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Created: 10 April 2010Leader: Lynnette Heng
Members: Lorelle Ang
Soh Chin Yi
Goh Ai Ting
Li Yuen Ying
♥SIP placements
Lynnette: KK Hospital- DietitianChin Yi: Gardenia- R&D
Ai Ting: Singapore Sports Council- Nutritionist
Yuen Ying: KH Roberts- lab assistant
Lorelle: OSIP (China)
Product Recall (HSA)
Friday, May 14, 2010
Health Sciences Authority (HSA): Guidelines On Recall Procedures
Definition:
Product Recall - A permanent removal of the affected products from the market OR a temporary removal for product correction, after which the corrected products may be returned to the market for sale. A specified timeline will be given by HSA to a Company to recall the affected product from the market. The classification and level of recall will depend on the potential hazard of the defective product and the extent of product distribution. These are determined after consultation between the Company and HSA.
Assessment of Recall:
(a) Classification of Recall
A recall will be classified as a Class 1 recall or Class 2 recall depending on the potential hazard of the defective product.
Class 1 Recall - Initiated when the product defect poses a life-threatening situation to users. Some examples of defects that will result in Class 1 recall are non-sterile injections, contamination with toxic substances and products with major labelling errors.
Class 2 Recall - Initiated when the problem or defect is unlikely to cause serious harm to users. Some examples of defects that will result in Class 2 recall include products with minor labelling errors or products which fail to meet product specification or pharmacopoeia standards but are likely to cause minimal hazard to users.
(b) Level of Recall
There are 3 levels of recall, namely: Wholesale, Retail and Consumer. Each recall will be assigned the appropriate level of recall depending on the nature of defect, the distribution networks of the product and the extent of distribution.
Recall to Wholesale level includes - All parties involved in wholesale sale and may include wholesalers and retail pharmacies
Recall to Retail level includes - All restructured and private hospital pharmacies; Retail pharmacies; Medical, dental and other healthcare practitioners' establishments; Nursing homes and other related institutions; Clinical trial centres; Other retail outlets eg. health food stores, supermarkets; Wholesale level
Recall to Consumer level includes - Patients; Other consumers; Wholesale and retail levels
Initiation of Recall:
(a) Recall Initiated by Company - Recall may be initiated by the Company as a result of defective reports from various sources such as manufacturers, wholesalers, retailers, medical practitioners, hospital and retail pharmacists, end-users and members of the public.
(b) Recall Initiated by HSA - Recall may also be initiated by HSA as a result of adverse drug reaction monitoring, product quality surveillance or defective reports from reputable sources.
Definition:
Product Recall - A permanent removal of the affected products from the market OR a temporary removal for product correction, after which the corrected products may be returned to the market for sale. A specified timeline will be given by HSA to a Company to recall the affected product from the market. The classification and level of recall will depend on the potential hazard of the defective product and the extent of product distribution. These are determined after consultation between the Company and HSA.
Assessment of Recall:
(a) Classification of Recall
A recall will be classified as a Class 1 recall or Class 2 recall depending on the potential hazard of the defective product.
Class 1 Recall - Initiated when the product defect poses a life-threatening situation to users. Some examples of defects that will result in Class 1 recall are non-sterile injections, contamination with toxic substances and products with major labelling errors.
Class 2 Recall - Initiated when the problem or defect is unlikely to cause serious harm to users. Some examples of defects that will result in Class 2 recall include products with minor labelling errors or products which fail to meet product specification or pharmacopoeia standards but are likely to cause minimal hazard to users.
(b) Level of Recall
There are 3 levels of recall, namely: Wholesale, Retail and Consumer. Each recall will be assigned the appropriate level of recall depending on the nature of defect, the distribution networks of the product and the extent of distribution.
Recall to Wholesale level includes - All parties involved in wholesale sale and may include wholesalers and retail pharmacies
Recall to Retail level includes - All restructured and private hospital pharmacies; Retail pharmacies; Medical, dental and other healthcare practitioners' establishments; Nursing homes and other related institutions; Clinical trial centres; Other retail outlets eg. health food stores, supermarkets; Wholesale level
Recall to Consumer level includes - Patients; Other consumers; Wholesale and retail levels
Initiation of Recall:
(a) Recall Initiated by Company - Recall may be initiated by the Company as a result of defective reports from various sources such as manufacturers, wholesalers, retailers, medical practitioners, hospital and retail pharmacists, end-users and members of the public.
(b) Recall Initiated by HSA - Recall may also be initiated by HSA as a result of adverse drug reaction monitoring, product quality surveillance or defective reports from reputable sources.
- Health Sciences Authority. (2007). Guidelines on Product Defect Reporting and Recall Procedures. Retrieved on 27th April 2010, from HSA. Website: http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/safety_information/report_product_defects.html