How CGMP compliance builds confidence in your pharma company

CGMP compliance can help your pharmaceutical company accelerate time to market – with confidence. Now, and in a post-COVID-19 world. 

Aerin Kim

by Aerin Kim

Compliance with Current Good Manufacturing Practice regulations (CGMP compliance) may not be exciting. However, there is growing evidence that it may very well be a big part of the answer to confidence in pharmaceuticals in a post-COVID world. We all know that COVID-19 has had a huge impact on our world, including on society’s views about pharma companies. As a result, compliance officers and other EHS-responsible persons in pharma companies will need to take heed of the lessons from this period, including both positives and negatives. 

CGMP compliance amidst the impact of the pandemic

The initial stages of the COVID-19 pandemic brought challenges for everyone but of course in particular, problems for the pharmaceutical sector. Its global supply chains meant that supplies of basic drugs such as paracetamol were affected by lockdowns around the world.  

The sector was then challenged to provide answers to the emerging disease. It rose to the challenge, and many people have praised pharma companies for their speed in both finding effective treatments and developing new vaccines.  

Regulators have also acted rapidly to license drugs and vaccines to ensure that the pandemic could be brought under control. However, this speed has not necessarily been seen as positive by everyone. In fact, it’s even been cited as part of the reason for COVID-19 vaccine hesitancy.  

The rise of vaccine hesitancy

The World Health Organization (WHO) describes vaccine hesitancy as a delay in accepting vaccines, or refusal to have them, despite the availability of vaccine services. Of course, it’s not new—but it is both complex and context-specific. It will therefore vary with time, place, and vaccine. Many factors influence this hesitancy, but the 3 main issues are: 

  • Convenience – describes issues such as access and cost. We can increase convenience by making appointments for vaccinations automatically, and notifying people, or sending them text messages to remind them that they are eligible and telling them how to book vaccines.  
  • Complacency – describes whether people feel that they need a vaccine. People who feel less vulnerable to a particular condition are much less likely to choose to be vaccinated against it. With COVID-19, for example, there were media reports of people in hospital saying that they hadn’t been vaccinated because they didn’t expect to become so ill.  
  • Confidence – describes whether people believe that the vaccine will have more benefits than harms. This was the factor that influenced the reduction in vaccination levels against measles, mumps and rubella (MMR) following Andrew Wakefield’s now-discredited paper. 

All of these issues are also affected in different ways by sociodemographic issues. 

The first step is to comply with regulations. The second is to demonstrate this compliance.

Figures for COVID-19 vaccination hesitancy around the world

Different countries have seen different levels of vaccination for COVID-19. For example, in Gibraltar and Cuba, over 300 doses of vaccine have been administered per 100 people in the population. At the other end of the scale, the average number of doses per 100 people in African countries is just over 30. However, this is not all about vaccine hesitancy, it’s also about access, including availability of vaccines. 

How can we therefore measure hesitancy? It’s generally judged by responses to a survey question asking how likely people are to get a vaccine, rated on a 5-point scale from “definitely will” to “definitely won’t.” People are considered hesitant if they say that they “probably” or “definitely” won’t get a vaccine. 

The figures for hesitancy in the US show a strongly geographical pattern. Some areas are much more strongly hesitant than others. Broadly, more urban areas are more likely to be less hesitant: generally, fewer than 12% of the population of these areas is hesitant, compared with more rural areas, where hesitancy rises to 25% in some areas. 

We see a similar pattern in the UK. In this region, those living in more deprived areas are more likely to be hesitant. However, according to the UK’s Office for National Statistics, the picture is also influenced by ethnicity. Its report from 9 August 2021, stated that black adults showed an average of 21% hesitancy, compared with just 4% in white adults.  

What causes hesitancy about COVID-19 vaccines?

Because vaccine hesitancy is context-specific, then we need to know its causes for each vaccine. What, then, is the issue with COVID-19 vaccines?  

Studies have found several different causes, but most related to confidence in vaccines. Some people cited concerns about the long-term effects and side effects of vaccines. Others had a low level of confidence in vaccines generally, with doubts about their safety and efficacy.  

However, perhaps more importantly for pharma companies, some people cited “Lack of trust in the manufacturing and country of production of vaccines, vaccine technology, the pharmaceutical industry, government, and public health bodies” (“COVID-19 vaccination hesitancy” report from The British Medical Journal, 20 May 2021) Another study from the CDC in the US found concerns that COVID-19 vaccines were developed too quickly. 

Delivering confidence: the importance of CGMP compliance in vaccine hesitancy

What can pharma companies do to increase confidence in their operations? The first and most obvious step is that you can comply with regulations to ensure the safety, purity, potency and effectiveness of pharmaceutical products. The second is to demonstrate this compliance. 

The US Food and Drug Administration (FDA) only licenses a product, including a vaccine, once it has been thoroughly tested in clinical trials. These trials range from small to large scale. They’re designed to test the efficacy of any potential drug or vaccine and identify possible side effects. The first step that pharma companies can take to increase confidence is to increase transparency by publishing the results of clinical trials. A report in the British Medical Journal back in 2016 found that the rate of publication of clinical trial results ranged from 35% to 67%, increasing over time. (“Publication and reporting of clinical trial results” 1 Feb 2016) Increased publication would reduce suspicion that there was anything to hide.  

Pharma companies must also demonstrate CGMP compliance. In the US, the FDA inspects manufacturing sites to ensure that they are compliant with CGMP regulations. Around the world, the WHO and national agencies also inspect sites and check for any potential vaccine manufacturing quality issues. The key to showing your compliance is maintaining complete, consistent, and accurate records of your understanding of CGMP regulations and your efforts to align with them. 

No workaround for CGMP compliance

CGMP regulations are set out by regulatory bodies around the world. In the US, this is the FDA. In the European Union, it is the European Medicines Agency. These bodies also inspect sites to check GCMP compliance. 

The purpose of good manufacturing practice is to ensure that medicines are of a consistently high quality, appropriate for their intended use, and meet the requirements of their marketing authorization. The regulations cover all aspects of manufacturing, including employee training, lighting, sanitation and ventilation. They therefore range from basic health and safety law to more advanced aspects of quality control. 

The regulations apply to medicines intended for use within a jurisdiction, and not just those manufactured there. Companies therefore cannot get around the regulations by moving manufacturing to a country with lower standards of manufacturing practice. 

Did CGMP compliance change during COVID-19?

Regulators did take some steps to relax the timescales for inspections and certification for CGMP during the COVID-19 pandemic. For example, in Europe, the European Medicines Agency announced that some GMP certificates would be automatically extended until the end of 2022, because of the difficulty in organizing inspections. However, the Agency was quick to stress that this did not in any way waive the CGMP compliance obligations on manufacturers and importers. 

In the US, however, the FDA has seen inspections as crucial. This is especially true for sites that wish to be licensed to manufacture COVID-19 vaccines. For example, an FDA press release mentioned a recent inspection of a Johnson & Johnson site in the US. The inspection report highlighted some concerns. The company has agreed to pause new production while it works with the FDA to resolve these concerns. It is clear that both Johnson & Johnson and the FDA want to be certain that everything has been done to ensure the quality of the vaccine once manufacturing starts. In fact, FDA has resumed domestic surveillance inspections since February and anticipates foreign inspection starting April. 

Where next for pharma in a post-COVID world?

We aren’t quite in a post-COVID world yet, although our progress towards that point already owes a lot to the pharmaceutical sector. However, the sector still has work to do: It must also build on lessons from the last 2 years if it’s to respond positively to future global challenges. 

The year 2019 saw the start of the WHO’s 13th 5-year plan of work. This has been derailed somewhat over the last 2 years, and the mention of a flu pandemic looks a bit out of date. However, there are 3 key priorities that are particularly relevant for the pharmaceutical sector. The first is the threat of antimicrobial resistance, which will need a strong response from pharma companies to develop new alternatives.  

The other 2 priorities are linked. The first is delivering health in fragile settings. In these locations, large numbers of people are vulnerable to disease and disaster. Immunization is expected to play a key role in improving child health. Finally, the WHO program highlights the importance of addressing vaccine hesitancy. It recognizes that this is a complex issue, but notes the importance of increasing confidence in vaccines, and providing reliable, trustworthy advice.  

As we’ve discussed, increasing transparency and being CGMP compliant are both good ways to increase confidence in vaccines and medicines around the world. This will help ensure that nobody needs to be concerned about the quality of their medicines. Through CGMP compliance and other actions, pharma companies have a vital role to play in addressing the WHO’s priorities.  

Rapid change, CGMP compliance, and your company

There’s certainly no room for complacency in addressing CGMP compliance. Both technology-driven capability and pharmaceutical regulations are changing fast. And pharmaceutical companies are at the front line of this change.  

Not only compliance officers, but also facility operators, site managers, and corporate management – all internal stakeholders that play a part in bringing a vaccine to the market – are responsible for keeping their companies in line with the evolution. There will be much work to do over the next few months and years – and further into the future. The best way for your company to stay ahead of wavering confidence is to stay compliant with changing regulations. 

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