STANDARD OPERATING

PROCEDURE
(SOP)
Version 01

Prepared by:
REGINE G. SEVILLA
Registered Pharmacist
License no: 0080986
 TABLE OF CONTENTS

SOP No. SOP TITLE PAGE

1 Reporting of Adverse Drug Reaction/ Events 1

2 Good Storage Practices 3

3 Product Complaint 5

4 Cold Chain Management 7

5 Procurement of Stocks 10

6 Product Recall 12

7 Good Dispensing Practices 14

8 Pest control 16

9 Housekeeping and Garbage Disposal 18

10 Transfer of Stocks 20

11 Disposal of Damage, Expired, Returned or 22

Rejected Products

12 Product Return/ Exchange 24

13 Guidelines in Dispensing Generic Medicine 26

 Company: Ananias Ma. Luz Pharma and Medical Supplies Trading

Address:
SOP No. 001 Version 01
Brgy. Salvacion, Palo Leyte, 6501

Supersedes: N/A
Title: SOP on Reporting of Adverse Drug
Attachment: None
Reaction/Events
Effective Date:
JULY 2022

Title: SOP on REPORTING ADVERSE DRUG REACTION/EVENTS

I. PURPOSE: To detect and report possible adverse drug reaction and to properly
address customers concern in case ADR’s occurred

II. SCOPE: Applies to all personnel involved in the implementation and coordination of
ADR of Ananias Ma. Luz Pharma and Medical Supplies Trading. All complaints that
caused from the unusual side effects of drugs that may appear after the clinical studies
of the drug and/or phase IV and that only specific group of individuals can experience
it.

III. RESPONSIBILITY:

1. Pharmacist
2. Pharmacy Assistant

IV. PROCEDURE:

1. Give courtesy greeting to the customer and ask what his concern all about.

2. After hearing the complaint, conduct an interview. The interview should be

personal and private.

3. While interviewing the client, there should be a documentation of it, and if

possible, there must be proof of the adverse reaction of the drug such as pictures
of it, recording of the talk and so on to forth.

4. Ask about his lifestyle and other medicines that he is taking.

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 5. The answers should be true and valid.

6. The ADR should be categorized according to its type and classification.

7. A form must be filled up and let the interviewee sign it to prove that all written
complaints are true and original.

8. Keep the ADR form and report it to the company that involved and to the nearest
FDA office, so that analyses, tests and studies on that event can be performed.

End of SOP

Prepared by: Approved by:

REGINE G. SEVILLA, RPh. ALMIRA S. SABELA

Pharmacist Owner

Page 2 of 30
 Company: Ananias Ma. Luz Pharma and Medical Supplies Trading

Address:
SOP No. 002 Version 01
Brgy. Salvacion, Palo Leyte, 6501

Supersedes: N/A
Title: SOP on Good Storage Practices
Attachment: None
Effective Date:
JULY 2022

Title: SOP on GOOD STORAGE PRACTICES

I. PURPOSE: To retain the safety and efficacy of drugs available in the store

SCOPE: All products that within the drugstore. Should be under specific temperature for
other temperature-sensitive drugs and proper categorized.

II. RESPONSIBILITY

1. Pharmacist
2. Owner/Purchaser
3. Pharmacy Assistant

III. PROCEDURE:

1. After initially checking the medicines delivered, all products should be wrapped
by a clear plastic to avoid accumulation of dust particulates.

2. Transfer the goods to their respective areas.

3. Store the goods in an organized and orderly manner with the label bearing the
name of the product in front.

4. First-Expire-First-Out will be the basis of disposing drugs.

5. Avoid direct contact to the sun or on the walls to avoid moisture accumulation.

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 6. Store controlled drugs substances and other potent drugs in the designated.
Access this area should only be allowed to the pharmacist and owner
7. Store expired goods in the storage room, marking it with “Expired” to prevent use.
8. Store medicines at stipulated temperature areas, protected from excessive light,
dust and humidity. The temperature should be checked by the pharmacist daily
and recorded in the monitoring sheet if necessary for cold chain drugs.
9. Store the other stock in a separated area. Maintain all sales invoice records for
return or exchange of products to the supplier.
10. Clean and maintain the storage areas neat and tidy all the times.

End of SOP

Prepared by: Approved by:

REGINE G. SEVILLA, RPh. ALMIRA S. SABELA

Pharmacist Owner

Page 4 of 30
 Company: Ananias Ma. Luz Pharma and Medical Supplies Trading

Address:
SOP No. 003 Version 01
Brgy. Salvacion, Palo Leyte, 6501

Supersedes: N/A
Attachment: None
Title: SOP on Product Complaint
Effective Date:
JULY 2022

Title: SOP on PRODUCT COMPLAINT

I. PURPOSE: This procedure descries the process to ensure that product manufacture
by the site are documented, evaluated, monitored, reported, and trended in accordance
with regulatory and corporate requirements.

II. SCOPE:

● Complaints are expressed by customer and other involved parties.

● DHO-FDA or local regulator body has authority to review actual complaint and
other related cases.

● This procedure is applied in a case to case basis only.

III. RESPONSIBILITY:

● Pharmacist

● Owner/Manager

● Pharmacy Assistant

IV. PROCEDURE:

1. Upon receiving the complaint, the pharmacy assistant immediately calls the

attention of the pharmacist.

2. Ask the complainant for the official receipt to ensure that the product was bought

in the drugstore.
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 3. The pharmacist will ask for details regarding the complaint. An interview shall be

imposed.

4. Check the batch no., expiry date and condition of the medicine.

5. Have a record of the complaint.

6. If the complaint is justified the following will be done:

7. Investigate proper action to prevent recurrence.

8. Replace or refund the money.

9. Inform the supplier.

10. If the complaint is not justified, advice the customer about the findings.

11. Submit a report to the authority.

End of SOP

Prepared by: Approved by:

REGINE G. SEVILLA, RPh. ALMIRA S. SABELA

Pharmacist Owner

Page 6 of 30
 Company: Ananias Ma. Luz Pharma and Medical Supplies Trading

Address:
SOP No. 004 Version 01
Brgy. Salvacion, Palo Leyte, 6501

Supersedes: N/A
Attachment: None
Title: SOP on Cold Chain Management
Effective Date:
JULY 2022

Title: SOP on COLD CHAIN MANAGEMENT

I. PURPOSE:

1. To ensure that proper storage of drugs is strictly observed.

2. Provide proper equipment that will maintain the stability and efficacy of drugs.

3. Unbroken temperature storage, maybe transit or shipment, must be achieved.

II. SCOPE:

● All drugs products, especially biological, vaccines and other drugs, under special
temperature condition.

III. RESPONSIBILITY:

● Pharmacist

● Personnel

● Forwarder

IV. Procedure:

1. Pharmaceutical Refrigerator/Chiller/Freezers

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● Strictly requirement and implemented for vaccines, biological and drug products
under cold storage condition.

● Monitoring of temperature range and observed cleanliness.

● Must be organized and icepack when dispensing or delivering.

2. Temperature

● The thermometer must be calibrated and minimum of two thermometers are

needed. Calibration must be done twice a year.

● Read the thermometer at least twice daily. Probably, morning and afternoon are
the appropriate time or when the peak of the heat is to prevent spoilage of
vaccines and biological products

● Have temperature monitoring chart and should be accomplished by the

pharmacist or personnel

● Monitor the room temperature twice a day too.

3. Dispensing

● If the customer's location is far away, ice pack should be attached.

● The drugs must be dispensed under regulated and desired temperature condition.

4. Stocking

● Should be organized.

● If needed, use some plastic containers or plastic wares to maintain the good
appearance of the box and freshness of the product.

5. Emergency and Safety measures

● Delivered products from company to the store should be closely monitored as to

maker, specifications and most importantly the expiration dates of each products
to ensure the safety and welfare of the end users.

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 ● In case of refrigerated drugs are accidentally break such as ampules/vials,
broken pieces should be cleaned and the person clearing it must be careful.

● When power-interruption is occurred, electric generator should be utilized to

sustain the ranged temperature of the drug products, especially the biological
and vaccines.

6. Product Returned or Complaint

● The product must be in proper temperature storage before returning it.

● If ever the product is not in well-monitored temperature and storage, the

acceptance of the returning drug will be denied.

● 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 arise, customers are advised to return the
product with the accompanying receipt for proper inspection and cold chain
should be maintained as the the veracity of the complaints.

Quality of Record:

● Systematic actions necessary to ensure adequate confidence that the product

and documentation will satisfy the requirements for quality assurance.

● Temperature monitoring chart should be checked frequently to sustain the

stability of the drug.

End of SOP

Prepared by: Approved by:

REGINE G. SEVILLA, RPh. ALMIRA S. SABELA

Pharmacist Owner

Page 9 of 30
 Company: Ananias Ma. Luz Pharma and Medical Supplies Trading

Address:
SOP No. 005 Version 01
Brgy. Salvacion, Palo Leyte, 6501

Supersedes: N/A
Title: SOP on Procurement of Stocks
Attachment: None
Effective Date:
JULY 2022

Title: SOP on PROCUREMENT OF STOCKS

I. PURPOSE: To provide proper guidelines in procuring of stocks.

II. SCOPE: Applied to all products

III. RESPONSIBILITY

● Pharmacist
● Owner/Manager
IV. PROCEDURE:

1. The procurer will make an order through phone, SMS, facsimile, sales
representative and other media.

2. There should be a copy or list of the products to facilitate checking of them when
delivered.

3. Upon delivery of the product, check the product's count, amount, batch no. and
make sure that the expiry date is very far to make sure the product is safe and
effective.

4. The procurer will pay the delivery man and ask for official receipt and copy of the
sales invoice and filed them.

5. The procurer will price the product through an acceptable price mark-up.

6. The product will then display and ready to be sold.

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 V. QUALITY OF RECORDS:

The purchaser will file the invoice for future use and other case.

End of SOP

Prepared by: Approved by:

REGINE G. SEVILLA, RPh. ALMIRA S. SABELA

Pharmacist Owner

Page 11 of 30
 Company: Ananias Ma. Luz Pharma and Medical Supplies Trading

Address:
SOP No. 006 Version 01
Brgy. Salvacion, Palo Leyte, 6501

Supersedes: N/A
Attachment: None
Title: SOP on Product Recall
Effective Date:
JULY 2022

Title: SOP on PRODUCT RECALL

I. PURPOSE: To carry out an effective method of removing or connecting violative

products that may represent a health hazard to the customer or user.

II. SCOPE: All products that are subjected to be recalled under the DOH-FDA
declaration.

III. RESPONSIBILITY:

● Pharmacist

● Owner

IV. PROCEDURE

1. The pharmacist is important person to accomplish this task.

2. The distributor company will inform the drugstore about the product recall
through a Product Recall Letter* containing the details of product/s to be recalled.

3. The pharmacist must be particular on the batch no or lot no of the product that is
being recalled from the market to facilitate removal of stock in the shelves and
the store.

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 4. After the batch no has been checked, see to it that the product is removed from
the shelves so that it will not be sold anymore.

5. Coordinate to the supplier when will be the product withdrawn.

6. Wait for further pronouncement of the recall to be updated.

End of SOP

Prepared by: Approved by:

REGINE G. SEVILLA, RPh. ALMIRA S. SABELA

Pharmacist Owner

Page 13 of 30
 Company: Ananias Ma. Luz Pharma and Medical Supplies Trading

Address:
SOP No. 007 Version 01
Brgy. Salvacion, Palo Leyte, 6501

Supersedes: N/A
Attachment: None
Title: SOP on Good Dispensing Practices
Effective Date:
JULY 2022

Title: SOP on GOOD DISPENSING PRACTICES

I. PURPOSE: To provide standard operating procedure for Dispensing Prescription

Drugs.
To insist use of generic equivalent drugs which are cost-effective in nature.

II. SCOPE: All prescriptions, generic equivalent drugs and Over-The-Counter drugs.

III. RESPONSIBILITY
● Pharmacist
● Pharmacy Assistant

IV. PROCEDURE

1. Greet the client with a smile.

2. Receive the 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.

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 5. If the prescription is illegible of in case of doubt, confirm with the doctor over
phone. Do not dispense a prescription drug without a proper prescription order
and do not dispense when doubting.

6. After that check for the availability of the stock and make sure that the product is
the 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 cheapest but quality and
effective when use.

8. Obtain the medicines from the gondola, double check if it is the medicine in the
prescription order, and ask for the quantity 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
and etc.

10. Proceed to the billing and an official receipt should be issued.

End of SOP

Prepared by: Approved by:

REGINE G. SEVILLA, RPh. ALMIRA S. SABELA

Pharmacist Owner

Page 15 of 30
 Company: Ananias Ma. Luz Pharma and Medical Supplies Trading

Address:
SOP No. 008 Version 01
Brgy. Salvacion, Palo Leyte, 6501

Supersedes: N/A
Attachment: None
Title: SOP on Pest control
Effective Date:
JULY 2022

Title: SOP on PEST CONTROL

I. PURPOSE: The purpose of the SOP is to describe the processes and procedures
used at Ananias Ma. Luz Pharma and Medical Supplies Trading to support Pest
Control System.

II. SCOPE: Ananias Ma. Luz Pharma and Medical Supplies Trading

III. RESPONSIBILITY:

● Pharmacist
● PA
● Owner
● Agency for Pest Control

IV. PROCEDURE

1. Nature of Service

- Applied by spray as a suspension of a wet table powder to floor only,

placing particular emphasis to cracks and services.
- Care must be exercised to avoid over-spray onto shelves and medicine
cabinets
- Spraying of insecticides must be implemented twice a month

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 2. Frequency

- To be conducted on a quarterly basis and when a need is identified, or

when infestation is possible.
3. Location

- Only the High and Low Storage areas are considered as suitable for this
type of spraying. Should a need should arise in other areas, e.g. office,
this will evaluate separately.

End of SOP

Prepared by: Approved by:

REGINE G. SEVILLA, RPh. ALMIRA S. SABELA

Pharmacist Owner
Page 17 of 30
 Company: Ananias Ma. Luz Pharma and Medical Supplies Trading

Address:
SOP No. 009 Version 01
Brgy. Salvacion, Palo Leyte, 6501

Supersedes: N/A
Attachment: None
Title: SOP on Housekeeping and Garbage
Disposal Effective Date:
JULY 2022

Title: SOP on HOUSEKEEPING AND GARBAGE DISPOSAL

I. PURPOSE: The purpose of this SOP is to describe the process and procedure used
in Three J Pharmacy to maintain the cleanliness and orderliness of the store.

II. SCOPE: Within the vicinity of the drugstore and cleaning of the shelves and good
housekeeping.

III. RESPONSIBILITY:

● Pharmacist

● Pharmacy Assistant

IV. 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.

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 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. Try to search for pest and make necessary action to eliminate them.

End of SOP

Prepared by: Approved by:

REGINE G. SEVILLA, RPh. ALMIRA S. SABELA

Pharmacist Owner

Page 19 of 30
 Company: Ananias Ma. Luz Pharma and Medical Supplies Trading

Address:
SOP No. 010 Version 01
Brgy. Salvacion, Palo Leyte, 6501

Supersedes: N/A
Attachment: None
Title: SOP on Transfer of Stocks
Effective Date:
JULY 2022

Title: SOP on TRANSFER OF STOCKS

I. PURPOSE: To set standard of transfer of items from store to another store

II. SCOPE: Ananias Ma. Luz Pharma and Medical Supplies Trading

III. PROCEDURE:

1. Requesting store will inform IM via email of the intention to request stocks
from issuing stores.

2. List down the items being requested

3. IM, upon receipt of the email of request, will forward the same to issuing
store to check availability of the subject items. If ok, the IM will reply
approval of the transfer request.

4. Requesting store, once received the approval of IM will prepare P.O of the
items approved for transfer and send the same to IM.

5. IM, after receipt of the P.O will give go-signal to the issuing store to
prepare the goods for pick up by requesting store. IM will process P.O
post dr. and forward to warehouse for sales invoice posting.

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 6. Issuing store, after receipt of the go-signal from IM, then will transact “misc
withdrawal store to warehouse” to document the transfer, then release the
items to requesting store.

7. IM, will transact “misc receiving” of the items transacted by issuing store
under “misc withdrawal”, for cm issuance and to document the receipt of
the items transferred by issuing store

End of SOP

Prepared by: Approved by:

REGINE G. SEVILLA, RPh. ALMIRA S. SABELA

Pharmacist Owner

Page 21 of 30
 Company: Ananias Ma. Luz Pharma and Medical Supplies Trading

Address:
SOP No. 011 Version 01
Brgy. Salvacion, Palo Leyte, 6501

Supersedes: N/A
Title: SOP on Disposal of Damage, Expired,
Attachment: None
Returned or Rejected products
Effective Date:
JULY 2022

Title: SOP on DISPOSAL OF DAMAGE, EXPIRED, RETURNED OR REJECTED

PRODUCTS

I. PURPOSE: To execute the disposal of damage, expired, returned or rejected

products.

II. SCOPE: Products that are expired, damaged, rejected or returned by customers due
to defect.

III. RESPONSIBILITY

● Pharmacist

● Owner/Manager

● Pharmacy Assistant

IV. PROCEDURE

1. Pharmacy assistants are assigned to a specific shelf for checking near expired
drugs. Nearly expiry drugs that are 3 months before to expire shall be removed.

2. Checking expiry date shall be done every month and shall be recorded and
inventoried.

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 3. Pharmacist will ask the attention of the supplier to return nearly expire drugs,
damaged, returned and rejected so that the product will be pulled-out and
disposed.

4. When the supplier cannot accept anymore the product. The pharmacy must then
dispose the products in an environmental conscious way. It can be done by
coordinating to the garbage collector for proper disposal.

End of SOP

Prepared by: Approved by:

REGINE G. SEVILLA, RPh. ALMIRA S. SABELA

Pharmacist Owner

Page 23 of 30
 Company: Ananias Ma. Luz Pharma and Medical Supplies Trading

Address:
SOP No. 012 Version 01
Brgy. Salvacion, Palo Leyte, 6501

Supersedes: N/A
Attachment: None
Title: SOP on Product Return/Exchange
Effective Date:
JULY 2022

TITLE: SOP on PRODUCT RETURN/EXCHANGE

I. PURPOSE: To set standard on the return/exchange of items from customers

II. SCOPE: Ananias Ma. Luz Pharma and Medical Supplies Trading

III. RESPONSIBILITY:

● Pharmacist
● Owner
● Pharmacy Assistant

IV. PROCEDURE:

1. Check the Official Receipt and the erring items the customer intends to
return/exchange. Return and exchange can only be processed in the
presence of original OR. The official receipt is the best proof of purchase.
However, he/she may still demand replacement or refund if he/she can
prove that a defective item was bought from a certain store.
2. Biological items such as vaccines, refrigerated items and loose items not
in original packaging are not acceptable for return/exchange of potency
precautionary measures.
3. Check items if still in good condition such as, foils/blisters/ boxes are not
crumpled

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 4. If the defect is due to mishandling on the part of buyer, he or she could not
return the item and demand am exchange or refund as the prohibition
covers only the hidden defects and shoddy products.
5. If above items have been met, process the return/exchange using the
POS.
6. Record the transaction in the logbook for reference purposes.

End of SOP

Prepared by: Approved by:

REGINE G. SEVILLA, RPh. ALMIRA S. SABELA

Pharmacist Owner

Page 25 of 30
 Company: Ananias Ma. Luz Pharma and Medical Supplies Trading

Address:
SOP No. 013 Version 01
Brgy. Salvacion, Palo Leyte, 6501

Supersedes: N/A
Attachment: None
Title: Guidelines in Dispensing Generic
Medicine Effective Date:
JULY 2022

Title: GUIDELINES IN DISPENSING GENERIC MEDICINE

I. PURPOSE: To provide a safety mechanism as it ensures independent review of a

prescription occurs prior to the commencement of treatment

II. SCOPE: Ananias Ma. Luz Pharma and Medical Supplies Trading

III. RESPONSIBILITY:

● Pharmacist
● Pharmacy Assistant

IV. PROCEDURE:

1. Accept and check prescription details

● Prescriber and patient details
● Confirm items to be dispensed
● Preference for generic medicine
2. Script Validity
● Meets legal requirements
3. Safety and appropriateness
● Safe dosage
● Appropriateness of prescription for age, weight etc.
4. Select product
● Appropriate drug and quantity

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 ● Prepare where needed (reconstitute or compound from raw ingredients) -
Pharmacist
5. Dispensing check
● Correct drug, brand, strength form, and quantity
● Correct formula/methodology to compound products
6. Label and assemble dispensed products
● Review expiry, instructions and cautionary labels
● Complete documentation and records
● Organize counseling aids
7. Return prescription to patient
● Correct patient
● Correct medicines
8. Counsel patient for sale and appropriate use

End of SOP

Prepared by: Approved by:

REGINE G. SEVILLA, RPh. ALMIRA S. SABELA

Pharmacist Owner
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