Monday, 3 November 2014

Good Documentation Practices

Good documentation practice is part of Good Manufacturing Practice (GMP) and therefore plays an important part in the manufacture of pharmaceuticals and medical devices[i]. To comply with GMP, facilities require documented systems based on specifications, manufacturing and packaging instructions, procedures and records. GMP demands that a Quality Assurance System is established within which documentation is essential. In particular, specific batch manufacturing documentation must be in place and the documents must make it possible to trace the history of each batch. This traceability needs to be possible for a minimum defined period (typically for at least one year after expiry of the batch).

In relation to this subject, Tim Sandle has written an article on Good Documentation Practice for the Journal of Validation Technology.

To view the article, go to: JVT.

The reference is:

Sandle, T. (2014) Good Documentation Practice, Journal of Validation Technology, Vol. 20, Issue 3, pp1-11

Posted by Tim Sandle