Articles — medizap

Recently, the FDA has been providing much heavier guidance - and more Form 483s for objectionable conditions - with respect to the regulatory requirements of cGMP controlled raw materials. As a result, they are also providing more information on overall best practices for these materials. It is critical for those working in the pharmaceutical industry to understand the ever-changing requirements and best practices pertaining to cGMP. Regulations Guiding cGMP Controlled Raw Material are in FDA regulations 21 CFR 211.84 Subpart E: Testing and Approval or Rejection of Components, Drug Product Containers, and Closures Overview of the Regulation Section D of the FDA...

Aseptic pharmaceutical manufacturing requires that all sterile drug products be filled into clean and hygienic containers, then sealed using primary and secondary packaging. However, this practice, though widely used, cannot obtain the Sterility Assurance Level, or SAL of 10-6. This has required new methods of sterilization to be brought to the market. Why Terminal Sterilization Terminal sterilization can provide this proper Sterility Assurance Level. This sterilization process has products sterilized in their final container or packaging, which permits the measurement and evaluation of quantifiable microbial lethality. It is an essential process as it ensures the parenteral/injectable drug products remain sterile and without the...