Review of Annex 1: 2022
Read this paper for an easy-to-understand explanation of the meaning of the newest EU GMP Annex 1 2022. The charts provide a section-by-section practical explanation and interpretation of Annex 1.
Archives: Papers
Risk Assessments as a Process Quality Assurance Tool
Environmental contamination control is a critical component of sterile pharmaceutical manufacturing, and Risk Management is necessary to ensure that the correct control practices are in place. The Risk Management process is a series of steps, including risk assessment, that allows for a deeper understanding of the manufacturing environment. Removing, reducing, or monitoring activities associated with a product or process to mitigate risk may be the result of such an assessment. This qualitative risk assessment can be transformed into a quantitative evaluation using modern risk analysis tools and procedures; these tools deliver the fully documented rationale behind the path chosen.
USP 1788 Methods
In May 2021 a revision to USP<1788> Methods for Determination of Subvisible Particulate Matter was published, its aim is to aid in clarification and support of the information given in chapters <788> Particulate Matter in Injections, <789> Particulate Matter in Ophthalmic Solutions, and <787> Sub-visible Particulate Matter in Therapeutic Protein Injections.
4 Hour BioCapt Single Use Impactor Case Study
The scope of this study was to evaluate the BioCapt® Single-Use’s (BCSU’s) ability to recover microorganisms in stressed conditions after four hours of continuous air sampling at 28 LPM. The European Pharmacopoeia Growth Promotion Test performed on the BCSU after incubation shows a good recovery rate (≥ 70%), comparable between the two impactors tested (stressed and unstressed). All three test results aligned with acceptance criteria, and visual inspection of the media post-sampling was satisfactory. This study supports the use of BCSU for four-hour sampling with no change to its monitoring capabilities.