By Sarfaraz K. Niazi
content material: v. 1. Compressed good items --
v. 2. Uncompressed sturdy items --
v. three. Liquid items --
v. four. Semisolids items --
v. five. over the counter items --
v. 6. Sterile products.
Read or Download Handbook of Pharmaceutical Manufacturing Formulations - Uncompressed Solid Products (Volume 2 of 6) PDF
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Extra resources for Handbook of Pharmaceutical Manufacturing Formulations - Uncompressed Solid Products (Volume 2 of 6)
Example text
A statement of the weight or measure of sample used for each test, where appropriate. 18 Handbook of Pharmaceutical Manufacturing Formulations: Uncompressed Solid Products 4. A complete record of all data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, drug product container, closure, in-process material, or drug product, and lot tested. 5. A record of all calculations performed in connection with the test, including units of measure, conversion factors, and equivalency factors.
Guidance documents are not to be referred to as the justification for an inspectional observation. The justification comes from the CGMPs. Current Guides to Inspection and Guidance to Industry documents provide interpretations of requirements, which may assist in the evaluation of the adequacy of CGMP systems. Current inspectional observation policy as stated in the inspection operations manual (IOM) says that the © 2004 by CRC Press LLC 25 FDA-483, when issued, should be specific and contain only significant items.
1. Selecting the Full Inspection Option — The Full Inspection Option will include inspection of at least four of the systems as listed in Part II “Strategy,” one of which must be the Quality System. a. Select the Full Inspection Option for an initial FDA inspection of a facility. A full inspection may revert to the Abbreviated Inspection Option, with District concurrence, based on the finding of objectionable conditions as listed in Part V in one or more systems (a minimum of two systems must be completed).