Account Navigation

Account Navigation

Currency - All prices are in AUD

Currency - All prices are in AUD
 Loading... Please wait...

FDA Lab Controls Manual - new for 2020!


FDA Lab Controls Manual - new for 2020!

8.00 LBS
Calculated at checkout

Product Description

Save 25% if you order before April 1, 2020

Avoid 483 citations for out-of-specification (OOS) results and other QC laboratory controls issues by having this handy FDA Lab Controls Manual in your regulatory/quality library.


Get more than 600 pages of FDA and EMA rules, guidance documents, compliance guides and additional assistance so you can ensure you can show inspectors you are in compliance.

The book includes, BUT not limited to the following:

* FDA guidance on OOS

* FDA Laboratory Procedures Manual used by its Office of Regulatory Affairs to inspect drug and biologics facilities

* FDA and ICH guidance on analytical methods related to labs

* Applicable CMC documents

* USP document titles to help you be in compliance

* Sample inspection reports on recent 483 and EIR citations for QC lab issue

* Extensive Q&A with FDA officials on various lab control issues

SPECIAL SECTION ON Avoiding Impurities and Contaminants in Drug Products.  This section is most critical with FDA and other international regulators concerns with nitrosamines (NDMA), glass particles and other impurities.  Get the latest scientific and regulatory guidance with our 2020 edition. 

PLUS, DVD of major FDA inspection guides and international documents on lab controls!

PDF version available for download .  Just email us at if you would prefer the PDF version instead.

The FDA Lab Controls Manual regularly costs $795 plus shipping, but is available for a PRE PUBLICATION 25% discount of $596 plus shipping if you place your order by the expiration date above.  Books will be shipped in April by US Postal Service unless you pay for DHL or Fedex

Keep impurities out of your drug products!  Avoid 483s and enforcement hassles for lab non-compliance.  Get this important FDA compliance manual today!

Product Reviews

Find Similar Products by Category