Personnel

All personnel involved in distribution activities should be trained and qualified in the
requirements of GDP, as applicable. Training shall be based on written standard operating
procedures (SOPs). Personnel shall receive initial and continuing training relevant to their tasks,
and be assessed as applicable, by a written training program. In addition, training of the
personnel shall include the topic of product security, as well as aspects of product identification,
the detection of counterfeits, and the avoidance of counterfeits entering the supply chain. A
record of all training, which includes details of subjects covered and participants trained shall be
kept.
Key personnel involved in the distribution of medical devices shall have the ability and
experience appropriate to their responsibility for ensuring that pharmaceutical products are
distributed properly. There shall be an adequate number of competent personnel involved in all
stages of the distribution of pharmaceutical products to ensure that the quality of the product is
maintained. National regulations relating to the qualifications and experience of personnel should
be adhered to.
Personnel dealing with hazardous pharmaceutical 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.
Personnel involved in the distribution of pharmaceutical 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.
Appropriate procedures relating to personnel hygiene, relevant to the activities to be carried out,
should be established and observed. Such procedures should cover the health, hygiene, and
clothing of personnel.

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Procedures and conditions of employment for employees, including contract and temporary staff,
and other personnel having access to pharmaceutical products must be designed and administered
to assist in minimizing the possibility of such products coming into the possession of
unauthorized persons or entities.
Codes of practice and punitive procedures should be in place to prevent and address situations
where persons involved in the distribution of pharmaceutical products are suspected of, or found
to be implicated in, any activities relating to the misappropriation, tampering, diversion or
counterfeiting of any product.

Stores Department’s Responsibilities

Receiving of imports/international supplies
A packing list and invoice from the manufacturer/supplier are forwarded to the Procurement
Department upon receipt of imports, with which goods are received in the HDU stores.
Right product, quantity, quality, and expiry dates are verified upon receiving, after which a
physical inspection form is filled and filed, and a Goods Received Note is prepared, and
forwarded to the CEO and the technical operations team.

Receiving local supplies

All local supplies are received at the stores. The checklist used for receiving is LPO and that is
raised in-house by the Procurement Officer.
After verification of the product, quantity, expiry date, price, and quality, the supplier invoice is
signed and stamped and a copy is given to the supplier as confirmation of receipt, however, if
there are any returns a Goods returned note (GRN) is raised and the same is noted to follow up
on the credit note or replacement from the supplier.

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The supplies are then uploaded into the system and the stock card is updated appropriately.

Storage
Goods received are stored at HDU stores and the alternative company warehouse.
Items are stored under the manufacturer’s recommended storage conditions; those that are to be
under cold chain are stored in the cold room under a range of 2-8 ⁰c and those not requiring cold
storage are stored in the main store in a range of 15 - 35 ⁰c. Temperature logs should be filled in
every morning, afternoon, and evening.

Filing
Copies of invoices are filed by the store personnel and accountant for future reference and goods
follow-up.
Upon receipt of invoices stamped by local suppliers, the procurement and stores officer
countercheck and then file accordingly.

Goods follow-ups
A routine follow-up with clients (up-country) via telephone/email is done to verify whether they
have received their goods in the right quantity and condition.
Dispatch of orders
Upon confirmation of requests for products from clients or internal requests from the sales
representatives in the field, the goods are packed, and labeled and a copy of the delivery note
and invoice are included accordingly. Depending on the urgency of local deliveries, goods are
dispatched to clients according to route plans, either by Dispatch officers or sales teams. Bulk
orders are packed and dispatched by third parties and ensures courier meets all the transportation
conditions as per the product requirements.

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THE STANDARD OPERATING PROCEDURES
1.0 PROCEDURE FOR RECEIVING AND INSPECTING
1.1 Local supplies.
 Once goods are received at the HDU store, each item is checked and verified with the
supplier invoice and LPO reference document. Clarifications about expiry date, batch
number, and quantities are made. The Stores Officer records the Goods Received Note
(GRN) and forwards it to the CEO, field, and finance teams.
 In cases of any damages /leakages, the item(s) shall be returned with a “goods returned
note”, which is eventually noted in the supplier file.
 Approved goods are received and supplier invoices are acknowledged by authorized
signatory and stamped.

1.2 Overseas consignments.

 Before offloading consignments, the seal of the consignment is checked to ensure it’s
intact, therefore the seal is broken in the presence of the Stores Officer and the
transporter,

 The consignment is then offloaded at the stores/warehouse

 Items and quantities are verified as per the proforma invoice, invoice, and or packing list.

 Upon confirmation of the right product with the right quantity and quality of packaging
against the packing list, the items are received & stored under the recommended
manufacturer’s conditions.

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  In case of any damages/leakages, they must be reported on the transporter's delivery note/
suppliers, the supplier is contacted and the items are stored in the quarantine for
subsequent inspection.

2.0 STORAGE.
The products received for storage, range from medical laboratory equipment, reagents,
consumables, and their accessories to rapid diagnostic test kits and point-of-care devices. Each
kind of product is stored as per the manufacturer’s storage specifications.
There is a dedicated cold room for products that need to be stored under low temperatures and a
main storage area for items that require room temperature or 15-35⁰c storage.
Storage area is labeled as per product and independent shelves are allocated for different
categories of products. Room thermometers are used to ensure appropriate temperatures are
maintained and recorded.
2.1 Cold Room - Procedures
 The cold room has compartments and shelves.
 Reagents are stored in the cold room and temperatures range from 2 0C – 8 0C, as per the
manufacturer’s instructions.
 Temperature recordings are done three times a day and are recorded in the daily
temperature log, that is for; morning, mid-day, and evening.
 The temperature monitoring thermometers are calibrated annually by a contracted service
provider as per Uganda National Bureau of Standards (UNBS) requirements.
 Daily cleaning of cold room floor, compartments, and the shelf is in place and is marked
once per day.
 Documentation done; stock cards and electronic systems are used simultaneously.
2.2 Store (room temperature) - Procedures
 The main store is a gazette for equipment, some reagents and accessories, spare parts, and
point-of-care devices.
 The store room temperatures are kept between 15 0C – 35 0C

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  Temperature recordings are taken three times a day and are recorded in the temperature
log at morning, mid-day, and evening intervals.
 The room thermometers used are calibrated annually as per the Uganda National
Bureau of Standards UNBS requirements by a contracted service provider.
 Daily cleaning of storeroom floor, compartments, and shelves is in place and is
marked once per day.
 Documentation done; stock cards and an electronic system are used
simultaneously.

3.0 DISPATCH PROCEDURE

 The store officer receives orders either from clients via email or sales representatives in
the field in the form of a Local Purchase Order (LPO).
 The store officer confirms the availability of the products requested.
 The store officer transmits the LPO to the Finance department for processing of the
invoice
 The store officer confirms the following: LPO number, pack size as on the LPO and
invoice, quantities, expiry dates, and the invoice amount.
 The store officer does a final check then packs the products in the right packages and
labelling and sealing. The product is then dispatched to the customers or the sales
representatives, and or/ transported by the dispatch officers.
 Deliveries can either be done by motorbikes or delivery vans/ hired vehicles depending
on the size of the orders and transit requirements of the goods.
 Cool boxes are used for cold chain items to ensure temperatures are maintained as per the
products' requirements, whose temperatures are monitored by temperature data loggers
during transit.

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  The original invoice and a copy of the delivery note are also packed together with the
item(s) and a copy of the invoice filed to the respective customer’s files in the Finance
department.

4. 0 PROCEDURE FOR HANDLING EXPIRED AND DAMAGED PRODUCTS

 Identify the damaged/expired product or with a short expiry (at least 1 week to expiry
date)
 Fill out the expired /damaged product form which shall be approved by the QAM and
accountant.
 Once approved, the expired/damaged products are invoiced.
 The expired products are then removed from the shelves are transferred to the quarantine
area. If it is equipment, it shall be removed from the store and isolated.
 Fill out the quarantine register and store the expired/damaged products in the quarantine
area.

5.0 PROCEDURE FOR DISPOSING OF EXPIRED/DAMAGED PRODUCTS

 Once the expired/ damaged products in the quarantine have accumulated, a National
Environment Management Authority (NEMA) authorized company, contracted for waste
disposal is called upon to collect the products for disposal.
 The products are weighed and the waste acceptance form is filled by the disposing
company.
 The disposing company issues the invoice
 Payments are made

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  An approved waste disposal certificate from the company is then issued on completion of
waste disposal.

6.0 PROCEDURE FOR HANDLING GOODS RETURNED

 Goods might be returned due to wrong orders, short expiries, excess supply or shortages
and damages must be communicated by the client immediately through the customer
service number, via email, or through the respective sales representatives.
 The respective sales representative is contacted by the Procurement Officer to find out the
reason for the client's return of goods.
 All goods returned with quality-related concerns must be authorized by the QAM.
 Goods Returned Note (GRN) may be communicated either by calling the Customer or by
contacting a sales representative to communicate the same to the Customer.
 After obtaining the GRN, the Customer must prepare a goods return note capturing the
Customer name, reason for return, invoice number, quantity, batch number, and expiry
dates that accompany the goods back to HDU Limited.
 Issuance of the GRN does not guarantee credit.
 On receipt of the goods HDU personnel will confirm receipt of the returned goods and
will review them.
 If they meet the terms of the goods return policy, the HDU personnel will then update the
goods return register and fill out the goods return form.
 The goods return form should then be submitted to the QAM for approval and to the
Finance Office.
 Crediting approval or denial will be communicated to the customer.
 All products must be returned at least 2 months before expiry.
 Products purchased more than one month before the return request will not be accepted.
 Products returned in altered or damaged packaging, or in packaging other than original
packaging will not be accepted.

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  Packs broken, breached, or damaged at the customer premises will not be accepted.

7.0 PRODUCT RECALL PROCEDURE

 Any written communication received from the complainant (hospital/ lab facilities/ Field
staff /customer/ medical personnel) regarding the defects in product quality (purity,
efficacy, and any adverse product and reagent reaction) including its physical
characteristics, packaging, labeling, etc. shall be investigated as per “SOP on the handling
of Customer complaints - of the QMS”.
 Based on the recommendations given in the Customer complaint Investigation, QAM
shall decide on product recall.
 The product recall could be voluntary or forced.
 Voluntary Recall is done for Products by the manufacturer when any adverse reaction is
brought to the notice directly to the manufacturer or when the manufacturer has noticed
problems in the product quality or stability.
 Forced Recall is done on instructions by the regulatory body; including but not limited to
UNBS and NDA when any adverse reaction or incident is reported by the general public,
hospitals, physicians, or any laboratories.
 Recall can be classified as:
 Class I recall: a situation in which there is a reasonable probability that the use of or
exposure to a volatile product will cause serious adverse health consequences or death.
 Class II recall: a situation in which the use of or exposure to a volatile product may
cause temporary or medically reversible adverse health consequences or where the
probability of serious adverse health consequences is remote.
 Class III recall: a situation in which the use of or exposure to a volatile product is not
likely to cause adverse health consequences.
 QAM shall fill up the “Product Recall Form

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 Each product recall form shall be assigned a unique alphanumeric number by the QAM,
for example, PR24000 Where, the first two characters of PR stand for “Product Recall”,
3rd and 4th characters represent the last two digits of the year and the last three characters
denote sequential serial number.
 The form shall be forwarded to the CEO for approval.
 The reasons and conditions of the product recall and its class shall be discussed by the
QAM and the technical department (sales, applications, and marketing / Service and
maintenance department). An action plan shall be prepared by this group.
 If the product batches to be recalled are from the regulated markets, necessary
communication will be sent by the QAM to the respective regulatory body.
 The Product Recall shall be initiated promptly no sooner after the decision is taken by the
CEO. Necessary communication shall be sent to all concerned parties within the shortest
period, but not later than 72 hours in case of Class I and Class II recalls.
 The Distribution record shall be checked by the Procurement Officer in consultation with
the stores department to identify the destinations, quantities, and batch numbers.
 The QAM shall advise HDU management and the Procurement department to instruct the
sales team to stop further dissemination and sale of the affected product batches.
 The communication can be sent by telephone, email, and any other mode. Where required
this may also be put on news media, but only in case of Class I recall.
 A follow-up on the communication and response to it shall be monitored by the QAM and
HDU management.
 Necessary arrangements shall be administered by the Supply chain to receive the recalled
product. The returned stock shall be reconciled to the closest quantity of actual
distribution.
 The batch documentation and reconciliation shall be thoroughly scrutinized by competent
personnel from the Technical, Stores, and Procurement departments.

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 In the likelihood of the possibility of destruction of stocks in the country of the market,
the QAM shall seek permission from the local Regulatory body.
 All records and communications related to Product Recall shall be properly maintained
by the respective departments, such as Procurement, Stores, and technical departments.
These records shall be reviewed by QAM for adequacy and accuracy.
 The National Drug Authority shall also be informed of such recalls by QAM.

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 Document Ref : HDU-GDP-QMAN-001
Revision : 00

Author : QA Manager

Approved : Managing Director

GDP Manual Date Issued : 21/02/2024

Revision Date : 00
Page : 12 of 27

 Mock Recall-In order to evaluate the product recall program, periodic mock recalls
should be carried out at least once a year. All information obtained during the Mock recall
shall be documented on the Recall Log. The mock recall file should include the name,
address, and telephone number of clients for the lot tested, production records, inventory,
and distribution of the lot.
 Mock recalls are used to determine whether the recall procedure is capable of identifying
and quickly controlling a given lot of potentially affected products and reconciling the
quantities procured, quantities in inventory, and quantities distributed.
 A mock recall will identify potential problems and allow personnel to become familiar
with recall procedures. If problems are identified in the recall procedures, they should be
corrected.
 All corrective actions and deficiencies shall be documented in the Recall Report.

8.0 PROCEDURE FOR STOCK TAKE

 Major Stock takes should be done at least 12 times a year and if possible, should be
conducted by external personnel/those who are not in the Stores.
  All transactions related to inventory management should be put on hold i.e., invoicing,
crediting, and any other transaction that can affect stocks until the exercise is completed.
 The personnel involved should be informed by e-mail or through a memo at least three
weeks in advance to avoid inconveniences on the material day.
 The store personnel should arrange the store one week in advance in readiness for the
activity and proper labeling of shelves.
 It should be done by two or more teams to ensure accuracy is attained during
reconciliation.
 Always involve the store personnel for easy location/ identification of the products and
on what to count and what is not to count.
 Strictly use the same stock-taking sheets for easy compiling of different products and if
there is a need for personal records it should be done after reconciliation to avoid
conflicting reports.
 All counts should be put on one master sheet for easy reconciliation.
 In case of disputes the variance should be done by a fresh recount of the items that have
variances.
 If there is a need for clarification of variance and explanation about the same then there
should be a window since stock take is not a final process on every count and
reconciliation should be done.
 The obtained physical count of information should correlate with that in QuickBooks.
 Final tally and report should be done and this should summarize the stock take activity.
N/B
The objective of stock takes is to verify the accuracy of the stock records, to disclose the
possibility of theft/ fraud or loss, and to reveal any weakness in the overall storage system to
make improvements.

9.0 PROCEDURE FOR HANDLING SPILLAGES

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9.1 Solid materials
 If any breakage occurs, the store personnel shall segregate or shift other surrounding
materials to avoid contamination.
 Store personnel shall communicate to HDU management staff about the incidence of
corrective action.
 With the help of a broom, the broken material shall be collected by taking sufficient
safety precautions before cleaning the area (wear safety goggles, nose mask, hand gloves,
etc.)
 Transfer the contents of the affected container or bag to another good and cleaned
container or bag.
 Take note of the affected quantity and transfer it to the quarantine.
 After approval from the QAM and Accountant, the same quantity is to be deducted from
the inventory management system and respective stock cards.
 Prepare the incident report with the cause of the accident and appropriate corrective
action to avoid the recurrence of such incidents.
9.2 For Liquids
 In case of spillage or breakage of Liquids, immediately open the windows and doors (if
possible) for proper ventilation.
 Store personnel shall restrict the area for minimum movement.
 Mop the area with all safety precautions like wearing a nose mask
 Transfer the remaining contents of the affected container or drum to another appropriate
and clean container (if possible)
 Take note of the quantity of the spilled material and transfer it to the quarantine area.
 After approval from the QAM and Accountant, the same quantity is to be deducted from
the inventory management system and respective stock cards.
 Prepare the incident report with the cause of the accident and appropriate corrective
action to avoid the recurrence of such incidents.

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10.0 TEMPERATURE MAPPING PROCEDURE
 Temperature mapping is to be carried out using calibrated room thermometers three times
a day (morning, mid-day, and evening).
 Identify positions and the number of locations for temperature mapping such that it
covers every corner and center of the company stores.
 Place temperature thermometers at the identified locations without touching the tip to any
surface in the HDU stores.
 Start the mapping after stabilization of the displayed temperature.
 Record the temperature readings of each thermometer in a temperature mapping record.
 If the results do not fall within the specified limits take the necessary corrective actions
and perform mapping again.
 The monthly temperature mapping records are to be filed, for future reference.
 Annual calibration of thermometers is done and a calibration certificate is issued by the
contracted service provider.

11.0 PROCEDURE FOR HANDLING PARAMETERS OUT OF SPECIFICATION

When a product/material/system parameter goes out of specification, a thorough investigation
should be initiated to get to the root cause and initiate a corrective action. Details are indicated
below;
 In the HDU stores, retained sample rooms areas, the limit for temperature limit 15 0c -
350c (main storage area) and 2 0c – 8 0c (cold room). If these get out of the specification in
any area, the following procedure shall be followed:
 The details of the out-of-specification records shall be entered in the temperature logs.

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  The QAM shall review the data recorded every two weeks and perform risk analysis on
the impact of the materials or products stored in the same environment.
 The service provider in charge of cold room and AC servicing shall be contacted
 Verification of the service provider’s corrective action(s) shall be evidenced by a report or
job card.
 Any particular area showing persistent deviation will be considered for further action

12.0 PROCEDURE FOR CLEANING

The cleaning process is divided into four categories as
Follows;
 The HDU store cleaning process is controlled by the company janitor daily. – The
cleaning checklist shall be filled.
 Vehicles cleaning process using the Vehicles Weekly Cleaning Checklist
 Washroom cleaning process using the Wash Rooms Daily Cleaning Checklist.
 The scope of the cleaning must cover the areas stated in the cleaning checklist. On
completion of cleaning the responsible person must indicate appropriately the status
by signing activity at the columns indicated, the supervisor will then inspect and sign
off the work if completed to the satisfaction or raise a nonconformity if this is not the
case. The cleaning process for all areas is conducted daily early in the morning
between 8:00 am and 10:00 am by the designated personnel.

12.1 Office areas:

 Office cleaning involves cleaning all the offices, meeting area, and Reception as per the
checklist stated above.

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  Start the cleaning activity with dry cleaning followed by a wet cleaning system.
 Dry clean the reception area, doors, glass panel, furniture, waste bin, and electrical
fittings with a duster followed by wet cleaning except for electrical fittings.
 Dry clean the offices, windows, floor, furniture, and electrical fittings, with a duster and a
mop, as applicable.
 The office reception area is cleaned once in a day

12.2 HDU stores cleaning:

 HDU store cleaning is conducted in compliance with good distribution practices for
pharmaceuticals, medical products, and consumables.
 A specific cleaning checklist for the HDU cleaning has been developed to ensure the
process covers mopping the floor, dusting the shelves & products, arranging the products
on racks and pallets, checking and emptying the bait stations for rodents, and emptying
the waste bins.

12.3 Vehicle cleaning and testing:

(**The activity is conducted from a washing bay used for washing company staff cars**)
 The motor vehicle cleaning also includes testing the vehicles to be mechanically
sound before they are released for delivery.
 Check that all the windows are closed and retract the antenna.
 Pull the windshield wipers away from the windshield until they click into their
propped position, away from the glass.
 Soak a large washcloth in plain water and clean the vehicle being certain to wash
out any dirt in it. Wash the car section by section, starting at the top.
 Rinse the dirt out of the cloth in the bucket with plain water frequently.
 Scrub the lower body and the wheels last. Use a brush to clean the openings of the
wheels.
Cleaning Frequency: Once a week (away from working hours) i.e., over the weekends.

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12.4 Washroom cleaning
(This is a role for the janitor)
 Put on the protective gloves.
 Flush the toilet, if the flush is not working properly then inform the control desk to create
a maintenance job order for the same.
 Sprinkle the cleaning solution in a circular motion around and inside the top of the water
closet bowl and leave it for 10 minutes.
 Apply cleaning solution on the walls beside and behind the toilet and under the vanity.
 Wipe the outside of the toilet bowl and the walls around the toilet with a damp sponge.
 Wipe the pipes leading to the toilet.
 Wipe the walls under the vanity and the drain pipe.
 Use a toilet bowl brush to scrub the inside of the toilet bowl.
 Clean under the rim and the seats.
 Clean the top of the rim of the water closet, in and around the hinges, bottom of the water
closet seat cover.
 Flush the toilet.
 Rinse the brush in the toilet once the cleaning is done.
 Dry the entire water closet, using a clean dry cloth to remove all marks.
 Polish the walls and pipes.
 Recheck inside the water closet bowl, especially under the rim, and ensure the water is
clear.
 Close the water closet seat cover.
13.0 PROCEDURE FOR ENSURING STORE PREMISES SAFETY
 Store staff, with the help of the shall inspect received equipment (newly received or
old/retrieved) before use to ensure no problems exist that would make it unsafe. Any
problems or defects found shall be brought to the attention of experienced and qualified
staff (engineers and application specialists) to be immediately repaired or replaced.

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  Ladders; Staff shall ensure ladders are used for their manufacturer-designed purpose. Staff
shall never use the top step or use it on unstable surfaces.

13.1 Health and safety precautions

 Precaution shall be followed at all times to assure the safety of the general public and staff
while storing or handling company equipment.

 This program shall provide appropriate personal protective equipment to staff and ensure
use while operating equipment

 Adequate airflow shall be provided in work areas to lessen potential exposures to vapors or
gas emitted from equipment or other reagents under storage.

 Employees should wear protective shoes and helmets while in the HDU stores.

14.0 PROCEDURE FOR TRAINING NEW STAFF

 All new staff shall be oriented on store procedures, transport, and procurement
procedures as applicable.
 New staff shall also be trained on micro and macro processes of the HDU stores
department in the first week of their reporting.

15.0 PROCEDURE FOR HANDLING MOTOR VEHICLES BY MOTOR VEHICLE

DRIVERS

Personal protective equipment

 Hard hat and high-visibility clothing to be worn when not inside the cab.
 Safety boots in good condition, properly laced, must be worn at all times. Worn-out soles
and heels could lead to slips and falls.

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  Eye protection will be worn where there is a danger of falling or flying debris from
equipment or loads, especially in windy conditions.
 Hand protection will be worn when handling cable or any other material where there
might be a danger of cuts or puncture injury.
 Hearing protection will be worn when exposed to noise levels exceeding 85 dBA.

15.1 Inspection and repairs

 Trucks will be inspected before use to ensure good mechanical condition.
 When working under or around trucks, for inspections or repairs, the truck must be
locked and tagged out, and immobilized and secured against inadvertent movement.
15.2 Housekeeping
 Cabs, steps, windows, windshields, and mirrors must be kept clean at all times. All debris
should be removed from the truck and trailer.

15.3 Parking
 The motor vehicle must be parked on level ground, clear of hazards, to allow ease of
access.

15.4 Travelling
 Proper gear selection must be used to maintain control.
 Drive according to terrain conditions. Drivers are responsible for load security.

15.5 Danger zone

 Danger zone is defined as the area around operating machines or working personnel, in
which there is potential for being struck by moving equipment or objects. The danger
zone may vary according to the machine or work being performed.
 Operators must make sure that all persons, vehicles, and equipment are clear of the
danger zone before the vehicle or its components are moved.

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15.6 Fueling
 Shut off the engine while fueling. No smoking. Be aware of slip and trip hazards.
 Beware of spills and splash-back. Return the hose to its proper storage position when
fueling is completed.
15.7 Hazardous materials
 Read label. If there is no label, contact the supervisor.
 Use protective equipment and follow safe handling instructions as outlined on the stores
safety label.
 Use proper storage procedures.
 With extra care – is easy to over brake.

16.0 PROCEDURE FOR PEST CONTROL

 All pest control activities shall be performed by an outside pest control agency
 The area and pesticide points shall be mentioned and documented.
 The person who shall be involved in pest and rodent control activity, shall be trained and
must wear a proper gown, nose mask, hand gloves, and shoe cover
 In case of any seasonal effect in the environment/ climatic change due to which there is
an increase of insects, flies, etc., additional services shall be taken from the contractor and
records should be maintained thereof.
 Records shall be checked by the QAM.
 Ensure that the area shall be free from medical-related components during and after the
pest control until it is cleaned by the janitor.
 Ensure the cleaning of each pest-controlled area for the absence of pesticides by the
QAM.

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17.0 PROCEDURE FOR AVOIDING COUNTERFEITS
17.1 Purchasing
 Products are to be purchased, whenever possible, directly from manufacturers or from
Manufacturer’s authorized suppliers.
 Independent distributors are used only after authorization has been obtained from the
procurement officer who maintains a register of approved suppliers. Procurement
assurance processes for avoiding counterfeit products begin at purchasing.
 Assurances, at minimum, include the use of the Approved Suppliers Register.

17.2 Vendor evaluation

 The Procurement Officer shall perform a periodic evaluation of suppliers to ensure that
approved/ongoing sources of supply are maintaining effective processes for mitigating
the risks of supplying counterfeit products and to evaluate overall performance against
criteria.
Criteria include:
 Meeting HDUL Client’s specifications
 On time delivery
 correct quantity
 Quality and condition (including the absence of counterfeit evidence)
 Competitive pricing
 When a product or service provided does not meet the requirements of the order,
purchasing, or quality a non-conformity form is initiated, and the supplier is informed.
 The procurement officer sends a copy of the Non-Conformance Report Form to the
supplier for follow-up.
 All follow-up information received from the supplier will be added to the non-
conformance Report form.

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17.3 Documents
 Reception documents specify contract/purchase order requirements to minimize the risk
of being provided counterfeit products. These documents may contain, where or when
appropriate:
 Requirements for Catalogue number, item number, or other accurate description of the
item.
 Requirement for Certificate of Analysis for non-pharmaceuticals and reagents, being
imported.
 Requirement for Product Traceability, when applicable.

17.4 Material Control

 If a product is identified to be counterfeit, HDU will contact the supplier/vendor for the
affected item(s) and provide any data supporting the counterfeit nature of the material.
 HDU will discuss options with the supplier for the disposal of the affected material to
prevent re-entry into the supply chain. This may include:
 Upon mutual agreement, destruction of the product in HDU stores to render it unusable in
any form and documented evidence provided to the supplier.
 Return the product to the supplier and request evidence of disposal to prevent re-entry
into the supply chain.
 Reporting the incident to the appropriate regulatory agency so that other users at large
may become aware of the existence of the product in question and review their supply
chain for any risks as applicable.
 All identification, segregation, and disposition will be documented in accordance with
Nonconformity Procedure.

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17.5 Reporting
 All occurrences of counterfeit parts are reported, as appropriate, to internal organizations,
Customers, regulatory authorities, government reporting organizations, industry-
supported reporting programs, and criminal investigation departments.

17.6 Inspection Training

 All HDU store staff are to use the packing checklist and goods receiving procedure as a
guideline when determining whether or not products are potentially counterfeit or
suspect. Any suspicions should be immediately brought to the attention of the QAM.

18.0 COMPLAINTS PROCEDURE

 Receive complaints via phone call, email, and social media platforms from hospitals, lab
facilities, customers, or medical staff regarding the defects in product quality (as per SOP
on the handling of Customer complaints - of the QMS).
 Assess the nature of the complaint and record and give feedback.
 If it’s a material defect it will be recorded and thoroughly investigated to identify the
origin or reason for the complaint.
 If the defect of the product is discovered or suspected, other batches of the product will
also be checked and flagged out.
 If the complaint is about the quality of a product or its packaging, the manufacturer
and/or the supplier will be informed as soon as possible.
 Product quality problems or suspected cases of counterfeit products will be documented
and the information shared with the regulatory authorities - National Drug Authority
(NDA).
 Details of the action taken will be communicated to the complainant and if necessary,
initiate a recall as per the product recall procedure

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19.0 SELF INSPECTION PROCEDURE
The self-inspection shall be conducted, at least twice a year and exhibit neither objectivity nor
partiality. The internal auditors shall not audit the departments/ functions they work under
This is as stated below;

 The Store Officer is responsible for the daily self-inspection

 The Store Officer should check on the cleanliness of the offices, reception area, dispatch,
and receiving bay.
 The Store Officer should confirm that the stock for sale is marked and that a system is in
place to facilitate the ease with which goods are located in the HDU stores.
 The Store Officer should perform random stock take to confirm the quantity of the goods.
He/ she should check the conditions of storage in the HDU stores and confirm that there
is a segregation of samples, rejected goods, counterfeits, and quarantined goods.
 The Store Officer should check on the procedures involved from the time an order is
received through to invoicing and dispatch of goods.
 The Store Officer should check whether; the procedures are correctly followed, the
invoice contains all the necessary information, the physical goods correspond to the
goods in the invoice, the packaging material is of good quality, and the goods to be
delivered are well protected from humidity and light.
 The Store Officer should also check on the cleanliness of equipment and vehicles used to
transport the goods.

19.1 Annual inspection

 This shall be done by other departments; management and finance departments.
 Various departments should be assigned to inspect other departments.
 All the respective departments shall be audited by the QAM.
19.2 The finance representative should inspect HDU stores
 He/she should confirm that the stock for sale is marked and that a verifiable system is in
place to facilitate the ease with which goods are located in the HDU stores.

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  He/she should perform random stock take to confirm the quantity of the goods. He/ she
should check the conditions of storage in the HDU stores and confirm that there is a
segregation of samples, rejected goods, counterfeits, and quarantined goods.
 He/ she should also check that documentation related to the process being audited is
updated as evidence that the GDP system is adhered to.

19.3 The store/procurement officer should inspect the Finance and Administration
department.
 They should check whether they issue statements regularly whether they follow up with
Customers and how they do it.
 The finance department should be able to indicate for how long a client should stay with
credit.
 What is the procedure for goods returned?
 Who writes the credit note?
 How documents are filed.

19.4 Fields technical representative should inspect sales/ reception and dispatch of
goods.
 Sales assistant should be able to explain the criteria used for calling Customers, the
procedure after receiving orders and how he/she ensures good customer relations.
 A report should be prepared by every department/ auditor at completion of inspection.
 The report should include; results, evaluation, conclusions and recommended corrective
measures.
 Follow-up action should include Effective follow-up program and company management
to evaluate both the report and corrective actions.

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Examples of Major Deficiency in good distribution practices:
a. Lack of qualification and validation for equipment and instruments, process and procedures
b. Failure to monitor temperature and humidity within specified limits
c. Lack of appropriate procedures and records for handling/management of temperature
excursions outside of predefined temperature limit extremes.
d. Damage (holes, cracks, peeling paint) to walls/ceilings in the warehouse
e. Design of a warehouse that does not permit effective cleaning that could lead to mix-ups
f. Lack of designated and labelled storage area for expired, recalled/returned and/or substandard
medical products
g. Inadequate initial and ongoing training and/or no training records
h. Cleaning procedures not documented and/or no cleaning records
i. Deviations from instructions not approved
j. No or inadequate internal inspection program
k. No proper release for supply procedure
l. No system/procedures for handling complaints or returned goods
m. Insufficient lighting in storage areas
n. The containers from which samples have been taken were not identified
o. Inadequate change control system
p. Inadequate deviation system
q. No investigation into alarms and temperature excursions for deviations from storage or
transport requirements
r. Unpacking of finished products for individual unit’s sales.
s. QA is not independent from the person responsible for operations
t. Lack restriction access measures to storage areas and/or computerized system.
u. The computerized system was not validated
v. Lack of procedures for software data back-up
w. Lack of cleaning procedures and records of implementation
x. Lack of pest control procedures and records of implementation

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