GOOD STORAGE AND DISTRIBUTION PRACTICE (GS&DP) GUIDELINE

AUDIT CRITERIA AUDIT COMMENTS STATUS

1. Quality risk management

1.1 There should be a system to assess, control, communicate and
review risks identified at all stages in the supply chain.
1.2 The evaluation of risk should be based on scientific knowledge
and experience and ultimately be linked to the protection of the
patient.
1.3 Appropriate controls should be developed and implemented to
address all risks. The effectiveness of the controls implemented
should be evaluated at periodic intervals.
2. Management review
2.1 There should be a system for periodic management review. The
review should include at least: senior management; review of the
quality system and its effectiveness by using quality metrics and key
performance indicators; identification of opportunities for continual
improvement; and follow-up on recommendations from previous
management review meetings.
2.2 Minutes and related documentation from management review
meetings should be available.
3. Complaints
3.1 There should be a written procedure for the handling of
complaints. In the case of a complaint about the quality of a medical
product or its packaging, the original manufacturer and/or marketing
authorization holder should be informed as soon as possible.
3.2 All complaints should be recorded and appropriately investigated.
The root cause should be Identified, and the impact (e.g. on other
batches or products) risk-assessed. Appropriate CAPAs should be
taken.
3.3 Where required, the information should be shared with the NRA
and a recall initiated where appropriate.
3.4 A distinction should be made between complaints about a medical
product or its packaging and those relating to distribution.
3.5 The relevant information, such as the results of the investigation of
the complaint, should be shared with the relevant entities.

3.6 Medical product quality problems and suspected cases of

substandard or falsified products identified should be handled
according to relevant authorized procedures. The information should
be shared with the manufacturer and appropriate national and/or
regional regulatory authorities, without delay.

4. Returned goods
4.1 Returned medical products should be handled in accordance with
authorized procedures.
4.2 All returned medical products should be placed in quarantine upon
receipt. The status of the goods should be clear. Precautions should
be taken to prevent access and distribution until a decision has been
taken with regard to their disposition. The particular storage conditions
applicable to the medical products should be maintained until their
disposition.

4.3 Medical products returned should be destroyed unless it is certain

that their quality is satisfactory, after they have been critically
assessed in accordance with a written and authorized procedure.

4.4 The nature of the medical product, any special storage conditions
it requires, its condition and history and the time lapse since it was
issued, should all be taken into account in this assessment. Where
any doubt arises over the quality of the medical product, it should not
be considered suitable for reissue or reuse. Any action taken should
be appropriately recorded.

4.5 When handling returned goods, the following considerations at

least should be taken: a risk-based process should be followed when
deciding on the fate of the returned goods. This should include, but
not be limited to, the nature of the product, storage conditions,
condition of the product history, time-lapse since distribution and the
manner and condition of transport while being returned; the terms and
conditions of the agreement between the parties; and examination of
the returned goods, with decisions taken by suitably qualified,
experienced and authorized persons.
4.6 Where products are rejected, authorized procedures should be
followed, including safe transport.
4.7 Destruction of products should be done in accordance with
international, national and local requirements regarding disposal of
such products, and with due consideration to the protection of the
environment.
4.8 Records of all returned, rejected and destroyed medical products
should be kept for a defined period, in accordance with national
requirements.
5. Recalls
5.1 There should be a written procedure, in compliance with national
or regional requirements, to effectively and promptly recall medical
products.
5.2 The effectiveness of the procedure should be checked annually
and updated as necessary.
5.3 The original manufacturer and/or marketing authorization holder,
or other relevant contract party, should be informed in the event of a
recall.
5.4 Information on a recall should be shared with the appropriate
national or regional regulatory authority.
5.5 All recalled products should be secure, segregated, transported
and stored under appropriate conditions. These should be clearly
labelled as recalled products. The particular storage conditions
applicable to the product should be maintained where possible.
5.6 All customers and competent authorities of all countries to which a
given medical product may have been distributed should be informed
promptly of the recall of the product.

5.7 All records, including distribution records, should be readily

accessible to the designated person(s) responsible for recalls. These
records should contain sufficient information on products supplied to
customers (e.g. name, address, contact detail, batch numbers,
quantities and safety features – including exported products).

5.8 The progress of a recall process should be recorded and a final

report issued, which includes a reconciliation between delivered and
recovered quantities of medical products.
6. Self-inspection
6.1 The quality system should include self-inspections. These should
be conducted to monitor the implementation, compliance with and
effectiveness of SOPs, as well as compliance with regulations, GSP,
GDP and other appropriate guidelines.
6.2 Self-inspections should be conducted periodically, according to an
annual schedule.
6.3 The team conducting the inspection should be free from bias and
individual members should have appropriate knowledge and
experience.
6.4 The results of all self-inspections should be recorded. Reports
should contain all observations made during the inspection and
presented to the relevant personnel and management.
6.5 Necessary CAPAs should be taken and their effectiveness should
be reviewed within a defined timeframe.
7. Premises
General
7.1 Premises should be suitably located, designed, constructed and
maintained, to ensure appropriate operations such as receiving,
storage, picking, packing and dispatch of medical products. Comply
7.2 There should be sufficient space, lighting and ventilation to ensure
required segregation, appropriate storage conditions and cleanliness.
Comply
7.3 Sufficient security should be provided and access should be
controlled. Comply
7.4 Appropriate controls and segregation should be provided for
products requiring specific handling or storage conditions, such as
radioactive materials, products containing hazardous substances and
products to be stored under controlled temperature and relative
humidity conditions.
7.5 Where possible, receiving and dispatch bays should be separate,
to avoid mix-ups. Bays should protect products from weather
conditions.
7.6 Activities relating to receiving and dispatch should be done in
accordance with authorized procedures. Areas should be suitably
equipped for the operations.
7.7 Premises should be kept clean. Cleaning equipment and cleaning
agents should not become possible sources of contamination.

7.8 Premises should be protected from the entry of birds, rodents,

insects and other animals. A rodent and pest control programme
should be in place.
7.9 Toilets, washing, rest and canteen facilities should be separate
from areas where products are handled. Food, eating, drinking and
smoking should be prohibited in all areas where medical products are
stored or handled.
8. Receiving area
8.1 Each incoming delivery should be checked against the relevant
documentation, to ensure that the correct product is delivered from
the correct supplier. This may include, for example, the purchase
order, containers, label description, batch number, expiry date,
product and quantity.
8.2 The consignment should be examined for uniformity of the
containers and, if necessary, should be subdivided according to the
supplier’s batch number should the delivery comprise more than one
batch. Each batch should be dealt with separately.
8.3 Each consignment should be carefully checked for possible
contamination, tampering and damage. A representative number of
containers in a consignment should be sampled and checked
according to a written procedure. Any suspect containers or, if
necessary, the entire delivery, should be quarantined for further
investigation.
8.4 Receiving areas should be of sufficient size to allow the cleaning
of incoming medical products.
8.5 When required, samples of medical products should be taken by
appropriately trained and qualified personnel and in strict accordance
with a written sampling procedure and sampling plans. Containers
from which samples have been taken should be labelled accordingly.

8.6 Following sampling, the goods should be subject to quarantine.

Batch segregation should be maintained during quarantine and all
subsequent storage.
8.7 Materials and products requiring transport and storage under
controlled conditions of temperature and relative humidity, as
applicable, should be handled as a priority. The transportation
temperature data, where appropriate, should be reviewed upon
receipt, to ensure that the required conditions had been maintained.
Where applicable, cold-chain materials and products should be
handled according to the approved conditions by the authority, or as
recommended by the manufacturer, as appropriate.

8.8 Medical products should not be transferred to saleable stock until

an authorized release is obtained.
8.9 Measures should be taken to ensure that rejected medical
products cannot be used. They should be segregated and securely
stored while awaiting destruction or return to the supplier.
9. Storage areas
9.1 Precautions should be taken to prevent unauthorized persons
from entering storage areas.
9.2 Storage areas should be of sufficient capacity to allow orderly
storage of the various categories of medical products.
9.3 Storage areas should be appropriately designed, constructed,
maintained or adapted. They should be kept clean and there should
be sufficient space and lighting.
9.4 Storage areas should be maintained within acceptable and
specified temperature limits. Where the labels show special storage
conditions are required (e.g. temperature, relative humidity), these
should be provided, controlled, monitored and recorded.
9.5 Materials and medical products should be stored off the floor,
away from walls and ceilings, protected from direct sunlight and
suitably spaced, to permit ventilation, cleaning and inspection.
Suitable pallets should be used and kept in a good state of cleanliness
and repair.
9.6 A written sanitation programme should be available, indicating the
frequency of cleaning and the methods to be used to clean the
premises and storage areas.
9.7 There should be appropriate procedures for the clean-up of any
spillage, to ensure complete removal of any risk of contamination.
9.8 Where the status is ensured by storage in separate areas, these
areas should be clearly marked and their access restricted to
authorized personnel. Any system replacing physical separation and
labelling or demarcation should provide equivalent security. For
example, computerized systems can be used, provided that they are
validated to demonstrate security of access.
9.9 Sampling should be done under controlled conditions and
conducted in such a way that there is no risk of contamination or
cross-contamination. Adequate cleaning procedures should be
followed after sampling.
9.10 Certain materials and products, such as highly active and
radioactive materials, narcotics and other hazardous, sensitive and/or
dangerous materials and products, as well as substances presenting
special risks of abuse, fire or explosion (e.g. combustible liquids and
solids and pressurized gases), should be stored in a dedicated area
that is subject to appropriate additional safety and security measures,
and in accordance with national legislation.

9.11Materials and medical products should be handled and stored in

such a manner as to prevent contamination, mix-ups and cross-
contamination.
9.12 Materials and medical products should be stored in conditions
that assure that their quality is maintained. Stock should be
appropriately rotated. The “first expired/first out” (FEFO) principle
should be followed.
9.13 Narcotic medical products should be stored in compliance with
international conventions, national laws and regulations on narcotics.

9.14 Broken or damaged items should be withdrawn from usable

stock and separated.
9.15 There should be a written procedure for fire control, including
prevention of fire, fire detection and fire drills. Fire-detection and
firefighting equipment should be available and should be serviced
regularly.
10. Storage conditions
10.1The storage conditions for medical products should be in
compliance with their labelling and information provided by the
manufacturer.
10.2 Heating, ventilation and air conditioning systems should be
appropriately designed, installed, qualified and maintained, to ensure
that the required storage conditions are upheld (9).
10.3 Mapping studies for temperature, and relative humidity where
appropriate, should be done, for example in storage areas,
refrigerators and freezers (10).
10.4 Temperature and relative humidity, as appropriate, should be
controlled and monitored at regular intervals. Data should be recorded
and the records should be reviewed. The equipment used for
monitoring should be calibrated and be suitable for its intended use.
All records pertaining to mapping and monitoring should be kept for a
suitable period of time and as required by national legislation.
11. Stock control and rotation
11.1 Records of stock levels for all medical products in store should
be maintained, in either paper or electronic format. These records
should be updated after each operation (e.g. entries, issues, losses,
adjustments). These records should be kept for a suitable period of
time and as required by national legislation. Periodic stock
reconciliation should be performed at defined intervals, by comparing
the actual and recorded stock.

11.2 The root cause for stock discrepancies should be identified and
appropriate CAPAs taken to prevent recurrence.
11.3 When damaged containers are received, this should be brought
to the attention of the person responsible for quality. Any action taken
should be documented. (These containers should not be issued
unless the quality of the medical products has been shown to be
unaffected.)
11.4 All stock should be checked at regular intervals, to identify those
items that are close to their retest or expiry date. Appropriate action
should be taken, such as removal of these items from useable stock.

12. Equipment
12.1 Equipment, including computerized systems, should be suitable
for its intended use. All equipment should be appropriately designed,
located, installed, qualified and maintained.
12.2 Computerized systems should be capable of achieving the
desired output and results.
12.3 Where electronic commerce (e-commerce) is used, i.e. electronic
means for any of the steps, defined procedures and adequate
systems should be in place to ensure traceability and confidence in
the supply chain and products concerned.
12.4 Electronic transactions (including those conducted via the
Internet) relating to the distribution of medical products should be
performed only by authorized persons, according to defined and
authorized access and privileges.
12.5 Where GXP systems are used, these should meet the
requirements of WHO or other appropriate guidelines on
computerized systems (8, 11).
13. Qualification and validation
13.1 The scope and extent of qualification, and validation where
appropriate, should be determined using documented risk
management principles.
13.2 Premises, utilities, equipment and instruments, processes and
procedures should be considered.
13.3 Qualification and validation should be done following procedures
and protocols. The results and outcome of the qualification and
validation should be recorded in reports. Deviations should be
investigated and the completion of the qualification and validation
should be concluded and approved.

14. Personnel
14.1 There should be an adequate number of personnel.
14.2 Personnel should have appropriate educational qualification,
experience and training relative to the activities undertaken.
14.3 A designated person within the organization, with appropriate
qualification and training, should have the defined authority and
responsibility for ensuring that a quality management system is
implemented and maintained. This person should preferably be
independent from the person responsible for operations and should
ensure compliance with GSP and GDP.
14.4. Personnel should have the authority and resources needed to
carry out their duties and to follow the quality systems, as well as to
identify and correct deviations from the established procedures.
14.5 There should be arrangements in place to ensure that
management and personnel are not subjected to commercial, political,
financial or other pressures or conflict of interest that may have an
adverse effect on the quality of service provided or on the integrity of
medical products.
14.6 Safety procedures should be in place relating to all relevant
personnel and property, environmental protection and product
integrity.
14.7 Personnel should receive initial and continued training in
accordance with a written training programme. The training should
cover the requirements of GSP and GDP ( as applicable), as well as
on-the-job training. Other topics should be included, such as product
security, product identification and the detection of falsified products.
14.8 Personnel dealing with hazardous products (such as highly
active materials, radioactive materials, narcotics and other hazardous,
environmentally sensitive and/or dangerous pharmaceutical products,
as well as products presenting special risks of abuse, fire or
explosion) should be given specific training.
14.9 Personnel should be trained in, and observe high levels of,
personal hygiene and sanitation.
14.10 Records of all training, attendance and assessments should be
kept.
14.11 Personnel handling products should wear garments suitable for
the activities that they perform. Personnel dealing with hazardous
pharmaceutical products, including products containing materials that
are highly active, toxic, infectious or sensitizing, should be provided
with protective garments as necessary.
14.12 Appropriate procedures relating to personnel hygiene, relevant
to the activities to be carried out, should be established and observed.
Such procedures should cover health, hygiene and the clothing of
personnel.
14.13 Procedures and conditions of employment for employees,
including contract and temporary staff, and other personnel having
access to medical products, must be designed and implemented to
assist in minimizing the possibility of such products coming into the
possession of unauthorized persons or entities.
14.14 Codes of practice and procedures should be in place to prevent
and address situations where persons involved in the storage and
distribution of medical products are suspected of, or found to be
implicated in, any activities relating to the misappropriation, tampering,
diversion or falsification of any product.

15. Documentation
15.1 Documentation includes all procedures, records and data,
whether in paper or electronic form. Documents should be
appropriately designed, completed, reviewed, authorized, distributed
and kept as required. Documents should be readily available.

15.2 Written procedures should be followed for the preparation,

review, approval, use of and control of all documents relating to the
policies and activities for the process of storage and distribution of
medical products.
15.3 Documents should be laid out in an orderly fashion and be easy
to complete, review and check. The title, scope, objective and purpose
of each document should be clear.
15.4 All documents should be completed, signed and dated as
required by authorized person(s) and should not be changed without
the necessary authorization.
15.5 Documentation should be prepared and maintained in
accordance with the national legislation and principles of good
documentation practices (11).
15.6 Records should be accurate, legible, traceable, attributable and
unambiguous. Electronic data should be backed-up in accordance
with written procedures. Records should be maintained for the back-
up and restoration of data.
15.7 Procedures for the identification, collection, indexing, retrieval,
storage, maintenance, disposal of and access to all applicable
documentation should be followed.
15.8 Documents should be reviewed regularly and kept up-to-date.
When a document has been revised, a system should exist to prevent
inadvertent use of the superseded version.
15.9 All records should be stored and retained using facilities that
prevent unauthorized access, modification, damage, deterioration
and/or loss of documentation during the entire life-cycle of the record.
Records must be readily retrievable.
15.10 Comprehensive records should be maintained for all receipts,
storage, issues and distribution. The records should include, for
example: date (e.g. receipt or dispatch, as appropriate); name and
description of the product; quantity received, or supplied; name and
address of the supplier and customer; batch number(s); expiry date;
15.11 All containers should be clearly labelled with at least the name
of the medical product, batch number, expiry date or retest date, and
the specified storage conditions.
16. Activities and operations
16.1 All activities and operations should be conducted in accordance
with national legislation, GSP, GDP and associated guidelines.

16.2 Storage and distribution of medical products should be done by

persons authorized to do so, in accordance with national legislation.

16.3 Activities and operations should be performed in accordance with

documented procedures.
16.4 Automated storage and retrieval systems and operations should
comply with current GSP, GDP and GXP guidelines, as well as the
recommendations in this guideline.
17. Receipt
17.1 Medical products should be procured from appropriately
authorized suppliers.
17.2 Deliveries should be examined for damage, seal intactness,
signs of tampering, labelling, completeness of order and other related
aspects (e.g. availability of a certificate of analysis, where applicable),
at the time of receiving.
17.3 Containers and consignments that do not meet acceptance
criteria at the time of receipt should be labelled, kept separate and
investigated. This includes suspected falsified products.
18. Storage
18.1 Medical products requiring specific storage conditions, or
controlled access (e.g. narcotics), should be processed without delay
and stored in accordance with their requirements.
18.2 Appropriate controls should be implemented to prevent
contamination and/or mix-ups during storage.
18.3 Controls and procedures should be in place to prevent and
handle spillage and breakage.
19. Repackaging and relabelling
19.1 Repackaging and relabelling of materials and products are not
recommended. Where repackaging and relabelling occur, these
activities should only be performed by entities appropriately
authorized to do so and in compliance with the applicable national,
regional and international requirements, and in accordance with GMP.

19.2 Procedures should be in place for the controlled disposal of

original packaging, to prevent re-use thereof.
20. Distribution and transport
20.1 Medical products should be transported in accordance with the
conditions stated on the labels and described by the manufacturer.
The risk to the quality of the medical product during transport and
distribution should be eliminated or minimized to an acceptable level.

20.2 Product, batch and container identity should be maintained at all

times.
20.3 All labels should remain legible.
20.4 Distribution records should be sufficiently detailed to allow for a
recall when required.
20.5 Drivers of vehicles should be identified and present appropriate
documentation to demonstrate that they are authorized to transport
medical products.
20.6 Vehicles should be suitable for their purpose, with sufficient
space and appropriately equipped to protect medical products.
20.7 The design and use of vehicles and equipment must aim to
minimize the risk of errors and permit effective cleaning and/or
maintenance, to avoid contamination, build-up of dust or dirt and/or
any adverse effect on the quality of the products.
20.8 Where feasible, consideration should be given to adding
technology, such as global positioning system (GPS) electronic
tracking devices and engine-kill buttons to vehicles, which would
enhance the security and traceability of vehicles with products.
20.9 Where possible, dedicated vehicles and equipment should be
used for medical products. Where non-dedicated vehicles and
equipment are used, procedures should be in place to ensure that the
quality of the products will not be compromised. Defective vehicles
and equipment should not be used. These should either be labelled as
such or removed from service.
20.10 There should be procedures in place for the operation and
maintenance of all vehicles and equipment.
20.11 Equipment and materials used for the cleaning of vehicles
should not become a source of contamination or have an adverse
effect on product quality.
20.11 Vehicles used for transportation of medical products should be
qualified, where applicable, to demonstrate their capability to maintain
the required transport conditions. There should be a maintenance
programme for the cooling/heating system.
20.12 Appropriate environmental conditions should be maintained,
monitored and recorded. All monitoring records should be kept for a
defined period of time, as required by national legislation. Records of
monitoring data should be made available for inspection by the
regulatory or other oversight body.
20.13 Instruments used for monitoring conditions, for example,
temperature and humidity, within vehicles and containers should be
calibrated at regular intervals.
20.14 Rejected, recalled and returned products, as well as those
suspected as being falsified, should be securely packaged, clearly
labelled and accompanied by the appropriate supporting
documentation.
20.15 Measures should be in place to prevent unauthorized persons
from entering and/or tampering with vehicles and/or equipment, as
well as to prevent the theft or misappropriation thereof.

20.16 Shipment containers should have no adverse effect on the

quality of the medical products and should offer adequate protection
to materials and these products. Containers should be labelled
indicating, for example, handling and storage conditions, precautions,
contents and source, and safety symbols, as appropriate.

20.17 Special care should be taken when using dry ice and liquid
nitrogen in shipment containers, owing to safety issues and possible
adverse effects on the quality of medical products.
20.18 Written procedures should be available for the handling of
damaged and/ or broken shipment containers. Particular attention
should be paid to those containing potentially toxic and hazardous
products.
21. Dispatch
21.1 There should be documented, detailed procedures for the
dispatch of products.
21.2 Medical products should only be sold and/or distributed to
persons or entities that are authorized to acquire such products in
accordance with the applicable national legislation and marketing
authorization. Written proof of such authorization, or an import permit
or equivalent where there is no marketing authorization, must be
obtained prior to the distribution of products to such persons or
entities.

21.3 Dispatch and transportation should be undertaken only after the

receipt of a valid order, which should be documented.
21.4 Records for the dispatch of products should be prepared and
should include information such as, but not limited to: date of dispatch;
complete business name and address (no acronyms), type of entity
responsible for the transportation, telephone number, names of
contact persons; status of the addressee (e.g. retail pharmacy,
hospital or community clinic); a description of the products, including,
for example, name, dosage form and strength (if applicable);
applicable transport and storage conditions; a unique number to allow
identification of the delivery order; and assigned batch number and
expiry date (where not possible at dispatch, this information should at
least be kept at receipt, to facilitate traceability).

21.5 Records of dispatch should contain sufficient information to

enable traceability of the product. Such records should facilitate the
recall of a batch of a product, if necessary, as well as the investigation
of falsified or potentially falsified products. In addition, the assigned
batch number and expiry date of products should be recorded at the
point of receipt, to facilitate traceability.
21.6 Vehicles and containers should be loaded carefully and
systematically on a last-in/first-out (LIFO) basis, to save time when
unloading, to prevent physical damage and to reduce security risks.
Extra care should be taken during loading and unloading of cartons, to
avoid damage.
21.7 Medical products should not be supplied or received after their
expiry date, or so close to the expiry date that this date is likely to be
reached before the products are used by the consumer (12).
21.8 Medical products and shipment containers should be secured in
order to prevent or to provide evidence of unauthorized access.
Vehicles and operators should be provided with additional security
where necessary, to prevent theft and other misappropriation of
products during transportation.
21.9 Medical products should be stored and transported in
accordance with procedures such that: the identity of the product is
not lost; the product does not contaminate and is not contaminated by
other products; adequate precautions are taken against spillage,
breakage, misappropriation and theft; and appropriate environmental
conditions are maintained, for example, using cold-chain for
thermolabile products.
21.10 Written procedures should be in place for investigating and
dealing with any failure to comply with storage requirements, for
example, temperature deviations. If a deviation has been noticed
during transportation, by the person or entity responsible for
transportation, this should be reported to the supplier, distributor and
recipient. In cases where the recipient notices the deviation, it should
be reported to the distributor.

21.11 Transportation of products containing hazardous substances or

narcotics and other dependence-producing substances, should be
transported in safe, suitably designed, secured containers and
vehicles. In addition, the requirements of applicable international
agreements and national legislation should be met.
21.12 Spillages should be cleaned up as soon as possible, in order to
prevent possible contamination, cross-contamination and hazards.
Written procedures should be in place for the handling of such
occurrences.
21.13 Damage to containers and any other event or problem that
occurs during transit must be recorded and reported to the relevant
department, entity or authority and investigated.
21.14 Products in transit must be accompanied by the appropriate
documentation.
22. Outsourced activities
22.1 Any activity relating to the storage and distribution of a medical
product that is delegated to another person or entity should be
performed by the appropriately authorized parties, in accordance with
national legislation and the terms of a written contract.
22.2 There should be a written contract between the entities. The
contract should define the responsibilities of each entity (contract giver
and contract acceptor) and cover at least the following: compliance
with this guideline and the principles of GSP and GDP; the
responsibilities of all entities for measures to avoid the entry of
substandard and falsified products into the distribution chain; training
of personnel; conditions of subcontracting subject to the written
approval of the contract giver; and periodic audits.

22.3 The contract giver should assess the contract acceptor before
entering into the contract, e.g. through on-site audits, documentation
and licensing status review.
22.4 The contract giver should provide to the contract acceptor all
relevant information relating to the material and medical products.
22.5 The contract acceptor should have adequate resources (e.g.
premises, equipment, personnel, knowledge, experience and vehicles,
as appropriate) to carry out the work.
22.6 The contract acceptor should refrain from performing any activity
that may adversely affect the materials or products handled.

23. Substandard and falsified products

23.1 The quality system should include procedures to assist in
identifying and handling medical products that are suspected to be
substandard and/or falsified.
23.2 Where such medical products are identified, the holder of the
marketing authorization, the manufacturer and the appropriate
national, regional and international regulatory bodies (as appropriate),
as well as other relevant competent authorities, should be informed.

23.4 Such products should be stored in a secure, segregated area

and clearly identified to prevent further distribution or sale. Access
should be controlled.
23.5 Records should be maintained reflecting the investigations and
action taken, such as disposal of the product. Falsified products
should not reenter the market.
24. Inspection of storage and distribution
facilities

24.1 Storage and distribution facilities should be inspected by

inspectors authorized by national legislation. This should be done at
determined, periodic intervals.
24.2 Inspectors should have appropriate educational qualifications,
knowledge and experience
24.3 An inspection should normally be conducted by a team of
inspectors.
24.4 Inspectors should assess compliance with national legislation,
GSP, GDP and related guidelines (GXP), as appropriate.
24.5 Inspections should cover the premises, equipment, personnel,
activities, quality system, qualification and validation and other related
aspects, as contained in this guideline.
24.6 An inspection report should be prepared and provided to the
inspected entity within a defined period of time from the last day of the
inspection. Observations may be categorized based on risk
assessment.
24.7 CAPA for observations listed as non-compliances in the
inspection report, with the national legislation and guidelines, should
be submitted for review by the inspectors within the defined period, as
stated by the inspectors.
24.8 Inspections should be closed with a conclusion after the review
of the CAPAs.