the Food and Drug Administration (FDA) deals with both categories. More recently, the FDA has defined a new “live biotherapeutic products” (LBP) category, clarifying pharmaceutical expectations. Since 2019, the quality requirements for this category of drug products have also been clarified by th...
6.3. Good Manufacturing Practices (GMP) Good Manufacturing Practices (GMP) dictate the manufacturing processes, quality control, and quality assurance standards for pharmaceutical products. Pharmaceutical foil manufacturers must adhere to GMP guidelines to ensure the safety, efficacy, and quality of their ...
4. Evaluation of the pharmaceutical excipients’ quality Shortage of testing strategies, protocols or guidelines affects efficient evaluation of excipients. One of the debates about excipient production is the difficulty of consistency which is one of the fundamental issues in the GMP implementation, othe...
When it comes to the importance of blood donorship and blood products for the development of new therapies, Block says that they are critical. He said: “A great example of this is the collection of Covid convalescent plasma (CCP) during the pandemic. BCA members and affiliates ramped up t...
Applicability of Standards requires excipients recognized in USP–NF to be prepared according to recognized principles of GMP [good manufacturing practice] and from ingredients complying with specifications designed to ensure that the resultant substances meet the requirements of the compendial monographs. ...
Part 210 –Current GMP, Manufacturing, Processing, Packing, or Holding of Drugs: Contains the minimum current good manufacturing practice for methods to be used in the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requireme...
When developing new injectable drugs, manufacturers must consider the importance of primary packaging to ensure the drug is protected from the initial filling process to being administered to a patient. Silicone is added to every elastomeric closure component and is essential to ensure...
Once created, XML tag elements defined in the schema can be used, as needed, to record the actual data values in the XML file. FDA provides a large set of elements in a predefined SPL schema for representing labeling data. This SPL schema set is dedicated to recording drug product ...
GMP certifications were formed as an extension of FDA approval for products. 1962 was the year in which the FDA introduced drug amendments and the formalized certification known as the GMP. Since 1962 the certification has been amended numerous times in response to large-scale events, with one ...
In addition to making sure that the buffer is compatible with the drug product and the process one is using, one must ensure it is compatible with the production facility and the intended method of environmental disposition, and that it is easy to handle in terms of health and safety. A ...