Name: Mr. Gladmore Tonderai Duri
Position: Warehouse Storekeeper
Warehousing Procedures:
A warehouse is a facility that, along with storage racks, handling equipment, personnel and management
resources, allows us to control the differences between the incoming flow of goods (received from
suppliers, production centers, etc.) and the outgoing flow of goods (goods being sent to production, sales,
etc.). Usually, these flows are not coordinated, and this is one of the reasons why it is important to have
storage facilities.
Warehouse Specs:
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Some products should be stored separate from other goods to avoid the risk of cross
contamination
Incoming goods should be physically or electronically separated from goods awaiting distribution
until approved by the responsible person
A segregated area must be provided for the holding and storage of returned and rejected goods
prior to a decision on further action
A secure, segregated area must be provided for the storage of controlled drugs
A separate, designed area should be provided for the assembly of customer orders
Security:
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Storage areas should be provided with security to prevent theft or unauthorized 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:
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All drug products must be stored at appropriate conditions as stated on the label of the product
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 be a backup system in case the main system fails
The humidity of all storage areas should be regularly monitored using recorders and devices
which document the humidity measures
If the product spec requires 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.
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Equipment:
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There should be a planned preventative maintenance program in place.
Recording and control equipment should be calibrated and checked at defined intervals by
appropriate methods
Alarm set-points should be checked on periodic intervals
A computerized system used for stock control/distribution should be validated
Employee:
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The organization chart should be in place
There should be a sufficient number of employees
There should be a 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 kept in place
The trainers should have established and approved training qualifications.
Sanitation:
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A written sanitation program should be in place indicating the frequency and method of cleaning
the facility
Storage areas 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 areas, and not in those
areas used for the storage and handling of final drug product
Spills involving drug products 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 areas
Receipt of incoming goods:
It should be carried out according to approved adequate SOP:
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Visually examine for identity against the relevant supplier’s documentation
Visually examine for damage
Sub-divide according to batch numbers if more than one batch
Reject product if damage or otherwise unfit for use
Handle high security materials (control drug, high value items, products requiring a specific
storage temperature)
Confirm with signature that receiving goods are as specified by supplier or if not provide adequate
comments
Assembling orders and issuing goods:
It should be carried out according to approved adequate SOP:
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Pick up goods according to formal dispatched documents
Assemble complete order
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Visually examine for identity and completeness
Visually examine for damage
Confirm with signature properly assembled order
Prepare adequate shipping package to protect any damage of goods, seal pack and provide
relevant identification
The heat sensitive drugs if not transported by appropriate specialized means should be provided
in isolated packaging
Packing for transportation:
Products should be packed in such a way that:
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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 spillage and 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:
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The safety, identity, strength, quality and purity of the product is not lost
The product is not contaminated by other products or materials
Adequate precautions are taken against spillage or 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
Drug products requiring controlled temperature storage by appropriate specialized means or
should be packed with adequate insulation.
Transportation of Goods:
Documents should be provided to cover all shipments. These documents should include as minimum:
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Name of the product
Quantity of the product
Special storage and handling instructions
Records:
Following records should be in place:
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Receiving goods
Issuing goods
Training
Monitoring temperature and humidity
Cleaning operation
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vi.
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viii.
ix.
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xii.
Pest control
Calibration
Preventative maintenance
Recall
Complaints
Inventory
Log of signature
Goods Distribution Practices
Documentation and Records:
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A written or electronic data sheet should exist for each stored product indicating recommended
storage conditions, safety precautions to be observed and the shelf life.
Written procedures should describe the different operations which may affect the quality of the
products or of the distribution activity.
Records should be made at the time each operation is taken and in such a way that all significant
activities or events are traceable.
Records should be clear and readily available.
Records should be retained for a period of at least five years.
Procedures:
Each procedure should be approved, signed, and dated by the person responsible for the quality system.
The following procedure should be developed.
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viii.
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Receipt of incoming product
Processing orders
Stock movement and control
Thefts, losses and discrepancies in inventory
Returned goods
Recall
Complaints
Disposal of unsaleable goods
Repacking and labelling
Deviation
Change control
Receipt of incoming product:
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Visually examine for identity against the relevant supplier’s documentation
Visually examine for damage
Sub-divide according to batch numbers if more than one batch
Reject product if damage or otherwise unfit for receipt/ distribution
Define the record-keeping process identifying
Source of item
Name and address of seller and transferor
Identity of the items
Quantity
Date of receipt and disposition
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Handle high security materials (minimize movements, high value items, products requiring a
specific storage temperature)
Processing orders:
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Formal sales order or formal records of customer’s order requirements
Dispatch documents should contain as a minimum:
Date of dispatch,
Customer’s name and address,
Product name/ form/ lot number/ expiry date/ quantity sent,
Any special handling or storage instruction,
Additional information according to local or international regulation
Visually examine for identity
Visually examine for damage
Not shipped if these requirements are not met
Stock rotation and control:
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Define process by which product stock should be issued (first in -first out) and any exceptions to
process (specific demands from a specific batch)
Define when periodic stock reconciliation should be performed
Define process to be used to investigate any significant stock discrepancies
Define a process of identifying outdated stock and moving it to a quarantine area
Thefts, losses and discrepancies in inventory:
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Conduct a thorough investigation and document all action
Record losses, thefts or diversions and notify appropriate corporate personnel
Take measures to address the cause of theft, loss or diversion
Returned goods:
Products which have left the control of the wholesaler, should only be returned to saleable stock if:
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The goods are in their original unopened containers and in good condition,
It is known that the goods have been stored and handled under proper conditions,
The remaining shelf life period is acceptable,
They have been examined and assessed by a person authorized to do so,
Special attention should be given to products requiring special storage conditions.
All returned goods should be kept apart from saleable stock until approved by a nominated
responsible person
Records of returns should be kept and the responsible person should formally release goods
to be returned to stock
Recall:
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Products can only be recalled by decision of the Head of Quality Assurance
Define who contacts regulatory authorities concerning any recall
Define the means whereby recalled products can be traced and obtained from the market
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Establish records of any recalled products
Establish segregated storage area for any recalled products
Remove recalled product from saleable stock and store in a segregated area
Only relevant QA Manager or responsible person could make decision on recalled product fate
The effectiveness of the arrangements for recalls should be evaluated from time to time
Complaints Handling:
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Any complaint concerning a product defect must be immediately reported to supplier and
processed according to local regulations
Complaints relating to customer service or shipping errors should be processed according to
established procedure
Each received complaint should be recorded
Disposal of unsaleable goods:
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Stock which is no longer fit for sale must be segregated from other stock before ultimate disposal
or destruction
Destruction of unsaleable goods must be carried out in accordance with local legislation or
guidelines issued by each manufacturer
There must be a written record kept of all goods destroyed showing product name, batch number,
pack size, quantity and methods of destruction
Repacking and labelling:
Wherever possible, repacking and labelling process should be carried out at the Principal’s own licensed
premises.
In any necessary case of carrying out repacking or labelling process at wholesaler site following factors
must be applied:
 Dedicated area for this operation,
 Adequate procedure described in operation,
 Each step of the operation should be recorded and documented.
 Records should also contain identification and quantity of product and packaging materials.
 All work should be supervised by Principal’s QC or QA representative
Deviation:
Deviation is defined as an accidental departure from established process described in procedures.
Each site should develop a written procedure for processing deviation. Deviation Procedure should
include:
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Identification of deviation,
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Impact of deviation for safety, identity, strength, purity or quality
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Investigation of root cause if rationale,
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Corrective action,
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Preventative action
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Records of deviation
Change control:
Change is defined as a planned alteration or replacement of items such as, but not limited to, the
following:
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Buildings and facilities,
Equipment
Storage and distribution procedure.
There should be change control sop in place.
The change must be described and justified.
Determine the impact of the change for various areas.
The proposed change must be reviewed by affected areas.
The change is executed in co-operation with affected areas.
Prior to filing the documentation, an appropriate person must review and approve the completed
change to ensure the documentation is complete and accurate.
Records of change must be retained.
The distributor should inform supplier in advance of any significant change he is going to
implement.
Computerized system:
Computer hardware:
 Detailed specification (model, version of all hardware, drawings of circuits, networks, routes),
 Maintenance (planned and breakdown),
 Location and environment,
 Change control
Computer Software:
Specification should include:
 The version number of all the programs e.g. Operating systems, source codes, application
languages etc.
 Schematics /diagrams illustrating the main architecture of the program and/or security detections,
e.g. Against unauthorized changes
 A program list, e.g. Source codes and necessary back-up media, to enable re-installation of the
same programs to occur in the event of breakdown etc.
 All aspects of computer system should be described in adequate procedures
 Every significant modification should be validated
 Data should be protected by backing-up at regular intervals
 Back-up data should be stored as long as necessary at a separate and secure location
 Establish and validate procedure to be followed if system fails or breaks down
 Any failures and remedial action taken should be recorded
 Establish procedure to record and analyze errors and to enable corrective action to be taken
 Implement adequate training program for operators
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