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Checklist for Good Storage and Distribution Practices

A Management & Personnel Remarks


1 There should be an adequate organizational structure defined
with an organizational chart. The responsibility, authority and
interrelationships of all personnel should be clearly defined
and documented through clear job descriptions.
2 At each storage site there should be an adequate number of
qualified personnel available at all working hours to achieve
pharmaceutical quality assurance objectives.
3 A designated person should be appointed at the distribution
point with defined authority and responsibility for ensuring
that a quality management system is implemented and
maintained.
4 All personnel in the storage area should be provided proper
initial and continuous training related to the Good
Distribution and Storage Practice, related rules and
regulations, and safety regulations, in addition to be capable
of meeting these requirements. The training records should
be kept for review.

5 All members of staff should be trained in, and observe high


levels of, personal hygiene and sanitation.
6 Clear instructions for personal Hygiene should be distributed
and observed.
7 Personnel employed in storage areas should wear suitable
protective or working garments appropriate for the activities
they perform.
8 First-aid procedures and equipment for dealing with
emergencies involving personnel should be available.
B Outsourced Activities
9 Contracting (outsourcing) of certain storing or distribution
services or activities is acceptable provided that these are
outsourced from qualified and legitimate parties.

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Checklist for Good Storage and Distribution Practices
10 Any outsourced activity relating to the distribution of a
pharmaceutical product should be performed in terms of a
written contract which is agreed upon by the contract giver
and the contract accepter. The contract should define the
responsibilities of each party including observance of the
principles of GS &DP.

C Premise
11 Storage areas shall be of hygienic design and maintained
12 clean.
Storage areas shall be maintained in a dry condition with
relative humidity to not exceed 60%.
13 Temperature within the storage areas shall be maintained
between 8oC to 25oC.
14 Stored Goods and Materials should be stored off the floor.
15 Stored materials shall be suitably spaced to permit cleaning
and inspection.
16 Pallets should be kept in a good state of cleanliness and
repair.
17 There shall be a clear differentiation between all the materials
stored and their locations adequately identified.
18 Resting areas and areas for having food should be isolated
from storing area.
19 Toilets and hand washing areas should be made available.
20 Toilets should not open directly into the storage area.
21 Only authorized personnel shall be allowed access into
storage areas.
22 Storage area should have sufficient light to perform tasks in a
correct, safe and accurate manner.
23 In case of windows present in the storage area, arrangements
should be made to block Sunlight away from the stored
items.
24 All surfaces, shelves, cupboards used should have an
impermeable and easy to clean surface.

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Checklist for Good Storage and Distribution Practices
D Receiving and Dispatch area.
25 Receiving and dispatch bays should protect products from the
external environmental conditions.
26 Reception areas should be designed and equipped to allow
containers of incoming pharmaceutical products to be
cleaned, if necessary, before storage.
E Quarantined Area
27 Quarantined areas shall be isolated and identified.
Sampling Area
28 Sampling area shall be isolated and its environment shall be
controlled and monitored.
29 Sampling shall be carried out according to the documented
procedure.
30 Sampling shall be carried out in a manner to prevent any
cross contamination.
31 There shall be a specific cleaning procedure documented,
implemented and monitored for the sampling area.
F Rejected product area
32 Any rejected/recalled/expired product shall be stored at a
separate designated and identified location.
33 Materials stored in the rejected product area shall be
adequately labelled.
34 Rejected product area shall permit only entry of authorized
personnel.
G Instruments
35 Equipment available in the storage area should only be used
for its intended purpose with valid relavant license.
36 All equipments should be calibrated and validated
periodically.
H Vehicles

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Checklist for Good Storage and Distribution Practices
37 Vehicles and equipment used to distribute, store, or handle
concerned materials and products should be properly
designed and equipped to insure protection from different
environmental and weather conditions.
38 The design and use of vehicles and equipment must aim to
avoid contamination, build-up of dust or dirt and/or any
adverse effect on the quality of pharmaceutical products
being distributed.
39 The use of vehicles with defects shall not be permitted and
any such vehicle should be clearly labeled with its condition
until defect removal is accomplished.
40 Storage conditions required for maintaining the quality of
transported products or material (as mentioned on their label)
should be provided, checked, monitored and recorded. All
monitoring records should be kept and made available for
review at any time.

41 There shall be clear documented procedures and methods for


cleaning of vehicles which also indicate the cleaning
frequency. Records shall be maintained and available for the
same.
42 Written standard procedures should be made available for
operating and maintenance of transporting vehicles clarifying
the frequency of each maintenance measure. Records signed
by a qualified party contracted for maintenance should be
available and used to provide maintenance history evidence
of the concerned vehicle.

I Handling of stored items


43 Stored material should be isolated according to its specified
storage conditions mentioned on the label and dangerous or
radioactive substances should be clearly identified and
labeled.

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Checklist for Good Storage and Distribution Practices
44 Starting material and products should be isolated and be
properly labeled in a way which prevents mix-up and cross
contamination.
45 Stored materials and products should be secured firmly
within the containers.
46 A system should be in place to ensure that pharmaceutical
products due to expire first are sold and/or distributed first
(FEFO).
47 Broken or damaged items should be withdrawn from usable
stock, separated and labeled clearly.
48 Items that require refrigeration should be kept in refrigerators
and their temperature should be recorded periodically.
49 Temperature and humidity monitoring records shall be kept
for at least the shelf-life of the stored material or product plus
one year.
50 There shall be a clear documented cleaning program which
shall include the frequency and method of cleaning.
51 There shall be a system for periodic disinfection and the
same shall be inplemented and monitored.
53 Adequate facilities shall be available for hand washing and
hand drying by the provision of hot air and tissue papers.
54 Periodic stock reconciliation should be performed by
comparing the actual and recorded stocks. All significant
stock discrepancies should be investigated as a check against
inadvertent mix-ups and/or incorrect issue.
55 Regular checks should be carried out for all stocks to identify
and remove obsolete and outdated materials or products.
J Quality Management System and Documentation
56 There should be a documented quality policy describing the
overall intentions and policies of the establishment regarding
quality, as formally expressed and authorized by upper
management.

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57 Written standardized work procedures (SOP), instructions
and records should be available for review clearly explaining
work procedures, all activities and procedures followed in the
storage premises and to clearly identify the distribution
channels for materials and products.

58 Standardized operation procedures (SOP) should be in place


for the following:
59 Procedures to be followed in case of RECALL of any
products.
60 To ensure that appropriate pharmaceutical products are
sourced from approved, legitimate and licensed suppliers and
distributed by approved legitimate entities.
61 There shall be a documented procedure for traceability of the
products through its entire chain.
62 A data Sheet of permanent information, written or electronic,
should exist for each stored material or product indicating:
Brand name, International Non-Proprietary Name (INN)
name/s, recommended storage conditions, any precautions to
be observed, retest dates, Pharmacopoeial requirements, Art
work of labels and containers, safety and first aid
instructions.

63 Records should be kept for each delivery and must be


retained for a period equal to the shelf-life of the incoming
materials and products, where applicable, plus 1 year.
64 These records should include as a minimum description of
the received goods Pharmaceutical Dosage form, size of pack
unit, number of units per pack, quality, quantity, supplier,
supplier’s batch number, date of receipt, assigned batch
number, Expiry date.

Electronic records are backed up to prevent accidental data


loss

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Checklist for Good Storage and Distribution Practices
SOP exists for indexing, retrieving, storing, maintaining,
disposing and retention of all applicable documentation and
records.
K Labelling
65 Labels applied to containers should be clear, unambiguous,
permanently fixed to the container and be indelible. The
labeling should be written in a language which is understood
by persons involved in the distribution chain.
66 Labels on secondary packaging should include at least the
following:
- Material or product name
- Quantity (weight, size, unit number)
- Batch number
- Expiry date or retest date for active ingredients.
- Receiving date should be conducted in an independent and
67 Self-inspections
-detailed
Production
way date
by a designated, competent person. All self-
- Quality Control
inspections shouldsection approval
be recorded. and release
Reports shoulddate withall
contain
signature of person
observations in charge.
made during the inspection. Follow- up
-corrective
Storage conditions (clear
actions taken and specific)
should be documented and recorded.
- Transportation conditions and precautions.
- Handling precautions
L -Complaints
Manufacturer name with its trade mark.
handling
- Supplier’s name (in case
68 There shall be in place it is a procedure
a written wholesalerfor
or the
so) handling
with
contact details.with clarity in procedures to be followed for
of complaints
information collection, investigating facts and follow up
corrective actions.
69 There shall be a clear distinction between complaints about a
product or its packaging and those relating to distribution.
70 In the case of a complaint about the quality of a product or its
packaging the original manufacturers hould be informed as
soon as possible and not wait until full investigation is
performed.
71 Every complaints, investigation carried out and their results
should be documented.

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M Counterfeit Pharmaceutica / Food products
72 Counterfeit or suspected counterfeit medicines are segregated
immediately from other pharmaceutical products and
recorded.
73 Upon confirmation of the product being counterfeit a formal
decision is taken on the disposal of counterfeit
pharmaceutical products and the decision is recorded.
74 Procedures are in place to immediately inform the
appropriate national and/or international regulatory bodies.
75 Such products are clearly labeled to prevent further
distribution or sale.
N Training
76 All personnel involved in distribution activities are trained
according to a written training program.
77 Records of all initial and refresher training are kept and are
available.
O Pest Control
78 There shall be a documented pest control program with list of
approved treatment agents.
79 The effectivity of pest control shall be evident onsite.

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