Comprehensive Quality Assurance Plan for Medicine Supply Chain

This report provides a comprehensive overview of the quality assurance plan for the supply of medicines, focusing on the implementation of supply chain management (SCM) to ensure product quality and safety. It explores the various components of the SCM process, from the sourcing of raw materials to the delivery of the final product, emphasizing the importance of customer satisfaction. The report details the quality assurance plan (QAP), outlining the measures taken to prevent errors, maintain product quality, and comply with relevant laws and regulations. It also discusses the associated laws and regulations, such as those related to hazardous substances, chemical registration, and traceability of medical equipment. The report further addresses the principles of supply chain for medicine, including Good Distribution Practice (GDP), and the transportation options for investigated medicines, highlighting the challenges faced in establishing a robust and efficient supply chain for medical products, such as counterfeit drugs, temperature control, and inventory management. The report concludes by summarizing the key challenges and offering insights into potential solutions to ensure the safe and effective delivery of medicines to patients.

Running head: QUALITY ASSURANCE PLAN FOR SUPPLY OF A MEDICINE
Quality Assurance Plan for Supply of a Medicine
Name of the Student
Name of the University
Authors note

1QUALITY ASSURANCE PLAN FOR SUPPLY OF A MEDICINE
Table of Contents
Introduction................................................................................................................................2
Supply chain of an investigation medicine................................................................................2
Quality assurance plan...........................................................................................................2
Associated laws and regulation..............................................................................................2
Principles of supply chain for medicine.................................................................................2
Transportation options for investigated medicines................................................................2
Challenges faced in establishing supply chain...........................................................................2
Conclusion..................................................................................................................................2
References..................................................................................................................................3

2QUALITY ASSURANCE PLAN FOR SUPPLY OF A MEDICINE
Introduction
This paper investigates the quality assurance plan for the medicine and drugs
company. The paper describes the implementation of supply chain management in order to
carry out the process. It also depicts the rules and regulation that has to be followed by the
Drug Companyand source of transportation for the same. The Supply chain management
(SCM) involves all the activities to manage the flow of goods and service. It comprises of all
the processes that is used to convert raw materials to a final product. The management of
products involves development of an effective supply chain which helps in customer
satisfaction (Christopher 2016). The SCM is the method of planning, executing and
controlling of products in an integrated manner. With the implementation of good supply
chain any enterprise can experience advantage over their competitors. SCM requires efforts
by the supplier in order to deliver potential goods and service to the customers. The method
of SCM depends upon partner to partner. Customers depends upon suppliers and suppliers
depends upon manufacturer (Monczka et al. 2015). SCM transforms the raw materials that is
needed by the enterprise to create a product to deliver the customers. It tends to improve the
performance of supply chain. SCM boosts the efficiency of the company by generating higher
profits and reducing cost. The concept of SCM helps the enterprise to plan structures that will
help in managing the resources of the organization (Hugos 2018). It helps in sourcing by
selecting their suppliers who will deliver the product to their customer. SCM helps in
building good relationship of the company with the suppliers. The process of delivering also
comes under SCM. In includes scheduling, dispatching, invoicing the customers and then
finally getting their payments.

3QUALITY ASSURANCE PLAN FOR SUPPLY OF A MEDICINE
Supply chain of an investigation medicine
Quality assurance plan
Quality assurance plan (QAP) consists of a documentation that will help the company
to prevent any kind mistake that can occur while delivering the products to the customers. It
involves planning and strategizing that will help the business to create a 100 per cent quality
product (Arora and Gigras 2018). It contains a set of activities that will help in delivering
final product with best quality. The QMP will help in determining several policies and
procedure that help in satisfying the customers to the fullest. The objective of QMP is to
deliver standard quality product, meet the expectations of the stakeholder and customer
satisfaction. This plan helps in avoiding problems that can arise while delivering products. It
monitors and measures the quality of the productthat is manufactured and checks if there is
any deficiency in the product (Taylor 2018). It makes sure that the company provides the
desired output.
The quality assurance plan for medicine deals with all the important activities that is
essential to make sure that the medicine that is manufactured is safe for the patient to use or
not. It requires determining the types of side effects of the medicine. The QAP helps the
confirmation of the end product that whether it has met the requirements or not (Ceberg,
Benedek and Knöös 2018). The QAP checks the safety and affectivity of the product with
help of various procurement product. It maintains the quality by storing the medicines in
appropriate temperatureand monitoring them with the help of dispensers. The process of QAP
is continuous and helps in measurement and judgment of the medicine that is relevant to
disease or not (Candeias et al. 2017). Quality assurance in medical labs arenecessary on order
to provide the exact medicine to the patient. The methods of quality assurance include:
 Identification of active ingredient.

4QUALITY ASSURANCE PLAN FOR SUPPLY OF A MEDICINE
 The purity of the medicines are tested. It helps in detecting any contamination in the
product and presence of any harmful substances.
 The consistency of the medicine is checked. The size, shape and color.
 The stability of the medicine.
 The visual inspection of products are done after arrival and the expiry dates are
analyzed.
Associated laws and regulation
The set of rules and regulations by the government has a major impact in the supply
chain.The overall supply chain process must be viewed as whole. The external and internal
connections is a method not a department (Fredendall and Hill 2016). The inventory must be
common for all the supply chain that must be examined. The private as well the public
company needs to follow the laws (Hajjou et al. 2015).
 Limiting the use of hazardous substances: the government of US has restricted the use
of harmful substance like mercury, lead chromium and cadmium. Due to the use of
these hazardous substance the electronics productssuch as computer systems, lamps
and other tools are getting distorted. The RoHS has banned the use of these
poisonous substances within the organization.
 Registering, restricting and authorization of chemicals: the company needs to register
the name of chemical that is used by them under the REACH law. The authorization
to use that chemical must be taken (Heizer et al. 2017). It also restricts the use of
SVHC chemicals beyond 0.1 per cent.
 Title 21 CFR Part II: The food and drug administration has related this regulation to
which is related to food delivery record. For the process of delivery, the company
must undergo proper training in order to follow the correct protocol.

5QUALITY ASSURANCE PLAN FOR SUPPLY OF A MEDICINE
 Traceability of medical equipment: the organization must keep a record of products
that has been used by the company. The information of raw materials supplies to the
manufacture and then to the supplier must be kept in data format (Touboulic and
Walker 2015).
 The Dodd-frank Act: the minerals that are used by the company must come from an
authenticated source. The minerals must not be derived from those companies that
are financing conflict. The source of the minerals must be cleared by US government
(Brindley 2017).
Principles of supply chain for medicine
The parties that are responsible for the distribution of the medicines must take into
consideration that the quality and integrity of the product is preserved throughout the
transportation and distribution of the medicine. The principle of Good Distribution Practice
(GDP) must be followed. GDP is an important factor that measures the value of goods and
services that are provided by the organization (Ayers and Odegaard 2017). The distributor
organization must get proper authorization from the legislation to carry out the process. The
authorized entity which process the license will only be allowed to carry out the process of
import and export of the products. The agent must distribute the product within the
authorized territory. Beyond that it will be termed as smuggling. The use of medicine must be
for only those country that has been permitted by the legislation. The distributor can further
handle the product only to that supplier who possess appropriate authorization to sell the
medicines and drugs. The person who is assigned for the duty must be only carry out this
process. the duties of the SCM must be handled to the suitable person by the legislation.
Those must be also be saved in a form of written agreement (Durach, Kembro and Wieland
2017). If those duties and responsibilities are given to any authorized person then severe
charge will be adhered by the legislation. If the distributors intent to sell the medicines via

6QUALITY ASSURANCE PLAN FOR SUPPLY OF A MEDICINE
internet using the E commerce platform then should also be registered to the legislative
council.
Transportation of investigated medicines
The most important phase of the SCM system is distribution. The proper handling and
storage of the medicines are required before transportation. This several aspects of
transportation includes the packaging and labeling of the medicines (Van Oyen et al. 2017)
This system ensures that there is no counterfeit while in the distribution of the product to the
marketplace. The transportation of the investigated medicine must be done in such a manner
that it meets the temperature. The general condition of storing the drugs is 2 degrees to 8
degrees. The collaboration of the government, law enforcement, manufactures, suppliers,
distributors and the patient together are responsible for the safety of the medicines. I will
alsoprotect the medicine to be counterfeited (Iyengar et al. 2016). The products are delivered
in an optimized manner. Exporting the medicine to the required place involves great effort.
Many medicine reacts to the climatic condition. The impact of humidity, sunlight and
vibration could damage the product. Numerous drugs are very sensitive to temperature. The
medicines could even melt in the warm area. The chances of getting rejected and expired
There are also several medicines that should only be stored in a cool place. The
pharmaceutical products are always prone to damage because of the temperature and time.
The proper transportation of these kinds of drug should be implemented in the supply chain.
It is matter of concern that less investment is made to manage the storage of pharmaceutical
products (Arora and Gigras 2018 )

7QUALITY ASSURANCE PLAN FOR SUPPLY OF A MEDICINE
Challenges faced in establishing supply chainfor medical products
There are several challenges that can be faced while implementing the SCM process for the
medicines. There can be instances that counterfeit drugs can enter into the supply chain. The
consequences can be very disastrous for the patients. Getting them the right medicine is
necessary. The major challenge for the drug supply chain management is temperature. The
exposure of the drugs for log can damage them. By incorrect handling the packaging of the
medicines gets torn and even medicines can spill all over the surface. According to (Brindley
2017), the 30% of the medicines are ether damaged or found missing after the distribution.
There are some medicines that come in liquid state. There may be chances of dilution of these
kinds of products. The criminals could misplace the brand names also to get high payment for
the same. It can also happen that the stocks become empty and there is a shortage of drug.
Every organization seeks plans to get profit either by hook or by crook. The chances of
getting rejected and expired products are high in these cases. Other challenges such as failure
in customer satisfaction is encountered. It can be a complicated process sometimes to deliver
the right product with correct quantity to the exact place. The cost of operations can also
make the company vulnerable and loose the control. The overnight shipping of medicine also
arises as there can any unexpected situation in the hospital. This can be a difficult situation
because the supplier encounters great loss in the revenue. There are also certain kinds of
hidden cost associated with the distribution of medicines (Touboulic and Walker 2015).
Additional cost like inventory can make the suppliers suffer from huge loss and uncontrolled
budget. Three can also be cases of missing of some drugs and shortages. This makes them
suffer a lot as the industry forced them to purchase the medicine again and supply with utter
safety. The difference of preferences by different doctors has also impacted the system. They
can even change the orders which will make to execute the whole process of SCM once

8QUALITY ASSURANCE PLAN FOR SUPPLY OF A MEDICINE
again. Bad workflow design can generate unnecessary duplication of processes (Ceberg,
Benedek and Knöös 2018).
The common types of challenges are:
 Inventory management
 Order management
 Warehouse management
 Lack of coordination
 Expired drugs
Conclusion
Finally, the paper concludes by giving the brief implementation of SCM for medicine.
The several changes faced must be mitigated in order to get potential results. Therefore
several factors must kept under considered while implementing the SCM. The increase in
transparency will help in standardizing the process of SCM. The elimination of traditional
method is important to acquire real time inventory management.
There are ample amount of benefits associated with fair implementation of SCM
within an organization. It helps in achieving higher efficiency and incredibly increases the
output by improving the coordination with the shipping and transportation company. It boosts
the profit gain of the company by introducing effective and innovative technology that will
improve the collaboration. Thus, if the business wants to grow then it must adapt the SCM
systems which help the work done in much ease.

9QUALITY ASSURANCE PLAN FOR SUPPLY OF A MEDICINE
References
Arora, M. and Gigras, Y., 2018. Importance of Supply Chain Management in Healthcare of
Third World Countries. International Journal of Supply and Operations Management, 5(1),
pp.101-106.
Ayers, J.B. and Odegaard, M.A., 2017. Retail supply chain management. CRC Press.
Brindley, C., 2017. Supply chain risk. Routledge.
Candeias, A., Carapeto, M.J., Grácio, L., Lebeer, J., Costa, N., Coelho, C. and Rebelo, H.,
2017. Enabling+ Quality Assurance Plan. ENABLIN+ Quality Assurance & Self-evaluation
Report (Work package 7, Deliverable 27), pp.6-28.
Ceberg, C., Benedek, H.J. and Knöös, T., 2018. [I233] Automated treatment planning and
quality assurance. Physica Medica, 52, p.87.
Christopher, M., 2016. Logistics & supply chain management. Pearson UK.
Durach, C.F., Kembro, J. and Wieland, A., 2017. A new paradigm for systematic literature
reviews in supply chain management. Journal of Supply Chain Management, 53(4), pp.67-85.
Fredendall, L.D. and Hill, E., 2016. Basics of supply chain management. CRC Press.
Hajjou, M., Krech, L., Lane-Barlow, C., Roth, L., Pribluda, V.S., Phanouvong, S., El-Hadri,
L., Evans III, L., Raymond, C., Yuan, E. and Siv, L., 2015. Monitoring the quality of
medicines: results from Africa, Asia, and South America. The American journal of tropical
medicine and hygiene, 92(6_Suppl), pp.68-74.
Heizer, J., Render, B., Munson, C. and Sachan, A., 2017. Operations management:
sustainability and supply chain management, 12/e. Pearson Education.

10QUALITY ASSURANCE PLAN FOR SUPPLY OF A MEDICINE
Hugos, M.H., 2018. Essentials of supply chain management. John Wiley & Sons.
Iyengar, S., Hedman, L., Forte, G. and Hill, S., 2016. Medicine shortages: a commentary on
causes and mitigation strategies. BMC medicine, 14(1), p.124.
Monczka, R.M., Handfield, R.B., Giunipero, L.C. and Patterson, J.L., 2015. Purchasing and
supply chain management. Cengage Learning.
Taylor, J., 2018. Quality assurance of chemical measurements. Routledge.
Touboulic, A. and Walker, H., 2015. Theories in sustainable supply chain management: a
structured literature review. International Journal of Physical Distribution & Logistics
Management, 45(1/2), pp.16-42.
Van Oyen, M.P., Aljure, E., Busse, L., Hahn, J. and Hayes, S., 2017. Standardizing and
improving the efficiency of Michigan Medicine’s supply chain management of hospital
supplies.