After the risk assessment, your company will need to perform an on-site audit which should be planned with precision. Your
time on site is going to be limited, so obtaining as much information about the company as possible upfront will be beneficial.
Try to find out whether personnel at your potential supplier understand quality issues. Take a draft agreement with you addressing
responsibilities (e.g., notifying you about changes, reprocessed or reworked batches, and major process deviations) that could
result in a different impurity profile if not followed. Before approving a new vendor, make sure the new supplier/manufacturer
(and you will need full information about both if using a distributor) is a quality partner willing to listen to and accommodate
your GMP needs.
Ask the supplier whether it has other manufacturing sites before you leave for your audit. You need to visit any site that
is a potential supplier. Do not assume that if one site meets your requirements, the other(s) will be equivalent.
Think about what the change to a new supplier will involve within your company regarding approved and pending applications
and how they will be handled. Different markets take different lengths of time to approve variations or amendments to licensing
submissions, so a global pharmaceutical company could find itself continuing to purchase material from its previous supplier
for three to, in extreme cases, five years. As a result, the compay ends up having to segregate product destined for various
countries. Additional stability studies and process validation may be needed as well. These activities will have to be handled
as part of the change management plan.
At the other end of the spectrum are distribution issues. GDPs constitute the part of quality assurance that ensures products
are consistently stored, transported, and handled under suitable conditions as required by the marketing authorization or
product specification. Storage, transportation, and handling are obvious points for entry of counterfeits into a supply chain
and therefore require careful control. Although quality systems generally have well developed procedures in place for managing
changes to the starting materials supply chain, the distribution chain may be a different story. Granted, in the past few
years, distribution agreements have become far more sophisticated and commonly include a quality/technical agreement, but
you need to ask yourself whether the resolution is sufficient. With distribution being a global activity in today's market,
there are local laws and regulations that need to be addressed that may require relabeling or repackaging and again offer
an opportunity for substitution of the real product with a counterfeit. Tamper-evident seals may not be a solution if the
patient insert needs to be replaced with one in the local language. A formal risk assessment (e.g., Ishikawa follwed by FMEA),
can allow your cross-functional team to assess potential hazards in the distribution chain. A few items to be considered include:
- Responsibilities such as ownership of vehicles used for transport
- Management of the product at the airport or throughout shipping
- Handling of customs and verification that a genuine official opened a shipment (e.g., certified tape might be easy to forge)
- Transportation temperatures
- Temperature deviations (e.g., owing to a strike at the port)
- Activation of the temperature datalogger
- Relabeling procedures
- Returns policy.
Having completed your analysis, take time to consider the unlikely. For example, after you put procedures in place to control
all identified risks and sign a distribution agreement with your chosen contractor, how will your company handle a new distributor
trying to grab the business? How much time and effort will your quality department need to invest to place the necessary controls
in place with the replacement?
In the case of change management and sourcing of starting materials and contractors for distribution, companies would be well
placed to remember one of Deming's 14 principles for quality management:
End lowest tender contract. Cease the practice of awarding business solely on the basis of price tag. Instead require meaningful
measures of quality along with price. Reduce the number of suppliers for the same item by eliminating those that do not qualify
with statistical and other evidence of quality. The aim is to minimize total cost, not merely initial cost, by minimizing
variation. This may be achieved by moving toward a single supplier for any one item, on a long term relationship of loyalty
and trust. Purchasing managers have a new job, and must learn it.
In a global environment, the hazards that exist at both ends of the supply chain require drug manufacturers to be cautious
with regard to managing change. Unfortunately, drugmakers must also consider potential rogues within the growing counterfeiting
industry waiting to make a fast buck. The current business environment obliges quality professionals to be willing to make
necessary changes when proved justified. The way to manage these changes effectively is through partnering: first, partnering
internally between your quality and purchasing departments; second, partnering externally with new vendors by ensuring they
are on the same page with respect to quality systems. If appropriate risk assessments are made and controls are put in place
based on the outcome, the changes should move forward smoothly and efficiently to the benefit of all parties.
Karen Ginsbury is president of Pharmaceutical Consulting Israel Ltd., firstname.lastname@example.org