Lecture 6 Flashcards
What are standards in microbiology?
Standards are legally binding and mandatory regulations enshrined in laws, ordinances, or administrative regulations. Regulatory agencies are responsible for enforcing these standards.
What are guidelines in microbiology?
Guidelines are not legally binding but are used by regulatory bodies to monitor compliance. They help ensure that the finished product falls within the expected range and evaluate processing efficiency at critical control points. While usually advisory, guidelines can be mandatory in some cases, such as those from the EU or FDA.
What are specifications in microbiology?
Specifications are technical prerequisites used in commercial transactions. They can be either mandatory or advisory, and non-compliant materials may be rejected when specifications are mandatory. Specifications must be continuously reviewed, updated, and modified to maintain relevance, such as the requirements for TSA in test sample preparation.
