|Item No.||Item Name/Description||Price Each||Qty|
|40.001||Mini-Booklets - GMPs|
This booklet is larger than the typical ones - making it easier to read. This booklet includes the regulations as commonly referred to as the cGMPs – Title 21 CFR, parts 210 and 211. Also included is the code regarding electronic records and electronic signatures – Title 21 CFR, Part 11. As a bonus, we are also including an electronic copy of the ICH Guideline Q7a – commonly referred to as the cGMPs for APIs. With these three guidelines, quality and compliance professionals will have the general regulations at their fingertips. As stated, the print of the code in this booklet is also larger for ease in reading.
|40.002||Quality System Regulations: 21 CFR, Part 820|
This is a handy reference booklet listing all of the regulaitons as listed by the FDA for QSR's. This is a compilation of the code found in 21 CFR, Part 820.
A mini-booklet containing the "GMP's" for API's.
|40.005||Barr Decision Court Transcript|
Transcript from the 1993 court ruling. A must have for any serious QA person.
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