STANDARD OPERATING PROCEDURE

RECEPTION
Prepared by:
Q.F. MILWARD MENDOZA PAREDES
VALIDITY PERIOD
F. ISSUE: 26.01.2011
01/26/2012

OBJECTIVE: To receive the products or medications in an orderly manner and

efficient, checking some aspects regarding the quality of the product.

RESPONSIBILITY: It is the responsibility of the personnel working in the pharmacy and the
The inspection of the same is the exclusive responsibility of the Pharmaceutical Chemist.

FREQUENCY: Each time a product enters the pharmacy.

PROCEDURE:
The staff working in the pharmacy must take the following into account
instructions:
1. Before receiving the products, the delivery guide must be compared or
invoice from the supplier or delivery guide from the manufacturing laboratory that
accompany the product with the purchase order or the manufacturing order, to
verify the following data:
a) The product name, batch number, and expiration date
b) Concentration and pharmaceutical form
c) Manufacturer
d) Presentation
e) Amount requested
f) Any other information established in the purchase order or
manufacturing

PRODUCT INSPECTION
At the time of receipt, the quantity received and the number will be verified.
batch and expiration date, then an inspection will be carried out of the
external characteristics of a representative sample of the product.
The inspection will include the review of:
a) Packaging
b) Indirect packaging
c) Immediate packaging
labeled
e) Content

REASONS FOR REJECTION

The products will be rejected in the following cases:
1. In case the batch number and the expiration date of the
products do not match those on the invoice and/or receipt guide.
2. In the event that the product has a very close expiration date to
moment of receiving it (1 month).
3. In case the batch number and the expiration date of the box do not
match that of the bottle or blister.
STANDARD OPERATING PROCEDURE

STORAGE
Prepared by:
Q.F. MILWARD MENDOZA PAREDES
PERIOD OF VALIDITY
F. ISSUANCE: 26.01.2011
01/26/2012

OBJECTIVE: To store and safeguard medications in an orderly manner.

received, in order not to alter their quality, which does not
confusions occur and allow for a correct rotation of the stock.

It is the responsibility of the staff working in the pharmacy and the

The inspection of the same is the exclusive responsibility of the Pharmaceutical Chemist.

PROCEDURE:
Immediately after the receipt and verification of the product
it will proceed to storage to avoid confusion.
2. Review the storage conditions (temperature) (in this warehouse
only products will be stored at a temperature lower than 250C and with
a humidity of less than 80%.
3. Before arranging the products, clean them; likewise, clean the area.
where they will be located.
4. The product will be located in the corresponding area by Laboratory or
Supplier.
5. The merchandise will be organized by lot number, it will always be located the
old batches in sight to be able to serve you first.
6. The expiration date will be manually recorded by the number of
batch and this must be verified periodically.
The merchandise or product will only be handled by the staff.
who works at the Pharmacy.
8. Whenever dispatch occurs and there are remaining balances, they must remain.
in its box or in any case in a bag with its identification label,
There should not be any loose blisters or ampoules in the warehouse, as this may lead to
to confusion.
Goods should not be placed directly on the floor, they should always be
to go on clean shelves.
10. The free spaces in the pharmacy designated for should not be interrupted.
personnel circulation and to facilitate the dispensing of the
medications.
11.For no reason should the places where they are located be hidden or obstructed.
the fire extinguishers.
STANDARD OPERATING PROCEDURE

Dispensation
Prepared by:
Q.F. MILWARD MENDOZA PAREDES
PERIOD OF VALIDITY
F. ISSUE: 26.01.2011
01/26/2012

OBJECTIVE: To attend to user requests efficiently, to avoid

confusions and allow them to reach their destination in perfect conditions,
maintaining the quality of the pharmaceutical products to be marketed.

RESPONSIBILITY: It is the responsibility of the staff working in the pharmacy and the
The inspection of it is exclusive to the Pharmaceutical Chemist.

PROCEDURE:
1. To carry out the dispensing, the origin and validity must first be verified.
of the order.
2. Check if the requested quantity exists.
3. Separate and review the products to be dispensed.
4. Check if it corresponds to what was requested.
5. Stock Rotation: whenever items are dispatched, the order must always be respected.
from the expiration dates (FEFO System), that is, distributing
first what has the shortest lifespan, second what
first in (FIFO system).
6. Select the packaging material, bag or box, in such a way that it
resist the adversities during transportation.
7. In the case of fragile products, place the warning of FRAGILE.
a visible place of the packaging. Likewise, the indication to keep it in
one way.
8. After packing, the identification label will be placed on the
product with quantities and storage recommendations and
this should not be easily removable.
9. In the guides and invoices used for marketing, there are
you must indicate the batch number of the product. This document
must be available to health inspectors.
10. They should be kept away from other products or materials that may
affect their integrity.
It must be transported in safe environments to prevent theft and not expose them to
unacceptable degrees of heat, cold, light, humidity or other influence
adverse.
12. At the time of delivering the merchandise, it must be checked
quantities with the client.
STANDARD OPERATING PROCEDURE

LOCATION OF THE PRODUCTS

Prepared by:
Q.F. MILWARD MENDOZA PAREDES
PERIOD OF VALIDITY
F. ISSUE: 01.26.2011
01/26/2012

OBJECTIVE: To maintain order in the placement of products

pharmacists, in order to allow for a rapid and efficient response to the
clients, as well as avoid confusion at the time of dispatch.

RESPONSIBILITY: It is the responsibility of the staff working in the pharmacy and the
The inspection of it is the exclusive responsibility of the Pharmaceutical Chemist.

FREQUENCY: Every time a pharmaceutical product is received.

PROCEDURE:
Upon receiving the merchandise, it will be distributed on the shelves.
designated for that purpose.
2. The products will be sorted by laboratory and in alphabetical order.
separating ethical medications, generics, OTC, preparations
galenic, dietary and natural products with upcoming expiration date
expiration and low products.
3. The products will be arranged in such a way that those with an expiration date of
the closest expiration dates come before those with a date of
farthest expiration (FEFO system).
4. The products that are expired will be separated and placed.
on the respective shelf.
5. A daily control of the products will be carried out to verify their date of
expiration.
6. Those products that have a near expiration date will be
a red label will be placed indicating that they should be separated and
placed on the expired shelf.
The vials will be placed on a separate shelf.
8. The medications that require refrigeration, those subject to
cold chain, they must be stored at a temperature of 2 to 8°C,
for which a freezer will be used.
STANDARD OPERATING PROCEDURE

INVENTORY POLICY
Prepared by:
Q.F. MILWARD MENDOZA PAREDES
VALIDITY PERIOD
F F. BROADCAST: 26.01.2011
01/26/2012

OBJECTIVE: Verify the existence of losses or surpluses, control the date

of expiration and condition of the products.

It is the responsibility of the person in charge of the

pharmacy the quarterly inventory.

FREQUENCY:
Every 3 months (Saturday)

PROCEDURE:
The day before the inventory, the pharmacy manager will clean and
He will organize all the products in the warehouse.
The responsible person will count the products by Item.
3. You will record the expiration date of each product.
4. It will identify with an asterisk (*) all products whose date of
the expiration is less than 6 months.
5. He/She will check the conservation status of the products and communicate.
any defect in writing.
6. You will carry out a reconciliation of the inventory results.
7. In case the amounts do not match, these will be verified.
together with an accounting representative who will sign the
Inventory format to confirm the actual existing quantity.
The cause of the differences will be investigated and communicated to management.
general in order to take the necessary measures and then it will be adjusted
Kardex to the actual physical quantity, since it always records the quantity.
the kardex must match the physical stock.
9. Will communicate the results of the inventory to the Chemist in writing.
Responsible Pharmacist.
10. Registrar.
STANDARD OPERATING PROCEDURE

COMPLAINTS - CLAIMS - RETURNS

Prepared by:
Q.F. MILWARD MENDOZA PAREDES
VALIDITY PERIOD
January 26, 2011
01/26/2012

RESPONSIBILITY: It is the responsibility of the staff working in the pharmacy and the
The inspection of the same is the exclusive responsibility of the Pharmaceutical Chemist.

FREQUENCY: Every time a complaint, claim, and/or

return of a medication.

PROCEDURE:
When complaints, grievances, or returns arrive, the person in charge of the
pharmacy will proceed to:
1. Verify if the product being claimed corresponds to the dispensed one.
by the pharmacy, checking the delivery guide:
2. Product name.
3
4. Batch Number.
5. Carefully analyze the complaint, claim or return; only then will you
will accept the return of the product in the following cases:
6. In case a product recall alert is issued.
7. In case of manufacturing defects: missing tablets in a
blister, lack of content in a syrup (not powder for reconstitution) or
ampoule. These must be closed and in their original packaging.
8. Place the returned products correctly identified in
separate, restricted environments under strict control until their
elimination, reprocessing or return to the supplier.
9.Store returned products by low expiration date
strict control until its elimination.
10. When the claim or return is due to defect, damage, or other
serious problem, the Pharmaceutical Chemist with knowledge of the case
will proceed to:
11. Analyze the problem thoroughly.
12. Communicate immediately the Laboratory Manufacturer,
specifically to the Quality Control Area in order to make
an assessment and investigation of the problem, in the shortest time possible
possible.
13. Immobilize the existing product in the pharmacy.
14.Request the Manufacturer or Supplier Laboratory for the results of the
evaluation - research, that these be issued in writing for
communicate to the Health Entity "DIGEMID".
15. When it is certain that its quality is defective
depending on the magnitude of the defect with the results of the
Investigation by the Manufacturing Laboratory will proceed even
to the withdrawal of the product.
STANDARD OPERATING PROCEDURE

Market Withdrawal
1
PREPARED BY:
Q.F. MILWARD MENDOZA PAREDES
VALIDITY PERIOD
F. ISSUE: 01/26/2011
Expiration Date: 01/26/2012

OBJECTIVE: To prevent a product with a defect or suspicion of one from continuing.

circulating in the market.

This task directly holds the Chemist responsible.

Pharmacist and also engages the people who work in the
pharmacy.

Not established.

PROCEDURE:

THE RESPONSIBLE PHARMACEUTICAL CHEMIST, with knowledge that a

If the product has a defect or there is suspicion of it, proceed to:
1. Review the Sales Register and verify with the sales receipts.
who have been the buying clients or consumers of this
product with the respective batch No.
2. Communicate immediately to all purchasing customers of this
product immobilization whether by phone or fax while
I received an official written communication.
3. Make the official communication in writing through a letter indicating the
reason for the withdrawal of the product from the market.
4. Carry out the withdrawal of all defective lot products from the market.
5. Proceed to replace it with another batch or it will be announced
restock as soon as possible.
6. Proceed to reconcile the amounts in order to try to
seize the entire batch.
The person responsible for the withdrawal will proceed to record in the notebook.
The complaint details all the steps taken for the product withdrawal as follows
also like the quantity of the product.
Insist that the commission make a decision on the final destination of the product.
as soon as possible.
STANDARD OPERATING PROCEDURE

CLEANING OF PRODUCTS, AREA, SCAFFOLDS AND EQUIPMENT

Prepared by:
Q.F. MILWARD MENDOZA PAREDES
PERIOD OF VALIDITY
01/26/2011
01/26/2012

OBJECTIVE: To ensure cleanliness, prevent the accumulation of dust, waste or

insects.
RESPONSIBILITY: This task specifically commits to the people.
who work in the pharmacy.

FREQUENCY
Daily cleaning.
General Cleaning (once a week).

CLEANING OF PRODUCTS AND SCAFFOLDING (INTERDAILY)

The staff will proceed to:

Place the merchandise on the clean display case of the pharmacy.
Then he will proceed to clean the product with a cloth, avoiding lifting
dust.
The cleaning of the products located in the drugstore will be carried out with
plenty of care to avoid confusion, it will be cleaned by area and item.
This cleaning will be done every other day, for which a cloth will be used.
clean for the products and another cloth to clean the scaffolding or
shelves.
The product remnants will not be disposed of without the supervisor's authorization.
immediate superior and in this case it will be noted in the notebook of
daily occurrences.
After cleaning, the staff will proceed to wash with
detergent all the material he used for it and will rinse it with
enough water to keep it clean until the next cleaning.

FLOOR CLEANING (DAILY)

The most effective method is mopping.
The person in charge will wear gloves to carry out this operation.
- He will proceed to sweep with a short bristle broom to
remove dirt from the floor such as papers, dust, etc. This sweeping is
it will be done with firm but slow movements to avoid lifting the
dust. He will pick up the trash with the dustpan and place it in a bag.
plastic.
Then you will put water and detergent in a large bucket to carry out the
mopped
The mopping is done first with detergent and then it will be changed
water as many times as necessary to continue rinsing the
mop and leave no detergent residue.
Mop the entire floor trying to reach all the areas.
inaccessible.
STANDARD OPERATING PROCEDURE
FIRE EXTINGUISHER HANDLING
1
Prepared by:
Q.F. MILWARD MENDOZA PAREDES
VALIDITY PERIOD
F. ISSUE: 26.01.2011
01/26/2012

GOAL: To allow the person or persons working in the pharmacy

know how to use a fire extinguisher in case of fire.

RESPONSIBILITY: It is the responsibility of the pharmacist to train and

evaluate the staff on the use of the fire extinguisher.

PROCEDURE:

FIRE EXTINGUISHER INSPECTION:

1. Inspect the fire extinguisher once a month in case there is a possibility of
that they have used it.
2. Control the load, verify that the needle of the pressure gauge is in the zone
green, otherwise the fire extinguisher:
3. "NO - THIS - READY TO BE USED"
If you find any abnormalities during the inspection, you must call.
immediately to the company that performs the maintenance.
The breaking of the safety seal voids the warranty of the extinguisher.
Check and keep the fire extinguisher clean, with no dents.
responses or any other damage.
Check that the discharge flue is clean and free of
any obstruction.

INSTRUCTIONS FOR USE:

Remove the insurance by breaking the security seal.
Aim the extinguisher at the base of the fire.
Squeeze the handle and discharge the extinguisher from side to side, towards:
oWood.
Papers.
Carton.
Flammable liquids.
Electrical equipment.
STANDARD OPERATING PROCEDURE

FLAMMABLE MATERIAL HANDLING

Prepared by:
Q.F. MILWARD MENDOZA PAREDES
VALIDITY PERIOD
F. ISSUANCE: 26.01.2011
01/26/2012

Prevent a fire from starting.

SCOPE: To instruct the staff working in the pharmacy on the management of

flammable material or another that may cause fire.

RESPONSIBILITY: It is the responsibility of the person in charge of the

pharmacy and also involves those who work in it.

FREQUENCY: Whenever working with flammable material or something similar.

PROCEDURE:

1. The person in charge of the pharmacy whenever using a material

flammable such as: alcohol, kerosene, oil, gasoline, etc., must
do it very carefully to avoid spills.

2.Store flammable liquids, such as alcohol, in a safe container;

whenever they are used, cover them and place them in a safe place.

3. After working with packaging materials such as cardboard, paper

The stretchers should be removed from the pharmacy to avoid accumulations.
that can feed the fire.

4. Avoid open flames inside or outside the pharmacy.

5. Demand that people working outside the pharmacy (surroundings) do not

throw lit matches or cigarette butts on the floor; for this purpose
put up a relevant sign.
STANDARD OPERATING PROCEDURE

TRAINING
1
Prepared by:
Q.F. MILWARD MENDOZA PAREDES
PERIOD OF VALIDITY
F. ISSUE: 26.01.2011
Due Date: 01/26/2012

To inform and instruct the people who work in the drugstore.

about
the function or task they must develop and the responsibilities that are theirs
is assigned.

SCOPE: Provide the necessary guidelines to meet the objective

RESPONSIBILITY: Of the responsible pharmaceutical chemist, to schedule and

designate the trainers.

FREQUENCY: Every 6 months

PROCEDURE:

1. The person in charge of the drugstore (pharmaceutical chemist)

the person in charge must carry out training for the staff on
basis of a program written to comply with Best Practices of
Storage.

The person in charge of the pharmacy (pharmaceutical chemist

the responsible person must train the new staff immediately afterwards
upon your entry to indicate the role you will perform.

3. Training will be conducted every 6 months and periodically must

evaluate its effectiveness.

4. During the training sessions, they must be discussed carefully.

the concept of quality assurance.

5. A record of all training programs must be kept.