To receive free validation downloads please complete details as required below. Your copy of your selected document is only seconds away. Documents that are offered for free download have a faint watermark of the Validation Online email address. These documents are for your own use and are not editable but are able to be copied. We intend to extend this document list over the next few months.
We have encountered many companies that claimed that they operated a ‘no blame culture’, where employee regulatory compliance is questioned. They in their infinite wisdom seemed to think this was perfectly acceptable. The harsh facts are that the regulators expect everyone to be accountable for their respective actions and are quite prepared (after due legal process) to demand custodial sentences for serious infringements. We have on several occasions had to edit client policy documents (in the light of regulatory comments) to reflect that certain regulatory infringements by staff, would no longer be considered as minor mistakes and would carry more severe penalties; such as employment termination and accountability assessment. Below is an extract from an FDA document regarding CAPA compliance; it is informative to note how often they refer to the individual’s responsibility and accountability.
Content of the Corrective Action Operating Plan (CAPA) - The corrective action operating plan should include:
When goods or services are purchase by a cGMP approved organization from a none cGMP approved vendor; it is a legal requirement that the would-be purchaser audits the supplier to establish the scope of any work required to render the item or process cGMP compliant
This elevates the Vendor Audit (VA) Document to a “Must be in Place” status. So, your list of pre validation doc's must include: (VA) + (FAT) + (SAT)
These are mandatory & available as a package;