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What are the SOP we need to remove finish product product from warhouse to sale expedition
Medicinal 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
Storage areas should be provided with security to prevent theft or unauthorised entry
Maintain a control of who may enter the facilities
uEstablish system for controlling access to the facility (including all entrances and exits)
Temperature and Humidity Control
uAll drug products must be stored at appropriate conditions as stated on the label of the product
uThe temperature of all storage areas should be regularly monitored.
uControlled temperature storage areas should be equipped with recorders and devices which indicate when the specific temperature range has not been maintained.
uA 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
uShould always be a back up system in case main system fails
uThe humidity of all storage areas should be regularly monitored using recorders and devices which document the humidity measures
uIf the product spec require a specific humidity, a written procedure must specify the action to be taken when the specified humidity range has not been maintained.
uEstablish 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
Equipments
There should be a planned preventative maintenance programme in place
, recording and control equipment should becalibrated and checked at defined intervals by appropriate methods
Alarm set-points should be checked on periodic intervals
A computerised system used for stock control/distributionshould be validated
Person
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
Sanitation
A written sanitation program should be in place indicatingthe frequency and method of cleaning the facility
Storage areas should be cleaned and accumulated wasteremoved 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:
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:
Pick up goods according to formal despatch documents
Assemble complete order
>Visually examine for identity and completeness
Visually examine for damage
Confirm with signature properly assembled order
Prepare adequate shipping package to protect any damageof goods, seal pack and provide relevant identification
The heat sensitive drugs if not transported by appropriate specialised means should be provided isolated packing
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 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:
The safety, identity, strength, quality and purity of the product is not lost
The product is not contaminated by other products ormaterials
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 specialised means or should be packed with adequate insulation
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:
receiving goods
issuing goods
training
monitoring temperature and humidity
cleaning operation
pest control
calibration
preventative maintenance
recall
complaints
inventory
log of signature
Good Distribution Practices
Documentation and Records
A written or electronic data sheet should exist for each stored product indicating recommended storage conditions, any 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 five years at least.
Procedures
Each procedure should be approved, signed, and dated by the person responsible for the quality system. The following procedure should be developed.
1.Receipt of incoming product
2.Processing orders
3.Stock movement and control
4.Thefts, losses and discrepancies in inventory
5.Returned goods
6.Recall
7.Complaints
8.Disposal of unsaleable goods
9.Repacking and labelling
10.Deviation
11.Change control
Receipt of incoming product
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 drug,
- name and address of seller and transferor
- identity of drug
- quantity
- date of receipt and disposition
Handle high security materials (control drug, high value items, products requiring a specific storage temperature)
Processing orders
Formal sales order or formal records of customer’s order requirements
Despatch documents should contained as a minimum:
- date of despatch,
- 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
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
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:
- 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 authorised to do so,
- special attention should be given to products requiring special storageconditions.
All returned goods should be kept apart from saleable stockuntil approved by a nominated responsible person
Records of returns should be kept,the responsible person should formally release goods to be returned to stock
Recall
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
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 beevaluated from time to time
Complaints
Any complaint concerning a product defect must be immediately reported to supplier and processed according to local regulations
Complaints relating to customer service or shippingerrors should be processed according to established procedure
Each received complaint should be recorded
Disposal of unsaleable goods
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 inaccordance 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 operation,
each step of the operation should be recorded,records should
also contain identification and quantity of productand packaging materials
all work should be supervised by Principal’s QC or QA
representative
Deviation
Deviation is defined as an accidental departure from establishedprocess described in procedures.
Each site should develop a written procedure for processing deviation. Deviation Procedure should include:
-identification of deviation,
- impact of deviationfor safety, identity, strength, purity or quality,
- investigation of root cause if rationale,
- corrective action,
- preventative action,
- records of deviation
Change control
Change is defined as a planned alteration or replacement of items such as, but not limited to, the following:
-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 programmes egoperating systems, source
codes, application languages etc.
-schematics /diagrams illustrating the main architecture of the programme and/or security detections, eg against unauthorised changes
-a programme listing, eg source codes and necessary back-up media, to enable re-installation of the same programme 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 analyse errors and to enable corrective action to be taken
Implement adequate training program for operators
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