Sterling International Consulting FZE

White Paper on GDP – Good Distribution Practices

Introduction

Distribution is an important activity in the integrated supply-chain management of pharmaceutical

products. Various people and entities are generally responsible for the handling, storage and
distribution of such products.

Various individuals and entities are generally responsible for

the handling, storage and distribution of such products. So
it’s very important to have adequate controls over the entire
chain of distribution. To maintain the original quality of
pharmaceutical products, every party involved in the
distribution chain has to comply with the applicable
requirement. Each activity in the distribution of
pharmaceutical products shall be carried out according to the
principles of Good Distribution Practices (GDP) as
applicable.

The nature of the risks involved is likely to be similar to that

for risks encountered in the manufacturing environment, e.g.
mix-ups, adulteration, contamination, cross-contamination,
spurious. Further, the involvement of unauthorized entities in
the distribution and sale of pharmaceutical products is a
particular concern.

Only a joint approach of all parties involved in the supply chain can be successful in the fight
against spurious/sub-standard pharmaceutical products. Therefore, all parties in supply chain shall
take an active part in collaborative activities to protect the pharmaceutical supply chain against the
penetration of spurious/substandard pharmaceutical products.

The objective of the GDP guideline is to assist in ensuring the quality and identity of pharmaceutical
products during all aspects of the distribution process. These aspects include, but are not limited
to, procurement, purchasing, storage, distribution, transportation, repackaging, re-labelling,
documentation and record-keeping practices.

GDP sets out appropriate steps to assist in fulfilling the responsibilities involved in the different
aspects of the distribution process within the supply chain and to avoid the introduction of
counterfeits into the marketplace via the distribution chain. It regulates the distribution of health
care products from the premises of the manufacture to the end user and is therefore part of the
entire quality assurance process. It ensures the that products are consistently stored , transported,
and handed under suitable conditions as required by the marketing authorization or product
specifications during all aspects of the distribution process.

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White Paper on GDP – Good Distribution Practices

Application of GDP

GDP extends to sourcing materials from approved suppliers and continues through manufacturing
(under GMP) and on to delivery of the product to the final customer or patient.

Hence these guidelines are intended to be applicable to all persons and outlets involved in any
aspect of the distribution of pharmaceutical products from the premises of the manufacturer of the
product to the person dispensing or providing pharmaceutical products directly to a patient or his
or her agent. This includes all parties involved in trade and distribution of medicines,
pharmaceutical manufacturers, including the manufacturers of finished products and
pharmaceutical wholesalers as well as other parties such as brokers, suppliers, distributors,
logistics providers, traders, transport companies and forwarding agents and their employees.

The relevant sections of these guidelines should also be considered for implementation by
governments, regulatory bodies, international procurement organizations, donor agencies and
certifying bodies, as well as all parties involved in any aspect of the trade and distribution of
pharmaceutical products, including health care workers. The guidelines can also be used as a tool
in the prevention of the distribution of counterfeit pharmaceutical products.

Level 6, Office 605 – The Fairmont, Sheikh Zayed Road, PO BOX 27363, Dubai, UAE
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White Paper on GDP – Good Distribution Practices

Benefits of GDP

Good Distribution Practices (GDP) is a quality system for warehouse and distribution
centers dedicated for medicines. Internationally accepted pharmaceutical GDP
regulations stipulate that distributors of pharmaceutical products must align their
operations with the standards.
Maintaining product safety and quality during distribution is of utmost importance in the
pharmaceutical industry. Good Distribution Practices (GDP) Certification for
Pharmaceuticals demonstrates your dedication to good distributive practices and quality
in every aspect of your service.

The scheme ensures that consistent quality management systems are in place
throughout your entire supply chain, from the early delivery of raw materials to the
manufacturing plants, to the final shipment of finished drugs to the end user. An
independent assessment of compliance against international GDP requirements is the
most effective way to establish that your quality management system aligns with GDP
guidance.

Good Distribution Practices mean:

 Compliant and consistent Supply Chain of Pharmaceutical products

 Reduced counterfeit risks
 Reduced transport and storage risks
 More safety for the final consumer

Level 6, Office 605 – The Fairmont, Sheikh Zayed Road, PO BOX 27363, Dubai, UAE
I 24 Hours Customer Care: +971 562014736 I Phone +971 4 455 8677 I Web: www.uaeiso.com I Email: kaushal@uaeiso.com I
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White Paper on GDP – Good Distribution Practices

Guidelines on Good Distribution Practice of Medicinal Products for Human Use

 Personnel

A management representative should be appointed in each distribution point, who should

have defined authority and responsibility for ensuring that a quality system is implemented
and maintained.

He should fulfil his responsibilities personally. This person should be appropriately qualified:
although a degree in Pharmacy is desirable, the qualification requirements may be
established by the Member State on whose territory the wholesaler is located.

 Documentation

All documentation should be made available on request of competent authorities.

 Orders

Orders from wholesalers should be addressed only to persons authorised to supply

medicinal products as wholesalers or holders of a manufacturing or importing authorisation

 Procedures

Written procedures should describe the different operations which may affect the quality of
the products or of the distribution activity: receipt and checking of deliveries, storage,
cleaning and maintenance of the premises (including pest control), recording of the storage
conditions, security of stocks on site and of consignments in transit, withdrawal from
saleable stock, records, including records of clients orders, returned products, recall plans,
etc. These procedures should be approved, signed and dated by the person responsible for
the quality system.

 Records

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.
They should be retained for a period of five years at least.

 Premises and equipment

Premises and equipment should be suitable and adequate to ensure proper conservation
and distribution of medicinal products. Monitoring devices should be calibrated.

 Receipt

Receiving bays should protect deliveries from bad weather during unloading. The reception
area should be separate from the storage area. Deliveries should be examined at receipt in
order to check that containers are not damaged and that the consignment corresponds to
the order.
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White Paper on GDP – Good Distribution Practices

Medicinal products subject to specific storage measures (e.g. narcotics, products requiring
a specific storage temperature) should be immediately identified and stored in accordance
with written instructions and with relevant legislative provisions.

 Storage

Medicinal products should normally be stored apart from other goods and under the
conditions specified by the manufacturer in order to avoid any deterioration by light, moisture
or temperature.

Temperature should be monitored and recorded periodically. Records of temperature

should be reviewed regularly.

Medicinal products with broken seals, damaged packaging, or suspected of possible

contamination should be withdrawn from saleable stock, and if not immediately destroyed,
they should be kept in a clearly separated area so that they cannot be sold in error or
contaminate other goods.

 Deliveries to customers

Deliveries should be made only to other authorised wholesalers or to persons authorised to

supply medicinal products to the public in the Member State concerned.

 Returns

Non-defective medicinal products which have been returned should be kept apart from
saleable stock to prevent redistribution until a decision has been reached regarding their
disposal.

Records of returns should be kept. The responsible person should formally release goods
to be returned to stock. Products returned to saleable stock should be placed such that the
"first in first out" system operates effectively.

 Emergency plan and recalls

An emergency plan for urgent recalls and a non-urgent recall procedure should be described
in writing. A person should be designated as responsible for execution and co-ordination of
recalls.

 Counterfeit medicinal products

Counterfeit medicinal products found in the distribution network should be kept apart from
other medicinal products to avoid any confusion. They should be clearly labelled as not for
sale and competent authorities and the holder of marketing authorisation of the original
product should be informed immediately
Level 6, Office 605 – The Fairmont, Sheikh Zayed Road, PO BOX 27363, Dubai, UAE
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White Paper on GDP – Good Distribution Practices

 Special provisions concerning products classified as not for sale

Any return, rejection, and recall operation and receipt of counterfeit products should be
recorded at the time it is carried out and records should be made available to the competent
authorities. In each case, a formal decision should be taken on the disposal of these
products and the decision should be documented and recorded. The person responsible for
the quality system of the wholesaler and, where relevant, the holder of the marketing
authorisation should be involved in the decision making process.

 Self inspections

Self-inspections should be conducted (and recorded) in order to monitor the implementation

of and compliance with this guideline.

 Provision of information to Member States in relation to wholesale activities

Wholesalers wishing to distribute or distributing medicinal products in Member State(s) other

than the Member State in which the authorisation was granted should make available on
request to the competent authorities of the other Member State(s) any information in relation
to the authorisation granted in the Member State of origin, namely the nature of the
wholesaling activity, the address of sites of storage and distribution point(s) and, if
appropriate, the area covered. Where appropriate, the competent authorities of this (these)
other Member State(s) will inform the wholesaler of any public service obligation imposed
on wholesalers operating on their territory.

Level 6, Office 605 – The Fairmont, Sheikh Zayed Road, PO BOX 27363, Dubai, UAE
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White Paper on GDP – Good Distribution Practices

Certification

Once the GDP requirements are in place and the organization is confident of having met all the
requirements, the external audit and certification process can be initiated. This process requires
multiple steps:

A site visit is conducted by the certification body to audit the company with respect to the
requirements of the standard. The audit includes interview, inspections of facilities and records.
The time requirement for a small company is as little as one day. Larger organizations can
expect the audit to be conducted within several days.

After the site visit, an audit report will be submitted to top-management including the results and
recommendations for improvements.

The last step is the issue of the certificate. The certificate is valid for three years. After conducting
the first audit and the certificate is issued, the certification body will conduct surveillance audits
on a regular basis (yearly follow-ups).

What We Offer?
With a team of highly qualified consultants and trainers having vast industrial experience,
Sterling International Consulting FZE partners organizations across the world to implement and
achieve GDP certification.

Our consulting approach is highly professional, time bound and effective resulting in ease of
implementation and adds value to the business processes of the client organization.

Contact us at kaushal@uaeiso.com to get your organization GDP certified.

Level 6, Office 605 – The Fairmont, Sheikh Zayed Road, PO BOX 27363, Dubai, UAE
I 24 Hours Customer Care: +971 562014736 I Phone +971 4 455 8677 I Web: www.uaeiso.com I Email: kaushal@uaeiso.com I
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