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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5428_Библиотеки_им_академика_М_И_Перельмана
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(courier), inland water transportation, fixed transport installation, and multimodal
transportation
36,37
.
Good Distribution Practices
Good transportation practice should be followed for each type of goods, particularly for
pharmaceutical product so that the product must retain its physical, chemical and therapeutic
properties as maintained at the time its manufacture. Earlier, people were interested in or
concerned to the manufacturing process only and for this, a good manufacturing practices
(GMPs) were developed. It was not realized that if a drug is reached to patient in good
condition, then only it can work good. Thereafter, the importance of transportation is
realized and good supply chain management made it possible. Supply chain management as
such is a complex process. It starts at international level, where a private or public sector
companies import drugs from foreign companies. It can also happen with national
manufacturers who import drugs from international suppliers. Whatever the case may be the
drug as it is or after conversion into its product shall be distributed throughout the country
(all over the territory of the nation). This requires a local distribution company having a wide
network to supply the drug product to all private pharmacies, hospitals, government
institutions that deal with selling of drugs to community either through healthcare
professionals (physicians) or directly to the drug stores
38,39
. In each and every case, the drug
must be distributed in proper condition. The first draft of good distribution practices was
prepared in 2004
40
. It was then continued in 2009
41
, and the good distribution practices
appeared as WHOGDP in 2010
42
. According to the WHO good distribution practices
(WHOGDPs) there are seventeen areas to be taken care of. These are
Organization and management,
Personnel,
Quality system,
Premises,
Warehousing and storage,
Vehicles and equipment,
Shipment containers and container labeling,
Dispatch and receipt,
Transportation and products in transit,
Documentation,
Repackaging and relabeling,
Complaints,
Recalls,
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Returned goods,
Counterfeit pharmaceutical products,
Importation,
Contract activities and shelf-inspection
43
The Good Distribution Practices may be defined as a part of quality assurance which ensures
that the drugs and pharmaceutical products are consistently stored, transported and handled
under suitable conditions as required by the marketing authorization or product specification
39,44
. In addition to WHO, European Commission (EC) introduced guidelines on good
distribution practices of medicinal products for human use in 2013. The EC guidelines
mentioned appropriate tools to help the whole sale distributor not only in carrying out their
activities but also to protect fallacious medicines from entering the legal supply chain.
According to this guideline the wholesale distributor must have at least 11 items, which are:
Quality management,
Personnel,
Premises and equipment,
Documentation,
Operations,
Complaints,
Returns,
Suspected falsified medicinal products and medicinal product recalls,
Outsourced activities,
Shelf-inspections,
Transportation and specific provision for brokers
45
.
In 2013 in India, the Organization of Pharmaceutical Producers of India (OPPI) prepared a
guideline for Good Distribution Practice for pharmaceutical products. The Guideline
mentioned the following requirements such as
Organization and management,
Personnel,
Quality system,
Premises,
Warehousing and storage,
Temperature,
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Environment, and storage control,
Transportation,
Shipment containers and labeling,
Dispatch and receipts,
Documentation, complaints,
Recalls and returns,
Spurious pharmaceutical products,
Importation,
Contract activities and self-inspection
46
.
In 2015 the Health Science Authority of Singapore released a Guidance Note on Distribution
Practice. The guidance mentioned the requirements of the following:
Personnel,
Premises and equipment,
Stock handling,
Stock control and deliveries,
Product complaints,
Product recall,
Returned products,
Counterfeit products,
Self-inspection,
Contract activities,
Handling of active pharmaceutical ingredient or intermediates
47
.
In 2017 the Health Product Regulatory Authority (HPRA) of Ireland released a Guide to
Good Distribution Practice of Medicinal Products for Human Use. The guidance provided a
list of components the wholesalers to comply with.
Quality management,
Personnel,
Premises and equipment,
Documentation,
Operations,
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Complaints,
Returns,
Suspected falsified medicinal products,
Medicinal product recalls,
Outsourced activities,
Shelf-inspections,
Transportation and brokers
48
.
Similarly, most countries have also prepared and released guidelines to good distribution
practice. These guidelines have proved that good transportation is necessary for supply of
quality medicines. Based on the places where the distributed medicines are to be delivered,
the function of transportation may be independent from the function of distribution.
Particularly in international transaction export-import of drugs across the nations and across
the oceans, different modes of transportation may be required. Thus, an independent
transporter may be required by the distribution company.
It has been observed that the distribution company does not have enough transportation
vehicles to meet the distribution activities and capability to enter specific area. Thus, the
transportation companies should have sufficient vehicles to deliver the drugs to across the
countries.
Inventory Management and Control
In an organization production is placed at center of all activities. All other activities such as
finance, personnel, purchase, marketing, etc. are there in an industry because of production
activity. Thus, the production management is very much important. Depending on the policy
of the company it may be line function or staff functions. Production is the process that takes
place after an effective planning and regulating the operations of the process. This is a
process responsible for transformation of materials into finished product. Production
management takes the decision related to production process so that the goods and services
are obtained or produced at a minimum cost according to the qualitative and quantitative
specifications and demand schedule. From the above description it is understood that
production planning and its control are the main functions of production management.
In large scale manufacturing industry production, planning and control are separate
departments headed by separate personnel. The organization structure and functions of
production, planning and control is shown in Fig. 4.10.
img
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1.
2.
3.
4.
5.
Fig. 4.10 Organization structure and functions of production, planning control department of a large scale pharmaceiutical
manufacturing industry
Types of Inventory: Inventories are used for different purposes and by various departments
for their respective needs and requirements. There are generally five types of inventories that
every production organization should give importance on:
Movement inventories,
Buffer inventories,
Anticipation inventories,
Decoupling inventories, and
Cycle inventories
Movement Inventories
Everyday resources are being transported to the industries and kept them for use by
production department of the organization through various modes of transportation.
Movement inventories can also be called transit or pipeline inventories. Basically this deals
with transporting the resources from source to destination. For example, coal is transported
from coalfields to an industrial township for power generation or for burning furnaces etc.
During transport, coal cannot be used for any purpose
49
.
Buffer Inventories
These inventories are primarily kept for future needs for the organization in stock. Every
organization keeps an average amount of inventories in stock so that the organization can
utilize those resources efficiently and effectively without any delay. This mainly calls for
uncertainty in demand, as every organization would need the required amount of stock. What
would happen when the stock is exhausted? For anything the production would stop. So, it is
very important that excess amount of resources should be kept in stock to avoid the average
lead time. The concept of holding the buffer stocks is to enhance the level of providing
customer service and gradual reduction of the number of stock outs and back-orders. Stock
out refers to the situation when the stock is exhausted; as a result, the needs of the customers
are not fulfilled but, in some situations, back ordering are possible. That is the order for
goods demanded is fulfilled as soon as the next shipment of stock arrives. In other cases, it
may happen that the demand might be lost forever which leads to temporary or permanent
loss of customer goodwill. So it is very important to keep buffer stocks as demand may arise
at any point of time.
Anticipation Inventories
Anticipation inventories are generally put under scrutiny for future demands. When required
the supply of products flow rapidly. Like producing rain coats before the rainy season,
producing crackers before Diwali, seasonal drugs such as cetirizine before rainy season and
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winter season, etc. The idea under this is to make the flow of production process smooth for
longer time instead of operating with excess overtime in a particular period. However, with
respect to pharmaceutical products this does not happen; throughout the year the production
continues.
Decoupling Inventories
This type of inventory deals with the work rate of different machines and people because
normally machines work at different rates, some slower and some faster. Yes, this may be
applicable for other products such as crackers. For example, a machine might be producing
half the output of the machine on which the item being handled is to be processed the next.
Inventories in between the various machines are held to disengage the processing on those
machines. In absence of those inventories, different machines and people cannot work on a
continuous basis. Clearly, therefore the decoupling inventories act as shock absorbers and
have a cushioning effect in the face of varying work rates, and machine breakdowns and
failures and so on.
Cycle Inventories
Cycle inventories are those when purchases in lots instead in exact amount of required stock
during a specific point of time. If all the purchases are made as per the exact requirement of
stock there would have been no cycle inventories. The cost in getting these stocks would be
much higher as per the customer needs and requirements. They are also called lot-size
inventories and larger the lot-size inventory the greater would be the level of cycle inventory.
Inventory Decisions
Taking decision on inventory is very important in a production organization, because the
future and present performance of the company depend on this decision. In general, in any
production organization the inventories are decided according to the needs and requirements
of it. This can enhance the performance or bring down the efficiency. The production
manager should keep certain things in mind before making decisions. These are:
How much to order? – This is decided by the manager as to how much quantity to be
ordered for optimal performance and effective utilization of resources.
When to order? – This is the most important aspect the manager should emphasize on to
because this would decide when the products should be ordered.
How much stock should be kept in safety? – This indicates how much quantity should be
taken under consideration so that the stock can be used safely in future without any
hesitation.
Inventory cost
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The cost function is considered as the top most criteria for selection of the best inventory
policy. There are four components used in the analysis of inventory policy:
Purchase Cost
Primarily this is the nominal cost of an inventory. It is the cost of purchasing from the
outside sources. It can be called as production cost provided the items are produced within
the organization. The cost is constant for a unit but may vary according to the quantity
purchased. For example, the unit price is Rs.25 for up to 10 units and Rs.24.50 for more than
10 units. When a unit cost is constant, the control decisions would not have any effect,
whether all the requirements are produced just once or made in installments. The total
amount of money involved would be the same.
Ordering Cost/Set-up Cost
When the stock replenishes, this happens. The ordering cost is related to the processing and
chasing the purchased order, transportation, and inspection for quality. It may also be called
procurement cost. When the units are produced within the organization is the set-up cost, its
parallel would be the ordering cost. The set-up cost is the cost incurred in relation to
developing production schedules. Both ordering cost and set-up cost are independent to the
order size. So, the unit ordering/set-up cost decreases when the purchase order increases.
Carrying Cost
Carrying cost is also called as holding cost. It refers to the cost associated with storing of an
item in the inventory. It varies with the amount of inventory and the time for holding that
inventory. The elements of carrying cost are the opportunity cost, obsolescence cost,
deterioration cost. The carrying cost is expressed in terms of rate per unit or as a percentage
of the inventory value.
Stock out Cost
Stock out cost is the cost incurred when customers are not being served. These costs involve
shortages. If stock out is internal, it means that some production is lost internally as a result
there was idle time for man and machines. If stock out were external, it means that a
potential sales or loss of customer due to loss of goodwill was resulted. On the arrival of new
shipment, a customer who denied earlier would be immediately supplied the goods. But it
would involve costs like packaging costs and shipment costs
50
.
Inventory Management Systems
Primarily there are two types of inventory management systems:
img
Fig. 4.11 Production cycle
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(a)
(b)
(c)
(d)
(e)
Fixed order quantity system: This is also called as ‘re-order point’ or Q-system. When a
specific level is arrived at a particular level, it is called re-order level and the stock level also
arrived at this point. Then an order for a particular number of units is placed.
Periodic Review System: This is a system where after a fixed period the stock is replenished.
In this system, after this fixed period, the order is placed. The order is fixed, but the quantity
may vary.
Fixed Order Quantity System: In this system, a re-order point is established. Once the stock
level arrives at this level, new set of orders are placed. This system is considered as certainty.
Based on different conditions several models can be developed to study various aspects of
the system under deterministic conditions.
Model I: The Classical EOQ Model
EOQ means Economic Order Quantity. It is also known as the Wilson Formulation. It is the
most basic of all the inventory models. For this, a fixed cost model is prepared and then it is
operated to form an inventory model. This model is based on the following assumptions:
The demand for a particular item is continuous, constant, and certain during a time
period.
The purchase price is fixed, and no discount is available even on a large lot.
The inventory is refilled immediately as the stock level reaches level equal to zero. So,
there is no shortage or overage.
The lead is always known and fixed. When the lead-time is zero, the delivery of item
is instantaneous.
Within the range of quantities ordered, per unit holding cost and the ordering cost are
constant. Thus, EOQ is independent of the quantity ordered.
With these assumptions, the inventory level would vary over time as shown in the Fig. 4.12
shown below.
img
Fig. 4.12 Variation of inventory level with time
The re-ordering level can be calculated as:
Re-order level = Maximum Rate of Consumption × maximum leadtime
Production , Planning and Control (PPC)
For implementing the plans, the production planning and control is necessary in a
manufacturing company. Planning means detailed scheduling of jobs, assignment of
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workloads to machines and manpower, the practical or actual work-flow through the system,
etc.
Production is an organized activity of converting raw materials into finished products of
desired quality. The production system requires the optimal utilization of natural resources
such as men, machine, money, material, and time. Production planning and control
synchronize with various departments such as production, marketing, logistics, warehouse,
and other departments depending on the nature of the organization. The production planning
and control gets data related to orders from marketing departments. Based on marketing and
production data, production plan is prepared. Thus, the production plan gives a clear idea
about utilization of manufacturing resources for production. This production plan prepared is
handed over to the production department. Then the production department starts
manufacturing the products according to the plan. The ultimate objective of PPC is to
contribute to the profits of the company
51
.
Like inventory management and control, this is achieved by keeping the customers satisfied
through maintaining the delivery schedules.
Objectives of PPC
The main objectives of PPC can be summarized as:
It can be used to set up the target and ensure the deviations by comparing measures on
some performance.
It decides the nature and magnitude of different input factors to produce the output.
Coordinates different resources of production system most effectively and in
economic manner and to coordinate among different departments.
Elimination of bottleneck
Utilization of inventory in the optimal way
Smooth flow of material
Production of right quantity and quality of material at right time
Scheduling of production activities to meet the delivery schedule
Expediting the system under production
To ensure flexibility in production system to accommodate changes and uncertainty
Optimizes the use of resources for minimum overall production cost
To ensure the production of right product at right time in right quantity with
specification rightly suited to customers
Stable production system, with least chaos, confusion and undue hurry.
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Meaning of Production Planning and Control
To ensure an efficient and economical manufacture of products, production planning and
control becomes a very critical decision. Planned production is an important feature of any
manufacturing industry. Production planning and control (PPC) is a tool used to organize
and combine the entire manufacturing activities in a production system. Basically, it
comprises of planning the production before start of actual production activities. Then the
PPC starts exercising control over those activities to ensure that the planned production is
realized in terms of quantity, quality, delivery schedule and cost of production. Usually, the
PPC is involved in the organization and planning of manufacturing process. It includes entire
organization. The various activities involved in production planning are:
Designing the product,
Determining the equipment and capacity requirement,
Designing the layout of physical facilities and material and material handling system,
Determining the sequence of operations and the nature of the operations to be
performed along with time requirements and specifying certain production and
quantity and quality levels.
Production planning also includes the plans of
Routing,
Scheduling,
Dispatching,
Inspection and coordination,
Control of materials,
Methods machines, tools and operating times.
Its ultimate objective is to plan and control the supply and movement of materials and labor,
machines utilization and related activities; so that the desired manufacturing results is
brought about in terms of quality, quantity, time and place. This provides a physical system
together with a set of operation guidelines for efficient conversion of raw materials, human
skills and other inputs to finished product.
Procedure of Production Planning and Control
The PPC is based on the pre-design format. In a manufacturing company planning is done
before actual production starts. It tries to carry out and execute all activities or operations
according to the plan set. All operations should be carried out in a proper way with a close
observation on all the facts to ensure that the time period and the stipulated costs should not
go beyond the limit. The production should be done under the excepted/agreed policies
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.
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