Compliance Toolkit SOP Index

N.B REMMBER TO PRINT AND INSERT

PHARMACY & OWNER NAMES ON EACH SOP

1. Introduction , Reviewing & Updating SOP’s

2. SOP 1 : Good House Keeping
3. SOP 2 : Daily Routines & Working Hours
4. SOP 3 : Enquiry Or Complaint Procedures
5. SOP 4 : Pest, Rodent, Insects, etc Elimination Procedure
6. SOP 5 : Effective Stock Rotation
7. SOP 6 : Stocktaking
8. SOP 7 : Disposal or Removal Of Damaged or Expired Stock
9. SOP 8 : Obsolete & Unusable Products
10. SOP 9 : Special Storage & Handling Instructions
11. SOP 10 : Separation & Handling of Goods Returned From Patients
12. SOP 11 : Recall Of Medicine
13. SOP 12 : Delivery Of Medicine
14. SOP 13 : Receipt Of Stock
15. SOP 14 : Storage Of Medicine
16. SOP 15 : Procurement Of Medicine
17. SOP 16 : Handling Of Product Complaints
18. SOP 17 : Pre-Packing
19. SOP 18 : Procedure For A Locum/Relief Pharmacist
20. SOP 19 : Handling Of Schedule 5 & 6 Medicines
21. SOP 20 : Cold Chain Management & Refrigerator Power Failure

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

SOP’S REVIEWED AND UPDATED

REF NO: SOP 26

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO ENSURE SOPS ARE REGULARLY REVIEWED AND UPDATED

PROCEDURE:

1) GENERAL
1.1) All SOPS will be reviewed once a year, as per date on each SOP
1.2) The Responsible Pharmacist is responsible for maintaining and updating
SOPS, with the input of the Shop Manager, Store Manager and any other
essential staff members
1.3) If any changes need to be made to an SOP before the annual anniversary of
the SOP, these need to be brought to the attention of the Shop Manager
and/or Store Manager and the Responsible Pharmacist
1.4) SOPS will be updated by the Responsible Pharmacist if deemed necessary
and productive
1.5) Once SOPS have been updated, it must be distributed amongst the relevant
staff
1.6) Staff must legibly sign the back of the updated SOP, along with the date.
1.7) This updated SOP must be filed in the SOP file, stapled on top of the out-
dated SOP
1.8) The SOP file must be made available to all staff at all times

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

GOOD HOUSE KEEPING

REF NO: SOP 1

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO ENSURE REGULAR, SUPERVISED CLEANING PROCEDURE IN THE

PHARMACY

PROCEDURE:

1) GENERAL
1.1) Cleaning will be conducted by the cleaners and supervised by the manager
1.2) Supervised cleaning must be conducted daily
1.3) Cleaners must wear suitable clothing
1.4) Cleaning to follow the Cleaning Roster
1.5) All dustbins must be emptied before the end of each day
1.6) No eating or drinking on the shop floor
1.7) All computers and telephones are to be kept dust-free
1.8) Toilet facilities and all basins must be cleaned daily with suitable cleaning
products

2) DISPENSARY
2.1) All working surfaces and floors in the dispensary must be cleaned every day
2.2) All dispensary shelves must be wiped or dusted at least once a week
2.3) After use, all dispensing equipment must be cleaned to ensure that no
residue remains ie. Ointment slabs, measuring cylinders, scales, mortar and
pestle
2.4) Pill counters and pill cutters should be wiped between uses to ensure no
cross-contamination
2.5) All computers and telephones are to be kept dust-free
2.6) Expired stock must be removed for destruction (See SOP 7)

3) FRONT SHOP
3.1) All flooring is to be vacuumed or swept daily, and mopped with appropriate
cleaning products once a week.
3.2) All shelving must be wiped or dusted at least once a week and kept in a tidy
manner
3.3) Expired stock must be removed for destruction (see SOP 7)

4) STAFF ROOM/KITCHEN AREA

4.1) All crockery and utensils must be cleaned and put away before the end of the
day
4.2) Staff refrigerator must be cleaned out once a week and defrosted and
cleaned once a month

NAME OF PHARMACY OWNER

th
DATE: 9 September 2017
th
REVIEW DATE: 9 September 2018
PHARMACY NAME :

STANDARD OPERATING PROCEDURES

DAILY ROUTINE AND WORKING HOURS

REF NO: SOP 2

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO ENSURE PROPER PROCEDURES IN TERMS OF DAILY ROUTINE

PROCEDURE:

1) WORKING HOURS
1.1) The pharmacy is open during the following hours: (Pharmacy manager to
insert hours)
Weekdays
Saturdays
Sundays
Public Holidays
1.2) Staff Hours are set according to a schedule as set out by the manager.
This schedule is subject to change, with coordination between the staff
member and the manager.
All leave is to be planned, with at least a month’s notice.
The manager is to be notified as soon as possible should there be any
illness, accidents, emergencies or Family Responsibility requests

2) DAILY ROUTINE – OPENING

2.1) Opening in to be done by the Key Holder on duty
2.2) Alarm to be switched off
2.3) All lights, computers, tills, air conditioners (if needed) to be switched on
2.4) Phone must be switched from Night service to Day service
2.5) Dispensary staff and Front shop staff must report to their stations
2.6) Cleaning is to commence as per SOP 1

3) DAILY ROUTINE - CLOSING

3.1) All computers to be shut-down
3.2) Phone to be switched from Day service to Night Service
3.3) Ensure all doors and windows are locked
3.4) All lights, computers, tills, air conditioners (if needed) to be switched off
3.5) Alarm must be set and the Key Holder to lock up

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

ENQUIRY OR COMPLAINT PROCEDURE

REF NO: SOP 3

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO ENSURE THAT ALL PATIENT / CUSTOMER ENQUIRIES OR

COMPLAINTS ARE HANDLED APPROPRIATELY IN THE PHARMACY

PROCEDURE:

1) GENERAL
1.1) All staff must be aware of all procedures when dealing with a customer
complaint or enquiry.
1.2) Enquires and complaints will be handled by the appropriate staff concerned.
1.3) All details of the enquiry or complaint must be recorded in the
Complaints/Enquiry book – Customer’s name, phone number, nature of
complaint/enquiry.
1.4) The complaint/enquiry must be directed to the correct person to attend to
and resolve.
1.5) The customer must be informed timeously of the outcome of the
complaint/enquiry.
1.6) The outcome must be recorded in the Complaints/Enquiry book for future
reference.
1.7) The Complaints/Enquiry book will be reviewed by the Responsible
Pharmacist on a monthly basis, and may be subject to in-house training
during the next staff meeting.

2) ENQUIRIES
2.1) All medicine/prescription enquiries must be directed to Dispensary staff
2.2) Front shop product availability enquiries must be directed to the person
responsible for that particular product range, or to the pharmacy buyer

3) COMPLAINTS
3.1) Complaints must be directed to the Pharmacist in charge or the Manager
immediately

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

PESTS (INSECTS, RODENTS, ETC) ELIMINATION

REF NO: SOP 4

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO AVOID CONTAMINATION AND DAMAGE OF STOCK DUE TO PESTS

PROCEDURE:

1) GENERAL
1.1) Pharmacy must be sprayed and treated as per contract every three months
through a suitable pest control company
1.2) All staff to be on alert for any signs of pest infestation, and should any be
seen, it must be reported immediately to the Responsible Pharmacist or
Manager, and the pest control company is to be notified
1.3) The pharmacy is to be kept clean and dusted as stated in SOP 1
1.4) No food is allowed in the dispensary, the front shop or in the storeroom at any
time
1.5) No dirty dishes or utensils to be left in the kitchen overnight
1.6) Staff lockers to be checked once a month for evidence of pest infestation and
appropriate action to be taken if such evidence is found.

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

EFFECTIVE STOCK ROTATION (FEEFO – FIRST ENTRY, EXPIRY, FIRST OUT)

REF NO: SOP 5

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO MAINTAIN FEEFO – FIRST ENTRY, EXPIRY, FIRST OUT – AND TO

REDUCE THE POSSIBLITY OF EXPIRED STOCK ON THE SHELVES

PROCEDURE:

1) GENERAL
1.1) On receipt of stock, expiry dates must be checked, with any short-dated stock
(i.e. 3 months or less) to be brought to the attention of the buyer.
1.2) All new stock must be packed on the shelf, with the newest stock at the back.
However, if new stock arrives with a shorter expiry date than the stock
already on the shelf, the product with the shortest expiry date must be packed
in the front.
1.3) When packing out new stock, staff are to check dates of stock already on the
shelves
1.4) Any stock that has less than 3 months until expiry date must be brought to
the attention of the head of that department.
1.5) Any near-to-expiry date stock that can be returned to the Wholesaler for
credit or exchange must be removed from the shelves and credit/exchange
requested.
1.6) All expired drugs must be removed from the shelves and disposed of in the
prescribed manner

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

STOCK-TAKING

REF NO: SOP 6

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO ENSURE AN ACCURATE STOCK-TAKING SYSTEM

PROCEDURE:

1) GENERAL
1.1) Staff will be notified at least 2 weeks in advance on the date and time for
Stock-taking (Annual or otherwise)
1.2) Notices for customers and patients must be put up and staff must let
customers know the shop will be closed
1.3) One week before stock-take, staff are to check for expired or expiring stock,
and these must be removed from the shelves and dealt with accordingly.

2) ONE DAY BEFORE STOCK-TAKE

2.1) No more pre-packing of stock
2.2) All shelves to be straightened to assist with counting
2.3) In Dispensary, open packs to be combined if possible to make original packs,
ensuring that stock with different expiry dates are not mixed in the same
original pack.
2.4) Stock-sheets must be printed
2.5) Staff are to be divided into counting pairs

3) ON THE DAY OF STOCK-TAKE

3.1) Stock-sheets are to be handed out to counting pairs – and a record of which
pairs are responsible for which stock-sheets is to be kept
3.2) One staff member must count (and check expiry dates) and the other must
record
3.3) Completed stock-sheets are to be returned to the stock-take controller, who
must record them as returned
3.4) Auditors will check random sheets

4) AFTER STOCK-TAKE
4.1) Stock figures will be processed by the Admin staff, under the supervision of
the auditors
4.2) Provisional figures will be checked by the Responsible Pharmacist, Store
Manager and Accountant.
4.3) Any discrepancies are to be corrected

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

DISPOSAL OR REMOVAL OF S1-S6 EXPIRED, DAMAGED AND/OR CONTAMINATED
STOCK AS REQUIRED IN REGULATION 27 OF ACT 101 OF 1965

REF NO: SOP 7

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO ENSURE A SYSTEMATIC REMOVAL AND DISPOSAL OF UNUSABLE

MEDICINE

PROCEDURE:

1) GENERAL
1.1) All staff to check expiry dates on all medications when restocking shelves, as
well as for damaged stock
1.2) Expired stock must be removed from the shelf immediately, and re-ordered if
necessary
1.3) Damaged stock to be removed from the shelf
1.4) The Store Manager / Stock Controller must contact the relevant wholesaler
and request credits or exchange for the returnable stock – see Annexure A
for list of wholesalers
1.5) All medication that is to be destroyed must be recorded on the Written off
stock – See Annexure B
1.6) Medicine for destruction is to be stored in the containers provided by the
contracted medical waste company, which are to be kept in a designated
area of the dispensary, away from all other medications.
1.7) All medicine for destruction must be written up on the Medicine for
Destruction Form – see Annexure C – and attached to the Waste container.
1.8) Once ready for collection, the Waste company must be notified that their
container is to be collected

2) ATTACHMENTS
2.1) Annexure A – List of suppliers
2.2) Annexure B – Written off stock list
2.3) Annexure C – Medicine for Destruction form

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
SOP 7 – ANNEXURE A
LIST OF WHOLESALERS
NAME CONTACT NUMBER CONTACT PERSON EMAIL ADDRESS
SOP 7 – ANNEXURE B
WRITTEN OFF STOCK LIST
DATE MEDICATION QUANTITY EXPIRY SUPPLIER REASON
SOP 7 – ANNEXURE C
MEDICINE FOR DESTRUCTION LIST
DATE MEDICATION QUANTITY EXPIRY SUPPLIER REASON
 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

OBSOLUTE OR UNUSABLE STOCK

REF NO: SOP 8

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO ENSURE REMOVAL OF UNUSABLE STOCK

PROCEDURE:

1) GENERAL
1.1) All expired, damaged or discontinued stock is deemed as unusable stock
1.2) All unusable stock must be removed from the shelves as soon as possible
1.3) Expired stock that can be returned for credit or exchange must be given to
the wholesaler – Annexure A
1.4) All other expired or damaged stock must be destroyed as set out in SOP 7
1.5) Discontinued stock must be sold off or given away, and compensated by the
Sales Representative of that particular product
1.6) Obsolete stock can also be written off or destroyed, with record of such stock
on the Written off stock list – Annexure B
1.7) All expired, damaged and discontinued stock to be kept away from saleable
stock

2) ATTACHMENTS
2.1) Annexure A – List of suppliers
2.2) Annexure B – Written off stock list
2.3) Annexure C – Medicine for Destruction form

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
SOP 8 – ANNEXURE A
LIST OF WHOLESALERS
NAME CONTACT NUMBER CONTACT PERSON EMAIL ADDRESS
SOP 8 – ANNEXURE B
WRITTEN OFF STOCK LIST
DATE MEDICATION QUANTITY EXPIRY SUPPLIER REASON
SOP 8 – ANNEXURE C
MEDICINE FOR DESTRUCTION LIST
DATE MEDICATION QUANTITY EXPIRY SUPPLIER REASON
 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

PRODUCT TYPES REQUIRING SPECIAL STORAGE OR HANDLING INSTRUCTIONS

REF NO: SOP 9

DISTRIBUTION: PHARMACISTS,
PHARMACIST’S ASSISTANTS,
INTERNS, STOREROOM MANAGER,

OBJECTIVE: TO ENSURE THAT THERMOLABILE PRODUCTS AND HAZARDOUS

CHEMICALS ARE HANDLED AND STORED CORRECTLY

PROCEDURE:

1) RECEIVING
1.1) Delivery must be received by the authorised person
1.2) When goods arrive, ensure that they have been transported correctly – if you
have any doubts, raise concerns immediately and contact the supplier for
exchange
1.3) Check for damaged stock and expiry dates
1.4) Once checked against the invoice, the product must immediately be placed in
the dispensary refrigerator.

2) STORAGE
2.1) Only medications to be stored in the Dispensary refrigerator
2.2) Only ice-packs to be stored in the freezer compartment – not medicines
2.3) The fridge door is to be kept closed at all times – only open when necessary
2.4) The temperature of the fridge must be maintained between 2 and 8 degrees
Celsius
2.5) Take a reading from the thermometer twice a day – morning and afternoon –
and record on the Temp Chart – Annexure A – that is fixed to the door of the
fridge
2.6) An alarm must be installed to alert the pharmacist on duty should the fridge
temperature drop of rise beyond the acceptable temperatures
2.7) Should there be a power failure, SOP 20 procedures should be followed

3) DISPENSING
3.1) When dispensing any of these items, patients must be informed on the
storage conditions
3.2) The product must have a “Keep Refrigerated” sticker
3.3) The pharmacist must determine from the patient the travelling time to home
to the fridge – if there is going to be a delay, the product must be packaged
with an ice-pack and wrapped appropriately

4) ATTACHMENTS
4.1) Annexure A – Temperature Chart

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
SOP 9 - ANNEXURE A

DATE AM PM DATE AM PM DATE AM PM

 PHARMACY NAME:

STANDARD OPERATING PROCEDURES

SEPERATION AND HANDLING OF GOODS RETURNED FROM PATIENTS

REF NO: SOP 10

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO ENSURE THAT ALL STAFF KNOW HOW TO DEAL WITH

MEDICATIONS RETURNED BY PATIENTS

PROCEDURE:

1) MEDICINES
1.1) Customers wanting to return medications must be referred to the pharmacist
on duty
1.2) All medications returned by patients may not be re-dispensed for other
patients
1.3) Returned medications must be stored separately from other medications in a
clearly marked container, and must be disposed of as per SOP 7

2) OTHER PRODUCTS
2.1) Customers wanting to return front-shop items must be referred to the shop
manager
2.2) If goods damaged or expired, the supplier must be notified, and replacement
stock is to be requested
2.3) Goods to be collected by the supplier must be stored separately, so as not to
be re-sold
2.4) Products to be destroyed must be stored and await destruction as per SOP 7

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

RECALL OF MEDICINE

REF NO: SOP 12

DISTRIBUTION: ALL DISPENSARY
STAFF AND STORE ROOM MANAGER

OBJECTIVE: TO ENSURE PROBLEMATIC BATCH MEDICINE IS RETURNED TO THE

MANUFACTURER AND THE PUBLIC ARE PROTECTED

PROCEDURE:

1) GENERAL
1.1) Once a Medicine Recall Notice is received, the Responsible Pharmacist must
immediately check whether or not any of the recalled medications are in stock
1.2) The details of the recalled medication – name, strength, batch number, etc –
must be given to the storeroom staff and receiving staff to ensure that any
new stock does not come from that batch
1.3) Any recalled medication must be removed from the shelf
1.4) If any recalled medications have been received, dispensary staff must do an
audit trail and confirm if any patients have received this stock
1.5) Contact these patients and explain the medicine recall, as well as any further
action required, if needed
1.6) Replace recalled medications returned from patients if deemed safe and
necessary
1.7) Any patient incidents to be recorded and the MCC and manufacturer must be
made aware
1.8) All recalled stock must be returned to the supplier or manufacturer for credit
or exchange

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

DELIVERY OF MEDICINE

REF NO: SOP 12

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO ENSURE THAT ALL MEDICINES ARE DELIVERED PROMPTLY AND

THAT THE STOCK MAINTAINS ITS QUALITY DURING THE PROCESS

PROCEDURE:

1) GENERAL
1.1) Deliveries take place between ____ and ____ Monday to Friday and between
_____ and _____ on Saturday. There are no deliveries on a Sunday, nor on
Public Holidays
1.2) All details must be recorded by the staff member taking the delivery – i.e.
Name of customer, delivery address, contact phone number, payment
method, goods to be supplied, etc
1.3) Staff taking orders for delivery are not to promise delivery time, but to make a
note and let the pharmacist or shop manager know so that they may liaise
with the driver
1.4) If the order requires medications to be dispensed by the pharmacist, the
order must be placed in dispensary in a container with the other front-shop
items (if any ordered) with all details for the pharmacist – Medical aid,
patient’s name and surname, etc
1.5) Dispensed medication for delivery must have clear and concise instructions
on storage and dosage
1.6) Once the medication(s) have been dispensed, they must be sealed in a
packet by the pharmacist, with the pharmacist generated script copy on the
outside, and returned to the front shop staff for delivery.
1.7) If medications are to be refrigerated, a “Refrigerate Item” sticker must be put
on the pharmacist generated copy, and the item must be kept in the fridge
until the driver is ready for that particular delivery
1.8) If the order is urgent, and “Urgent” or “Immediate Delivery” sticker must be
stuck on the outside of the parcel and left in the box for awaiting deliveries
1.9) If any other front shop items are to be added to the order, the staff member
needs to collect all the items, and invoice accordingly i.e. COD, Account or
Cape Consumers
1.10) Once packaged together, this parcel must be put in the box for awaiting
deliveries.
1.11) Ensure that the correct delivery address is visible on the outside of the
package, as well as the amount due
1.12) Any Schedule 6 items need to be collected from the pharmacist by the driver,
and put immediately in the delivery vehicle – under no circumstances can a
Schedule 6 parcel be left unattended.
1.13) All Schedule 6 parcels must be written up in the marked “Delivery of
Schedule 6 parcels” book, and the driver must get a signature and name on
delivery – these parcels cannot be left in a letterbox or on a door mat, and nor
with young children
1.14) The driver must write up each parcel on the Delivery Sheet – Annexure A
1.15) The delivery vehicle must be packed appropriately so as to minimise any
damages during transport
 1.16) Items requiring refrigeration must be packed in cool boxes with ice packs,
and should be given priority on the delivery route
1.17) No parcels to be handed over without payment, unless otherwise arranged by
the shop manager or responsible pharmacist
1.18) On return to the pharmacy, the driver must check for any urgent deliveries,
which must be attended to, otherwise COD’s must be paid at the till
1.19) Any queries or complaints with deliveries that the driver receives from the
customers must be taken to the shop manager or responsible pharmacist
immediately so that suitable action may be taken

2) ATTACHMENTS
2.1) Annexure A – Delivery Sheet

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
SOP 12 – ANNEXURE A

DATE NAME ADDRESS TIME OUT TIME IN PAID

 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

RECEIPT OF STOCK

REF NO: SOP 13

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO ENSURE PROPER STOCK MANAGEMENTS

PROCEDURE:

1) GENERAL
1.1) All deliveries are to be received at the Stock Receiving Area, unless
otherwise stated
1.2) Thermolabile medicines must be separated and checked first – as per SOP 9
1.3) The pharmacist on duty must check Schedule 6 medicines against the
invoice and sign for them – and stored as per SOP 19
1.4) All other medicines must be checked against the invoice and signed for by
the Storeroom staff
1.5) Any discrepancies, damages or expired stock must be brought to the
attention of the storeroom manger, the pharmacist on duty and the supplier.
If any of this stock is required urgently for a script, arrangements must be
made with the supplier for special delivery, and the customer should be
alerted to the delay
1.6) Once stock has been checked against the invoice, it must be entered onto
the computer system
1.7) Once stock is on the system, it can be packed out onto the shelves as soon
as possible – with expiry dates being checked again
1.8) SOP 5 and SOP 7 must be followed as stock is put out on the shelves
1.9) Excess stock may be stored in the designated “Excess Stock” area and must
be regularly checked as to when it can be put out on the shelf

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
 PHARMACY NAME:

STANDARD OPERATING PROCEDURES

STORAGE OF MEDICINE

REF NO: SOP 14

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO ENSURE THAT STANDARDS ARE UPHELD IN THE STORAGE OF

MEDICINES TO MAINTAIN THEIR QUALITY AND EFFECTIVENESS

PROCEDURE:

1) GENERAL
1.1) The storeroom is to be kept clean and free of dust – see SOP 1
1.2) SOP 4 must be followed for effective Pest Control
1.3) No stock is to be stored on the floor and shelving is to be cleaned regularly as
per SOP 1
1.4) The air conditioner must be serviced regularly, and a temperature at below 25
degrees must be maintained to reduce moisture content
1.5) No food is to be stored or eaten in the medicine storage area
1.6) Any spills must be cleaned immediately
1.7) All stock to be stored using FEEFO – First entry, expiry, first out
1.8) The storeroom must be kept locked, with either the pharmacist on duty or the
storeroom manager in charge of the key, to prevent any loss of stock due to
theft

2) SCHEDULED MEDICINE
2.1) All scheduled medicine must be separated from other stock received, and
given to dispensary staff
2.2) All Schedule 6 medicines are to be stored in a locked cupboard in dispensary
2.3) All thermolabile medicines are to be stored in a fridge between 2 and 8
degrees – see SOP 8
2.4) All hazardous substances are to be kept away from other stock in a fume
cupboard with a ventilation hole
2.5) Only Schedule 1 and Schedule 2 excess stock may be stored in the
storeroom – but in a special designated area. All other excess scheduled
stock must be stored in a special designated area in the dispensary

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
 PHARMACY NAME:

STANDARD OPERATING PROCEDURES

PROCUREMENT OF MEDICINE

REF NO: SOP 15

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO ENSURE THAT PROCUREMENT OF SUPPLIES ARE FROM

RELIABLE AND ETHICAL SOURCES

PROCEDURE:

1) GENERAL
1.1) Stock may only be ordered from reputable suppliers – see Annexure A for
preferred wholesaler list – get authorisation from responsible person before
using a new supplier
1.2) Any urgent medication must be ordered from the wholesaler that would be
able to deliver timeously, or who would be able to make the delivery a priority
1.3) The pharmacist on duty must place the order on the order system
1.4) Any out-of-stocks must be ordered with an alternative supplier
1.5) Schedule 6 order forms must be completed by the pharmacist and faxed or
emailed to the supplier
1.6) Any orders that Reps may want to place must be authorised by the
pharmacist or the store manager

2) ATTACHEMENTS
2.1) Annexure A – List of approved providers

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
SOP 15 – ANNEXURE A

LIST OF WHOLESALERS
NAME CONTACT NUMBER CONTACT PERSON EMAIL ADDRESS
 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

HANDLING OF PRODUCT COMPLAINTS

REF NO: SOP 16

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO ENSURE PROPER MANAGEMENT OF PRODUCT COMPLAINT AND

SAFETY OF PATIENTS ALWAYS

PROCEDURE:

1) GENERAL
1.1) Listen carefully to the customer and remain objective – do not admit liability
1.2) Remain calm and show concern for the customer – also apologise for any
inconvenience caused
1.3) Record all details of the product complaint in the Product Complaint book –
customer’s name, address and telephone number; date of purchase; nature
of complaint
1.4) If the customer would like a replacement of the product, the manager may do
so
1.5) Any products returned to the pharmacy must be dealt with as per SOP 10

2) SCHEDULED MEDICINES
2.1) If the complaint is against a scheduled medication, the responsible
pharmacist needs to be informed and involved
2.2) The pharmacist may replace the medication if it is deemed to be a problem
with the original medication – but the supplier must also be informed
immediately and replacement stock arranged
2.3) If the complaint is related to an adverse effect, the pharmacist must alert the
stockist, as well as the MCC
2.4) The customer must be informed of any outcome on all product complaints
received

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
PHARMACY NAME :

STANDARD OPERATING PROCEDURES

PRE-PACKING (INCLUDING QUALITY ASSURANCE PROCEDURES)
(WHERE APPLICABLE)

REF NO: SOP 17

DISTRIBUTION: DISPENSARY STAFF

OBJECTIVE: TO ENSURE THAT STANDARDS ARE UPHELD WITH ALL PRE-

PACKING OF BULK MEDICATIONS

PROCEDURE:

1) GENERAL
1.1) Bulk stock may be repacked into smaller pack sizes for sale
1.2) All repacking must be in accordance with terms provided in the Medicines
Act, as well as MCC standards\
1.3) Pre-packing can only be done by a pharmacist, or under strict supervision of
a pharmacist, by a registered pharmacist assistant
1.4) All pre-packing must be done in a designated area, separate from the general
dispensing area
1.5) All apparatus used for pill counting must be kept clean, and cleaned between
different batches and products to avoid any cross-contaminations
1.6) Tablets must be manually counted – measuring by volume is not allowed
1.7) Any product that is pre-packed must be recorded on the “Pre-packed Product
Record” page (see Annexure A), and filed as per product and date in the
“Pre-Packed Product” file
1.8) The labels for the Pre-packed product must be printed out as and when the
“Pre-packed Product Record” page is completed, with a copy attached to the
page, with the following information:
1.8.1) Approved name of medicine
1.8.2) Strength of product
1.8.3) Quantity or volume of medicine
1.8.4) Expiry date and batch number
1.8.5) Packaging date
1.8.6) Any additional information if necessary, e.g. storage conditions,
warnings, etc
1.8.7) Directions for use
1.9) Any unused or damaged labels must be discarded

2) ATTACHMENTS
2.1) Annexure A – Pre-packed Product Record

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
SOP 17 – ANNEXURE A

PRE-PACKING RECORD OF :

NAME OF PRODUCT DATE

STRENGTH

DOSAGE MANUFACTURER

EXPIRY DATE

BATCH
NUMBER

LABEL
 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

PROCEDURES FOR A LOCUM OR RELIEF PHARMACIST(S)
(WHERE APPLICABLE)

REF NO: SOP 18

DISTRIBUTION: RESPONSIBLE PHARMACIST,
DISPENSARY STAFF

OBJECTIVE: TO ENSURE A SMOOTH HANDOVER TO A LOCUM PHARMACIST

PROCEDURE:

1) GENERAL
1.1) The responsible pharmacist will maintain a list of suitably qualified locum
pharmacists that may be called on should it be necessary
1.2) The locum pharmacists must be vetted and checked by the responsible
pharmacist – i.e. qualifications and registration with the Pharmacy Council
1.3) Should a locum pharmacist be required, the responsible pharmacist or shop
manager must call and book a locum, confirming dates and times
1.4) The locum pharmacist must be made aware of all pharmacy procedures –
with the SOP file and with a brief introduction by the responsible pharmacist
or the shop manager

2) INFORMATION FOR THE LOCUM PHARMACIST

2.1) All information must be made readily available to the locum pharmacist
2.2) As per 1.4, the SOP file must be made available, as well as other information
2.3) As well as SOPs, there must be staffing information in the file, including the
following:
 The names, addresses, telephone numbers of key staff, as well as
their “In case of emergency” contact person
 Working times of staff
 Any details of staff leave during the locum’s shifts
 Any staff concessions
 Staff purchases
2.4) The file must also contain the following information with regards to the
dispensary:
 Computer instructions
 Contracted Medical Aids
 Keys to the Schedule 6 cupboard
 Ordering systems and a list of preferred wholesalers
2.5) With regards to the rest of the pharmacy, information in the file must include:
 Instructions of use of alarm system, as well as contact details for
security company
 Lights and air condition instructions
 Till operations and cash-up procedures
 List of service suppliers e.g. plumber, electrician, computer vendor
 Delivery service details
 3) COMPLETION OF SHIFT(S)
3.1) Upon the completion of the locum pharmacist’s shift(s), a complete handover
must be done
3.2) The locum pharmacist must share any information regarding any unresolved
problems or queries, as well as any difficulties experienced
3.3) Any staffing issues must also be mentioned

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

HANDLING OF S5 AND S6 MEDICINES

REF NO: SOP 19

DISTRIBUTION: ALL DISPENSARY STAFF

OBJECTIVE: TO ENSURE THAT SCHEDULE 5 AND 6 MEDICATIONS ARE HANDLED

CORRECTLY

PROCEDURE:

1) ORDERING AND RECEIVING

1.1) As per Regulation 28 of the Medicines and Related Substances Act 101 of
1965, the pharmacist must complete the Schedule 6 order form
1.2) The pharmacist’s name and signature on the form must be legible, as well as
his/her qualification and SAPC registration number
1.3) The order form must be faxed or scanned and emailed to the supplier, and
the original kept for delivery
1.4) On delivery, the order must be checked against the original order, signed for
by the pharmacist if correct, and the original form must be given to the driver

2) STORAGE
2.1) Once signed for, the medication must immediately be entered in the
Schedule 6 register by the pharmacist
2.2) If this cannot be done immediately, all paperwork and the sealed package
must be stored in the Schedule 6 cupboard
2.3) The Schedule 6 cupboard is to be kept locked always, and the key held by
the responsible pharmacist

3) DISPENSING
3.1) Only original prescriptions may be dispensed
3.2) Schedule 6 prescriptions must be dispensed by the pharmacist, and details of
the prescription must be entered in the Schedule 6 register
3.3) In an emergency, a 48 hours supply of medication may be dispensed in
accordance with Section 22A(6)(k) of the Medicines and Related Substances
Act on condition that arrangements have been made to attain the original
prescription within 72 hours
3.4) The original prescription must be filed in the Schedule 6 file, as per product
and date order. This file must be stored in the Schedule 6 cupboard
3.5) A copy of the prescription must be filed in the general prescription file

4) CHECKING AND BALANCING

4.1) All Schedule 6 transactions for the day must be recorded in the Schedule 6
register by the end of the day
4.2) The responsible pharmacist must check the register against the computer
printout at the end of the day – considering all medications dispensed and
medications received, as well as orders placed
4.3) As required by Regulation, the Schedule 6 register must be balanced
quarterly

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018
 PHARMACY NAME :

STANDARD OPERATING PROCEDURES

COLD CHAIN MANAGEMENT
(INCLUDING PROCEDURES TO BE FOLLOWED IN THE EVENT OF A
REFRIGERATOR POWER FAILURE)

REF NO: SOP 20

DISTRIBUTION: ALL STAFF

OBJECTIVE: TO ENSURE THAT COLDCHAIN IS MAINTAINED THROUGHOUT THE

DISTRIBUTION PROCESS, AS WELL AS IN THE EVENT OF FRIDGE
FAILURE

PROCEDURE:

1) DELIVERY TO CUSTOMER
1.1) Items must be kept in the fridge until the drivers is ready for delivery
1.2) All thermolabile items are to be packed in a cold box
1.3) Cold icepack must be packed in cold box, wrapped in plastic so as not to
cause any water damage from condensation
1.4) Items must be packed protectively to avoid damage
1.5) The lid must be closed and sealed
1.6) Delivery of cold items must be priority and delivered first

2) DELIVERY OF VACCINES
2.1) Items must be kept in the fridge until the driver is ready for delivery
2.2) All vaccines are to be packed in a cold box
2.3) Solid icepack must be packed in cold box, wrapped in plastic so as not to
cause any water damage from condensation
2.4) Pack Measles and Polio vaccines first, closer to the bottom and the icepack
2.5) Then BCG vaccines
2.6) Then DPT, DTP-hib, DT, TT, and HBV vaccines
2.7) Place a thermometer in the centre of the cold box
2.8) Close lid tightly and seal

3) FRIDGE FAILURE - ACCIDENTAL UNPLUGGING

3.1) Plug in immediately
3.2) Check the temperature on the thermometer
3.3) Note the date, time and temperature on the temperature chart
3.4) Do not open the fridge unnecessarily
3.5) Establish how long the fridge has been unplugged
3.6) The responsible pharmacist is to be informed of the incident, as well as the
temperature reading and the current products in the fridge
3.7) The fridge must be serviced as soon as possible by a reputable technician,
otherwise replaced
 4) FRIDGE FAILURE – MECHANICAL FAILURE
4.1) Check the fridge has not been accidently unplugged
4.2) Check the temperature on the thermometer
4.3) Note the date, time and temperature on the temperature chart
4.4) Report fridge failure to the responsible pharmacist
4.5) Pack all items in a cold box - as per SOP, points 1 and 2 – and transfer all
stock to the back-up fridge
4.6) Report to the responsible pharmacist a complete list of medication affected,
as well as their batch numbers

5) FRIDGE FAILURE – POWER FAILURE

5.1) Do not open the fridge unnecessarily
5.2) If the power failure persists, and the fridge shows signs of defrosting, remove
stock and place in cold boxes or back-up fridge
5.3) Report to the responsible pharmacist a complete list of medication affected,
as well as their batch numbers

6) FRIDGE MAINTENACE
6.1) The fridge must be cleaned and defrosted at least once a month
6.2) Whilst the fridge is being cleaned, all stock must be moved to cold boxes – as
per SOP, points 1 and 2 – and if possible, moved to the back-fridge

NAME OF PHARMACY OWNER:

th
DATE : 9 September 2017
th
REVIEW DATE : 9 September 2018