Master Batch and Completed Batch Records

Aug 21, 2016 by in PHARMACY Comments Off on Master Batch and Completed Batch Records

!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 42: Master Batch and Completed Batch Records Clearly written, detailed batch records are critical to ensuring product quality. The master batch record…

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Laboratory Investigations of Aberrant Results

Aug 21, 2016 by in PHARMACY Comments Off on Laboratory Investigations of Aberrant Results

  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…

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Shipping and Distribution

Aug 21, 2016 by in PHARMACY Comments Off on Shipping and Distribution

!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 39: Shipping and Distribution A finished pharmaceutical’s labeling and/or pharmacopeia monograph provide specific directions for the temperature and humidity conditions of storage…

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Material Storage, Identification, and Rotation

Aug 21, 2016 by in PHARMACY Comments Off on Material Storage, Identification, and Rotation

!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 38: Material Storage, Identification, and Rotation Material Storage Storage locations should meet the general principles outlined for pharmaceutical manufacturing facilities in each…

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Sampling Processes

Aug 21, 2016 by in PHARMACY Comments Off on Sampling Processes

!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 37: Sampling Processes General Sampling Requirements It is desirable to have written procedures for sampling that include the names of person(s) authorized…

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Audits and Self-Inspections

Aug 21, 2016 by in PHARMACY Comments Off on Audits and Self-Inspections

  First-Party Audits Internal audits are performed according to a schedule to evaluate the quality system in order to determine if it is effectively implemented and maintained. In addition, they…

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Receipt of Materials

Aug 21, 2016 by in PHARMACY Comments Off on Receipt of Materials

!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 36: Receipt of Materials Upon the receipt of any material, all documents associated with the shipment or delivery must be reviewed to…

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Cleaning, Sanitization, and Pest Control

Aug 21, 2016 by in PHARMACY Comments Off on Cleaning, Sanitization, and Pest Control

!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 33: Cleaning, Sanitization, and Pest Control Washing Facilities and Cleaning Procedures “Washing and cleaning equipment should be chosen and used in order…

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