IS there such a thing as FDA "Good Distribution Practices"

[Sidney Vianna]

I am familiar with FDA GMP. But is there such a thing as GDP - Good Distribution Practices?

When a pharmaceutical company outsources warehousing and distribution of their products, does the FDA oversees the company providing the logistical distribution service? If so, what requirements would the FDA impose onto this supplier?

Thanks in advance.

[Statistical Steven]

Originally Posted by Sidney Vianna

I am familiar with FDA GMP. But is there such a thing as GDP - Good Distribution Practices?

When a pharmaceutical company outsources warehousing and distribution of their products, does the FDA oversees the company providing the logistical distribution service? If so, what requirements would the FDA impose onto this supplier?

Thanks in advance.

I am no expert in this area, but from what I understand, the sponsor is responsible for auditing their suppliers. The FDA does not audit the warehouse and distribution sites, but rather relies on the sponsor to conduct the appropriate audits and documentations. Nonetheless, the GMP do cover storage of FDP.

[Al Rosen]

Originally Posted by Sidney Vianna

I am familiar with FDA GMP. But is there such a thing as GDP - Good Distribution Practices?

When a pharmaceutical company outsources warehousing and distribution of their products, does the FDA oversees the company providing the logistical distribution service? If so, what requirements would the FDA impose onto this supplier?

Thanks in advance.

I believe this along with pharmacies, is left to the individual states to regulate.

[Ajit Basrur]

Hi, yeah there is Good Distribution Practices which take into account the distribution chain of the product. If the product is not distributed in the rightful manner, deterioration may result and may compromise safety and efficacy of the drug.

In fact the term used now is GxP, where G and P stand for Good and Pracices resp and "x" could be anything from A to Z

[Statistical Steven]

Originally Posted by AjitB

In fact the term used now is GxP, where G and P stand for Good and Pracices resp and "x" could be anything from A to Z

I might be wrong, but GxP refers to only GCP (Clinical), GLP (Laboratory) and GMP (Manufacturing). I never heard it referred to anything else.

[Dan Armstrong]

[QUOTE=Sidney Vianna]I am familiar with FDA GMP. But is there such a thing as GDP - Good Distribution Practices?

When a pharmaceutical company outsources warehousing and distribution of their products, does the FDA oversees the company providing the logistical distribution service? If so, what requirements would the FDA impose onto this supplier?
QUOTE]

Holding and distribution practices are specified in part 211 Subpart H (Sec. 211.142 Warehousing procedures and Sec. 211.150 Distribution procedures) of the cGMP.

The USP specifies "<1079> Good Storage and Shipping Practices" in the general information chapters.

I hope this helps.

I should mention that, like everything else, the manufacturer is responsible for making sure his contracted vendors adhere to the requirements.

[rrramirez]

Please visit Answer.com at:
http://www.answers.com/topic/good-distribution-practice
And this website:
http://ec.europa.eu/enterprise/pharm...uidelines1.pdf