PHARMACY

Equipment

Aug 21, 2016 by in PHARMACY Comments Off on Equipment

!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 30: Equipment The basic good manufacturing practices (GMP) requirement is to ensure that production equipment is designed, located, and maintained to serve…

read more

Facilities

Aug 21, 2016 by in PHARMACY Comments Off on Facilities

!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 27: Facilities Introduction Good manufacturing practices (GMP) were invoked to maintain the quality of pharmaceutical and biopharmaceutical products manufactured for human consumption….

read more

Reserve Samples and Retains

Aug 21, 2016 by in PHARMACY Comments Off on Reserve Samples and Retains

!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 26: Reserve Samples and Retains 21 CFR 211.170 requires an appropriately identified reserve sample that is representative of each lot in each…

read more

Instrument Control and Record Keeping

Aug 21, 2016 by in PHARMACY Comments Off on Instrument Control and Record Keeping

!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 21: Instrument Control and Record Keeping All laboratory instrumentation must be maintained to ensure proper functioning. Instrumentation is numbered so it can…

read more

Supplier and Contractor Quality Management

Aug 21, 2016 by in PHARMACY Comments Off on Supplier and Contractor Quality Management

  Pharmaceutical good manufacturing practices (GMP) vary in the level of detail used to describe the ways that pharmaceutical manufacturers should ensure that their suppliers contribute to the quality of…

read more

Product Trend Requirements

Aug 21, 2016 by in PHARMACY Comments Off on Product Trend Requirements

!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 17: Product Trend Requirements Organizations, no matter what industry they’re in, generate a significant amount of data as a result of running…

read more

Product Quality Complaints versus Adverse Event Reports

Aug 21, 2016 by in PHARMACY Comments Off on Product Quality Complaints versus Adverse Event Reports

!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 16: Product Quality Complaints versus Adverse Event Reports The United States Food and Drug Administration (FDA) places a significant amount of emphasis…

read more

Change Control and Management

Aug 21, 2016 by in PHARMACY Comments Off on Change Control and Management

  Written production and process control procedures are followed in the execution of the various production and process control functions, and are documented at the time of performance. Any deviation…

read more

Regulatory Agency Reporting

Aug 21, 2016 by in PHARMACY Comments Off on Regulatory Agency Reporting

  In Europe, the marketing authorization holder is required to take into account technical and scientific progress and to submit amendments that incorporate changes (variations) based on that progress. Additionally,…

read more

Training and Personnel Qualifications

Aug 21, 2016 by in PHARMACY Comments Off on Training and Personnel Qualifications

!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 11: Training and Personnel Qualifications Good manufacturing practices (GMP) require that personnel have the education, training, and experience needed to perform their…

read more
Get Clinical Tree app for offline access