(1999; 168 pages) [Spanish]
Appendix 1. Checklist for inspection and the preparation of a report
Inspection Applicable to all drug distribution establishments
1. General information
(a) name of establishment inspected
(b) date of inspection
(c) name(s) of the inspector(s)
(d) date of last inspection.
2. Type of inspection
Comprehensive, concise, follow-up, special, investigative, announced, unannounced.
(a) licensing of premises
(b) person with supervisory role in establishments handling prescriptions and pharmacy sale-only drugs (is normally a registered pharmacist or a person so prescribed by national legislation)
(c) personnel authorized to sell only over-the-counter drugs (licensed, where such licensing is required)
(d) adherence to licensing provisions.
4. Activities undertaken on premises
Manufacturing, wholesale, importation, export, retail, hospital pharmacy, clinic, nursing and maternity homes.
5. Adequacy and suitability of premises
(a) premises clean, tidy and in good state of repair
(b) premises secure
(c) floor durable and easily cleaned
(d) premises constructed to prevent infestation by vermin and pests
(e) clean shelves in retail pharmacy and premises for sale of over-the-counter drugs
(f) changing rooms and toilet available
(g) adequacy of lighting and ventilation
(h) appropriate layout of premises.
(a) adequacy and suitability of warehouse/store
(b) warehouse/store clean and uncluttered
(c) warehouse/store inaccessible to unauthorized persons
(d) temperature and humidity control
(e) enforcement of stock rotation
(f) adequacy of shelving
(g) existence of areas for returned drugs, recalled drugs, expired drugs, and drugs in quarantine
(h) warehouse/store free from vermin and insects.
7. Special storage
(a) availability of cold room storage or refrigerator for vaccines and biological products
(b) suitability of the cold storage facilities
(c) standard written procedure prepared by an appropriate national regulatory agency for the maintenance of cold chain
(d) special storage area for controlled drugs and other prescription drugs
(e) suitable and secure storage facility for controlled drugs and poisons.
(a) name and address of supplier of each drug product with date
(b) name and address of purchaser of each drug product with date
(c) supplier or purchaser licensed
(d) retention of order forms, copy of delivery notes, stores receipt and issue vouchers, and book of records (controlled drugs book/prescription drugs book) on the premises as provided for in the drug laws
(e) accuracy of records kept.
9. Conditions for sale and supply
(a) sale and supply of prescription and pharmacy sale-only drugs under the control of a registered pharmacist
(b) sale and supply prescription and pharmacy sale-only drugs effected from registered/licensed premises
(c) sale of prescription drugs on the basis of valid prescription
(d) sale and supply of over-the-counter drugs undertaken in registered premises under the supervision of a pharmacist or premises licensed for the purpose of sale and supply of over-the-counter drugs only, where such registration or licensing is required by law.
10. Diversion of controlled drugs
Diversion of controlled drugs prevented by examining the records and by physical examination of stock.
11. Returned and expired drugs
Procedures in place for handling returned and time-expired drugs.
12. Product recall
Procedures in place for recall of drugs and handling recalled drugs.
13. Product complaints
Procedures in place for dealing with complaints about drugs.
14. Promotional activities
Assess promotional materials for compliance with drug laws.
(a) person responsible for supervising sale in a wholesale/retail pharmacy is a registered/licensed pharmacist
(b) name of the pharmacist in continuous personal control noted
(c) personnel wear clean protective clothing.
16. Labelling of drug products and package inserts
Check adequacy of labelling of drug and information on package inserts.
17. Physical examination and sampling of drugs
Conduct physical examination of drugs in stock and take samples of drugs for quality assessment.
18. Reference books
Check existence of reference books on premises, where they are required.
Specific inspection applicable to individual establishments
(a) all drugs accompanied by import documents such as bill of lading, export authorization, product licence and batch certificate
(b) controlled drugs also accompanied by export authorization certificate or export declaration, whichever is applicable
(c) imported drugs are in original packs, except for drugs imported in bulk for repackaging and/or manufacturing drug formulations.
20. Retail and hospital pharmacy
(a) compounding of drugs carried out by or under the supervision of a pharmacist
(b) quality of raw materials used in compounding complies with pharmacopoeial specifications
(c) dispensing of prescription drugs carried out by or under the supervision of a pharmacist
(d) entries of dispensed prescription drugs made in prescription book and for controlled drugs in controlled drugs book
(e) prescriptions for prescription drugs retained on premises for periods provided in the drug laws
(f) dispensed drugs labelled appropriately with name of drug, name of patient, name and address of pharmacy, clinic or hospital, instructions for using the drugs and, where appropriate, warning labels
(g) counselling of patients on use of dispensed drugs
(h) adequacy of containers for dispensed drugs
(i) personnel observe high standard of personal hygiene and wear clean protective clothing
(j) dispensing area clean, adequate and has necessary equipment
(k) walls in dispensing area easily cleaned
(l) quality of extemporaneous preparations
(m) sources of drugs sold and supplied from the pharmacy
(n) suitable cabinets for storage of controlled drugs and poisons.
21. Clinics, nursing and maternity homes
(a) sources of drugs used, supplied and administered
(b) records of controlled drugs used, supplied and administered
(c) storage facilities and security for controlled drugs.
22. Unauthorized markets
(a) investigate sources of drugs in the unauthorized market
(b) sample drugs for quality assessment
(c) seize drugs in the unauthorized market.