The first change, and arguable the most significant, is the change in title of the chapter from Contract Manufacture and Analysis to Outsourced Activities. This is very significant as it clearly broadens the scope of the chapter from the outsourcing of production, packaging and testing to controlling the outsourcing of all GMP related activities. There are a number of activities that a GMP purist could argue were out of scope of the current chapter. Typical activities that are outsourced by many organisations that would now become within scope of this chapter include calibration, transport, maintenance, cleaning, security, training, off-site document storage, secure pharmaceutical waste disposal, pest control, validation and qualification and even the use of consultants. These are just examples, but are used to show the broader scope of the chapter that can now be used to include activities that were not included before. In other words, any GMP activity that an organisation would normally be expected to do itself (in order to meet GMP requirements) that it chooses to outsource are covered. It will be therefore worthwhile checking that both you and your 3rd parties (contract acceptors) are meeting proposed requirements.
Main changes to the Chapter.
Increased requirements to review and monitor the performance of the 3rd party by the contract giver. This should be based on risk (7.3 and 7.7). This means an increased responsibility for the oversight of outsourced activities.
A bigger emphasis is placed on control of changes at the 3rd party to ensure that the contract giver is suitably informed of such changes (7.11). It will be therefore worth ensuring that suitable and appropriate change control processes are in place at the3rd party.
You also see the first mention of communication between contract acceptor and contract giver (7.12). This is likely to link with any changes and problems that may occur.
Finally there is now also a requirement to permit audits of 3rd party suppliers to be defined in the contract (7.15). The word “audit” is much stronger, as the word “visit” was used before, which could mean many things!
This is just an overview of the latest draft requirements. It is by no means an exhaustive comparison and there are many wording changes and new words used (such as knowledge management) that are open to interpretation. The main thing I think to consider is the broader coverage of activities beyond manufacturing and testing that the new chapter covers, and the need to ensure that both your 3rd parties and your own organisation are meeting the proposed new requirements.
As an overview I hope you find this useful. Please feel free to add your comments.
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I absolutely agree with you. The prerequisite of a successful audit is – how well the auditor is prepared for it, how much information he/she have on the company to be audited, for what purpose the audit is conducted, etc. I also perform a lot of audits – mostly our suppliers.