Risk management procedures for environmental API emissions during the manufacture of medicinal products

During the entire contract period, the supplier must implement procedures to reduce the risk of active pharmaceutical ingredients (APIs) being released into the environment during the manufacture of medicinal products that are included in the agreement. These procedures must be implemented when APIs are produced as well as when APIs are used in pharmaceutical formulation.  

At the start of the contract, the supplier must have: 

1. adopted a publicly available environmental policy approved by top level management that includes a commitment to reduce the risks of APIs being released into the environment during the manufacture of medicinal products included in the agreement;

2. appointed an individual at the management level who is responsible for ensuring compliance with the policy;

3. adopted procedures for forwarding the environmental policy in writing to any subcontractors it has a contractual relationship with, and for conveying the environmental policy to any subcontractors beyond the first step in the supply chain; 

4. adopted procedures for regularly identifying and prioritising the risks of APIs being released into the environment during the manufacture of medicinal products included in the agreement, including mapping the supply chain; 

5. adopted procedures for regularly monitoring compliance with the environmental policy; and

6. adopted procedures for taking measures without undue delay when deviations from the environmental policy are identified. 

The procedures must be documented and applied over the entire duration of the contract period in the supplier’s own operations as well as those of any subcontractors that contribute to fulfilling the contract.

The measures must be proportionate to the supplier’s operations and its ability to influence the supply chain. If the supplier considers that it lacks such influence, it must take appropriate measures in order to increase its influence. The supplier must be able to explain what measures have been taken with regards to its influence in the supply chain. 

Follow-up 

[The contracting authority] is entitled to check that the supplier fulfils its obligations under the special contract term. The follow-up may be carried out in different stages: self-assessment and audit. 

Upon the request of [the contracting authority] the supplier shall, [within eight (8) weeks/other time period specified by the contracting authority] of receiving the request, confirm compliance with the special contract term in writing. The confirmation can be submitted using the Self-assessment questionnaire—Environmental risk management annex. The supplier must provide the information requested in the form. 

The supplier must enable [the contracting authority] to perform audits—carried out by itself or through a representative—of the supplier and/or any subcontractors to ensure that the supplier fulfils its commitment. The supplier must provide the information and documentation needed for confirming that the commitment is followed. 

In case of non-compliance 

If the supplier does not participate in the follow-up or if there are deficiencies in the documentation that must be provided, corrections must be made within a reasonable time determined by [the contracting authority]. 

In case of non-compliance with the commitment, the supplier must rectify the situation in accordance with an action plan set by the supplier and approved by [the contracting authority]. The action plan must be prepared within the time frame decided by [the contracting authority], must be proportionate to the nature of the deficiencies and clearly describe how these are to be remedied within the specified time frame.