Westmin Pharmacy - SOP

STANDARD OPERATING PROCEDURES Document No.
HANDLING OF PRODUCT RECALL Revision No.

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Revision History
Revision Prepared by: Reviewed by: Approved by:
1 Patricia Anne R. Camandang Patricia Anne R. Camandang Patricia Anne R. Camandang
Issue No.:
1
Effective Date: November 2, 2018
1. PURPOSE
To remove or correct marketed products including their labelling and promotional literature, that in
presents a risk or injury or gross deception or otherwise deceptive which case violates the law
administered by FDA.
2. RESPONSIBILITY
Pharmacist
Pharmacy Assistant
3. DEFINITION OF TERMS
Class I Recall is a situation in which there is a reasonable probability that the use or exposure to
violative product will cause serious adverse health consequence or death. Notices and warnings shall be
issued by the tri media to the general public health professionals, health institutions, industry
associations, distribution outlets for such products and all other concerned parties.
Class II Recall is a situation in which use or exposure to a violative product may cause temporary or
medically reversible adverse health consequence or where the probability of serious adverse health
consequence is remote. Notices and warnings shall be issued to: 1.) group or institutions that are
identified as those generally use or are exposed to the product and 2.) those who could help to remove
such violative products from the market or prevent such product from being used.
Class III Recall is a situation in which the use or exposure to a violative is not likely to cause adverse
health consequences. Notices and warnings shall be issued to concerned parties and distribution outlets.
4. PROCEDURE
The following informat on shall be submitted to FDA:
For a firm initiative Recall
- Identify the product involved

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Revision History
Issue No.:
1
- Reason for the removal or correction on the date and circumstances under which the product
Deficiency or possible deficiency was discovered
- Evaluation of the risk associated with the deficiency or possible deficiency
Total amount of such product produced
Total estimated dispensed amount of such product

A copy of firm recall communication if any has been issued or a proposal communication if has
been issued.
Name and telephone number of the official who should be conducted concerning recall.
For FDA initiated recall:
Upon the receipt of the recall order from FDA, the firm shall response by submitting to FDA a
recall plan and other information listed in the firm initiated recall.
4.1 FDA and/or the recalling firm shall develop a recall strategy suitable for individual recall circumstances.
The following elements shall be included in a recall strategy
Depth of Recall – depending on the products degree of hazard and extent of distribution, the
recall strategy will specify the level in the distribution chain which the recall is extend.
Public Alert Warning to be issued by the recalling firm – the purpose is to alert the public that the
product being recalled present a serious hazard to health.
Effectiveness Checks – the purpose is to verify that all consignees at the recall depth specified by
the strategy have received notification about the recall and have taken appropriate action.
In developing a recall strategy, the duration to complete the recall operation should also be
considered. Completion of recall operation should be within the following period:
Class I Recall 7 days
Class II Recall 15 days
Class III Recall 30 days

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Revision History
Issue No.:
1
4.2 Periodic recall status reports shall be submitted to FDA. The frequency of such reports will be
determined by the relative urgency of the recall and will be specified by the FDA in each recall
case, generally the reporting interval will be between 2 and 4 weeks.
4.3 Upon completion of the recall procedure, the concerned drugstore shall notify the FDA of the final
disposition of the product. If the product is to be destroyed, the destruction shall be done in the
presence of FDA representative or if the product should be returned to its supplier.
5. END OF DOCUMENT
HANDLING OF RETURNED, EXPIRED AND Revision No.
DAMAGED PRODUCTS Page of: 1 of 1
Revision History
Issue No.:
1
1. PURPOSE
a. To be able to properly handle expired, damaged products.
2. SCOPE
a. Returned, expired and damaged products.
3. RESPONSIBILITY
a. Pharmacist
4. PROCEDURE
a. Check the record of the products.
b. Take unused, returned, damaged and expired drugs from the display or gondolas.
c. List down all the products that are damaged and expired on a pull-out form and put in a
separate box.
d. All the returned products must be properly listed and identify the cause of its return.
e. Return all the damaged and expired drugs to the supplier.
5. END OF DOCUMENT
CLEANING AND GARBAGE DISPOSAL Revision No.
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Revision History
Issue No.:
1
1. PURPOSE
a. Provide its immediate environment, a system for the timely cleaning and prevention of
infestation inside the drugstore.
2. RESPONSIBILITY
a. Personnel (Pharmacy Assistant)
3. PROCEDURE
a. SANITATION
3.1 The personnel shall be assigned in an area of responsibility of maintaining cleanliness.
Cleaning shall be conducted every morning prior to drugstore hours. The following shall
be observed:
3.1.1 Wipe off tables, cabinets, shelves, etc using clean damp clothes or others
3.1.2 Sweep off the floor. Make sure that all dust and trashed are collected.
3.1.3 Mop the floor using water with soap.
3.1.4 Cleaning of air ventilation like electric fan must be done at least twice a month
to maintain good functioning.
3.1.5 A general cleaning of the drugstore must be conducted once a month.
3.1.6 The comfort rooms must always be maintained clean.
3.1.7 There must be assigned area for keeping of all cleaning materials.
GARBAGE COLLECTION AND DISPOSAL
3.2 Personnel: All garbage must be disposed every after store hours. For trash removal,
the following procedures must be observed:
3.2.1 All garbage accumulated during the day shall be properly placed inside the
garbage bad and deposited on the garbage chute.
3.2.2 No dumping of rejected or outdated product into the garbage container will be
allowed.
PROPER STORAGE OF PURCHASE STOCKS Revision No.
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Revision History
Issue No.:
1
1. PURPOSE
a. This SOP shall cover detailed guidelines of proper storage of purchase stocks.
2. RESPONSIBILITY
a. Pharmacist
b. Pharmacy Assistant
3. PROCEDURE
3.1 All the delivery receipt of the incoming stocks shall be complied and stored by the officer-in -
charge. DR includes delivery date, quantity, lot/batch numbers, manufacturing dates, expiray
dates and delivery reference number.
3.2 All stocks should be properly arranged alphabetically according to its category, and it should
be properly labelled to avoid mixed-ups.
3.3 All stocks should be properly stored in a well-ventilated room.
3.4 All products shall be released according to first expiry, first out policy to avoid having
expiration products or near expiry products.
3.5 A separate place must be assigned for rejected products.
3.6 Proper housekeeping and sanitary conditions must be observed at all times.
4. END OF DOCUMENT
PROCUREMENT OF PRODUCTS Revision No.
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Revision History
Issue No.:
1
1. PURPOSE
a. To procure products on legal and authorized company.
2. SCOPE
a. Procurement of stocks thru centralized distribution.
3. RESPONSIBILITY
a. Pharmacist
4. PROCEDURE
a. Check the availability of the products from the gondolas and product record.
b. List down products that are low in quantity and fast moving.
c. Send purchase order to the main branch.
5. END OF DOCUMENT
GUIDELINES FOR RECEIVING GOODS Revision No.
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Revision History
Issue No.:
1
1. PURPOSE
a. This SOP shall covered detailed guidelines for receiving goods.
2. RESPONSIBILITY
a. Pharmacist
3. PROCEDURE
3.1 Pharmacist receives delivery receipts and sales invoice of products. Checks each box for
completeness, quality, expiration date, lot/batch number.
3.2 Rejected goods are set aside and are returned to the manufacturer/supplier delivery
personnel for replacement.
3.3 After accomplishes the receiving from base of the actual quantity of the finished goods
received except rejected goods if there are any. Received goods are stored in its designated areas.
3.4 Delivery receipts, sales invoice, receiving reports forwarded to the pharmacist for making an
acceptance for her files, and then for posting or encoding of the products.
3.5 The pharmacist forwarded the said receipts to the operation manager for payment.
4. END OF DOCUMENT
GUIDELINES FOR DISPENSING Revision No.
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Revision History
Issue No.:
1
1. PURPOSE
a. To ensure the safe and accurate dispensing of drug prescriptions.
2. SCOPE
a. Covers the procedure for receiving and dispensing drug prescriptions.
3. RESPONSIBILITY
a. Pharmacist
b. Pharmacy Assistant
4. PROCEDURE
a. Receive the prescription from the customer.
b. Check the prescription for the correct information, such as, name of the patient, age,
gender, name of the physician, contact number of the physician, medication (generic
name, brand name, dosage form and strength), and date of prescription.
c. Check the availability of the drug in the selling area. If the medicine is available, give the
customer the generic menu card and allow the patient to choose from the available
medicines.
d. When the patient has chosen what brand he wants to avail, give the price to the customer.
Ask him/her if he wants his prescription to be filled or not.
e. Get the payment from the customer.
f. Prepare the items that the customer bought.
g. Check the items and the change (if any) in front of the customer.
h. If the prescription is fully filled, get the prescription and keep it for filing. Record the
prescription in the prescription book. If the prescription is partially filled, deduct the
quantity that the patient bough from the quantity written in the prescription and return
prescription to the patient.
5. END OF DOCUMENT
PHARMACOVIGILANCE Revision No.
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Revision History
Issue No.:
1
1. PURPOSE
To determine and report to the government agency (FDA) the adverse drug reaction
whether drugs, biological, diagnostic agent, natural product or nutritional agents.
2. RESPONSIBILITY
Pharmacist
3. CLASSIFICATION OF ADVERSE DRUG REACTION
Class A type are common and predictable with most identified prior to marketing. They
are those related and result directly from pharmacological action of the drug, but can be due to
drug-drug interactions, drug-food interactions or concomitant illness as well. They are common
and have high morbidity. They have usually low mortality, ex. A type - a reaction includes
hypoglycemina for oral sulfonyl ureas, tachycardia from albuterol or diarrhea from the antibiotic.
Class B type are uncommon, cannot be predicted and are not dose-related and have
no relation to the pharmacological action of the drug. The mechanism involve in type B reactions
are unknown. Although rare on occurrence, mortality from type B reaction can be high. These
reactions predominantly affect the liver, skin, hemapoetic system. Include hypersensitivity
reaction such as anaphylaxis from penicillin, idiosyncracy reaction such as malignant
hyperthermal from antipsychotic and pseudoallergenic reaction. May be influence by genetic and
environmental factor and are frequently not discovered until after a drug is marketed.
Class C type are common dose and time-related and associated causing adrenal
suppression and benzodiazepine dependence.
Class D type are rare delayed in onset and are usually dose-related, ex. Includes
carcinogenesis are tardive dyskinesia for antipsychotic agent
Class E type are withdrawal symptoms. These generally occurs shortly after stopping
the drug and are uncommon, opiates withdrawal is an example of this reaction.
Class F type is an expected failure of therapy. These reaction is uncommon, dose
related and may result from drug-drug interaction. Note that the type F may not be considered
as adverse drug reaction.
4. METHOD OF MONITORING AND REPORTING

Several methods for detecting adverse drug reactions:
PHARMACOVIGILANCE Revision No.
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Revision History
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1
a. Retrospective chart review – one which review the details of all medicine taken from the
very beginning to the last intake.
b. Concurrence surveillance – one in which concurrently the medicine intake
c. Prospective monitoring – one in which particular monitor medicine intake.
System for evaluation reaction for severity, casualty and preventability

a. Once reported and an adverse reaction evaluated the severity
b. Determining the casualty of the drug reaction
c. Prevention first
Safety and efficacy data (a system for using the result of the ADR Program)
Phase I are generally focused on the drug safety. Studies are usually conducted in healthy
volunteers and assesses the most common acute side effects and evaluate the size of doses
subject can safely take without a high frequency of adverse reaction.
Phase II trials involve small numbers of patients with the disease to be treated.
Although the primary focus of these trials are efficacy. Safety data on short term used are also
gathered.
Phase III trials involve several hundred to several thousand patient with the primary goals
of confirming drug efficacy and safety at the doses to be used once the drug is marketed.
Upon completion of this trial/program, the concerning company shall notify to FDA of the
final disposition of the trials.
5. END OF DOCUMENT

Westmin Pharmacy - SOP

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STANDARD OPERATING PROCEDURES Document No.

HANDLING OF PRODUCT RECALL Revision No.

The following informat on shall be submitted to FDA:

For a firm initiative Recall

- Identify the product involved

Deficiency or possible deficiency was discovered

- Evaluation of the risk associated with the deficiency or possible deficiency

Total amount of such product produced

Total estimated dispensed amount of such product

For FDA initiated recall:

Class I Recall 7 days

Class II Recall 15 days

Class III Recall 30 days

GARBAGE COLLECTION AND DISPOSAL

4. METHOD OF MONITORING AND REPORTING

System for evaluation reaction for severity, casualty and preventability

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