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Pharmacovigilance: Friend or Foe?

Marty Boom at WCI Consulting Limited analyses the increasing impact of non-GMP regulations on pharmaceutical manufacturing

New laws focused on pharmacovigilance and safety, such as Volume 9A of the EU’s legislation on pharmaceuticals, affect manufacturing more than most people realise. For example, it defines the Qualified Person for Pharmacovigilance (QPPV) role in a manner similar to the Qualified Person role in manufacturing. In practice, this drives overlap between these roles, especially when it comes to process oversight. But it is not all bad news. Volume 9A also offers new opportunities for the manufacturing group to be more involved at an early stage of product development. Patient safety risk management (SRM) opens the door for closer collaboration between manufacturing and development. Where chemistry and manufacturing controls (CMC) often fail, SRM might just work.

BACKGROUND OF PHARMACOVIGILANCE

Five or 10 years ago, pharmacovigilance and drug safety were hardly on the radar screen of those involved in manufacturing. The closest you would get to pharmacovigilance was when dealing with product complaints resulting from the health of a patient being negatively affected – if the patient reported an adverse event (AE). The need to establish a process to communicate these AEs to the pharmacovigilance group was often the extent of interaction between the two organisations. Over the years, all companies have set up processes for triaging telephone calls and directing product complaints that, in reality, are AEs to pharmacovigilance. In addition, the complaints database is regularly screened for AEs. This is often where pharmacovigilance would stop for the manufacturers, apart from the compulsory introduction of training for every employee, which includes a section on pharmacovigilance and what you need to do when you hear your friends or family talk about a possible AE.

It all sounds a bit simplistic, but for most people in manufacturing this was what pharmacovigilance was about. However, the world of pharmacovigilance is changing rapidly. High profile cases like Vioxx have given the pharmaceutical industry better insight into the activities of pharmacovigilance, as well as its relationship with manufacturing. In addition, the EU’s legislation, Volume 9A, has driven a broader role for pharmacovigilance in the pharmaceutical organisation. The blip on the manufacturer’s radar screen has become bigger. How big is yet to be determined.

THE ROLE OF THE QUALIFIED PERSON IN PHARMACOVIGILANCE

Volume 9A introduces the concept of the QP in pharmacovigilance: the QPPV. The responsibilities of the QPPV are: 

  • Establishing, managing and maintaining the marketing authorisation holder’s pharmacovigilance system
  • Understanding the safety profiles and any emerging safety concerns in relation to the medicinal products for which the marketing authorisation holder holds authorisations
  • Serving as a single contact point for the competent authorities on a 24-hour basis

Any QP in manufacturing reading the above will notice that the regulators have modelled the QPPV role on Volume 4 of the GMP regulations. They are likely to draw the conclusion that having oversight is prerequisite for being able to perform the QP role adequately. In fact, Volume 9A stipulates this oversight specifically:

  • The QPPV should have oversight of the pharmacovigilance system in terms of structure and performance 
  • The oversight should cover the functioning of the marketing authorisation holder’s pharmacovigilance system in all relevant aspects, including quality control and assurance procedures, standard operating procedures, database operations, contractual arrangements, compliance data (for example, in relation to the quality, completeness and timeliness for expedited reporting and submission of periodic safety update reports), audit reports and training of personnel in relation to pharmacovigilance.

This indicates a broad scope of responsibilities, but where does the oversight stop? Training and complaints management are clearly in scope as are safety related recalls, but what about process deviations or definition of critical process parameters or stability testing? It is easy to see the potential overlap in the roles and responsibilities of the GMP QP and QPPV.

Well, I can see some QPs in manufacturing starting to curl their toes and worrying about the QPPV interfering in their traditional areas of responsibility. However, there is a positive side. Both QPs ultimately have the safety of the patient in mind. This means that different perspectives can be integrated when dealing with corrective and preventive actions (CAPAs) or risk mitigation actions, resulting in the best resolution for both the patient and the business.

So far, I have addressed the topic very much from a QPPV’s perspective. Some might have answered the question that I raised in the title of this article already. Some may simply feel the answer is ‘a proper pain’, but please do not jump to conclusions yet! Volume 9A also offers many opportunities to the people in manufacturing.

PHARMACOVIGILANCE IN MANUFACTURING

One of the hot topics in pharmacovigilance is SRM. A company is obliged to establish processes to identify and assess patient safety risks and to develop plans to mitigate these risks. SRM covers the full life cycle of a product, starting after Phase I clinical trials, and is part of the submission for a new marketing authorisation. Over the last two to three years, most companies have gained some experience with SRM plans, including submission to the authorities.

The SRM processes are driven by safety risk management teams. Typically, pharmacovigilance, development and regulatory affairs are members of these teams, while manufacturing and supply chain have little or no involvement. This gap creates internal risk, as many patient safety risks are introduced during the definition of the supply of the product and most safety mitigation actions (as described in the SRM plans) are actions that need to be implemented and executed in the supply chain.

Figure 2 shows the drug development process in parallel with the activities required within the supply chain to produce and distribute the product. Both processes are simplified and purely illustrative. During the set up of the supply chain for a new product, many decisions are made which affect patient safety. Sources of these risks include:

  • Product development – use of material or chemicals that are difficult to manufacture or process with consistency
  • Suppliers – global sources of material or manufacturing processes used in raw material production
  • Manufacturing – need to establish or introduce new manufacturing processes
  • Distribution – environmental considerations during storage or transport
  • Patient – package definition to avoid potential misuse or abuse Similar decisions are made once the product is on the market with post-launch changes to formulation, manufacturing processes or suppliers.

PHARMACOVIGILANCE IN THE SUPPLY CHAIN

Many of the risk mitigation actions, as currently defined by the SRM teams, are implemented and executed by the supply chain. Obvious examples are changes to the label or the inclusion of administration instructions in the package. Less obvious, and more difficult to implement, are changes to the package to avoid misuse of the product. Even more complicated are changes that affect the distribution model. Can you image the extent of changes required in the supply chain when the distribution model changes from direct-topharmacy to direct-to-patient? Nevertheless, in some instances these changes are required to ensure patient safety.

Are there not benefits in supply chain, pharmacovigilance and development working together when decisions related to these risks are taken? Does it not make sense for the supply chain to have a more prominent role in the SRM processes and to be a permanent member of the SRM team? The benefits of implementing effective SRM processes and developing holistic SRM plans extend beyond patient safety:

  • Consistent life cycle safety risk management process and organisation throughout the safety management team
  • Risk management becomes an integral and embedded part of product development and supply chain decisionmaking – there are no surprises
  • All known supply chain risks have agreed and documented mitigation actions
  • Early characterisation of risk and implementation of risk management into supply chain development will reduce post-launch issues and cost, as well as minimising effort and resources
  • Manufacturing processes and supply chain elements are compliant with regulatory requirements T

This can only be achieved when pharmacovigilance and manufacturing operate together closely. In practice, this will mean that processes on both sides of the business will need to be reviewed and updated to reflect correct and timely involvement of all stakeholders, that knowledge-sharing processes will need to be developed, and that an understanding is gained of each other’s capabilities and limitations. If this does not succeed, the consequences are significant. Without this collaboration and holistic focus on patient safety, the use of the product may ultimately cause further harm or death to the patient, rather than providing a positive benefit. Failure to ensure patient safety will have many negative impacts on the organisation:

  • Additional investment required to resolve issues or concerns
  • Negative publicity resulting from media coverage of incidents
  • Loss of revenue due to delayed product launch or product recall

Do not think too long about answering the question: pharmacovigilance – a manufacturer’s friend or foe? Both parties have patient safety as a first priority and want to protect the brand and the business. The answer has to be ‘friend’.


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Marty Boom is a Principal with WCI and has been with the organisation for the past 12 years. In his role, he has managed and led global business improvement assignments in the life science industry. Marty is an expert manager of change in strictly regulated environments, and is WCI’s Lean Compliant Operations proposition owner. He holds a degree in Mechanical Engineering and Manufacturing Automation from the Technical Institute of Arnhem, and a degree in Business Administration.
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