AIZA’s PHARMACY

STANDARD OPERATING
PROCEDURES
(SOP)

1
 STANDARD OPERATING PROCEDURE
OF
PRODUCT COMPLAINT
SOP-01
OBJECTIVES: To ensure that medicines and supplies being complained will
be reported anytime.

SCOPE: This SOP applies to complaint made to a certain product.

(Verbal or Written).

RESPONSIBILITIES:

1. Pharmacy aide/ assigned staff- evaluates and does

inventories of product complained.
2. Pharmacist– make report on product being complained.

DEFINITION OF TERMS:

1. Counterfeit– Refers to medicinal products with

correct ingredients but with insufficient quantity of
active ingredients which results in the reduction of
the drug’s safety, quality, strength and purity.
2. Expired or Expiry– Means the date on the label
of food, drug, cosmetic, device or hazardous
substance after which they are not expected to
retain their claimed safety, efficacy and quality or
potency and after which it is no longer permissible
to sell.
3. Mislabeled– Branded or labeled falsely and in
violent of statutory requirements.

PROCEDURE:

1. Evaluate the product complaint and the reason why it

was being complaint.
2. If necessary, replaced the medicines.
2.1 If suspected counterfeit drugs, replaced other kind
of same generic brand but not the product
complained.
2.1.1 If expired, do inventory and report for
proper disposal.
2.1.2 If mislabeled, do inventory and inform
the company.
2.1.3 Collect samples for analysis of BFAD.

2
3. Records product complained and the necessary
information.
4. Retrieved delivery receipt and contact the supplier’s
medical representative or the company concerned.
5. File product complaint’s report for future references.

3
 STANDARD OPERATING PROCEDURE
OF
PRODUCT RECALL
SOP-02

OBJECTIVES: To make sure that recalled products will be pulled out

immediately from the ware house.

SCOPE: This SOP applies to immediate pull out of recalled

medicines and supplies.

RESPONSIBILITIES:

1. Pharmacist– will inform and contact med rep

about the product.
2. Pharmacy aide/ assigned staff- Pull out stocks
from the shelves.
3. Proprietor– Approves the deduction of payments
of products returned.

DEFINITION OF TERMS:

1. Recalled– To request return of the product to the

manufacturer as for necessary repairs
or adjustments.
2. Credit Memo– The deduction of a payment made
by a debtor from an amount due.
3. Product– Something produced by human or
mechanical effort or by natural process.

PROCEDURE:

1. Contact the medical representative or the

distributor of the product being recalled.
2. If confirmed that the product needs to be recalled;
2.1.1 Removed recalled products from the
shelves and placed it in a separate box
or container and label it “RECALLED”.
2.1.2 Contact distributor and inform to pull out
the recalled product.
2.1.3 Recalled products earmarked for
returned to the supplier for investigating
or destruction.

4
3. Secure Credit Memo from the supplier so that the
amount of recalled product will be deducted on the
next payment.
4. Inform the proprietor/cashier of the recalled
products.
5. Post a notice at the bulletin board regarding the
product recalled for the benefit of the general
public.

5
 STANDARD OPERATING PROCEDURE
OF
PROCUREMENT OF STOCKS
SOP-03
OBJECTIVES: To ensure that the medicines and supplies are available at
all times and to purchase stocks only to duly licensed
distributor.

SCOPE: This SOP to the availability of the medicines and supplies

purchase only to duly licensed distributor.

RESPONSIBILITIES:

1. PHARMACIST- Prepare the requisition slip and the

purchase order of medicines and supplies.
- Counter check delivered medicines and
supplies and flies the official receipt and
invoices.
2. Proprietor/Cashier- Review and approve the purchase
order.
3. Assigned Staff- Receives and records the delivered
medicines and supplies.

DEFINITIONS OF TERMS:

1. Requisition- A formal written request for something is

needed.
2. Purchase- To act or an instance of buying.
3. Order- To give an order for; request to be supplied with.
4. Delivery- Something delivered, as a shipment or
package.
5. Biological- A preparation, such as a drug, a vaccine, or
an antitoxin, that is synthesized from living
organism or their products and used medically
as diagnostic, preventive or therapeutic agent.
6. Temperature- The degree of hotness or coldness of a
body or environment.
7. Expiry date- Means the date on the label of the food,
drug, cosmetic, device or hazardous substance
after which they are not expected to retain their
claimed safety, efficacy and quality or potency
and after which it is no longer permissible to
sell them.
8. Manufactured date- The date when the product was
processed or made.

6
 9. Batch Number- Means designation printed on the label
of drug or device that identifies the batch or
group and permits the production history of
the batch including all stages of manufacture
and control, to be traced and reviewed.

PROCEDURES:

1. Pharmacist will prepare requisition slip and or purchase

order for necessary stocks needed at the pharmacy to
duly licensed suppliers and distributors only.
2. Purchase order will be for forwarded to the proprietor or
cashier for approval.
3. Upon approval the pharmacist will do the ordering of the
stocks by either fax or phone.
4. Upon delivery, the assigned Pharmacy Staff together with
the Pharmacist will check the correctness of the stocks
served or delivered with the corresponding purchase
order.
5. Evaluate and countercheck delivered stocks by the
proprietor or cashier.
5.1. Check the lot number, expiry date,
manufactured date and the batch number.
5.2. Display the medicines in he shelves and
cabinets at room temperature.
5.3. For Biological:
5.3.1. Check the temperature devise in the
container.
5.3.2. Temperature should be 2-8 degree
Celsius.
5.3.3. Check for leakage.
5.3.4. Store the stock in a refrigerator with
2-8 degree Celsius.
6. Record delivered stock at record book and post in
designated stock cards.
7. Forward delivery receipt to the Proprietor or Cashier for
accountability of bills.

7
 STANDARD OPERATING PROCEDURES
OF
RETURNED, EXPIRED AND DAMAGED STOCKS
SOP-04
OBJECTIVE: To return expired and damaged medicines and supplies to
respective company and distributor.

SCOPE: This SOP applies to expired and damaged medicines and

supplies returned and replaced y respective company and
distributor.

RESPONSIBILITIES:

1. Pharmacist- Informs the medicinal representative on

nearly expired and damaged medicines and
supplies for return.
- Make a report on return stocks.
2. Pharmacy Aide/Assigned Staff- Monitor the expiration
date of medicines and supplies.
- Pullout medicines and supplies from
the shelves and seal in box by labeling it with
complete details.
3. Proprietor/Cashier- Received credit memo and
approves the disposal of expired medicines
and supplies.
- Deduct the amount of the credit
memo issued by the companies or distributors.

DEFINATION OF TERMS:

1. Returned- The act of bringing or sending something

back to a previous place, condition or owner.
2. Expired or Expiry- The date on the label of the food,
drug, cosmetic, device or hazardous
substances after which they are not expected
to retain their claimed safety, efficacy and
quality or potency and after which it is no
longer permissible to sell.
3. Damaged- Loss of value or the impairment of
usefulness.

8
PROCEDURE:

1. Monitor nearly expired medicines and supplies monthly

by designated pharmacist
2. Inform the medical representative at least three (3)
months before the expiry date.
3. The Pharmacist will do report on expired, returned and
damaged stocks.
3.1. Remove expired and damaged stocks from
the shelves
3.2. Segregate expired and damaged stocks
specification and value.
3.3. Sealed it in box with address to company
and corresponding details.
4. Expired medication and supplies for return will be picked
up by forwarder provided with issued credit memo.
5. Damaged stocks will be returned to the company or
distributor for replacement.
5.1. For expired and damaged stocks that
cannot be pulled out;
5.1.1. For syrups/suspension
bottle/vials- Empty and drained
content in sink.
5.1.2. For tablet/capsules- Flash in the
toilet bowl.
5.1.3. For ampoules/supplies- Crashed
ampoules/supplies and placed in
a plastic bag for proper disposal.

9
 STANDARD OPERATING PROCEDURE
OF
DAILY SALES INVENTORY
SOP-05
OBJECTIVES: To avoid losses of stocks in the pharmacy and to monitor
movements of stocks in terms of sale.

SCOPE: This SOP applied to duly daily monitoring of stocks through

actual inventory done by assigned pharmacy personnel.

RESPONSIBILITIES:

1. Pharmacist– Supervise the billing clerk.

2. Proprietor/Assigned Pharmacy staff – Make actual
inventory of the remaining stocks and check
corresponding stock cards.

DEFINITION OF TERMS:

1. Randomly- Having no specific pattern, purpose or

objective.
2. Inventory– The items listed in such a report or record.
3. Actual– Being, existing or acting at the present moment;
or claims, differences.
4. Proof– The evidence or argument that compels the mind
to accept an assertion as true.

PROCEDURE:

1. The Assigned pharmacy Inventory Staff will randomly

take five to fix stock cards.
1.1. Checks the stock card particularly the
sale of the day.
1.2. Performs an actual inventory of the
stocks.
1.3. The actual count of stocks should be the
same with the number of stocks in the
stock card
2. Record in the ledger the list of medicines and supplies
checked and the number of stocks actually counted
3. If there is discrepancy, the assigned staff and the
pharmacist will hold responsible for the loss the stock.
4. The pharmacist will sign in the ledger as proof that the
inventory is factual and counter signed by the Assigned
Inventory Staff.

10
 STANDARD OERATING PROCEDURE
OF
GOOD STORAGE PRACTICE
SOP-06
OBJECTIVES: To store medicines and supplies in safe, clean and well-
ventilated place.

SCOPE: This SOP covers the proper storage of medicines and

supplies.

RESPONSIBILITIES:

1. Pharmacist– Checks the proper storage of

medicines and supplies.
2. Pharmacy aide/Assigned Staff– Place medicines
and supplies in cabinet, shelves and
storage compartments in orderly manner.

DEFINITION OF TERM:

1. Injectable– Drug or medicines that can be injected.

2. Biological– A preparation, such as drug, vaccine or
an antitoxin that is synthesized from living
organisms or their products and used medically
as a diagnostic, preventive, or therapeutic
agent.
3. Oral Medicines– A preparation of medicines taken
orally.

PROCEDURE:

1. Receive stocks by the Pharmacist.

2. Store stocks in well ventilated place in the pharmacy.
2.1. Injectable and oral medicines – Place
cabinets and shelves.
2.2. Biological – place in the refrigerator with
temperature 2-8 degree Celsius.
2.3. IV Fluids and Bulk Supplies – Place in
the storage compartments and
displaying just enough in the shelves.
3. Maintain cleanliness and orderliness in the pharmacy at
all times.

11
 STANDARD OPERATING PROCEDURE
OF
GARBAGE DISPOSAL and PEST CONTROL
SOP-07

OBJECTIVES: To control and minimize infection at all times.

SCOPE: This SOP covers the daily collection, identification and

disposal of garbage and pest control.

RESPONSIBILITIES:

1. Assigned Staff– Collect and dispose pharmacy garbage

properly.
2. Pharmacist– Dissolve tablets and capsules and empty
liquid medicines.
3. Pest Control Technician– Called in by the Pharmacist
with the knowledge of the proprietor when
there is an occurrence of pest in the
pharmacy’s premises. Spray pesticides and or
insecticides.

DEFINITION OF TERMS:

1. Garbage– Any matter that is no longer wanted or

needed; Trash.
2. Disposal– A disposing of or getting rid of something.
3. Tablets – A flat slab or surface, esp. one bearing or
intended to bear an inscription, carving or the
like.
4. Syrup– A concentrated sugar solution that contains
medication or Flavoring.
5. Vials– A small container, usually with a closure, used
especially for liquids.
6. Pesticides/Insecticides– A chemical used to control
or kill pest and insects.

PROCEDURE:

GARBAGE DISPOSAL

1. Every day, at the closing hour of the warehouse

office the assigned staff collect and dispose the
garbage properly.

12
 1.1. Expired Pharmaceuticals:

1.1.1. Tablet and Capsules – Dissolved in

hot water and flushed down to the
drain.
1.1.2. Syrup/Suspension – Emptied and
flushed down to the drained.
1.1.3. Empty vials and Bottles – Dispose
properly.

PEST CONTROL

1. The Pest Control Technician will be called in to

treat and control infestation of pest insect`.

13
 STANDARD OPERATING PROCEDURE
OF
SANITATION
SOP-8
OBJECTIVE: To produce proper guidelines regarding the cleanliness of
the drugstore.

SCOPE: Within the vicinity of the drugstore and cleaning of the

shelves and good housekeeping.

RESPONSIBILITY:
1. Pharmacist --
2. Pharmacist assistant

PROCEDURE:
1. Use a clean cloth for cleaning the shelves, clean mop with
detergent or bleaching agent in cleaning the floors.
2. Transfer the medicines from the shelves to an empty box.
3. Wipe the shelves and clean it with cloth to remove dust.
4. In case of rigid smudges/stains, use damped cloth to clean them.
5. After completion, place the medicines back to where they belong.
6. Wash and dry up the cloth used in cleaning. Repeat cleaning every
week.
7. Clean the floor with mop.
8. Throw the garbage when the time of collection is near. Do not place
it outside because scavengers might scatter it.
9. Expired Pharmaceuticals:
a) Tablet and capsules – Dissolved in hot water and
flushed down to the drain.
b) Syrup/Suspension – Emptied and flushed down to the
drained.
c) Empty vials and bottles – Dispose properly.
10. The Pest Control Technician will be called in to treat and control
infestation of pest insect.

14
 STANDARD OPERATING PROCEDURE
OF
COLD CHAIN MANAGEMENT
SOP-9
OBJECTIVE: To ensure that proper storage of drugs is strictly observed.

SCOPE: All drug products, especially biological, vaccines and other

drugs, under special temperature condition.

RESPONSIBILITY:
1. Pharmacist--
2. Personnel
3. Forwarder

PROCEDURES:
1. Pharmaceutical Refrigerator/Chillier/ Freezers
a) Strictly requirement and implemented for vaccines,
biological and drug products under cold storage
condition.
b) Monitoring of temperature range and observes
cleanliness.
c) Must be organized and icepack when dispensing or
delivering.
2. Temperature
a) The thermometer must be calibrated and minimum of two
thermometers are needed.
b) Calibration must be done twice a year.
c) Read the thermometer at least twice daily. Properly,
morning and afternoon are the appropriate time or when
the peak of the heat is prevent spoilage of vaccines and
biological product.
d) Have temperature monitoring chart and should be
accomplished by the pharmacist or personnel.
e) Monitor the room temperature twice a day too.
3. Dispensing
a) If the customer’s located is far away, ice cube should be
attached.
b) The drug must be dispensed under regulated and desired
temperature condition.
4. Stocking
a) Should be organized

15
 b) If needed, use some plastic container or plastic wares to
maintain the good appearance of the box and freshness
of the product.
5. Emergency and safety measures
a) Delivered products from the company to the store should
be closely monitored to a maker, specifications and most
importantly the expiration dates of each product to
ensure the safety and welfare of the end users.
b) In case refrigerated drugs are accidentally break such as
ampoules/vials broken pieces should be cleaned and the
person cleaning it must be careful.
c) When power interruption is occurred, electric generation
should be utilized to sustain the ranged temperature of
the drug products, especially the biological and vaccines.
6. Product Returned or Complaint
a) The product must be in proper temperature storage
before returning it.
b) If ever the product is not well-monitored temperature and
storage, the acceptance of the returning drug will be
denied.
c) In case the cold chain is maintained, ask for the receipt
and do the necessary action to make.
7. Product Recall
In the event that product complaints arises, customers are
advised to return the product with the accompanying receipt
for proper inspection and cold chain should be maintained as
the veracity of the complaints.

16
 STANDARD OPERATING PROCEDURE
OF
GOOD DISPENSING PRACTICE
SOP-10
OBJECTIVE:
• To give a professional impression and outlook to the pharmacy.
• To ensure that an effective form of correct medicine is delivered to
the right patient, in the correct dosage or quantity, with clear
instructions and in a package that maintains the potency of the
medicine.

SCOPE: All prescription, generic equivalent drugs and over-the-counter

drugs.

RESPONSIBILITY:
1. Pharmacist—ensure that the prescription is valid, that the
medicine is clinically appropriate for the patient, and that
information is provided to ensure safe and appropriate use of
the medicine.
2. Pharmacist Assistant –- (with the supervision of the
pharmacist) interprets the physician’s requirements on the
prescription and accordingly supplies for the treatment of his
patient/s.

PROCEDURE:
1. Greet a client with a smile.
2. Receive prescription in a dignified manner.
3. Read the prescription properly the name, strength, dose and
quantity. If in case of doubt, ask the pharmacist.
4. Check the legality and legibility of the prescription.
5. If the prescription is illegible of in case of doubt, confirm with the
doctor over the phone. Do not dispense a prescription drug
without a proper prescription over and do not dispense when
doubting.
6. After that check for the availability of the stock and make sure
that the product is one that said in the prescription order. Make
sure that the product is under the good condition and the
expiration date is still far.
7. Give the client the chance to choose what is the cheap but
quality and effective when use.

17
8. Obtain medicines from the gondola, double check if it is the
medicine in the prescription order, and ask for quality to be
bought.
9. Check the product in front of the customer and interpret the
instruction of the doctor to him or give relevant information
regarding the storage, administration etc.
10. Proceed to the billing and official receipt should be issued.

18
 ADVERSE DRUG REACTION FORM
GENERIC NAME
BRAND NAME
DOSAGE STRENGTH
MANUFACTURING
DATE OF PURCHASE
OR NUMBER
QUANTITY
LOT NUMBER
MANUFACTURING DATE
EXPIRY DATE
AIZA PHARMACY ADDRESS

PATIENT COMPLAINT/S: DATE:

Pharmacist’s Signature over Printed Name Patient’s Signature over Printed

Name

19