PROCEDURES

STANDARD
OPERATIONS (POE)
LEGAL REPRESENTATIVE: Mrs .

TECHNICAL DIRECTOR: QF

VERSION I
 LIST OF STANDARD OPERATING PROCEDURES

ORDER CODE PROCEDURE P.

1 POE-BF-001 DEVELOPMENT OF THE STANDARD OPERATING PROCEDURE 07

2 POE-BF-002 EEFF STAFF TRAINING 16

3 POE-BF-003 RECEPTION AND ENTRY OF PHARMACEUTICAL PRODUCTS, 24

MEDICAL DEVICES AND SANITARY PRODUCTS

4 POE-BF-004 STORAGE OF PHARMACEUTICAL PRODUCTS, MEDICAL 33

DEVICES AND SANITARY PRODUCTS

5 POE - BF - 005 DISPENSATION OF PHARMACEUTICAL PRODUCTS, MEDICAL 41

DEVICES AND SANITARY PRODUCTS

6 POE - BF - 006 PHARMACEUTICAL PRODUCTS DISTRIBUTION, DM and PS 53

7 POE - BF - 007 PROCEDURE FOR EVALUATING A RECIPE 60

8 POE-BF-008 MANAGING PRODUCT RETURNS AND EXCHANGES: 67

RECORDS AND CAUSES

9 POE-BF-009 WITHDRAWAL OF EXPIRED AND DETERIORATED MEDICINES 74

AND THEIR DESTRUCTION

10 INVENTORY CONTROL AND STOCK MANAGEMENT OF 82

POE-BF-010 PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND
OTHERS

11 POE-BF-011 CLEANING OF THE PHARMACEUTICAL ESTABLISHMENT 88

12 POE-BF-012 SANITIZATION AND FUMIGATION OF THE EEFF 95

13 WORKPLACE SAFETY OF STAFF 101

POE-BF-013

14 POE-BF-014 ROOM TEMPERATURE CONTROL 107

15 POE-BF-015 RECORD OF THE OFFICIAL BOOK OF OCCURRENCES 112

16 POE-BF-016 NOTIFICATION OF SUSPECTED ADR PHARMACOVIGILANCE 123

17 POE-BF-017 NOTIFICATION OF SUSPECTED ADVERSE INCIDENT IN 130

MEDICAL DEVICES

18 POE-BF-018 HANDLING OF REFRIGERATED PRODUCTS 137

19 POE-BF-019 HANDLING OF CONTROLLED PRODUCTS 148

20 POE-BF-020 GOOD PRACTICES IN DISTRIBUTION AND TRANSPORTATION 162

ANNEXES 172

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 AQP PHARMA PHARMACY POE-BAQP No. 019

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Release Date: Expiration Date: Revision Date:
Version: No. 002
25-10-2014 25-10-2016 25-09-2016

PREPARED BY
NAME POST DATE SIGNATURE
QF AMPARO MARGOT ALVARADO FALL QF TECHNICAL DIRECTOR OF THE
25-10-2014
CQFP 00932 AQP PHARMA PHARMACY
It is the responsibility of the person who prepares the document to comply with the wording and maintain the chronological order of the documents. The
“Signature” cell will be completed with the record of the date on which the person registered the Preparation of the Procedure.

REVIEWED BY
NAME POST DATE SIGNATURE
QF AMPARO MARGOT ALVARADO FALL QF TECHNICAL DIRECTOR OF THE
25-10-2014
CQFP 00932 AQP PHARMA PHARMACY
It is the responsibility of the person reviewing the document to maintain the chronological order of the documents. The “Signature” cell will be completed
by recording the date on which the person registered the Procedure Review.

APPROVED BY
NAME POST DATE SIGNATURE
JUDITH PATRICIA ESTEVES GUZMAN REP. LEGAL OF THE
25-10-2014
DNI No. 29638431 AQP PHARMA PHARMACY
It is the responsibility of the person who approves the document to comply with maintaining the chronological order of the documents. The “Signature”
cell will be completed with the record of the date on which the person registered the Approval of the Procedure.

MODIFICATION LOG
P. Prepared by
Date Description of the Modification
No.
Name Post Signature

It is the responsibility of the person updating the document to keep track of changes and maintain their chronological order. The “Signature” cell will be
completed with the record of the date on which the person registered the change.

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GENERAL ASPECTS:
 This SOP must be read in its entirety before application.
 This SOP is the main work tool and will serve as a mandatory guide for the
development and achievement of daily activities, and to be carried out effectively and
efficiently.
 Any doubt and/or non-conformity observed during its application must be consulted
and communicated to the QF. Technical Director of the Pharmacy.
 If it is necessary to modify part or all of a POE, your immediate superior must be
notified in advance and when preparing the new POE, the guidelines indicated in the
POE of POE will be followed.

1. AIM:
 Establish basic standards for the proper maintenance of the cold chain for
pharmaceutical products that require special storage conditions, maintaining a controlled
temperature (between 2ºC and 8ºC), thus guaranteeing their quality until they reach the
hands of the patient or end user.

2. SCOPE

Applies to all products stored and distributed at temperatures between 2ºC and 8ºC,

3. REFERENCES

 Law No. 26842 – General Health Law.

 Law No. 29459 Law on Pharmaceutical Products, Medical Devices and Health
Products
 Supreme Decree No. 014-2011-SA Approves the Regulation of Pharmaceutical
Establishments, and its amendment** (Supreme Decree No. 002-2012/SA).
 Ministerial Resolution No. 720-2012/MINSA. From 08-29-12, "The Regulation of
Pharmaceutical Establishments, approved by DS, is modified No. 014-2011-SA”.
 Supreme Decree No. 016-2011-SA - Approves Regulations for the Registration,
Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and
Sanitary Products, and its amendment* (Supreme Decree No. 001-2012/SA).
 Ministerial Resolution No. 585-99-SA/DM of 11/27/99 - Manual of Good Storage
Practices for Pharmaceutical and Related Products.
 Ministerial Resolution No. 013-2009/MINSA Approves Manual of Good Dispensing
Practices.

4. PLACE OF APPLICATION
It is applied in the storage area, specifically in the refrigerator.

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5. FREQUENCY OF APPLICATION
Every time pharmaceutical products that require special temperature-controlled storage
conditions (between 2ºC and 8ºC) are imported.

6. DEFINITIONS
 Refrigerator.- Electrical equipment designed to maintain the products contained in it at
a low temperature.
 Cold Chain.- The cold chain or cold network is the stable and controlled conservation
system (ideal temperature): storage, handling, transportation and distribution of
refrigerated products, which allows maintaining their effectiveness from the moment
they leave the manufacturing laboratory until they reach the hands of the user, in order
to guarantee that they are kept at the appropriate temperature and prevent
deterioration.
 Thermal Boxes: These are styrofoam boxes with a hermetic lid and the capacity to
accommodate cold refrigeration units around the medications. They are used when it is
necessary to store and/or transport medications, for cleaning the refrigerator or due to
prolonged power outages.
 Refrigeration Unit.- Non-toxic element that accompanies the refrigerated products
without interacting in the thermal box, intended to maintain the pre-established
temperature conditions. Maintains refrigeration for no more than 12 hours.
 Digital Thermometer.- It is an element of the cold chain that has the purpose of
monitoring and controlling the temperatures that occur in a thermal unit (thermal box or
refrigerator).

7. RESPONSIBILITY

 The Technical Director of the Pharmacy is responsible for supervising compliance with
this procedure as appropriate.

 The legal representative and the technical pharmacy staff in charge are responsible for
carrying out compliance with this procedure as appropriate.

8. SPECIFIC CONDITIONS

8.1. FRIDGE

a) On the outside:

 Install it in a cool, ventilated environment, away from any heat source and in the
shade.

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 Be separated 15 cm to 20 cm from the wall, to allow air circulation and avoid

engine overheating
 Be level
 Be connected to the power grid, independent connection.
 The plug must be exclusive, sign “DO NOT UNPLUG”
 Easily accessible to pharmacy staff.
 List of pharmaceutical products
 Refrigerator resume.
 Daily temperature record

b) Inside

 Thermostat Graduated between 2 ºC and 8 ºC.

 Digital thermometer connected to the central tray and whose display will be on
the refrigerator for easy reading.
 Cooling units in the freezer (to be used in case products need to be moved to a
thermal box for home delivery, cleaning the refrigerator or due to prolonged
power outages.
 3 bottles with water (1/2 liter).
 Trays for arranging medications.
 Keep the vegetable drawer empty.
 Having 50% of capacity occupied.
 Allow air circulation between pharmaceutical products.

8.2. REFRIGERANT UNIT:

 It will be used according to the size of the thermal box, in such a way that it allows
the entire box to be surrounded.
 Do not use refrigeration units with eutectic solution because they keep the
temperature below 0ºC for a long time, maintaining their liquid state, which leads
to error.
 The refrigerant units to be used correspond to 0.4 Lts.

8.3. DIGITAL THERMOMETER

 Place it on the refrigerator, in a safe place where it will not fall.

 The sensor bulb should be located in the center tray of the refrigerator.
 It should not be removed from the site unless necessary.
 The top display shows the interior temperature.
 The lower display shows the outside temperature.

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 You should always have AAA batteries for replacement.

 Temperatures must be read and recorded every day

Chart No. 1 Inside the refrigerator:

MEDICATIONS

8.4. Storage conditions for cold preservation in the refrigerator

a) Keep the freezer free of ice build-up (no more than 5 mm), and preferably frost-free. To
do this, it must be defrosted periodically, since the accumulation of frost reduces the
cooling capacity of the appliance.

b) The refrigerator must have a thermometer in good condition that regulates the desired
temperature. The temperature inside the refrigerator must be between 2 and 8 ºC.

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c) Place 3 hermetically sealed plastic bottles of water on the bottom shelf of the
refrigerator (vegetable drawer), placed vertically at the bottom of the refrigerator,
separated from each other and from the walls by about 3 cm. (These help maintain and
stabilize the internal temperature of the refrigerator every time it is opened or when the
power supply is cut off).

d) Place 5 units of refrigerants in the refrigerator. These will be used for transporting or
preserving refrigerated products, as they help to stabilise the internal temperature of
the refrigerator and maintain a safety cold network (for 6-12 hours) in the event of a
breakdown or power outage. Cooling units also contribute to the temperature of the.
freezer to be lower and therefore the new cold packs will freeze more quickly.

e) For product storage, 50% of the available space should be considered as useful
capacity, to allow adequate circulation of cold air between the products. Products
should be separated from each other and from the walls of the refrigerator by
approximately 3 cm. Do not place products that require refrigeration on the doors.

f) The refrigerator must be used exclusively for vaccines and medications, and under no
circumstances should any other type of substance or food be introduced. If food or
drinks are stored, there is a deficiency in the cold chain since the heat of the food and
drinks, as well as the repeated opening of the door to introduce or remove these
products, will increase the internal temperature of the refrigerator, which can
deteriorate vaccines and medicines.

g) Refrigerator doors should be opened for the minimum amount of time to introduce or
remove products, so check the rubber seals on the door.

h) The storage method of the products must be respected according to the order in which
they are received, in order to clearly identify the oldest products from the newest ones
(comply with FIFO).

i) When the refrigerator stops, check the fuses before calling a technician. Check if the
refrigerator is plugged in properly. The temperature can be regulated by turning the
control knob. It cools more towards the higher numbers or where it says colder.

j) Temperatures close to the limits +2 ºC and +8 ºC should be avoided, to reduce the risk
of losses.

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 HANDLING OF REFRIGERATED PRODUCTS

9. PROCEDURE DEVELOPMENT

9.1. Regulating the temperature of the refrigerator.

 The thermostat must be set so that the internal temperature of the refrigerator
remains between 2 and 8 ºC.

 After adjusting the thermostat, you must wait at least 1 hour to check or modify the
temperature again.

9.2. Reading the digital thermometer.

 Pressing the MAX/MIN button and the maximum temperature appears on both
displays.
 Pressing the MAX/MIN button again will display the minimum temperature on both
displays.
 Pressing the MAX/MIN button once more returns the temperature to its current
value in both settings.
 To clear the maximum temperature, press the MAX/MIN buttons (the display shows
MAX) and press for 3 seconds to clear the figure.
 To clear the minimum temperature, press the MAX/MIN buttons again (the display
shows MIN) and press for 3 seconds to clear the figures.
 Pressing the MAX/MIN button again returns to the current temperature.
 Once the temperatures have been read, they must be recorded on the
corresponding forms and it must be verified that the thermometer is in good
condition for the next reading.

9.3. Temperature control record.

 During the course of the day, on two occasions (morning from 9:00 AM to 9:15 AM
and in the afternoon from 4:00 PM to 4:15 PM) assigned pharmacy personnel will
take temperature measurements.

 The temperature control form must be kept up to date and placed in a visible place
so that the pharmacist can check its status and monitor its temperature daily.

 At the end of each month, an analysis of the recorded temperatures is

recommended. A cooling system in good condition and with good control of its
operation, should maintain temperatures within the optimal range every day of the
month.

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  If after the previous analysis it is verified that the refrigerator does not maintain the
required conditions, it must be reported to the Supervisor of the premises in order
to coordinate its repair or definitive replacement according to the procedure.

9.4. Defrosting the refrigerator

When the thickness of the ice in the freezer exceeds 1.5 cm, it will be necessary to
defrost the refrigerator. If not, it will function poorly and will not allow the conditions
required for the storage of refrigerated medicines.

To defrost, proceed as follows:

 Place the cooling units that were in the freezer inside a thermal box and check that
the temperature is between 2 and 8 ºC.
 Move products from the refrigerator to the cooler.
 Disconnect the refrigerator from the electrical power source.
 Keep the appliance door open for the time necessary for it to defrost.
 Defrosting should be done naturally, do not accelerate it by using sharp
instruments as these can puncture the cabinet.
 Clean the inside of the refrigerator with a soft, non-abrasive cloth and mild
detergent.
 Remove all excess water by drying the walls and shelves with another cloth.
 After cleaning, close the door and turn on the refrigerator.
 Wait the necessary time for the refrigerator temperature to stabilize.
 Check that the temperature is correct (between 2 and 8 ºC)
 Transfer products from the cooler to the refrigerator.

9.5. Cleaning the refrigerator

 This should be done monthly. In the case of refrigerators that produce frost,
cleaning should be done when the freezer has a 1cm layer of ice. Thick.

 To clean the refrigerator you will need: a sponge, soap (not powdered detergent),
cloths and/or paper towels. In addition, prior to the process you must prepare
thermal boxes that will keep the medications at a temperature between 2 and 8 ºC.

 Once this is done, the products are removed from the refrigerator and carefully
placed in the thermal box.

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 Remove water bottles from the bottom of the refrigerator and coolants from the
freezer.

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  Disconnect the power supply to the refrigerator. If it does not produce frost, start
internal cleaning immediately. Otherwise wait until the ice melts (Do not use sharp
tools to remove ice).

 First clean the inside surface of the refrigerator using a sponge with soap, then
clean twice more with a damp cloth until all the soap is removed. Finally dry the
surface with a clean cloth or paper towel.

 Then follow the same procedure above with the outside of the refrigerator.
Remember that the compressor motor and the condenser or heat radiating grid
must be cleaned every two months. To do this, use a soft brush or a vacuum
cleaner to remove any dust accumulated on its surface. The accumulation of dirt
and dust in the condenser of the refrigeration system reduces its efficiency.

 Plug in the refrigerator and place the coolants and water bottles back inside.

 Place medications or biologicals (vaccines) in the refrigerator once it has reached

an optimal temperature inside.

 In addition to defrosting the refrigerator periodically, its interior should be checked

daily to keep it tidy and clean. The source of the cut

9.6. Emergency plan for a power outage

This plan must be known to the DT Pharmaceutical Chemist as well as all the staff
working at the AQP PHARMA PHARMACY, will be responsible for ensuring that the
procedure is carried out when necessary, for which reason they must verify that in the
event of a power outage the following is done:

 Investigate the origin of the cut

 Investigate the duration of the outage.
 If the premises has an emergency electric generator, check the connection to it and
its operation.
 If the premises do not have an emergency generator and the power outage lasts
less than 1 hour, the refrigerator must be sealed to prevent it from being opened
and losing its temperature. If a customer requests a refrigerator, it should be
explained to them that due to the power outage, the refrigerator cannot be opened
to protect the products inside.

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 If the premises do not have a system emergency power and the outage lasts
more than 3 hours, the products must be moved to the thermal box.

 If the refrigeration units begin to defrost, the products must be moved to the
nearest location with a delivery note.

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 9.7. Assembling the thermal box

 Place the cooling units (individually wrapped in plastic bags) in the thermal box so
that they surround its interior (one on each side of the box)
 Place styrofoam or cardboard sheets next to the cooling units.
 Wrap the medicine in plastic bags.
 Place the medication in the center of the box.
 Check the temperature by placing the thermometer on or next to the medication.
 Place a styrofoam or cardboard sheet over the medications.
 Close the box
 Wait an hour to check the temperature
 Open the box and remove the styrofoam or cardboard sheet
 Reading the temperature
 If it is between 2 - 8 ºC, remove the thermometer.
 Repeat previous steps

9.8. Breaking the cold chain

In the event that temperatures are recorded outside the established range due to a
power outage or refrigerator malfunctions, the DT Pharmaceutical Chemist must:

 Separate the affected products in a bag (without losing their refrigerated condition)
and mark them with a label indicating QUARANTINE – sale prohibited
 Perform a temperature deviation analysis as follows:
 Inventory the affected medications
 Calculate the number of hours during which the medications have remained outside
the established range and determine the temperature to which they have been
exposed. The refrigerator with the door closed maintains the cold chain for 3 hours,
after which time temperatures above 9 ºC are recorded.
 Report what happened to the QF Technical Director of the Pharmacy.

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HANDLING OF REFRIGERATED PRODUCTS

 Release the products from quarantine or send them to the Rejected Products area –
Deregistration and/or returns

9.9. List of refrigerated products

 It will be updated by the Technical Director of the Pharmacy.

10. EXHIBIT:

 Temperature Control Form included.

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11. ADDRESSED TO:

To all the staff of the pharmaceutical establishment.

12. DISTRIBUTION:

 Legal representative of La Botica

 Technical Director of the Pharmacy

 Technical Staff in Pharmacy

13. REASON FOR REVIEW OF THE PROCEDURE:

When the current regulations governing pharmaceutical establishments change and

become applicable; likewise when one or part of the procedure needs to be improved in
order to optimize and seek continuous improvement.

AQP PHARMA PHARMACY POE-BF No. 006

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PHARMACEUTICAL PRODUCTS DISTRIBUTION, DM and PS

F/Issue: 13-03-2013 Valid until: 13-03-2015 Next. Rev: 13-02-2015 Version: No. 001

PREPARED BY
NAME POST DATE SIGNATURE

It is the responsibility of the person who prepares the document to comply with the wording and maintain the chronological order of the documents. The
“Signature” cell will be completed with the record of the date on which the person registered the Preparation of the Procedure.

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 REVIEWED BY
NAME POST DATE SIGNATURE

It is the responsibility of the person reviewing the document to maintain the chronological order of the documents. The “Signature” cell will be completed
by recording the date on which the person registered the Procedure Review.

APPROVED BY
NAME POST DATE SIGNATURE

It is the responsibility of the person reviewing the document to maintain the chronological order of the documents. The “Signature” cell will be completed
with the record of the date on which the person registered the Approval of the Procedure.

MODIFICATION LOG
P. Prepared by
Date Description of the Modification
No.
Name Post Signature

It is the responsibility of the person updating the document to keep track of changes and maintain their chronological order. The “Signature” cell will be
completed with the record of the date on which the person registered the change.

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PHARMACEUTICAL PRODUCTS DISTRIBUTION, DM and PS

GENERAL ASPECTS:

 This SOP must be read in its entirety before applying it.

 This POE constitutes the main work tool and will serve as a mandatory guide for the
development and achievement of daily activities, and to be carried out in an effective
and efficient manner.
 Any doubt and/or non-conformity observed during its application must be consulted
and communicated to the QF. Technical Director of the Pharmacy.

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  If it is necessary to modify part or all of a POE, your immediate superior must be
notified in advance and when preparing the new POE, the guidelines indicated in the
POE of the POE will be followed.

1. GOALS

GENERAL:
Establish a procedure to provide the patient and/or user with the requested care through
the sale of over-the-counter (OTC) pharmaceutical products, medical devices and health
products in optimal conditions and, where applicable, care upon presentation of a Medical
Prescription.

2. SCOPE
This procedure applies to the Technical Pharmacy staff, who work at BOTICA AQP
PHARMA.

3. LEGAL BASIS – REFERENCES

 Law No. 26842 – General Health Law.

 Law No. 29459 Law on Pharmaceutical Products, Medical Devices and Health
Products
 Law No. 28173. Peruvian Pharmaceutical Chemist Labor Law.
 Regulation of Pharmaceutical Establishments DS 021-2001-SA
 Supreme Decree No. 016-2001-SA – Establishes that the pharmacies of Public Sector
entities are authorized to sell essential medicines and medical supplies directly to the
public.
 Supreme Decree No. 015-2009-SA Establishes modifications to DS No. 019-2001 that
establishes provisions for access to information on prices and DCI.
 Supreme Decree No. 023-2001-SA. Regulation on Psychotropic Narcotics and other
substances subject to Health Control.
 Supreme Decree No. 014-2011-SA Approves the Regulation of Pharmaceutical
Establishments, and its amendment** (Supreme Decree No. 002-2012/SA).

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PHARMACEUTICAL PRODUCTS DISTRIBUTION, DM and PS

 Supreme Decree No. 016-2011-SA - Approves Regulations for the Registration,

Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and
Sanitary Products, and its amendment* (Supreme Decree No. 001-2012/SA).
 Ministerial Resolution No. 720-2012/MINSA. From 08-29-12, they approved "Modify
the Regulation of Pharmaceutical Establishments, approved by DS" No. 014-2011-SA”.
 Ministerial Resolution No. 585-99-SA/DM of 11/27/99 - Manual of Good Storage
Practices for Pharmaceutical and Related Products.

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  Ministerial Resolution No. 013-2009/MINSA Approves Manual of Good Dispensing
Practices.
 List of Pharmaceutical Products for sale without a Prescription in Pharmaceutical
Establishments.
 Ministerial Resolution No. 1240-2004/MINSA. “National Drug Policy” approved.

4. PLACE OF APPLICATION
It is applied in the Pharmacy's Sales area.

5. FREQUENCY OF APPLICATION
Every time a pharmaceutical product, medical device or healthcare product is
dispensed or sold.

6. DEFINITIONS

 Dispensing: Professional act of the Pharmaceutical Chemist of providing one or more

pharmaceutical products, medical devices and health products to a patient or user,
generally in response to the presentation of a prescription prepared by an authorized
professional. In this act, the professional Pharmaceutical Chemist informs and guides
the patient or user on the proper use of the pharmaceutical product, adverse reactions,
drug interactions and the storage conditions of the product or device.
 Dosage / Posology.- Describes the dose of a medication, the intervals between
administrations and the duration of treatment.
 Expenditure.- Retail sale of pharmaceutical products, medical devices or health
products directly to the end user, without the act of dispensing.
 Incidence: Action aimed at modifying some characteristic of the treatment, of the patient
who uses it or of the conditions of use, and which aims to resolve a Problem Related to
the Medication.

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PHARMACEUTICAL PRODUCTS DISTRIBUTION, DM and PS

 Personalized Medication Information: This is the information that the pharmacist

provides to the patient about his/her treatment, during the dispensing process, with the
aim of achieving effective and safe use of the medication.
 Prescribers.- According to the General Health Law, Law 26842, “Only doctors can
prescribe medications. “Dentists and midwives can only prescribe medicines within the
scope of their profession.”
 Drug-Related Problem (DRP).- Health problem experienced by the patient, as a
negative clinical result derived from pharmacotherapy and that, due to its real or
potential interference, does not allow the expected therapeutic objective to be achieved
or generates undesirable effects.

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  Prescription.- Order issued by a prescribing professional, so that a quantity of
medication or medications, other pharmaceutical products and related products
specified therein, is dispensed to a patient or his representative and which contains
guidelines for its correct use.
 Health Registration.- Procedure through which the competent Health Authority, after
evaluation, authorizes the manufacture, importation or marketing of a pharmaceutical or
related product. The registration also establishes the intrinsic characteristics of the
product, its specific use, indications and contraindications for its use.
 Pharmacotherapeutic Monitoring.- Professional act in which the Pharmaceutical
Chemist professional guides and supervises the patient in relation to compliance with
his/her pharmacotherapy, through pharmaceutical interventions aimed at preventing,
identifying and resolving drug-related problems (DRP).

7. RESPONSIBILITY

From the Pharmaceutical Chemist:

 The Pharmaceutical Chemist will promote and facilitate the ongoing training of
technical staff, supervising their work in the sales department.

From the Pharmacy Technician:

 Carry out the sale of pharmaceutical products, medical devices and health products in
accordance with current legal regulations.
 Support the Pharmaceutical Chemist in the administrative and logistical tasks of the
processes carried out in Pharmaceutical Establishments.

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8. GENERAL CONDITIONS

a) The Technical Director of the Pharmacy is the only person responsible for the
dispensing of pharmaceutical products, medical devices and health products with a
medical prescription and/or without a medical prescription; therefore, in circumstances
where he/she does not do so personally, he/she must supervise the Technical
Personnel in Pharmacy who will carry out the care and dispensing of a pharmaceutical
product or medical device.

b) The Technical Director of the Pharmacy is the only person authorized to dispense an
alternative medication to the one prescribed.

c) The sale of medicines will always be supervised by the Technical Director of the
Pharmacy.
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 d) Under no circumstances should contaminated, adulterated, falsified, altered or expired
products be dispensed.

9. DEVELOPMENT OF THE PROCEDURE

a) This procedure is carried out by the Technical Staff in Pharmacy; and is supervised
by the professional pharmaceutical chemist.

b) Greets the user.

c) Receives and verifies the Prescription, or takes the verbal order.

d) He very politely makes the query, regarding the request of the user and/or patient.

e) It carries out the sale of over-the-counter (OTC) pharmaceutical products, medical

devices and health products; however, this act is not applicable in the following cases:
 When the user and/or patient is a minor or does not have full capacity for
discernment.
 When there is suspicion that the user and/or patient intends to misuse these
pharmaceutical products, the Technical Director of the Pharmacy is notified.

f) When the request contains pharmaceutical products whose sale is conditional on the
delivery of a prescription or requires special conditions for its administration and/or
storage, the attention will be referred to the Professional Pharmaceutical Chemist, who
will carry out the Dispensing Act; however, and exceptionally, this type of
pharmaceutical product may be dispensed when the user requests its sale by visibly
carrying his prescription and, in addition, the Technical staff is trained and authorized
for this purpose by the Professional Pharmaceutical Chemist.

AQP PHARMA PHARMACY POE-BF No. 006

STANDARD OPERATING PROCEDURE (SOP) PAGE: 6 of 7

PHARMACEUTICAL PRODUCTS DISTRIBUTION, DM and PS

Every prescription, to be processed, must comply with the requirements and formalities
detailed below:
 The Prescription must be current.
 It must not contain corrections, erasures and/or amendments.
 It must contain all the minimum required information: Patient data (name, age,
sex); Prescriber data (name, profession, membership, address, signature); Dosage
of the pharmacological treatment (name of pharmaceutical product: drugs in INN
and/or medical devices in DTI, concentration, pharmaceutical form, indicated daily
dose, frequency of use, treatment period and route of administration; place and
date of issue of the prescription.

g) In all cases, before completing the sale, care must be taken to deliver to the user
and/or patient exactly the Pharmaceutical Product, Medical Device and/or Sanitary

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 Product requested, in optimal conditions and under the supervision of the
Pharmaceutical Chemical Professional.

h) Verify the existence and price of the product and inform the patient and/or user.

i) If the user agrees, proceed to issue the ticket.

j) Receive the cancelled sales receipt or ticket and verify that it has a stamp and
signature as a sign of confirmation of cancellation.

k) Select the ticketed products, following the FIFO and FEFO system, verifying their data:
Name, Batch, Expiration Date, Pharmaceutical Form, Presentation,
Concentration.

l) Deliver the product(s) to the patient or user (counting the product in their presence).

m) If the product is sold in fragments, place it in a container and label it with the following
information: Name and address of the pharmacy, Name and concentration of the
product, Route of administration, Expiration date and Batch number.

n) When pharmaceutical products packaged in blisters or sheets are sold in fragmented

form, the section containing the expiration date and batch is kept until the end of the
sale.

10. EXHIBIT:

Not applicable

AQP PHARMA PHARMACY POE-BF No. 006

STANDARD OPERATING PROCEDURE (SOP) PAGE: 7 of 7

PHARMACEUTICAL PRODUCTS DISTRIBUTION, DM and PS

11. ADDRESSED TO:

To all the staff of the pharmaceutical establishment.

 Legal representative of La Botica

 Technical Director of the Pharmacy
 Technical Staff in Pharmacy

12. REASON FOR REVIEW OF THE PROCEDURE:

When the current regulations governing pharmaceutical establishments change and

become applicable; likewise when one or part of the procedure needs to be improved in
order to optimize and seek continuous improvement.

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EXHIBI
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T

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