Implementing global regulations into pharmaceutical quality assurance programmes

Christen Davis, Director of Quality, Capsule Delivery Solutions, talks about Lonza’s approach to keeping up with the regulators

As global pharmaceutical regulations continue to evolve, it is imperative for pharmaceutical companies, drug developers and ingredient suppliers to maintain compliance. It is critical for industry players — including regulators around the world — to constantly interpret new rules and what they mean for their quality programmes.

The penalties for failing to keep up with regulations can include lost time and capital to address non-compliance … as well as possibly losing market share to competitors. Christen Davis, Director of Quality, Capsule Delivery Solutions, Lonza, shared her insights with Manufacturing Chemist regarding how pharmaceutical companies can incorporate regulations into their quality assurance (QA) programmes and anticipate future regulations before they are made.

KSR: How have regulatory approaches and standards changed in terms of managing comprehensive quality control and assurance programmes?

CD: As regulatory standards for pharmaceutical quality control change, it is important for drug developers to understand them and foundationally know how to apply them to the business. Constantly seeking potential changes and updates to quality programmes to keep them reflective of the present environment puts the “c” for “current” in cGMP, cGDP and cGLP.

But, the most effective regulatory programmes go beyond dealing with current regulations and work to anticipate what might be around the corner and what it might mean for the company’s quality control policy.

Pharmaceutical companies can take steps to look ahead to future consumer, patient and regulator needs and work to have their products match those requirements as they develop them — rather than going back to add them in later. The goal is to anticipate changes and assess risk to quality programmes before being told to do so by a regulator.

KSR: What are some examples of risk management protocols that managers can implement with personnel at facilities or with equipment and utilities?

CD: The fundamentals — the foundations of quality control — when it comes to a strong quality system are intrinsically linked to developing personnel and staff with the formal training and skills they need to do their jobs. Colleagues will not be effective when it comes to checking for product safety, defects, performance and other critical to quality parameters if they don’t understand the foundation, mechanical aspects or operating procedures of the operational/quality processes.

Christen Davis, Director of Quality, Capsule Delivery Solutions, Lonza

Without the right knowledge and training, colleagues won’t be able to produce products that meet the needs of customers, patients and regulators. This is especially important at places such as Lonza where we ensure the foundation parameters of billions and billions of Capsugel capsules a year. For success, leaders need to lay the foundations of quality control throughout the company, starting with personnel.

KSR: When evaluating suppliers of raw materials/excipients, what processes or steps should a company take?

CD: The overarching goal is to understand product safety and customer requirement guidelines throughout the entire supply chain — from raw materials suppliers and drug product manufacturers all the way to patients — in a way that is streamlined while ensuring safety.

For example, we work to design specifications to ensure supply materials come to us within specifications for compliance and performance, and we want our processes to harmonise with those of our customers when it comes to capsules and excipients.

KSR: How has the globalisation of the pharmaceutical industry affected the quality, supply and regulatory considerations of pharmaceuticals?

CD: As the pharmaceutical industry becomes more globalised, there may be more of a challenge for pharma companies around the world to keep up with changing regulations between different countries. One answer is to embrace the constant flux of the regulatory space and work to understand current rules and anticipate future changes … and what they will mean for your quality control programmes.

For Lonza, globalisation translates to an opportunity for us to hone our truly worldwide supply chain and deliver the benefits to our customers and the patients they serve. We are determined to make our hard capsules meet the specifications of various global regulators, including Japan, Europe, China, the US and others.

At Lonza, our compliance department is constantly reviewing the regulatory space worldwide to ensure our insights are up to date; at the same time, we partner with experts worldwide to interpret local regulations. Overall, our global capabilities mean that when a customer is ready to launch a product and protect patients worldwide, we understand what kind of support they need in terms of regulatory counsel.

KSR: How have changing regulations, high speed filling machines, more accurate dosing requirements and higher customer demands affected product demand, specifications and quality?

CD: The introduction of more accurate dosing requirements, filling machine advancements and higher customer demands mean that attention to detail is more important than ever. The changes come down to being able to spot and avoid variation. If a company is making billions of units, it is important for each one to deliver the drug to consumers precisely and consistently.

Drug developers can take steps to reduce variation by partnering with customers and suppliers to minimise variation throughout the supply chain and ultimately create a delivery system that is consistent for the patient. Investing in R&D and world-class engineering can also help to reduce variation and drug product defects.

KSR: What are some examples of continuous improvement and investment that have driven new standards and support the need for pharmaceutical customisation?

CD: The overall goal of quality assurance systems is an absolute commitment to the continuous improvement of drug products for customers and patients. This includes developing processes within regulatory and operating boundaries and investing in technologies to reduce variation between units.

At Lonza, we are investing in technology to reduce opportunities for defects, improve capsule performance and ensure that every Capsugel capsule exceeds the level of quality to ensure there are no problems for consumers or regulators.

Overall, it’s about taking steps to ensure all these quality factors are accounted for at the beginning of the development process. Yes, it can require upfront investment but taking those steps at an early stage will save your company time and money in the future.

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