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Pharmaceutical Manufacturing and Packing Sourcer

Chain Compliance

The last few years have seen numerous updates to Good Distribution Practice (GDP) in pharma, to modernise standards and ensure they continue to steer quality assurance and integrity in the distribution of medicinal products. These revisions have impacted the way in which pharmaceutical companies and wholesalers manage their transportation providers.

Many of these recent changes are reflected in the GDP guide published by the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which acts as a benchmark for compliance. PIC/S facilitates cooperation between regulatory authorities in the fields of GDP and Good Manufacturing Practice. With regulatory bodies from 46 countries currently members of the scheme, its GDP guide is the closest paradigm to a universal standard.

he document is modelled on the EU's Guidelines for GDP (2013/C 343/01). It is applicable not only for medicinal products intended for humans, but can also be used for investigative products and veterinary purposes.

Impact on Supply Chain

From the standpoint of a transportation provider, GDP developments have had major implications for their operations, specifically in terms of compliance requirements, the role of risk management, and managing contract activities – and these are described in the PIC/S guide.

Compliance
This is now a two-fold requirement for both sides that enter into a contractual agreement. As contract givers, pharma companies are expected to ensure total compliance within the supply chain, including outsourced activities to service providers. As contract acceptors, service providers are responsible for activity covered by GDP, having had this responsibility delegated to them by pharma companies (1). To ensure compliance with GDP, it is in their own interest for service providers to develop a closely aligned quality system.

Role of Risk Management
Conceding that absolute control over the supply chain is not feasible, the PIC/S guide urges pharma companies to incorporate risk management into their quality systems. The recommended structure is based on the four key stages of risk governance set out in the ICH Q9 guideline on quality risk management: assessment, control, communication and review.

These steps are designed to help an organisation identify areas that have high criticality over the actual functioning of the supply chain, and which require additional levels of management, in a bid to neutralise the disruptive potential of risks before they materialise:
  • Risk assessment: what can go wrong (identify), what is the likelihood that it will go wrong (analyse), and what is the severity of the impact (evaluate)?
  • Risk control: decide whether to accept or reduce possible risks
  • Risk communication: disseminating the results of risk assessments to relevant parties; ensuring appropriate course of action taken
  • Risk review: a standard procedure to evaluate the effectiveness of risk control measures. Either hands-on intervention (inspections, audits or change controlled) or monitoring from afar (root cause analysis of deviations from established policies and procedures) (2)
The clearest indication of the growing impetus of risk management and its effect on best business practice can be observed through change control, as well as corrective and preventive action (CAPA). The procedures within CAPA obligate organisations to demonstrate that considerable effort has been made to adopt these processes. This further applies to the management of outsourced activity.

Managing Contract Activities
When it comes to administering contract activities, the PIC/S guide explicitly puts the onus on both pharma companies and service providers to ensure that both are unequivocal in their roles and responsibilities in any outsourced activity.

Where accountabilities inevitably diverge is in a pharma company's selection of a service provider. The guide emphasises the responsibility of contract givers to assess the suitability of potential acceptors before awarding them with the contract. This can be achieved by:
  • Ensuring there is a process to assess the suitability and competence of any prospective service provider
  • Clearly defined roles and responsibilities of all parties involved in the supply chain
  • Monitoring and reviewing the performance of service providers to guarantee an acceptable level of service, and to provide opportunities for making improvements on a regular basis
In practical terms for pharmaceutical companies and wholesalers, this means:
  • There should be a contract between giver and acceptor that establishes the roles and responsibilities of each party
  • Pharma companies and wholesalers must assess the competence of the contract acceptor to carry out outsourced activities properly through audit surveillance
  • It is necessary to investigate any potential service provider prior to the start of outsourced activities and whenever there are any major changes in their scope
  • Ensuring regular audits of service providers – the frequency of audits is decided by a risk assessment of the nature and criticality of outsourced activity and the importance of the service provider to the supply chain
As contract acceptors, service providers will need to:
  • Take responsibility for all activities outsourced to them
  • Agree to a contract with the contract giver and allow for audits
  • Ensure they have adequate premises, equipment, procedures and competent personnel to fulfil the requirements of the outsourced activities
  • If the service providers decide to outsource some of the activities assigned to them, they will also need to ensure they qualify and audit their own service providers, informing their clients accordingly
For pharma companies, it all depends on whether they are able to prove to regulators that they have managed to maintain the compliance of their transportation providers to applicable GDP standards(3).

Since 2009, it has become clear that the number of organisations starting to regularly audit their service providers has greatly increased, in line with GDP updates where compliance of the supply chain – including transportation companies – is the responsibility of pharma firms and wholesalers.

In their qualification and audits, pharma companies and wholesalers are focused on the following:
  • Whether the quality system of the service providers complies with the applicable GDP requirements
  • Whether the service providers have procedures to deal with risk management, change control, CAPA, managing of outsourced activities, training and documentation
The impact is being felt throughout the supply chain. For example, pharma companies will typically only work with service providers that are qualified and agree to comply with GDP requirements. In addition, transportation service providers are now facing greater scrutiny of their activities, and are developing new or modifying existing quality systems, in order to meet GDP standards. At the same time, they must be prepared for more qualification and audit exercises from their customers.

Renewed Approach

As the PIC/S guide underlines, changes to GDP mean that pharma and their transport service providers cannot carry on as before. Both parties have to evolve and take on board the revised requirements, developing their respective quality systems to manage compliance. Companies that fail to do so will not only fall foul of new GDP requirements, but will eventually lose out to competitors that do comply, and have been qualified and audited accordingly.

Note
The PIC/S Guide to Good Distribution Practice for Medicinal Products (PE 011-1) is available at: www.picscheme.org/publication.php?id=8

References
1. Chapter 7.2, PIC/S Guide to Good Distribution Practice for Medicinal Products, PE 011-1
2. ICH Q9, November 2005
3. Survey data of respondents taken from three webinars by World Courier in the Asia-Pacific region in 2009, 2012 and 2014


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Stanley Soh is the Asia-Pacific Regional Quality Manager at World Courier. He has over two decades of experience in the aviation and express courier industries, and has in-depth knowledge of cold chain management. In his role, Stanley provides support and advice on temperature control issues, and works to optimise operations, as well as ensuring World Courier's global compliance to GxP requirements. He holds an MBA in Strategic Management from Nanyang Technological University, Singapore and is a certified IATA Dangerous Goods Instructor.
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