaints

¾   Inventory (Inward, stock registers)

¾   Log of signature (formats)

 

REFERENCES: Good manufacturing practices for pharmaceutical products. In: Quality assurance of pharmaceuticals. A compendium of guidelines and related materials.

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