Mates, today we’re travelling Down Under to the land of kangaroos and kookaburra
ID: 59199 • Letter: M
Question
Mates, today we’re travelling Down Under to the land of kangaroos and kookaburras:
http://www.tga.gov.au/index.htm
Feast your eyes on the captivating view of the home page.
Sail towards the Industry tab, and drop anchor in “Manufacturing Therapeutic Goods”. Immerse yourself in “Manufacturing Basics”, then marvel on “Good Manufacturing Practice – an Overview”. Once there, explore “Good Manufacturing Practice for Medicines”. Dive down below to “Guide to Good Manufacturing Practice for Medicinal Products - Part II” and examine up close contents 15 and 17 (Complaints and Agents, etc). Describe your adventures
Mates, today we’re travelling Down Under to the land of kangaroos and kookaburras:
http://www.tga.gov.au/index.htm
Feast your eyes on the captivating view of the home page.
Sail towards the Industry tab, and drop anchor in “Manufacturing Therapeutic Goods”. Immerse yourself in “Manufacturing Basics”, then marvel on “Good Manufacturing Practice – an Overview”. Once there, explore “Good Manufacturing Practice for Medicines”. Dive down below to “Guide to Good Manufacturing Practice for Medicinal Products - Part II” and examine up close contents 15 and 17 (Complaints and Agents, etc). Describe your adventures
this the qustion just describe thats it .its biotechnology qustion by the way
Explanation / Answer
Section 15 describes the GMP standards for addressing, investing and documenting quality related complaints. The details of the complainants have to be documented. All other follow-ups, such as the action taken, response to the complainant all should be documented. Experts or authorities has to be consulted in case of serious matters.
Section 17 describes the GMP standards that should be followed by the retailer or distributer of the goods supplied by the manufacturer. They have to document the details, such as identity, details of purchases and reciepts, batch numbers and certificates of authenticity, expiry etc. of the manufacturer(s) they deal with. Repackaging has to be with the GMP standards. The norms of addressing the complaints are the same that has to be followed by the manufacturer. In addition, any complain that has been transferred to the manufacturer has to be documented including the response. Finally, there should be a written record for returns.