Checklist for Audit according to GDP for pharmaceutical products (WHO)

Guidance to auditor(s)
This document is intended to provide structured assistance to conduct an audit against WHO Good
distribution practices (GDP) for pharmaceutical products.
It contains key questions related to the main standard chapters. It shall not to be part of the audit report.
The checklist is to be used with a notebook to log any detailed entries that you can collect during the audit.
The answers Yes, No or N/A for not applicable be consistent with respect to questions that do not apply. An
asterisk and notebook page number should be entered on the checklist to identify where relevant comments,
observations or questions are recorded in the auditors notebook.

Item

Yes, No, or N/A

ORGANIZATION AND MANAGEMENT

Is the distributor authorized to perform its activities?
Is there a quality management system implemented?
Is the company certified ISO or others?
Are the responsibilities, authority and relationships in the organization defined?
Is the current organization adapted?
Is there for each distribution point a person with the responsibilities and authorities to
assure that the quality system is implemented and maintained?
Are the resources (technical and managerial) adapted to set up and to maintain quality
management system?
Does the scope of responsibilities of each individual generate any risk to product quality?
Are there arrangements in place to assure that there are no conflicts of interest?
Are the responsibilities of each person described in a job description?
Are the responsibilities of each person acknowledged and understood?
Are some activities outsourced or delegated?
If yes, is the contract or agreement documented and mentions the activities concerned?
Are there any periodic audits of those activities?
Are there procedures in place dealing with safety, property of the personnel, environmental
protection and product integrity?
PERSONNEL
Is there a written training program?
Do all people involved in distribution activities receive training about the requirements of
GDP?
Do the key people involved in distribution of pharmaceutical products have the ability and
experience corresponding to their responsibilities?
Are there an adequate number of competent personnel involved in all stages of the
distribution process?
Are the national regulations regarding the qualification and experience of personnel
followed?
Is there a job description for the personnel including temporary employees?
Did employees receive an initial training and continued training for their assignments
tasks?

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Item
Is the effectiveness of the training assessed?
Is there a specific training for the personnel dealing with hazardous pharmaceutical
products (narcotics, radioactive products)?
Are there records relating to training available for each employee, including temporary
employee?
Are employees training and qualification records kept?
Is there a procedure for training, addressing both permanent and temporary employees?
Are there procedures in place ensuring a good hygiene of personnel?
Are personnel involved in hazardous products wearing a suitable garment?
Is there a first-aid procedure and equipment available for dealing with emergencies for
personnel?
Are there procedures in place to minimize the access to the pharmaceutical products by
unauthorised person?
Is there a disciplinary procedure to prevent or to address situations where persons
involved in the distribution of pharmaceutical products are suspected?
QUALITY MANAGEMENT
Is there a quality management system in place?
Is there a documented quality policy describing the intentions of the distributor in terms of
quality?
Does the quality management include infrastructure, procedures, processes and
resources?
Are the QA organizations authorities and responsibilities clearly defined in writing?
Does the quality system cover the main principles of quality assurance described in WHO
guidelines?
Are the responsibilities of quality and safety shared with all parties involved in the
distribution of pharmaceutical products?
In case of e-commerce, are there procedures and adequate systems to assure the
traceability?
Is there a written procedure and records to assure the traceability of the product
distributed throughout the supply chain?
Are there authorized procedures for all administrative and technical operations performed?
PREMISES, WAREHOUSING AND STORAGE
Is there an adequate security to prevent unauthorized persons from entering storage
areas?
Is the storage capacity large enough to allow an orderly storage of the various categories
products (bulk, finished products, product in quarantine, released, rejected, returned,
recall products)?
Is the storage area designed and adapted to ensure good storage conditions?
Are facilities (including pallets) maintained in a clean, dry and orderly manner and in a
good state of repair?
Are the special conditions of storage provided, checked, monitored and recorded?
Are the products stored off the floor and is there a suitably space to permit cleaning and
inspection?

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Item
Is there a written sanitation program indicating the frequency of cleaning and the method
to clean the premises and storage areas?
Is there an adequate and written pest control program?
Are the pest control agents used safe for the materials and the pharmaceutical products?
Are there appropriate procedures for the clean up of any spillage to ensure any risk of
contamination?
Are the receiving and dispatching bays able to protect products from the weather?
Is the reception area equipped to allow the cleaning of the containers before storage?
Is the quarantine area clearly designed and its access restricted to authorized personnel?
If a computerized system is used to replace physical quarantine, is the system validated to
demonstrate security of the access?
Does the sampling in the storage area performed to prevent any cross- contamination?
Is there an adequate procedure for cleaning of the sampling areas?
Is there a physical and identified segregation (or equivalent) for the storage of rejected,
expired, recalled and returned products?
Are hazardous products, narcotics, radioactive products or products presenting a special
risk stored in a dedicated area?
Is there additional safety and security measure for hazardous products, narcotics?
Are the pharmaceutical products handled and stored to prevent cross-contamination?
Are the products handled and distributed to prevent contamination, mix-up and crosscontamination?
Is the principle of FIFO and FEFO applied?
Are the rejected products identified and stored in quarantine areas until a final decision is
taken?
Are the international conventions, national law and regulations applied for the storage of
narcotics?
Are broken and damaged products eliminated from the usable and separate stock?
Is the lighting adequate to allow operations in safety conditions?
Are the storage conditions in compliance with the information on the label?
Are the records of the temperature monitoring data available?
Is the equipment used for the temperature monitoring checked at suitable predetermined
intervals?
Are the monitoring records kept for at least the shelf life of the product + 1 year or as
nationally required?
Is the temperature uniform in the storage facilities?
Is the equipment used for temperature monitoring calibrated at defined intervals?
Are there records for each delivery including the description of the products, quality,
quantity, supplier, and suppliers batch number, date of the receipt, assigned batch number
and expiry date?
Are these records kept according to national regulations or at least the shelf life of the
product + 1 year?
Are there written instructions describing the system of storage and the route of the
products?
Are permanent written or electronic information available indicating the conditions of
storage, precautions to be observed and retest dates?
Are pharmacopoeial requirements and current national regulations concerning labels
respected?

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Item
Is there a procedure in place for :
- Temperature mapping?
- Security at the warehouse?
- Destruction of unsalable stocks?
- Retention of records?
Is a periodic stock reconciliation performed (actual v/s recorded)?
In case of significant discrepancies, is there an investigation to check eventual mix-up?
Are the containers physically verified?
Are the incoming deliveries checked against the relevant purchase order?
VEHICLES AND EQUIPMENT
Are the vehicles and equipment suitable for their use?
Are the vehicles and equipment suitable protection to prevent exposure of the products to
conditions that could affect their stability and packaging integrity?
Do the design of the equipment and the vehicle allow an effective cleaning and
maintenance?
Are there dedicated vehicles or equipment to handle pharmaceutical products?
If the vehicle or equipment is not dedicated, is there a procedure to prevent negative
impact on the pharmaceutical products?
Is defective equipment or vehicles removed and labeled?
Are there procedures for operations and maintenance of equipment and vehicles?
Is there a procedure for the cleaning and safety?
Are the vehicles, containers and equipment kept clean, dry and free from accumulated
waste?
Is there a written cleaning procedure (methods, frequency)?
Are vehicles, containers and equipment kept free from pests (birds, rodents, vermin)?
Is there a written program for pest control?
Is a study performed to check that cleaning and fumigation have no impact on the product
quality?
Is special attention given to the design, cleaning and maintenance of equipment used for
the handling of products without protective shipping carton?
Are the special storage conditions during the transit provided, checked, monitored and
recorded?
Are the monitoring records kept for at least the shelf life of the product + 1 year or as
nationally required?
Are the monitoring data reviewed at the receipt of the product to ensure that required
storage conditions have been maintained during the transport?
Is the equipment used for monitoring calibrated?
Is there enough equipment to perform all the required operations within the required time
frames?
Is there segregation for the rejected, recalled and returned products during the transit?
Are the products safely packaged, correctly labeled and accompanied by appropriate
supporting documentation?

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Is there a system in place to prevent unauthorized persons from entering or tampering with
vehicles and equipment and to prevent the theft?
CONTAINERS AND CONTAINERS LABELING
Are the pharmaceutical products stored and distributed in adequate containers (no
interaction, no contamination)?
Are the labels applied on the containers clear, unambiguous, indelible and well fixed on
the containers?
Does the information in the label comply with applicable national legislation?
Are the labels written in a language understood by all people involved in the distribution
chain?
Is all information relating to the handling, storage, precautions indicated on the label?
Are special transport and storage conditions including safety symbols stated in the label?
Are only international or national codes used on the label of containers when in use?
Are all the precautions taken to prevent contact with dry ice when in use?
Is there a procedure in place for the handling of damaged or broken containers and
especially for hazardous and toxic products?
DISPATCH
Are the products sold or distributed only to persons entitled to acquire these products
according to national, regional or international legislation?
Is there a document to prove the authorities of persons or entities entitled to acquire these
products?
Is the delivery order validated before the beginning of the dispatch or the transport?
Are there written procedures for the dispatch taking into account the nature of the product
and the specific precautions to be observed?
Does the record for the dispatch include :
- The date of the dispatch?
- The name and the address and the status of the addressee (hospital, clinic)?
- The name, dosage, form and strength?
- The quantity of the products: number of containers and number of products per
container?
- Assigned batch number and expiry date?
- Condition of transport and storage?
- The identification of delivery order?
Is there enough information about traceability in the record to facilitate the recall of the
product if necessary?
Does the selection of vehicles take into account the local conditions (climate, seasonal
variations)?
Is there a schedule and a route planning which are realistic and systematic?
Is the principle first-out/last-in applicable for the load?
Is some delivery of pharmaceutical products performed after or close to the expiry date?
TRANSPORTATION AND PRODUCTS IN TRANSIT

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Do the entities responsible for the transportation receive the relevant conditions for storage
and transportation?
Are there procedures in place to prevent damage during the transportation and the
storage: lost, mix-up or cross-contamination, spillage, breakage, theft?
Are appropriate temperature and relative humidity conditions maintained during the storage
and the transportation, if necessary?
Are there written procedure to fix acceptable limits and acceptable period of exceeded time
for storage conditions?
Are the special conditions required for the transportation provided, monitored and
recorded?
Is there a written procedure in place describing investigations and actions for deviation of
storage conditions?
Are dangerous, toxics and narcotic products stored and transported in safe conditions?
Are the national or international requirements followed?
Is there a written procedure in place to prevent contaminations when spillage occurs?
Is there a physical or equivalent segregation for the storage and the distribution during the
transit of rejected, expired, recalled and returned products?
Are these products correctly identified, securely packaged, clearly labeled and
accompanied by an appropriate document?
Are the interiors of the vehicles and containers maintained clean during the transit?
Are the packaging materials and transportation containers suitable to prevent damage
during the transport?
Is there a sufficient security system in place to prevent any misappropriation of
pharmaceutical products?
Are international requirements regarding safety, health and environmental aspects
followed?
Is procedure in place to manage damage or other event during the transit (investigation,
record, and report to relevant authority)?
Is batch tracking system used during the transportation?
Is appropriate documentation accompanying the products during the transit?
DOCUMENTATION
Are written instructions or records available to document all activities relating to the
distribution process?
Is the internal and external documentation relating to distribution process correctly
designed, completed, reviewed, approved and distributed?
Are all documents clear and unambiguous?
Are all documents completed, approved, dated and signed by appropriate authorized
persons?
Are the persons authorized to update the documentation defined?
Is the retention system for documentation in compliance with national legislative
requirements?
Without specific requirements, are the documents retained for a period equal to the shelflife + 1 year?

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Is there a procedure to manage the identification, collection, indexing, retrieval, storage,
maintenance, disposal and access of the documentation?
Is there in place a suitable environment to prevent modification, damage, deterioration or
loss of the documentation and records?
Is the documentation regularly reviewed?
Is there a system in place to prevent inadvertent use of superseded versions of
documents?
Is there a system in place to allow the transfer of information including quality and
regulatory information between the manufacturer and the customer and regulatory
authority as required?
Are the records of investigations or actions concerning temperature-sensitive products
retained for at least 1 year after the expiry date of the product?
For records in electronic form, are the back ups available to prevent any accidental data
loss?
REPACKAGING AND RELABELLING
Does the distributor perform repackaging or labelling?
If yes, does the distributor have the relevant authorization or the licence?
Is the repackaging or relabeling performed under an appropriate environment to prevent
any risk of contamination or cross-contamination?
COMPLAINTS
Is there a written procedure to handle orally or in writing complaints?
Is there a written procedure to describe the action taken for all information concerning a
potentially defective or counterfeit pharmaceutical product?
Is each complaint investigated and documented according to a written procedure?
In the case of a defect is observed on a pharmaceutical product, are others batches
checked?
Are the follow-up actions taken after the investigation and the evaluation of the complaint?
Are all complaints retained to evaluate trends, frequencies to take additional and
immediate corrective actions if appropriate?
RECALLS
Is there a written procedure describing the system in place to recall promptly and
effectively defective pharmaceutical products?
Is this procedure regularly checked and updated?
Is the manufacturer holder systematically informed in the event of a recall?
Is the effectiveness of the arrangements for recalls evaluated at regular intervals?
Are the recalled products stored in a secure and segregated area?
Are the recalled products segregated and clearly labelled during transit?
Are the storage conditions applicable to the pharmaceutical product maintained during
storage and transit before a final decision concerning the product is taken?
Are all customers and competent authorities informed of the intention to recall a product?
Are the records available for each recall including the name of the product, the address,
the batch number, the quantity recalled and the reason?

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Does the final report of the recall include the reconciliation between delivered and
recovered quantities of products?
REJECTED AND RETURNED PRODUCTS
Is there a procedure to handle the rejected and returned products?
Is there a physical segregation of these products in a dedicated area?
Are the storage conditions applicable to the pharmaceutical product maintained during the
storage and the transit before a final decision concerning the product?
Are the nature of the product, the conditions of the storage, its history and the time elapsed
since it was issued taken in account in the final decision concerning the product?
Is the person in charge of the rejected and returned product clearly defined?
Are all requirements and relevant storage taken into account for the transport of returned
products?
Are the products destroyed according to national, international, local requirements and with
due consideration to the protection of environment?
Are all returned, rejected and destroyed records kept?
COUNTERFEIT PHARMACEUTICAL PRODUCTS
Are any counterfeit or suspected counterfeit segregated and recorded immediately?
Are the relevant authorities informed immediately?
Are the products clearly labelled to prevent distribution or sale?
Is the decision about the counterfeit product recorded?
IMPORTATION
At the point of entry, are the best equipment and the most appropriate located to handle
imports of pharmaceutical products chosen?
Are the pharmaceutical products stored under suitable conditions at the port of entry?
Is a system in place to ensure that the product s are nor mishandled or exposed to adverse
storage conditions at wharves or airports?
CONTRACT ACTIVITIES
Is a written contract signed between the contract giver and the contract acceptor?
Is the contract defining the responsibilities of each party and observance of the principle of
GDP?
Do the contract givers approve all the changes before their application?
Is subcontracting existed?
If yes, are the conditions of subcontracting approved by the contract giver?
Is the contract acceptor periodically audited?
SELF-INSPECTION
Does the quality assurance system include self inspection?
Are self-inspections conducted by independent, designated and competent person?

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Are the self-inspections recorded?
Are the reports including proposals for corrective measures if necessary?
Is there a program of self-inspection?
Are the reports of self-inspection evaluated by the management and corrective actions
taken?

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