A Comprehensive Checklist for

Good Distribution Practices

(GDP) in Healthcare
CHEcklist by Rmoni

Quality Control and Good Distribution Practices in Healthcare

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Good distribution practices checklist

Good Distribution Practices (GDP) in

Pharma & Healthcare:
Comprehensive Checklist
Pharmaceuticals are something of a special case when it comes
to production and distribution. Most governments regulate
access to pharmaceutical products, and have more control over
its production and distribution than other goods.
Intermediaries in both the public and private sectors working with and distributing drugs
have special drug safety and security precautions to take into consideration. For some
pharmaceuticals, you’ll need to take cold chain management into account.

What is the Good Distribution

Practices framework (GDP)?
Good Distribution Practices (GDP) is a framework that sets the minimum standards
distributors need to meet to ensure quality and integrity of pharmaceutical medicines.

Initially created by the WHO and EEC, this quality warranty system regulates the
movement and distribution of pharmaceuticals from the moment they leave a producer
or central storage point, all the way until they’re received by the end user of the product.

If you want to be authorised to distribute pharmaceuticals wholesale within the EU, your
organization will have to comply with EU GDP guidelines and get a GDP certificate,
issued by an EU competent authority in the member state in which you operate.

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Good distribution practices checklist

Why is GDP important in pharma

and healthcare?

As a patient, you want to make sure that the medication you take is safe and of the
highest possible quality. But medicinal products and pharmaceuticals are often
distributed over long distances, through different climate zones, and stored in a large
variety of warehouses, before they end up in your hands.

This distribution network is also getting more and more complex. All the more reason for
an internationally recognized quality standard for distribution practices.

After all, you wouldn’t want to take a potentially life saving drug not knowing that it’d lost
its efficacy due to bad transportation or storage practices, for instance by temperature
monitoring failure or low quality packaging.

A comprehensive checklist for GDP

in healthcare
During a GDP audit, your quality systems and distribution practices will be checked on a
number of factors. To help you prepare for such an audit, we’ve compiled a
comprehensive checklist for healthcare businesses that want to comply with GDP
regulations.

Ask yourself the following questions, divided by topic:

Quality system
Is there a quality manual or equivalent documentation of your approach?
Are there change control systems in place for changes to critical processes?

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Good distribution practices checklist

Are the appropriate corrective and preventive actions taken to correct

deviations and prevent them?
Is there a system for management review in place?

Personnel
Do you have a clearly defined organizational chart with clearly indicated roles,
responsibilities and interrelationships?
Do job descriptions for employees in key positions clearly define their roles and
responsibilities?
Are all employees involved in distribution qualified in GDP requirements?
Does personnel training include product identification and avoidance of falsified
medicines entering the supply chain?
Does your personnel receive initial and continuing education relevant to the
tasks they perform, based on SOPs, according to a written training plan?
Is the effectiveness of this training assessed and documented regularly?
Have Responsible Persons (RP) been appointed?
Do the qualifications of RP meet the conditions provided by the legislation of
the Member State concerned (EU)?
Is there a written job description for RP in place?

Premises and equipment

If you’re outsourcing distribution activities to a third-party distributor, are there
clear contracts in place regarding activities on their premises?
Are you preventing unauthorised access to all areas of your premises?
Are products prevented from prevailing weather conditions in receiving and
dispatch bays?
Are there designated areas for storage of products suspected of falsification,
returned or rejected products, products awaiting disposal, recalled products,
etc.?

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Good distribution practices checklist

Are radioactive and other hazardous products stored in a dedicated area with
appropriate safety/security measures?
Is there adequate separation between storage areas and the receipt/dispatch
areas?
Are the rest- and washrooms for employees adequately separated from storage
areas?

Hygiene
Have you established clear procedures relating to personnel hygiene (health,
clothing, etc.) and are these being observed properly?
Is storing food, drinks or medication for personal use in the storage area
prohibited?
Are there cleaning instructions and records in place?
Are the premises and storage facilities clean and litter/dust free?
Are the facilities designed/equipped to protect against invading insects, rodents
and other animals?
Have you implemented a preventive pest control program?

Temperature and environment control

Are suitable equipment and procedures in place to ensure control of the
environment?
Are storage areas temperature mapped?
Is temperature monitoring equipment located according to the results of the
mapping exercise?
Do you have adequate control to maintain all parts of the relevant storage area
within defined temperature, humidity, or light parameters?
Is the equipment you use to control/monitor the environment calibrated?
Is this equipment calibrated and is its correct operation and suitability
periodically verified?

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Good distribution practices checklist

Are alarm systems in place to provide alerts when deviations occur?

Are the levels for those alarms set appropriately?
Are the alarms regularly tested?

Equipment
Is preventive maintenance planned for key equipment?
Is equipment calibration based on a primary standard?
Are you keeping records of repair, maintenance and calibration activities for key
equipment?
Do you have a documented risk assessment approach that determines the
extent of validation/qualification activities?
Are these validation and qualification activities documented in a plan?
Do you validate/qualify systems prior to implementation?
Do you validate/qualify systems after significant changes/upgrades?
Is the appropriate personnel producing and approving evidence of validation/
qualification and acceptance of processes or pieces of equipment?

Computer systems
Do you have detailed written descriptions of your computer systems (their
principles, objectives, security measures, scope, etc.)?
Is only authorized personnel able to enter or amend data in the computer
system?
Is all data physically and electronically secured against unauthorized access and
wilful/accidental damage?
Is data protected by regular backups?
Is backup data stored for at least 5 years at a separate, secure location?

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Good distribution practices checklist

Equipment
Are documents being stored for at least 5 years at a separate, secure location?
Are SOPs reviewed regularly and kept up to date?
Do the appropriate authorized people approve, sign and date the SOPs?
Is version control applied to SOPs?
Are superseded SOP versions archived?
Are you preventing the inadvertent use of these superseded SOPs?
Are superseded/obsolete SOPs removed from workstations?

Records
Are records kept for all transactions in medicinal products received, supplied or
brokered?
Do these records include the following information?
Date
Name of product
Quantity
Name and address of supplier/broker/consignee
Batch number
Do distribution records contain sufficient information on distributors and
customers directly supplied to?

Supplier qualification
Are all supplies of medicinal products obtained only from persons/organizations
who are in possession of a wholesale distribution authorisation, or
manufacturing authorisation for the product in question?
For medicinal products obtained from another wholesale distributor: is
compliance with the principles and guidelines of GDP of the supplying
wholesale distributor verified?

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Good distribution practices checklist

Is the purchase of medicinal products controlled by written procedures?

Is the supply chain of medicinal products known and documented?
Is appropriate qualification performed prior to any procurement?
Is qualification and approval of suppliers controlled by an SOP?
Are the results of qualification and approval of suppliers documented?
Are the results of qualification and approval of suppliers periodically rechecked?
For qualifying and approving new suppliers, are you using a risk-based approach
considering:
Searches for the new supplier’s reputation or reliability and its authorised
activities
Possible target of falsification
Large offers of medicinal product which are generally only available in
limited quantities
Out of range prices

Qualification of customers

Are medicinal products only supplied to persons/organizations who are

themselves in possession of a distribution authorisation or who are authorized
or entitled to supply medicinal products to the public?
Does qualification of customers and its periodic re-checks include:
Requesting copies of customer's authorisations
Verifying status on an authority website
Requesting evidence of qualifications or entitlement according to
national legislation
Is the qualification of customers appropriately documented?

Reception of goods
When receiving medicinal products from third countries for the purpose of
importation: is manufacturing/import authorisation in place?

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Good distribution practices checklist

Is it ensured that the arriving consignment is correct, the medicinal products

originate from approved suppliers and have not been damaged or altered during
transportation?
Are medicinal products which require special storage or security measures,
transferred to appropriate storage facilities immediately after appropriate
checks have been conducted?
Is a batch immediately segregated in the event of any suspicion of a falsified
medicinal product?
Is a batch immediately reported to the national competent authority in the event
of any suspicion of a falsified medicinal product?
Is a batch immediately reported to the marketing authorisation holder (where
applicable) in the event of any suspicion of a falsified medicinal product?
Are incoming containers of medicinal products cleaned, if necessary, before
storage?

Storage
Are medicinal products stored separately from other products?
Are medicinal products protected from harmful effects of light, temperature,
moisture or other external factors?
Is particular attention paid to products where specific storage conditions are
required?
Is stock rotation performed according to the expiry dates of batches of
medicinal products ("first expired first out" basis)?
Are medicinal products beyond their expiry date or shelf life withdrawn
immediately from saleable stock either physically or through other equivalent
electronic segregation?
Is physical removal of unsuitable stock performed regularly?
Are medicinal products not stored directly on the floor?
Are stock inventories performed regularly?
Are inventory irregularities investigated and documented?

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Good distribution practices checklist

Segregation of goods
Is segregation provided for the storage of rejected, expired, recalled or returned
products and suspected falsified medicinal products?
Do any systems replacing physical segregation (such as electronic segregation
based on a computerised system) provide equivalent security and are these
validated?

Destruction of obsolete goods

Are medicinal products intended to be destroyed kept separately and handled in
accordance with a written procedure?
Is destruction of medicinal products in accordance with national or international
requirements for disposal of such products?
Are records of all destroyed medicinal products maintained?

Picking and packaging

Are there controls in place to ensure the correct product is picked?
Do products have an appropriate remaining shelf life when picked?
Are products picked on a "first expired first out" (FEFO) basis?
Is packing adequate to maintain the storage conditions of the product during
transport?

Complaints
Is there a written procedure in place for the handling of complaints?
Are distinctions made between complaints about the quality of a medicinal
product and those relating to distribution?
Is there a person appointed for handling the complaints with sufficient
supporting personnel?

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Good distribution practices checklist

Are complaints concerning a potential product defect or a potential falsified

product recorded with all the original details and investigated?
Is the national competent authority notified without delay in case of a potential
product defect or a potential falsified product?
Are all product distribution complaints thoroughly investigated?
Are appropriate follow-up actions taken after investigation and evaluation of the
complaint?

Returned medicinal products

Are written procedures in place for the handling and acceptance of returned
medicinal products?
Are medicinal products which have left the distributor’s premises only returned
to saleable stock if:
The medicinal products are in their unopened and undamaged
secondary packaging and in good condition
Medicinal products returns from a customer not holding a wholesale
distribution are returned within five days of original dispatch
It’s demonstrated the medicinal products have been transported, stored
and handled under proper specified/predefined conditions
They have been examined and assessed by a sufficiently trained and
competent person authorised to do so
The distributor has reasonable evidence that the product was supplied
to that customer
The batch number of the dispatched product is known
A copy of the original delivery note is attached
There is no reason to believe that the product has been falsified
There is evidence that the product has been stored within the
authorised storage conditions throughout the entire time
Is a risk assessment performed taking into account the product concerned, any
specific storage requirements and the time elapsed since the medicinal product
was originally dispatched?

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Good distribution practices checklist

Are returned medicinal products kept segregated from saleable stock until a
decision is taken regarding their disposition?
Are products returned to saleable stock placed so the "first expired first out"
(FEFO) system operates effectively?
Are all handling of returned medicinal products including their return to saleable
stock or disposal approved by the Responsible Person and recorded?

Suspected falsified medicinal products

Are staff aware of the risks of falsified medicinal products entering the supply
chain?
Is there a procedure in place describing immediate information of the
competent authority and, where applicable, the marketing authorisation holder
of the medicinal products they identify as falsified or suspect to be falsified?
Are any suspected falsified medicinal products found in the supply chain
immediately physically and securely segregated from legitimate medicinal
products?
Are all relevant activities for this process recorded?

Medicinal product recalls

Are all relevant activities for this process recorded?
Is the management of recalls and its effectiveness periodically tested and
evaluated (Mock Recall)?
Are recall operations recorded at the time they are carried out?
Are the distribution records readily available to the person(s) responsible for the
recall?
Is the progress of a recall process recorded and a final report issued (including
reconciliation between the delivered and recovered quantities of the medicinal
products)?

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Good distribution practices checklist

Vehicles and equipment

Are required storage conditions maintained during transportation?
Are vehicles and equipment suitable and appropriately equipped to prevent
exposure of the products to conditions that could affect their quality and
packaging integrity, and to prevent contamination of any kind?
Are there procedures in place for the operation and maintenance of all vehicles
and equipment, including cleaning and safety precautions?
Is temperature mapping performed under representative conditions including
seasonal variations if refrigerated vehicles are used?
Is equipment used for temperature monitoring during transport within vehicles
and/or containers maintained and calibrated at regular intervals at least once a
year?
If cool-packs are used in insulated boxes, are they located so the product does
not come in direct contact with the cool-pack?
If cool-packs are used in insulated boxes, is staff trained on the procedures for
assembly of the insulated boxes (seasonal configurations) and on the reuse of
cool-packs?
Is the process for delivery of sensitive products and control of seasonal
temperature variations described in written procedures?
Do procedures cover management of unexpected occurrences such as vehicle
breakdown or non-delivery?
Is there a procedure in place for investigating and handling temperature
excursions?
Are there procedures in place to ensure the quality of the medicinal product will
not be compromised, where non-dedicated vehicles and equipment are used?

Deliveries
Are delivery drivers (including contract drivers) trained in the relevant areas of
GDP?

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Good distribution practices checklist

Are deliveries made directly to the address stated on the delivery note?
Are deliveries handed into the care of the consignee?
Are deliveries not left on alternative premises?

Transportation hubs
When using transportation hubs, has the maximum time limit for storage in
these locations been defined?
When using transportation hubs, are premises audited and approved prior to
deployment?
Is there a specification for transport hubs?
Is there a list of the transport hubs used by the transportation company?

Deviations
Are deviations reported to both the distributor and recipient?
In the case of deviations, is the manufacturer of the medicinal product
contacted for information about appropriate steps to be taken?

Containers, packaging and labelling

Are containers and packaging selected based on:
The storage and transportation requirements
The space required for the amount of medicines
The anticipated external temperature extremes
The estimated maximum time for transportation including transit storage
at customs
The validation status of the packaging and shipment containers
Are the containers in which medicinal products are shipped?

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Good distribution practices checklist

Is there a document enclosed to ascertain the following:

Date
Name and pharmaceutical form of the medicinal product
Batch number at least for products bearing the safety features, where
required
Quantity supplied
Name and address of the supplier
Name and delivery address of the consignee (actual physical storage
premises, if different)
Applicable transport and storage conditions
Do containers bear labels providing sufficient information on handling and
storage requirements and precautions?
Do containers bear labels enable identification?

Final notes on this GDP healthcare

checklist
The above checklist is relatively extensive, and will help you on your way to prepare for
GDP audits. However, do please refer to the official GDP guidelines set in your country, as
this checklist is not in any way intended to replace official guideline regulations.

That being said: using this checklist will be worth your time. Additionally, a lot of the
processes mentioned above can be automated with a solution like RmoniWeb.
Interested in hearing how that would work? Get in touch with us at info@rmoni.com.

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