Why Good Documentation Practices are Critical in a GMP Environment
By following the fundamental rules within good documentation practices companies will ensure the integrity of data.
Good Documentation is a key element in maintaining the safety and efficacy of medicinal products as they reach the market.
All products on the market that are still in their original containers must be traceable through lot numbers, including information such as which components were received from which suppliers, the equipment used to manufacture the product, as well as the dates of manufacture.
Good documentation practice facilitates this traceability.
Remember these four key Good Documentation points:
- Makes sure that everything that was supposed to take place occurred
- It enables independent review for compliance
- It enables future analysis and defense of actions if questions arise
- And It is required by law. Documents required by the GMPs can be inspected by regulatory agencies.
