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Wholesale Self Inspection Checklist Updated

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0% found this document useful (0 votes)
31 views4 pages

Wholesale Self Inspection Checklist Updated

Uploaded by

hassan musulo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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PHARMACEUTICAL SOCIETY OF UGANDA

SELF-INSPECTION CHECKLIST FOR PHARMACIES


(WHOLESALE PHARMACIES /IMPORTERS/DISTRIBUTORS)

(This checklist is a Quality assurance tool by the Council to improve, standardize and institutionalize the practice of
Pharmacy in Uganda. Council through its regular inspection and surveillance programme will be verifying the details
indicated. The supervising Pharmacists shall fill these forms at least twice a year and submit a copy to PSU. Wholesale and
Retail Pharmacies have to fill both Wholesale and retail self-inspection checklists separately)
Name of Pharmacy: ___________________________
Type of drugs stocked: Human Veterinary
Name of the Supervising Pharmacist: __________________________ Reg No: __________
Date of self-inspection__________________ Duration of existence of the Pharmacy___________

No Description Compliance

Yes (√) No (x)

1.0 License
1.1 Is there a valid Certificate of Practice for the Pharmacist?
1.2 Does the Pharmacy have a valid license from NDA?
1.3 Are both documents prominently displayed on the Premises?
2.0 Personnel
2.1 Is the Pharmacist Present at the stipulated times?
2.2 Are drugs handled only by persons qualified in medicines?
2.3 Is there an internal training programme for the technical staff?
2.4 Are there records for attendance times for the technical staff?
2.5 Are written job descriptions available for all technical staff?
2.6 Does the process of recruitment of technical staff measure staff
competency?
2.7 Are employee training files kept?
2.8 Do all the technical employees both temporary and permanent have
appointment letters?
2.9 Is the Pharmacists’ advice taken by management?
2.9.1 Do the staff in the Pharmacy have identification tags with titles?
2.9.2 Does the Pharmacy have an organization structure with clear
reporting mechanisms?
2.9.3 Do the staff hold regular technical review meetings on improving
the quality of service?
2.9.4 Have the sales and medical representatives undergone the sales and
medical representatives training by PSU
3.0 Premises and layout
3.1 Does the Pharmacist have a designated suitable sitting area in the
Pharmacy?
3.2 Does it allow for the Pharmacist to easily monitor the activities?

1 of 4 PSU/SINP/01
PHARMACEUTICAL SOCIETY OF UGANDA
SELF-INSPECTION CHECKLIST FOR PHARMACIES
(WHOLESALE PHARMACIES /IMPORTERS/DISTRIBUTORS)
No Description Compliance

Yes (√) No (x)


3.3 Are premises cleaned daily and cleaning records maintained?
4.0 Storage ,Procurement and Supply of Medicines
4.1 Are medicines stored as per their storage requirements?
4.2 Is there a temperature and relative humidity monitoring device for
recording the temperatures within the pharmacy and stores?
4.3 Are there records kept to capture the expiry dates of the stock?
4.4 Is there a dedicated area for placement of expired drugs?
4.5 Are the storage areas for the medicines raised above the floor?
4.6 Does the Pharmacist have access to the storage area?
4.7 Is the storage area inspected regularly?
4.8 Are the other persons having access to the storage area authorized
by the Pharmacists
4.9 Are the storage areas cleaned frequently?
4.9.1 Is there a screening system of ensuring that drugs are only supplied
to licensed drug outlets? (attach details)
4.9.2 Are records of sales made to the various drug outlets maintained
including the batch numbers supplied?
4.9.3 Does the Pharmacist approve all purchases of medicines?
4.9.4 Does the Pharmacy have a list of approved suppliers
4.9.5 Is stock taking done at least once a year and reconciled with sales
and receipts?
4.9.6 Does the storage area have pest controls?
5.0 Documentation
5.1 Is there a quality policy or manual on Pharmaceuticals?
Are there Standard Operating Procedures(SOPs) for the following
5.2 Counterfeit detection of medicines in the market?
5.3 Distribution of medicines
5.4 Receipt, Storage and handling of medicines
5.5 Sourcing of medicines and pre-qualification of suppliers?
5.6 Expiry date checking?
5.7 Storage and record keeping for controlled drugs?
5.8 Disposal and destruction of expired medicines?
5.9 Complaint handling and Recall of Medicines
5.10 In-house Sampling and testing of distributed medicines from the
market regularly?

2 of 4 PSU/SINP/01
PHARMACEUTICAL SOCIETY OF UGANDA
SELF-INSPECTION CHECKLIST FOR PHARMACIES
(WHOLESALE PHARMACIES /IMPORTERS/DISTRIBUTORS)

No Description Compliance
Yes (√) No (x)
5.11 Housekeeping and Personal hygiene?
5.12 Is there an implementation date for all SOPs?
5.13 Is there a review date for all SOPs?
5.14 Is there evidence that staff have been trained on SOPs?
5.15 Is there a duty register for technical staff?
Are the following reference books/communications available
5.16 British National Formulary( BNF) for Adults /Veterinary
formulary
5.17 British National Formulary(BNF) for Children(Human)
5.18 Uganda Clinical Guidelines (Human)
5.19 Is there a file of communications from PSU/NDA?
5.20 Is there a medical dictionary available?
6.0 Professional services
6.1 Are the technical Pharmacy staff dressed in clean uniforms labeled
with clear designations?
Quality score
Determine your Quality score in Percentage as prescribed below:

Quality rating
The Quality rating is as below
 85 and above –Green
 70 to 84 - Orange
 Below 70 - Red
Areas of Non-Compliance (Tick as
appropriate)  Premises
 Documentation
 Personnel
 Proffesional services
 License

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PHARMACEUTICAL SOCIETY OF UGANDA
SELF-INSPECTION CHECKLIST FOR PHARMACIES
(WHOLESALE PHARMACIES /IMPORTERS/DISTRIBUTORS)
Corrective Action (Please describe the corrective action to be undertaken. Attachments can be
made if needed)
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
Remarks (if Any)
____________________________________________________________________________________
____________________________________________________________________________________

Expected Completion date of all the corrective actions_____________________________

Signed: _________________________ Signed: _______________________________


Supervising Pharmacist Managing Director

NB:The Pharmacist should sign at the bottom of every page and on the final page

4 of 4 PSU/SINP/01

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