Pharmacy Inspection

Updated: over a week ago

Pharmacy Inspection

Registration Certificates

1. Is the current certificate of registration for the pharmacy available on the premises?


Photo Comment

2. Is the certificate of registration displayed such that it is legible from the public pharmacy area?


Photo Comment

3. Is the current certificate of the supervising pharmacist available and is it displayed such that it is legible from the public pharmacy area?


Photo Comment
Storage Of Medicinal Products

1. Are all prescription-only medicines, including veterinary prescription-only medicines stored in the dispensary?


Photo Comment

2. Are all codeine containing non-prescription medicines and other schedule 5 controlled drugs stored in the dispensary?


Photo Comment

3. Are all pharmacy only medicines stored behind the medicines counter?


Photo Comment

4. Are all other non-prescription medicines stored in an area of the pharmacy under the control of the pharmacist?


Photo Comment

5. Does the pharmacy have a pharmaceutical-grade fridge?


Photo Comment

6. Is the pharma-grade fridge cleaned regularly?


Photo Comment

7. Are all medicines stored in the fridge in good condition?


Photo Comment

8. Is the fridge of an adequate capacity to permit the orderly storage of medicines?


Photo Comment

9. Is the fridge serviced annually?


Photo Comment

10. Is the maximum/minimum fridge temperature monitored, recorded and reviewed on a daily basis as per the PSI Guidelines on the Sourcing, Storage and Disposal of Medicinal Products within a Retail Pharmacy Business?


Photo Comment

11. Is a separate fridge available to store food and beverages?


Photo Comment

12. Are all medicines stored in the pharmacy in date and is there an active documented expiry date management system in place?


Photo Comment

13. Is the maximum/minimum temperature in the dispensary and any additional storage areas monitored, recorded and reviewed on a daily basis as per the PSI Guidelines on the Sourcing, Storage and Disposal of Medicinal Products within a Retail Pharmacy Business?


Photo Comment

14. Are medicinal products only removed from their primary packaging in exceptional circumstances? Have all stability implications been considered?


Photo Comment
Policies And Standard Operating Procedures

1. Have all policies and procedures been approved by the Superintendent and Supervising Pharmacist?


Photo Comment

2. Is there an implementation date for all procedures?


Photo Comment

3. Is there a review date for all procedures and is documentation relating to previous reviews available?


Photo Comment

4. Are dated policy and procedure training records available for all staff for all relevant procedures?


Photo Comment
Duty Register

1. Does the pharmacy have a duty register for the current year?


Photo Comment

2. Is there a pharmacist supervising the pharmacy for all hours of opening and is this recorded in the duty register?


Photo Comment

3. Is the duty log maintained correctly?


Photo Comment

4. Are all duty log entries maintained accurately?


Photo Comment

5. Are the duty log entries signed by the pharmacist and do they include the pharmacists’ arrival and departure times?


Photo Comment

6. Does the supervising pharmacist work in the pharmacy for a significant proportion of the opening hours?


Photo Comment

7. Is the duty register reviewed regularly to ensure all details are correct?


Photo Comment
Prescription Register / Daily Audit / Daily Dispensing Report

1. Is the prescription register / daily dispensing report printed on a daily basis (within 24 hours)?


Photo Comment

2. Is the prescription register / daily dispensing report dated and signed by the pharmacist?


Photo Comment

3. Is the prescription register / daily dispensing report completed in the correct format in accordance with the legal requirements?


Photo Comment

4. Are emergency supplies recorded?


Photo Comment

5. If emergency supplies are requested by a patient is the reason for the emergency supply recorded?


Photo Comment

6. Is the prescription register/ daily dispensing report for the previous two years available for review at the premises?


Photo Comment

7. Are all prescriptions for the previous two years available for review at the premises?


Photo Comment
Controlled Drugs (CD) Register, Inventory & Safe

1. Does the pharmacy have a Controlled Drugs (CD) register?


Photo Comment

2. Is the CD register completed in accordance with legislation and instructions i.e., is a dedicated page provided for each product where all required details are entered in chronological order within 24 hours of supply and are errors corrected by footnotes etc.?


Photo Comment

3. Is there evidence of the pharmacist routinely reviewing and checking stock balances?


Photo Comment

4. Are all CD registers for the last two years available for review?


Photo Comment

5. Where controlled drugs have been removed from the active balance and destroyed is documentation relating to the witnessed destruction of controlled drugs available for review?


Photo Comment

6. Do the quantities of CDs recorded in the register match the quantities located in the CD safe?


Photo Comment

7. Is there a lockable safe for the storage of medicines (schedule 2 and 3 controlled drugs) in place in the dispensary?


Photo Comment

8. Is the CD safe secured (bolted to a solid wall/ floor) in accordance with regulations?


Photo Comment

9. Has the CD safe been certified and is the certificate available for review at the pharmacy?


Photo Comment

10. Does the CD safe have sufficient capacity to permit the orderly storage of all schedule 2 and 3 controlled drugs?


Photo Comment

11. Are all schedule 2 and 3 controlled drugs stored in the CD safe?


Photo Comment

12. Is the CD safe reserved solely for the storage of medicines?


Photo Comment

13. Are expired/ patient returned controlled drugs stored in a designated part of the CD safe and appropriately labelled?


Photo Comment
Prescriptions

1. Are the original prescriptions available for review?


Photo Comment

2. Are they valid and in date (dispensed within 14 days of the date on the prescription and not dispensed prior to the date on the prescription)?


Photo Comment

3. Do they meet the handwriting requirements for controlled drugs?


Photo Comment

4. Have they been entered correctly into the CD register and prescription register?


Photo Comment

5. Have they been endorsed with the date of dispensing and quantity dispensed?


Photo Comment

6. Are they valid and in date (dispensed within 6 months of the date on the prescription)?


Photo Comment

7. Have they been entered correctly into the prescription register?


Photo Comment
Premises

1. Are the premises self-contained?


Photo Comment

2. Has the security assessment been completed and are there adequate security arrangements in place e.g., alarm, shutters, CCTV, panic buttons, as applicable?


Photo Comment

3. Have any / all recommendations made by the crime prevention officer been implemented?


Photo Comment

4. Are the external and the internal premises in a good state of repair and decoration and are all fixtures and fittings of an acceptable standard?


Photo Comment

5. Are all storage areas in the premises in a good state of repair and decoration and are all fixtures and fittings of an acceptable standard?


Photo Comment

6. Are all entrances to the premises well maintained, clear and accessible?


Photo Comment

7. Is the trading name of the pharmacy displayed at all entrances to the premises?


Photo Comment
Dispensary

1. Is the dispensary area easily identifiable by signage?


Photo Comment

2. Does the layout enable the pharmacist to both maintain patient confidentiality and exercise supervision of the sale and supply of medicinal products in the dispensary, at the medicines counter and while in the patient consultation area?


Photo Comment

3. Is a dispensing bench with a smooth impervious and washable surface and adequate space for expected volume of activity in place?


Photo Comment

4. Is there a dedicated dispensary sink with access to hot and cold water?


Photo Comment

5. Are dedicated areas for preparing Extemporaneous Products/ Monitored Dosage Systems in place (if applicable)?


Photo Comment

6. Is adequate lighting / ventilation provided in the dispensary?


Photo Comment

7. Does the location of the medicines counter restrict access to pharmacy-only medicinal products?


Photo Comment

8. Is access to the dispensary/ non-prescription medicines area and all areas where medicines or confidential records are stored restricted to authorised personnel?


Photo Comment

9. Is a suitable waiting area available for patients?


Photo Comment

10. Do the premises have a designated private patient consultation area, which is directly accessible from the public area of the pharmacy?


Photo Comment

11. Does the patient consultation area comply with the PSI's Guidelines on Patient Consultation Areas, in terms of size, wheelchair accessibility, signage, provision of a table/ worktop & three chairs?


Photo Comment

12. If the seasonal influenza / flu vaccination service is provided in the pharmacy, does the patient consultation area meet the requirements of the PSI's Guidelines?


Photo Comment

13. Is there a clean and well-maintained staff toilet with sink?


Photo Comment

14. Is a staff break area provided at the premises?


Photo Comment

15. Are all areas of the premises where medicines or records are stored included in the floor plan of the registered premises submitted to the PSI?


Photo Comment

16. Is housekeeping in all areas of the pharmacy maintained at acceptable standards?


Photo Comment
Miscellaneous

1. Are extemporaneous medicinal products offered?


Photo Comment

2. Is the pharmacy in a residential care setting?


Photo Comment

3. Are veterinary medicinal products available?


Photo Comment

4. Does the pharmacy have all required equipment such as a computer with internet access, electronic dispensing system and drug interaction software, dispensing equipment, dispensing containers, child-resistant containers (CRCs), disposable plastic cups and extemporaneous equipment?


Photo Comment

5. Does the pharmacy have appropriate reference books and additional references if additional services are provided e.g., veterinary reference, if providing veterinary services?


Photo Comment

6. Does the pharmacy have a medicinal product waste bin and a designated storage area for the bin?


Photo Comment

7. Is all waste and patient returned medication stored in a designated area of the pharmacy and segregated from active stock?


Photo Comment

8. Is evidence of waste collections by an authorised waste management company available?


Photo Comment

9. Does the pharmacy have a methylated spirits register and license (if applicable) and is there a designated area for the storage of methylated sprits?


Photo Comment

10. Does the pharmacy have a poisons register (if applicable) and are poisons stored in an appropriate designated area of the pharmacy?


Photo Comment

11. Does the pharmacy have a shredder for confidential paper waste?


Photo Comment

12. Is the pharmacy registered with the Data Protection Commissioner and is a policy which covers all electronic and manual records in place?


Photo Comment

13. Does the pharmacy have a confidentiality policy in place for all staff?


Photo Comment

Is this sample what you are looking for?
Sign up to use & customise this template, or create your own custom checklist:

Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

goaudits app

Get started on a free trial

Seeing is believing! Try the full platform FREE for 14 days with your own data.
Or ask us to setup the system for you, at no cost.