Monday, June 22, 2009

GOOD WAREHOUSING and DISTRIBUTION PRACTICES

Good Warehouse Practices

1. Premises

2. Security

3. Temperature and humidity control

4. Equipment

5. Personnel

6. Sanitation

7. Receipt of incoming goods

8. Assembling orders and issuing goods

9. Packing for transportation

10. Transport


Premises

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

u Storage areas must be designed to provide adequate:

- lightening,

- ventilation,

- temperature,

- sanitation,

- humidity,

- space,

- equipment,

- security conditions


u Medicinal products should be stored separate from other goods to avoid the risk of cross contamination

u Incoming goods should be physically or electronically separated from goods awaiting distribution until approved by the responsible person

u A segregated area must be provided for the holding and storage of returned and rejected goods prior to a decision on further action

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

u A separate, designed area should be provided for the assembly of customer orders


Security

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

u Maintain a control of who may enter the facilities

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



Temperature and Humidity Control

u All drug products must be stored at appropriate conditions as stated on the label of the product

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

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

u 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

u Should always be a back up system in case main system fails


u The humidity of all storage areas should be regularly monitored using recorders and devices which document the humidity measures

u If 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.

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

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


Equipments

u There should be a planned preventative maintenance programme in place

u Measuring, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods

u Alarm set-points should be checked on periodic intervals

u A computerised system used for stock control/distribution should be validated

Personnel

u The organisation chart should be in place

u There should be a sufficient number of staff

u There should be clearly defined job description

u Personnel should be trained in relation to good storage and distribution practice and to

the duties assigned to them

u The current records of training should be in place

u The trainers should have established and approved qualification


Sanitation

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

u Storage areas should be cleaned and accumulated waste removed at regular intervals

u A pest control program should be in place

u 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

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

u 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:

u visually examine for identity against the relevant supplier’s documentation

u visually examine for damage

u sub-divide according to batch numbers if more than one batch

u reject product if damage or otherwise unfit for use

u handle high security materials (control drug, high value items, products requiring a specific storage temperature)

u 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:

u Pick up goods according to formal despatch documents

u Assemble complete order

u Visually examine for identity and completeness

u Visually examine for damage

u Confirm with signature properly assembled order

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

u 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:

u the identification of the product is not lost,

u the product does not contaminate and is not contaminated by other products or materials

u adequate precautions are taken against spillage and breakage

u products requiring controlled temperature storage should be provided with insulated packs

u 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:

u The safety, identity, strength, quality and purity of the product is not lost

u The product is not contaminated by other products or materials

u Adequate precautions are taken against spillage or breakage

u 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

u 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:

l name of the product

l quantity of the product

l special storage and handling instructions



Records

Following records should be in place:

l receiving goods

l issuing goods

l training

l monitoring temperature and humidity

l cleaning operation

l pest control

l calibration

l preventative maintenance

l recall

l complaints

l inventory

l log of signature


Good Distribution Practices

1. Personnel

2. Documentation and Records

3. Procedures

4. Computerized system


Documentation and Records

u 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.

u Written procedures should describe the different operations which may affect the quality of the products or of the distribution activity.

u 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

u Visually examine for identity against the relevant supplier’s documentation

u Visually examine for damage

u Sub-divide according to batch numbers if more than one batch

u Reject product if damage or otherwise unfit for receipt/ distribution

u 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

u Handle high security materials (control drug, high value items, products requiring a specific storage temperature)


Processing orders

u Formal sales order or formal records of customer’s order requirements

u 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,

u Visually examine for identity

u Visually examine for damage

u Not shipped if these requirements are not met

Stock rotation and control

u Define process by which product stock should be issued (first in -first out) and any exceptions to process (specific demands from a specific batch)

u Define when periodic stock reconciliation should be performed

u Define process to be used to investigate any significant stock discrepancies

u Define a process of identifying outdated stock and moving it to a quarantine area

Thefts, losses and discrepancies in inventory

u Conduct a thorough investigation and document all action

u Record losses, thefts or diversions and notify appropriate corporate personnel

u Take measures to address the cause of theft, loss or diversion


Returned goods

u 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 storage conditions.

u All returned goods should be kept apart from saleable stock until approved by a nominated responsible person

u Records of returns should be kept, the responsible person should formally release goods to be returned to stock

Recall

u Products can only be recalled by decision of the Head of Quality Assurance

u Define who contacts regulatory authorities concerning any recall

u Define the means whereby recalled products can be traced and obtained from the market

u Establish records of any recalled products

u Establish segregated storage area for any recalled products

u Remove recalled product from saleable stock and store in a segregated area

u Only relevant QA Manager or responsible person could make decision on recalled product fate

u The effectiveness of the arrangements for recalls should be evaluated from time to time

Complaints

u Any complaint concerning a product defect must be immediately reported to supplier and processed according to local regulations

u Complaints relating to customer service or shipping errors should be processed according to established procedure

u Each received complaint should be recorded


Disposal of unsaleable goods

u Stock which is no longer fit for sale must be segregated from other stock before ultimate disposal or destruction

u Destruction of unsaleable goods must be carried out in accordance with local legislation or guidelines issued by each manufacturer

u 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:

u dedicated area for this operation,

u adequate procedure described operation,

u each step of the operation should be recorded, records should

also contain identification and quantity of product and packaging materials

u 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:

- identification of deviation,

- impact of deviation for 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.

u There should be Change Control SOP in place.

u The change must be described and justified.

u Determine the impact of the change for various areas.

u The proposed change must be reviewed by affected areas.

u The change is executed in co-operation with affected areas.

u Prior to filing the documentation , an appropriate person must review and approve the completed change to ensure the documentation is complete and accurate.

u Records of change must be retained.

The distributor should inform supplier in advance of any significant change he is going to implement.

Computerized system

u Computer hardware

- detailed specification (model, version of all hardware, drawings of circuits, networks, routes),

- maintenance (planned and breakdown),

- location and environment,

- change control

u Computer Software

Ÿ Specification should include :

- the version number of all the programmes eg operating 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.

u All aspects of computer system should be described in adequate procedures

u Every significant modification should be validated

u Data should be protected by backing-up at regular intervals

u Back-up data should be stored as long as necessary at a separate and secure location

u Establish and validate procedure to be followed if system fails or breaks down

u Any failures and remedial action taken should be recorded

u Establish procedure to record and analyse errors and to enable corrective action to be taken

u Implement adequate training program for operators

1 comment:

Negi said...

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