A & C Your Global GMP Partner

Generally, packaging material suppliers maintain an ISO 9001 quality management system. The ISO 9001 requirements, however, may not provide the necessary levels of good manufacturing practices (GMPs) and rigor to guarantee that packaging materials are suitable for their intended use. The purpose of GMP packaging is to make sure harmful substances do not end up in food, drugs, cosmetics, medical devices, and other products. FDA regulations minimize the instances of product recalls possibly harmful side effects and lawsuits that might arise as a result of defective products. The term CGMP is used today for GMPs and has been established flexibly to allow manufacturers discretion in implementing the best controls for their organization. By making use of modern, innovative technologies, manufacturers can create products of higher quality. GMP Principles at a Glance Guidelines for GMP compliance with basic GMP do not constitute instructions on creating, manufacturing, labeling, storing,...

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...

In the pharmaceutical industry, tablet manufacturing is a complex method of making solid pharmaceutical dosage forms. Packaging follows with another round of complicated processes. Meanwhile, unit dose packaging has emerged as the most favored form.  Tablet manufacturing  The most prominent feature in tablet manufacturing is to ensure the right quantity of active ingredients and excipients. The first step starts with the process of granulation, before pressing or compacting. Here, it is essential to maintain the correct amount of the contents.  Manufacturers use mainly two processes of granulation: wet granulation and dry granulation. Wet granulation, as the name suggests, uses a liquid binder to agglomerate the contents after properly weighing and mixing the contents. Again this type of granulation has two processes the low-shear and high-shear procedures.  On the other hand, dry granulation generates granules by compression of the powder. This process is effective...