Any supply chain is complex, but when it involves the manufacture and sale of pharmaceuticals, a break in the chain is unacceptable
The question is, when a third-party supplier, manufacturer or packager makes a mistake, who is responsible? Here, Dale Pittock, Sales Director of pharmaceutical contract packaging provider, Valley Northern, explains how to manage pharmaceutical packaging regulatory compliance.
All packaging and labelling for medicines in the UK must be approved by the Medicines and Healthcare products Regulatory Agency (MHRA). This covers everything from bottles and boxes to the addition of patient leaflets. Even making small changes to approved packaging involves approval from the MHRA.
This is set to become increasingly complex with the introduction of the Falsified Medicines Directive (FMD), which has been introduced by the European Parliament and Council and will be enforced regionally by the MHRA.
The directive demands that a unique identifier to track medication from manufacture to sale and tamper-evident features to ensure the safety of medicines are incorporated into pharmaceutical packaging to help reduce the amount of fraudulent medication that makes it to market.
The FMD will be in force from 9 February 2019 in the UK. Manufacturers that handle their own packaging will have to make changes to packaging designs, get them approved and then implement any changes to processes and machinery. However, what about the increasing number of pharmaceutical manufactures that outsource packaging to a contractor? Who is responsible for ensuring regulatory compliance?
Research suggests that outsourcing pharmaceutical packaging can reduce total supply chain costs by up to 50%. Eliminating the investment required to regularly upgrade legacy equipment and technology on packaging production lines frees up pharmaceutical manufacturers to focus on the thing they specialise in — drug development.
However, this doesn’t mean that they can wash their hands of packaging regulations completely. Ensuring contract packers produce packaging that is compliant requires close management because, if anything goes wrong, it’s the pharmaceutical company’s reputation that’s on the line.
There are three simple steps to ensuring compliance: conduct thorough due diligence before partnering with a packer, create a detailed quality agreement as part of the contract and manage the relationship closely.
When selecting a contract packaging partner, whether they are based in the UK or overseas, it is important to invest the time in getting to know as much as you can about them. For instance, do they have the capacity and capability to fulfil your requirements? Are they familiar with the regulations your products must meet?
Is their supply chain reliable? When possible, taking a physical tour of the facility as part of your due diligence will give you the opportunity to assess whether the manufacturing set up matches the promises being made. It also gives you time to speak directly to the people that will manage your account, to build up a relationship with them and learn more about their supply chain.
After all, the business they rely on to supply bottles, syringes and boxes should understand the pressures of contract packaging requirements and be able to keep up with your needs — and provide the right packaging to keep you compliant.
Once you have selected your supplier, it is vital to draw up a clear quality agreement at the same time as the contract. As Peter Murray, former Quality Director at GSK explained, the quality agreement is “sometimes mistakenly considered an add on,” but this is an incorrect assumption.
Murray advises that although the agreement is likely to be modified owing to ongoing legislative and regulatory changes, it is important to be explicit about who is responsible for various actions and outcomes.
Murray also states: “Regulatory authorities are increasingly sensitive to the potential supply, patient safety and compliance issues inherent in complex supply chains.” Because of this, there is need for pharmaceutical companies to demonstrate appropriate control and management of all third-party suppliers and partners.
If a failure to comply with MHRA packaging legislation is the fault of a contract packager, even if it contravenes the quality agreement, responsibility falls at the feet of the manufacturer. Therefore, it is important to develop close relationships with contract packaging suppliers and invest time, money and staff into managing and documenting the partnership at every stage. This way, you will be able to mitigate negative repercussions should mistakes happen.