Question

discuss at least 2 best practices in pharmaceutical distribution. Illustrate why by providing examples, these are considered best practices. Discuss the ramifications of violation of the best practices you chose. Tie the best practices to cGMP practice. Do you feel that best practice mirrors or expands upon cGMP? How is that the case, and why do you feel this is so. Please discuss what you learned from this article. Your essay should be a minimum of 250 words, with sources cited.

Answer 1

5. PERSONNEL

5.1 All personnel involved in distribution activities should be trained in the requirements of GDP and be capable of meeting these requirements.

5.2 Key personnel involved in the distribution of pharmaceutical products should have the ability and experience appropriate to their responsibility for ensuring that pharmaceutical products are distributed properly.

5.3 There should be an adequate number of competent personnel involved in all stages of the distribution of pharmaceutical products in order to ensure that the quality of the product is maintained.

5.4 National regulations with regard to qualifications and experience of personnel should be followed.

5.5 Personnel should receive initial and continued training relevant to their tasks, including assessment as applicable, in accordance with a written training programme.

5.6 Personnel dealing with hazardous pharmaceutical products (such as highly active, and radioactive materials, narcotics, and other hazardous, sensitive and/or dangerous pharmaceutical products, as well as products presenting special risks of abuse, fire or explosion) should be given specific training.

5.7 Records of all training should be kept.

5.8 Personnel involved in the distribution of pharmaceutical products should wear working or protective garments suitable for the activities that they perform. Personnel dealing with hazardous pharmaceutical products, including products with materials (such as highly active, toxic, infectious or sensitizing products) should be provided with protective garments as necessary.

5.9 Procedures relating to personnel hygiene relevant to the activities to be carried out should be established and observed. Such procedures should relate to health, hygiene and clothing of personnel.

5.10 First-aid procedures and equipment for dealing with emergencies involving personnel should be available.

5.11 Procedures and conditions of employment for employees, including contract and temporary labour, and other personnel having access to pharmaceutical products must be designed and administered to assist in minimizing the possibility of such products coming into unauthorized possession.

5.12 Codes of practice and disciplinary procedures should be in place to prevent and address situations where persons involved in the distribution of pharmaceutical products are suspected of, or found to be implicated in, the misappropriation and/or theft thereof.

6. QUALITY MANAGEMENT

6.1 Within an organization, quality assurance serves as a management tool. In contractual situations quality assurance also serves to generate confidence in the supplier. There should be a documented quality policy describing the overall intentions and policies of the distributor regarding quality, as formally expressed and authorized by management.

6.2 Quality management should include: - an appropriate infrastructure or “quality system”, encompassing the organizational structure, procedures, processes and resources; and - systematic actions necessary to ensure adequate confidence that a product (or service) and documentation will satisfy given requirements for quality. The totality of these actions is termed “quality assurance”.

6.3 The system should at least cover the principles of quality assurance as embodied in the WHO guidelines on GMP for pharmaceutical products: main principles.

6.4 All parties involved in the distribution of pharmaceutical products should share responsibility for the quality and safety of products to ensure that they are fit for their intended use.

6.5 Where electronic commerce (e-commerce) is used, defined procedures and adequate systems should be in place to ensure traceability and confidence in the quality of pharmaceutical products.

6.6 Authorized procurement and release procedures should be in place, to ensure that appropriate pharmaceutical products are sourced from approved suppliers and distributed by approved entities.

6.7 All entities in the supply chain should be traceable as applicable, depending on the type of product, and on the national policies and legislation. There should be written procedures and records to ensure traceability of the products distributed.

6.8 Inspection and certification of compliance with a quality system (such as the applicable International Standardization Organization (ISO) series, or national or international guidelines) by external bodies is recommended. Such certification should not, however, be seen as a substitute for compliance with these guidelines and the applicable principles of GMP relating to pharmaceutical products.

6.9 Authorized SOPs for all administrative and technical operations performed should be in place.