Logistics: Goods Distribution Practice (GDP)

credit:[email protected]

The term GDP is currently still a new thing in Indonesia and has not been fully implemented in daily logistics activities. This high standard in logistics handling is still not widely understood by practitioners and workers in the logistics sector in Indonesia.

Specifically, this GDP is implemented in the pharmaceutical or drug industry with a local name, namely CDOB ( Cara Distribusi Obat yang Baik / Good Drug Distribution Method) and is controlled directly by BPOM (Food and Drug Supervisory Agency).

BPOM itself is a special agency formed by the Indonesian government to oversee the distribution of drugs and food. However, it should not be a problem if the GDP principles are also applied in all industrial sectors other than the pharmaceutical and drug industries.

The following are some of the requirements related to Good Distribution Practice or GDP, including:

Procurement
Receipt
Storage
Delivery of medicines

By implementing the clauses contained in the GDP in the logistics activities carried out, a clear commitment will be obtained. towards the goal of achieving customer satisfaction which is accommodated in perfect goods handling and delivery services as well as the ongoing developments of the logistics operational system that is carried out.

The clauses in the GDP itself consist of 20 clauses which are directly controlled by WHO. A total of seventeen important clauses of which cover the organization and logistics activities.

The clauses in the GDP include:

1. Organization and management

2. Personnel

3. Quality management

4. Warehousing and storage

5. Vehicles and equipment

6. Containers and container labeling

7. Dispatch

8. Transportation and products in transit

9. Documentation

10. Repackaging and relabelling

11. Complaints

12. Recalls

13. Rejected and returned products

14. Counterfeit pharmaceutical products

15. Importation

16. Contract activities

17. Self inspection

And in this article we will only discuss 10 clauses, please read explanation of each of these clauses in the following review.

1. Organization and Management

In GDP, it is necessary to have a management organization structure that is clear, concise and has functions that support each other.

The focus and goals of GDP are more towards warehouses and distribution, therefore, it must be ensured that in the warehouse and logistics department a clear structure has been established and has a deterrent function against any problems.

A complete job description that is in line with warehouse and logistics (distribution) conditions as well as the completeness of the Standard Operating Procedure (SOP) that is carried out consistently will guarantee that management has a high commitment to providing satisfaction to customers.

Important points in this regard are:

Clear organizational structure (authorization & responsibility)
Clear job description
Change management
Safety procedures (personnel and property, environmental protection)

2. Personnel

Requirements for employees who carry out logistics activities as well must be prepared and fulfilled in its entirety in its implementation.

A warehouseman, for example, must have the capability to read and write, have a minimum high school education and have a polite and clean appearance is one example of how the requirements for all levels of positions are prepared.

Training for employees and evaluations carried out on the training will provide added value in developing employee skills.

The important points in the training are:

GDP training for all staff
Sufficient and experienced staff in national quality standards
Recorded training data
Work equipment
Employee hygiene procedures
First aid procedures
Clear division and placement of staff

3. Quality Management

Management quality assurance is a form of guarantee that is required to be available for the implementation of logistics activities.

Quality Management includes the following:

Organizational structure, procedures, processes and sources
Systematic activities
Source of goods and approved partners
Activities
Inspection and certification (ISO)
Trackable

4.Warehouse and Storage

Warehouse conditions and storage areas are the most focused areas in the implementation of this GDP.

Important points in this regard are:

Limited staff access
Sufficient and separate capacity
Quarantine
Rejection
Cancellation
Return
Clean and tidy
Recorded air temperature or humidity
Cleanliness
Safe from weather disturbances
Dangerous goods : Separated
FEFO
Sufficient information
Rotation stock & control stock
Routine stock take
Stock investigation

5.Vehicle and Equipment

Condition of distribution fleet (vehicles and logistical support equipment) is the second part which has the heaviest clause which includes things as follows:

SOP for handling the vehicle as a whole
Safety of the vehicle for goods and people who use it
Cleanliness of the vehicle and does not cause contamination of the goods it carries
Special dedication to drugs, otherwise there must be a procedure that regulates how the replacement process for goods non-drugs
Pest control on vehicles
Materials for cleaning must be environmentally friendly and not a source of contamination with the goods they carry
Recording of temperature and changes, temperature mapping and calibration of vehicle temperature
Sufficient capacity
There is a separation for good goods, returned or rejected goods and recalled goods.
Clear labels on each package of goods

6. Container and Container Labeling

The provision of packaging facilities in shipping requires important attention, especially the labeling of the destination address and type of goods so that errors in shipping can be avoided.

Container shipping goods are required as follows:

SOPs for handling container damage and the impact of contamination caused
The packaging used must be anti-contamination and does not cause negative effects on the drugs contained in it
The packaging can protect from the influence of external weather and microbiology
Equipped with labels that explain how to handle the goods inside
International/national codes used on labels
Need special handling for goods that use dry ice

7. Dispatch

Delivery of goods or dispatching must have important things, namely:

a. Clear SOP for delivery

b. Clear contract with transporter

c. Data that must be present, among others:

Name & address
Date of departure
Goods name, Qty and batch number and Exp date
No DN or Invoice
All data is available to make it easier if one day you have to recall the goods
Delivery schedule
LIFO (Last In First Out)

8. Transportation and Products in transit

If the shipment is done by transit somewhere, then the company must have clear rules and stipulations in the implementation of the transit of the goods.

a. SOP - Obtain information from suppliers/factories regarding procedures for handling goods in transportation and transit

b. Equipped with storage and transportation procedures aimed at:

The identity of goods is not lost
Goods are not contaminated and contaminates other goods
Goods are safe from leakage, damage or theft
The temperature is in accordance with required standards
Do not exceed the maximum temperature storage standards required
Provide equipment, monitor and record special conditions required
Dangerous goods must be handled in a separate, special and easily controlled place
Tracking vehicles and goods in them and personal security
If transit is required, should be done with clear documentation

9. Documentation

One of the clauses that are very synonymous with ISO 9001 is the issue of documentation. All documents used in the form of SOPs, Work Instructions, Forms and records must have a clear identity and recorded document travel.

The important points in this case are as follows:

SOP – all procedures and documentation of work implementation must be clear and have the name of each one clearly
All documents are distributed in an orderly and complete manner with distribution lines
Documentation must be easy to clarify
Documentation must be accompanied by the signatures of the parties who are entitled and responsible and have a clear validity and expiration date
Documentation cannot be changed by unauthorized persons
Documentation procedures must be in accordance with local regulations
Documentation must be reviewed within a certain period and updated
Special for documentation of storage of goods must be aligned with the standard rules of WHO/BPOM
Documentation for recording temperature must be stored at least 1 year after the goods are stored
If temperature recording is done electronically, it is required to have a back up recording manually

10. Repackaging & Relabelling

Repacking is an act of repackaging activities into smaller packages of an item. This packaging may change due to regulations using the Indonesian language in the packaging or it is indeed necessary to change the large packaging to a smaller package.

In general, repacking or labeling rules must be based on Goods Manufacturing Practice (GMP) so it is very rare for companies to carry out these activities.

Thus a brief review related to Goods Distribution Practice (GDP), hopefully it can add to your insight.