!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 50: Environmental Monitoring Environmental monitoring is considered by regulators (United States Food and Drug Administration [FDA]) necessary to ensure that the material/products…
Warning Letter Citations Failure of pharmaceutical companies to adequately protect production lines from contamination and cross-contamination is a frequently cited Form 483 observation noted during establishment inspections. The focus…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 48: Reprocessed and Reworked Materials Reprocessing The reprocessing of any lot or batch of drug is given approval by quality control (QC)….
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 45: Dispensing and Weighing Controls Dispensing and weighing controls should be such that the identity, purity, and quality of the raw materials…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 44: In-Process Controls 21 CFR 211.110 and Eudralex Volume 4 21 CFR 211.110 “Sampling and Testing of In-process Materials and Drug Products”;…
Preparation of solutions to be used in the analysis can be documented on the controlled document or in a logbook designated for such preparations. Most laboratories have a solution…
Commercial Support Stability As part of the submission process, a company will include a commitment to continue stability evaluation over the commercial life of the product. The stability commitment…
Though not a compendial specification, the PhEur suggests a total aerobic microbial count (TAMC) action limit of 10 CFU/100 mL in its WFI monograph, which agrees with the 1993…
Sanitization and Hygiene Clean areas should be cleaned thoroughly according to documented procedures. Detailed hygiene programs should be established. They should include procedures relating to the health, hygiene practices,…
The principles of conducting an analytical OOS investigation heretofore described should be invoked throughout an MDD investigation, including proper documentation, collection of data, and interpretation of data by the…
