The management of human resources is of major importance in the assurance of good wholesale, distribution and manufacturing practices. Minimum standards for pharmacy human resources development are provided in section 3.2 of the manual. The following standards relate more specifically to wholesale and manufacturing pharmacies:
| (a) |
Wholesale and manufacturing pharmacies must have an adequate number of appropriately trained personnel to perform the required functions. |
| (b) |
Key supervisory and control personnel involved in the storage and distribution of medicine and scheduled substances must possess the necessary knowledge, experience, professional qualifications and authority to perform their duties efficiently. |
| (c) |
Every wholesale and manufacturing pharmacy must have a responsible pharmacist, who must comply with the authorities, duties and responsibilities as prescribed in terms of the Pharmacy Act. |
| (d) |
The pharmacy must subject to such conditions as may be prescribed at all times be conducted under the continuous personal supervision of a pharmacist. |
| (e) |
A pharmacist must be appointed in each area where the need exists to sign off certain procedures. |
| (f) |
Every wholesale and manufacturing pharmacy must have an organisational chart and written job descriptions for all the personnel. |
| (g) |
The authority of the responsible pharmacist, must be such that decisions relating to quality assurance and compliance with the Pharmacy Act remain his/hers and can only be altered by agreement with the said pharmacist(s). |
| 3.7.2 |
Pharmacy support personnel |
All pharmacy support personnel employed by wholesale and manufacturing pharmacies who perform functions which fall within the scope of practice of pharmacist's assistants and whose functions include the direct handling of medicine, must receive the prescribed in-service training and be registered with Council as pharmacist's assistants.
| 3.7.3 |
Responsible pharmacist |
| (a) |
The responsible pharmacist of a wholesale and manufacturing pharmacy must have expert knowledge with regard to the wholesale distribution of medicine and scheduled substances. |
| (b) |
The responsible pharmacist is responsible for safe-guarding product users against potential hazards arising from poor distribution practices — as a result of, for example, purchasing suspect products, poor storage or failure to establish the bona fides of purchasers. |
| (c) |
The responsible pharmacist must ensure that the conditions of the wholesale and manufacturing pharmacy's licence are met and that there is compliance with the standards and guidelines on pharmacy practice. |
| 3.7.3.1 |
Duties and responsibilities of the responsible pharmacist |
Refer to Annexure A of the manual for the duties and responsibilities of the responsible pharmacist. In addition, the responsible pharmacist of a wholesale or distribution pharmacy must:
| (a) |
have a direct line of communication with and be part of management; |
| (b) |
have access to all areas, sites, stores and records which relate to the activities being performed; |
| (c) |
regularly review and monitor all such areas, sites, etc. or have delegated arrangements whereby he/she receives written reports that such actions have been carried out on his/her behalf; |
| (d) |
keep appropriate records relating to the discharge of his/her responsibilities; |
| (e) |
ensure the physical security of the stock or have written assurance from the manager responsible for security that administrative and physical security systems are in place and are adhered to by all personnel. |
| (a) |
Wholesale and manufacturing pharmacies must provide training for all personnel whose activities could affect the quality of the product. |
| (b) |
All newly recruited personnel must receive orientation regarding the organisation and specific training appropriate to the duties assigned to them. |
| (c) |
Personnel working in areas where contamination is a hazard, e.g. areas where toxic substances are handled, must be given specific training. |
| (d) |
Ongoing training should be provided to all personnel and the practical effectiveness thereof should be assessed periodically. |
| (e) |
Records of training must be kept. |
| (a) |
Detailed programmes relating to hygiene must be established and adapted to the different needs within the wholesale, distribution and manufacturing pharmacy. They must include procedures relating to the health, hygiene practices and clothing of personnel. |
| (b) |
Steps must be taken to ensure as far as is practicable that no person affected by an infectious disease or having open lesions on an exposed surface of the body is engaged in the handling of medicine or scheduled substances. |
| (c) |
Eating, drinking, chewing or smoking in the pharmacy, or the storage of food, drink, smoking materials or personal medication in the storage areas must be prohibited. In general, any unhygienic practice within the facility where medicine or scheduled substances might be adversely affected, must be forbidden. |
| (d) |
Personnel must be instructed to use the hand-washing facilities regularly. |
Public Service Commission Act, 1997
