Quality & Compliance Remedies for Pharmaceutical Companies

The global pharmaceutical market is expected to grow at an annual growth rate of 4.9 per cent, reaching $1.3 trillion by 2020.[1] This growth must be accompanied by closer scrutiny of quality and compliance measures within pharmaceutical companies. The minimum requirement for pharmaceutical companies is adherence to industry standards; for instance, in the US, Current Good Manufacturing Practice (cGMP) regulations are enforced by the Food and Drug Administration (FDA). Though many companies are implementing quality systems that go beyond these standards, others are failing to achieve compliance across business processes, a concerning situation in light of the industry’s growth and increasing cross-border activity.

Robust quality processes ensure that issues are identified quickly and nipped in the bud, but this is not always the case: the FDA reports the number of warning letters issued to pharmaceutical companies in 2017 remains significantly above 2013 levels. A warning letter means that a FDA inspector has carried out an on-site inspection and has observed serious regulatory concerns, deemed to be violations of the Food Drug and Cosmetic Act[2], resulting in a form-483 being issued. The increase in warning letters can be seen both within and outside the US.

For pharmaceutical companies seeking to assess their operations, we have put together some areas for consideration, based on our experience and observations.

• Appropriate process documentation and tracking

A failure to properly document quality activities is likely to lead to oversight, which is why regulatory bodies take documentation procedures seriously. According to the FDA and the European Medicines Agency (EMA) the key violations within pharmaceutical manufacturing are: “the responsibilities and procedures applicable to the quality control unit are not in writing, or not fully followed” and “the absence of written procedures governing production and process controls”[3]. Businesses should be transitioning from paper-based to digital systems, but they must ensure that computerised systems are secure with controlled access to data, while documents related to quality must be disposed of appropriately.

• Proactive risk mitigation

Manufacturers should not wait for an inspection before beginning risk analysis; by then, it will be too late. A compliance evaluation of all quality, safety and risk controls may seem to be a costly and complex process, but the cost incurred by failed inspections and subsequent remediation is likely to be higher. It is advisable to seek support from experienced consultants to outline a comprehensive strategy to assess and address risks.

• Regular supplier evaluation

Supply chains present numerous compliance challenges, which can be tricky to keep up with. Companies must develop fool-proof monitoring processes, from the initial supplier agreements to the quality of the product or service purchased, with the aim of creating a real-time overview of all supplier relationships. If a supplier is found to be in violation of regulations by the relevant authorities, the contracting organisation will also bear the consequences, such as product recalls, so it is in their interests to be vigilant and thorough.

• Thorough due diligence during M&As

Companies are often in a rush to complete mergers and acquisitions, and important compliance audits are rushed or fall to the bottom of priority lists. Acquiring companies may have to pay the price for this later on when quality issues come to light, and have to be dealt with quickly. Due diligence in this area must be given the necessary attention from the get-go to ensure long-term success.

Regulatory authorities are heightening scrutiny of pharmaceutical companies and are becoming increasingly efficient through new initiatives and partnerships. As of November 2017, the FDA recognises pharmaceutical drug manufacturing inspection data from eight European regulatory authorities, while in June, the European Commission determined that the FDA had the capability and procedures to carry out GMP inspections at a level equivalent to the EU.[4] This collaboration reduces the burden on individual authorities by eliminating the need for dual inspections, benefitting all stakeholders: regulators can optimise resources; companies can quickly achieve compliance with more than one authority; and ultimately, the patient benefits from new products.

With the sector continuing to grow and evolve rapidly, pharmaceutical businesses must maintain high cGMP standards to stay competitive. Companies that receive sub-par feedback from regulatory authorities may undergo lasting damage to their reputation but also to their bottom line. Unsatisfactory quality can see products removed from the market until a solution is found, leading to avoidable financial pressures. On the other hand, businesses that take compliance seriously will see benefits across all departments, as effective quality operations provide improved transparency, and therefore enable greater understanding of demand and capacity, as well as improved visibility of areas of concern.

[1] https://www.trade.gov/topmarkets/pdf/Pharmaceuticals_Executive_Summary.pdf

[2] https://www.fda.gov/ICECI/Inspections/ucm256377.htm

[3] https://www.fda.org/ICECI/Inspections/ucm481432.htm#Drugs

[4] http://www.pharmtech.com/fda-recognize-inspections-eu-drug-authorities