Monday, 26 August 2019

Audit and Control for Healthcare Manufacturers: A Systems-Based Approach


Compliance is an affirmative indication or judgement that the supplier of a product or service has met the requirements of the relevant specifications, contract or regulation; also the state of meeting the requirements. Compliance is something that meets both the text and the spirit of a requirement. A key way to assess compliance is through auditing.

Auditing is the theme of a new book from Tim Sandle and Jennifer Sandle.

If designed and implemented appropriately, audits can provide valuable information for prevention of issues. The goal is to catch problems before they impact product quality, and putting patients at risk.  In addition to the regulations noted, the following points will contribute to an effective audit/control program:
  • Systems-Based Audits and Inspections
  • Defining Metrics
  • Risk Based Approach to Quality Auditing
  • Auditor Techniques
  • Documentation and Reporting Techniques
  • Computerized Systems Audits and Data Integrity Requirements

Each point is developed in detail in the book, together with practical examples and applicable regulations. The latter point has become an area of increasing attention and comment by the regulatory agencies. 

The book outlines why audits are important and how they feed into the quality system. The book has the objective of helping those who need to carry out audits. The reference is:

Sandle, T. and Sandle, J. (2019) Audit and Control for Healthcare Manufacturers: A Systems-Based Approach, PDA / DHI Books, River Grove, IL, USA

For further details, see the PDA Bookstore: https://www.pda.org/bookstore/product-detail/5014-audit-and-control-for-healthcare-manufacturers

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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