Filling Operations and Controls

Aug 21, 2016 by in PHARMACY Comments Off on Filling Operations and Controls

  Staged Materials Staging materials properly is a key process that prevents contamination or substitutions in a filling process and is accomplished through good line-clearance procedures with appropriate checklists and…

read more

Reprocessed and Reworked Materials

Aug 21, 2016 by in PHARMACY Comments Off on Reprocessed and Reworked Materials

!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)….

read more

Contamination and Cross-Contamination

Aug 21, 2016 by in PHARMACY Comments Off on Contamination and Cross-Contamination

  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…

read more

Dispensing and Weighing Controls

Aug 21, 2016 by in PHARMACY Comments Off on Dispensing and Weighing Controls

!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…

read more

In-Process Controls

Aug 21, 2016 by in PHARMACY Comments Off on In-Process Controls

!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”;…

read more

Stability Programs

Aug 21, 2016 by in PHARMACY Comments Off on Stability Programs

  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…

read more

Production Operations

Aug 21, 2016 by in PHARMACY Comments Off on Production Operations

  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,…

read more

Compendia (US, Europe, and Japan)

Aug 21, 2016 by in PHARMACY Comments Off on Compendia (US, Europe, and Japan)

  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…

read more

Salvaged/Returned Goods and Destruction

Aug 21, 2016 by in PHARMACY Comments Off on Salvaged/Returned Goods and Destruction

!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 41: Salvaged/Returned Goods and Destruction Good manufacturing practices (GMP) regulations were designed to ensure that pharmaceutical products that are manufactured and released…

read more
Get Clinical Tree app for offline access