Separation requirements in wholesale warehouse

GOOD MANUFACTURING PRACTICE (cGMP)
1

Hi,
what are the requirements for a wholesale warehouse, storing medicine items, medical devices, infant formula.
Thanks,

Milena

2

Milena,
For the medical items you need Cold chain management where ever they are require.
The FDA Guidelines for wearhousing works good for Medical products.
For infant product you need a cool temperature storage with controlled moisture inside the wear house.
We work on these products and we are building a wear house based on these guidelines.

Regards

3

Dear milena59,

If I got it right, I think you are looking for information regarding separation/segregation requirements for storage facilities handling pharmaceuticals, medical devices and infant formulae. I wasn’t able to find any guideline talking specifically about this issue. However, all of them (the guidelines) require three basic requirements for a warehouse/storage facility, the facility/storage should be such that:

  • the mix-up and cross contamination of products is prevented.
  • the integrity and quality of products is not compromised.
  • the storage conditions for products and materials are provided in compliance with the labeling.
As long as you can provide these and other features in a facility there shouldn’t be any problem. For other requirements I would recommend you to refer to following guidelines:
  • [b]WHO Good Distribution Practices for Pharmaceutical Products[/b]: http://whqlibdoc.who.int/trs/WHO_TRS_957_eng.pdf#page=249
  • [b]Good Distribution Practices for Medical Devices[/b]: http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/medical_devices/guidance_documents.Par.4351.File.tmp/TS-01-R2_GDPMDS.pdf
  • [b]NOTES FOR APPLICANTS AND HOLDERS OF A WHOLESALE DEALER’S LICENCE[/b]: http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=con007543&RevisionSelectionMethod=Latest
  • [b]Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products[/b]: http://www.mhra.gov.uk/home/groups/comms-ic/documents/publication/con007569.pdf

Other relevant references:

  • [b]PDA Technical Report No. 46[/b]: Last Mile: Guidance For Good Distribution Practices For Pharmaceutical Products To The End User
  • [b]PDA Technical Report No. 39[/b]: Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through the Transportation Environment
  • [b]USP General Chapter <1079>[/b]: Good Storage and Shipping practices: Distribution and Shipment of Pharmacopoeial Articles

Regards,

4

Its a good list of documents that Ovais added here.
There are specific guidances relating to specific products.

The main issue is Critical Control Points, Seggregation of specifc product ranges,Stacking & Retrieval of items stored.
There is one more document which will be released so soon relating to Transport into wearhouse and out of wearhouse.
Its under final revision. You must understand various docking systems for various products.
I think you must consider this guideline too.
No guideline gives you a clear idea how a Wearhouse looks and what sort of automation required.
To be very practical along with the guidance documents above mentioned you need to look into ISPE baseline guides for Oral , Sterile & Biopharmaceuticals.
You should have a fair Idea about GAMP & Documentation procedures.
Infant food products storage guidelines can be obtained from WHO & FDA sites.

5

Hi Durga,
thanks for the information provided. It will be great to sent me more information on the mentioned documennt regarding Transport into and out warehouse. Could be to my mail: smilena@promedico.co.il
Milena Samban
QA Director

6

Thank you very much - it is exactly my concern!

7

This Document is under final review.I shall mail this to you soon with in 15 days.

8

Please find enclosed the concept paper.[attach]154[/attach]

Concept paper.pdf (235.3 KB)

9

The shift towards a complex global supply chain incorporating many suppliers and service providers is driving adoption of modern analytical methods to ensure quality.

Contamination of heparin highlighted the risks of global outsourcing and has led to increased regulatory and industry interest in modern analytical methods. This is, in turn, changing the way the US Food and Drug Administration (FDA) and other regulators approach product quality.

At an AAPS session, entitled “Mitigating Risks in Global Drug Supply Chain: Opportunities for Modern Analytics”, Lucinda Buhse, director of the division of pharmaceutical analysis at the FDA, explained how the agency is changing its methods.

Buhse said the FDA is developing gatekeeper assays to alert it to samples that need further analysis. These specific, information rich assays will be used to identify potentially contaminated products which will then be sent for more thorough analysis, for example using 2D-NMR.

10

Hello Milena,
You can get best Docking sytems from Maxwel docking and Kelly docking systems.
They adhere to all GMP guidelines.