WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Close this folderAnnex 6. Guidelines for inspection of drug distribution channels
View the documentIntroductory note
View the documentGeneral considerations
View the documentGlossary
Open this folder and view contents1. Drug inspectors
Open this folder and view contents2. Inspection of establishments in the drug distribution chain
View the documentReferences
View the documentSelected further reading
View the documentAppendix 1. Checklist for inspection and the preparation of a report
View the documentAppendix 2. Guidance on sampling
View the documentAppendix 3. Guidance for inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard
View the documentAppendix 4. Sample receipt form
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

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.

3. Licensing

(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.

 

6. Warehouse/store

(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.

 

8. Record-keeping

(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.

15. Personnel

(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

19. Importer

(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.

 

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