A & C Your Global GMP Partner

QC testing is only designed to test for product attributes that are well-known and understood. These attributes are part of the product specification. However, laboratory testing cannot pick up all the defects the test may not exist, the test may not be sensitive enough, or the test may not be required for that product. Companies therefore have to rely upon GMP rules and QA systems to prevent these problems from occurring in the first place.  General Requirement  The establishment of any specifications, standard, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specification, standard, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate unit and reviewed and approved by the quality control unit. Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedu...

Novel Excipient performs a vital role in bringing new, enhanced, and safer drugs to the pharmaceutical market. There are, however, meaningful challenges in the growth of innovative excipient, mainly because of the lack of globally aligned regulatory mechanisms. Excipients are the main components of any pharmaceutical formulation and crucial for its safe and effective use. The excipients' functionality is very diverse: They can be used as fillers, lubricants, antioxidants, preservatives, adjuvant, stabilizers, permeation enhancers etc.   Although most approved products only contain traditional, well-studied compendia Novel Excipients Uk , the use of novel excipients is unavoidable for the formulation of some advanced products.  Also, progressively more companies prefer to develop sophisticated and innovative formulation involving novel excipients. This may open the way for advanced drug delivery systems to improve the therapeutic profile of drug substances or meet the req...