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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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calibrated on a regular basis as per the schedule.
Production equipment should be thoroughly cleaned on regular basis as scheduled.
Laboratory equipment and instruments should be suitable according to the testing
procedures to be undertaken.
Washing, cleaning and drying equipment should be selected and used in such a way
that they do not become the source of contamination.
Production equipment should not create any hazard to the products. The parts of the
production equipment that come in contact with the product must not be reactive,
additive, or absorptive to an extent that would affect the quality of the product.
Defective equipment should be removed from production and Quality Control areas. If
this is not possible, it should be clearly labeled as defective, NOT TO BE USED.
Closed equipment should be used for appropriate operation. Where open equipment is
used or equipment is opened, appropriate precautions should be taken to avoid
contamination.
Non-dedicated equipment should be cleaned according to validated cleaning
procedures between productions of different pharmaceutical products to avoid crosscontamination.
Current drawings of critical equipment and support systems should be maintained.
Written procedures should be established and followed for cleaning and maintenance of
equipment, including utensils, used in the manufacture, processing, packing, or holding of a
drug product. These procedures should include, but should not be limited to, the following:
The responsibility for scheduling the cleaning and maintaining equipment should be
assigned.
Maintenance and cleaning schedules, and where applicable sanitizing schedule are to
be made.
The methods of cleaning and maintenance operations for the equipment, and materials
to be used should be described in sufficiently detail without any confusion or
ambiguity.
The methods of disassembling and reassembling the equipment should be described in
sufficiently detail without any ambiguity to ensure proper cleaning and maintenance.
Clean equipment must be protected from contamination and checked and inspected
before use.
Previous batch identification must be removed.
Records of all the activities done as described above with respect to cleaning,
sanitization, maintenance, and inspection should be maintained.
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Production Management
Production Management is a process. In this process the raw material is converted into
finished products. Decisions on quality, quantity, cost, etc. of the products being produced
are taken in this process. Thus, production management includes the process of planning,
organizing, directing and controlling of activities related to production. In a pharmaceutical
company production consists of creation and maintenance of a clearly defined process, so
that the personnel, land, premises, equipment, and inventory assets are effectively used in a
coordinated way. Production management in a pharmaceutical industry is called as
Pharmaceutical Management
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Objective of production management
The production management utilizes the management principles for the production in a
factory. The quality of a drug product cannot be achieved through inspection or analysis of
product. The main objectives of production management are.
To produce the products of right quality and quantity in time at minimum cost is the
main objective of production management
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To improve the efficiency of the product.
To prepare the products in such a way that the quality is built into the product.
Importance of Production Management
In a pharmaceutical industry production management plays a very important role in an
industry.
It helps the industry to satisfy the needs of the customers and to achieve its objectives.
It helps to maintain the reputation, goodwill, and image.
It helps to establish new product.
The competition in the market can be faced by making the products of right quality,
quantity within a definite time.
Optimum utilization of the resources – manpower, machines, and money can be
facilitated.
It helps to reduce the cost of production and increase the efficiency,
It helps the company to expand its business and grow as the production management
works to improve the quality of the products at a reduced cost.
Good Manufacturing Practices
Nowadays the regulatory agencies have become very much strict and vigilant. With these
pharmaceutical industries are supposed to deliver the drugs of the highest quality and purity
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to the public
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. Recently, FDA has increased the surveillance introducing the Intensified
Drug Inspection Program and Drug Enforcement Administration
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. Quality management in
pharmaceutical industries has been critically examining the critical aspects of process
involved in manufacturing of the products. The international Organization for
Standardization (ISO 9000) has gained popularity in examining the quality standard in
pharmaceutical industry
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. With all these it has been aimed to serve the basic quality
standards, on which the individual industries, suppliers or customers can add their own more
specific requirements.
ISO 9000 is a set of universally accepted practices, if implemented can provide customers
satisfaction and confidence that the suppliers would consistently meet their needs.
The following information on manufacturing facilities can provide a guide to good
manufacturing practices for pharmaceutical operations: Weighing is the first essential
operation in any manufacturing industry. It plays the key role in the manufacturing processes
because the content of a drug in dosage form depends primarily on the amount of drug taken
for production. Thus, advancement and vigilance have been put on weighing in the
pharmaceutical industries. This operation must be supervised and checked properly. Since
the materials may deposit around the balance due to handling, regular and sufficient
sanitization would be required. The Fig 4.3 shows the basic concept of production
management in any organization.
Manufacture of tablets
Granulation for tablet manufacturing is a step that is to be considered
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. Before granulation,
grinding of the materials is necessary. However, various techniques have been developed to
grind the materials. Drying is another step which cannot be avoided. Whatever may be the
process of grinding or granulation or drying is adopted, all the parts which come in contact
with the product, should be of stainless steel. The entire area and machines should be
properly cleaned and recorded before and after operation.
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Fig. 4.3 Basic concept of production management in any organisation
Compression of granules requires room and compression machines. Now separate room is
recommended to be used for compression of a particular tablet to avoid cross contamination.
However, for large quantity of granules of same batch no are to be compressed, a large room
having two or more machines can be used for compression
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. There should be sufficient
space in the compression room to keep the in-process testing equipment such as weighing
balance, disintegration test machine, and hardness tester, slide caliper, etc. To maintain the
stability of the tablet low humidity is required to be maintained. The room should have glass
or transparent partition which extends from three feet height to ceiling level.
Coating of tablets produces noise and dust. Coating of tablets is being done to improve the
taste, stability and to release the drug in controlled manner. Currently robotized shower
covering is available. Mechanical methods are being used to cover the tablets with a thin
film or sugar coat
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Fig. 4.4 Processes involved in manufacture of pharmaceutical products
Manufacture of liquids
In an area where the oral liquids are manufactured, outer or corrective measures are to be
made. There should be isolate office for each gathering. If more than one gathering is there,
an isolated divider should be developed so that no odor can migrate from one place to
another
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and no cross contamination or adulteration can take place. All the pipelines and
equipment used should be made of stainless steel and kept clean. There should be a regular
check of the environment to examine the circulating air.
Packaging
Packaging lines should be sufficiently separated, at least 15 – 20 feet from the production
area, to avoid cross pollution, if any. Typically, a mobile segment between the packaging
lines should be used. Whether straight lines or U-molded lines are to be used for packaging,
this is decided based on premises design.
Integrated Production Management
According to the size of the business, the materials administration such as raw materials,
supplies, intermediates, stacking, and working hours, etc. is to change. Material
administration is responsible to measure the stock and inventories. From factual or
numerical methods production and stock control are calculated.
Production Management and Production Control
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Creation aggregation generally starts with the Aggregate Planning. Based on the information
the quantities of different items that can satisfy the orders can be decided. The available
stocks, cushion stocks used to meet in exigencies are to be considered additionally. All the
materials required to meet the purpose are to be decided by the production management
team.
Parameters of production management
There are several parameters based on which the production management team can take the
decision on increase in productivity. These are.
Inventories: The materials held at different areas in a production system are called as
inventories. Inventories may be planned or unplanned. During production planning,
the planned inventories are taken into consideration. Material control and management
department should arrange the materials required for production.
System productivity: In general, efficiency is the ratio of yields to inputs. It can be
calculated for a lonely activity and is useful for a manufacturing plant. It is a measure
of the effectiveness of the procedures. Each procedure has various contributing
elements such as individuals, machine, stocks, innovation, etc. which help in
achieving extreme profitability out of every component and attempts to improve the
commitment of different components.
Upgradation of efficiency is achieved by either decreasing the contributions for a
similar yield or expanding the yield by utilizing the same input
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Capital productivity: Capital invested in the plant, machinery, buildings, and the
distribution system as well as working capital are the components of the cost of
manufacture and need to be productive. Strategies are necessary to maximize the
utilization of the funds allotted towards capital.
Outsourcing strategies: After determination of capacity requirement, it becomes easy
to decide whether some products or services can be outsourced, so that capital and
manpower requirement can be reduced. The available capacities are used to increase
the core competencies. The cost of product or service to the customer would be
reduced.
Improvement of method begins with the analysis of method. This is applicable for
both running as well as new jobs. For new jobs the description is used as inputs for
analysis. For current jobs, the observations, records, and suggestions of the persons
involved in the job are used as inputs.
Assembly-lines requires out stringing together along the workstations. As a result, the
operations are carried out in a sequence so that the product can be prepared in stages.
Because the work flow has to be uniform and operations may require different time
periods for completion, the balancing of lines is required and for this work experts
from outside can be hired.
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Rationalization of packaging methods with logistics has become an important function
of the supply chain and outsourcing. Packaging is an important aspect. Space is at a
priority position; staking and storing have become more scientific. Automated systems
are being used for movement inside the factory from one location to another. In fact,
for safe movement and continuous monitoring packaging systems should be designed
accordingly.
Labor productivity: This is calculated as the number of products produced by an
employee per hour. Due to the differences in performance by different workers
standards are set. Design and allocation of machines at workstations by a variety of
operations can be balanced. Balancing a variety of operation has become the major
concern. On the basis of job description, and skill requirement, the workers are
allocated or reallocated.
Fig. 4.5 Five key elements to be addressed by the manager
Production Organization
Product
The term, product can be defined with various angles; for example, according to a consumer
it is a mix of potential utilities. Every consumer expects some uses from the product. Hence,
the consumer defines in terms of its uses. According to the production manager, a product
can be defined as the combination of various surfaces and processes. Similarly, according to
a finance manager a product can be defined as a mix of various cost elements
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Production
Production refers to application of processes to the raw materials by adding and using the
economic values to produce a desired product by utilizing the best method without
sacrificing the desired quality.
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The new rules of operation in today’s business environment make structure and design even
more critical. A manager must address five key elements while designing organization
structure. The five key elements are shown in Fig 4.4.
Definition of Production Management
Production management may be defined as the performance of the management activities
with respect to selection, design, operation, control, and updating of production system .
Production management is a process of effective planning, coordinating, and controlling the
production. Production management is responsible for actual transformation of raw materials
into finished products.
It is a function of the management related to planning, coordination and control of resources
required to produce specified products by using specific methods and by optimal utilization
of resources.
Objective of production management
The objective of production management is to produce the desired product by specific
method so that the available resources are utilized optimally, and the products can be sold in
the market at the cheapest price. For this proper planning, utilization of manpower, materials
and processes are required. Hence, the production management remains responsible for
delivery of right products of right quantity at right place and at right price. When this
objective is met, the production management system is called effective
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Benefits obtained from efficient production management
An efficient production management can give benefits to the various sections of the society.
The benefits are:
Consumer gets benefits from improved industrial productivity through increased value in
the product. The products are available to the consumer at the right place, at right time, at
right price, in desired quantity and of desired quality.
Investors get increased security for their investments, adequate market returns, creditability,
and good images in the society.
Employees get adequate wages, job security, and improved working environment and
increased personal and job satisfaction.
Suppliers get confidence in the management and feel good when their bills can be realized
without any delay.
Community enjoys benefits from economic and social stability.
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Nation can get adequate prospects and security because of increased productivity and
healthy industrial atmosphere.
Functions of production management department
Depending on the size of the company the function of the production management
department varies. For example, in a small-scale industry the production manager may have
to look after production, planning, and control along with personnel, marketing, finance, and
purchase functions. A medium scale industry can have separate managers for personnel,
marketing, and finance department. But the production manager may have to look after
production, planning, control and along with purchase and store. In large scale industries the
production manager is confined to the management of production activities only. Although
there is no hard and fast rule or guideline that specifies the functions of the production
management; here we shall be confined to the activities of production management related to
production only.
Materials: The production manager should have sufficient knowledge of the materials and
their properties; so that he/she can select appropriate material for a product. To find
alternatives, research on materials is necessary, because to replace a material the product
design is to be changed with proper justification.
Methods: The production management should suggest the best method for a process.
Searching for the appropriate method that would be most suitable with available resources
and identification of the sequences of the methods are the functions of the department.
Machines and equipment: The production management department is supposed to select
the appropriate machine for a particular process, design the maintenance policy, and to
design of layout of the machines.
Estimation: The production management department should estimate the production times
and production cost to fix up the production target, delivery dates and to keep the production
cost at minimum. This would help the management to decide what should be done to arrest
the cost at desired level in the competitive market.
Loading and scheduling: The production management department has to make a schedule
for various production activities with a mention of start and finish of each activity. It is
necessary to draw the timings of material movement, planning the manpower requirement.
During scheduling the department should consider the loads on hand and capacity of the
facilities available.
Routing: The line for movement of various raw materials, components, etc. from store to
packaging department is called routing. It is the most important function of the production
management department. All concerned should know about the movement of materials in
the shop floor.
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Dispatching: The production management department has to prepare various documents
such as Job cards, Route sheets, Move cards, Inspection cards for each and every component
of a product. All these documents are prepared in a set of five copies. These documents
when are released from the production management department just before the start of
production. All the activities should continue as per the time schedule given in these
documents. Releasing of these documents is called dispatching.
Follow up: Once these documents are released, the management starts asking or desires to
know whether the works have been started as per the given schedule or not. The
representatives of the management go round the production floor with the released
documents to see the extent of compliance with the plan and report to the management. This
helps the management to evaluate the plans.
Inspection: Inspection in this case is generally conducted during production; it is not related
to QC inspection. Quality control department conducts a separate inspection which is called
quality inspection. The quality inspection is not under the production management.
Evaluation: For fulfilling the company’s and departmental objectives the production
department must conduct self-inspection to evaluate its activities such as routing,
scheduling, loading, dispatching and follow up depending on the business size of the
company. This is necessary to set standards for future.
Materials Management
An organization buys the goods and services required to achieve its objectives of buying,
storage, and movement of materials. This process is known as materials management. In an
industry it is related to planning, procuring, storing, and providing the appropriate material
of correct quality, correct quantity at correct place in correct time so that it becomes possible
to coordinate and schedule the production activity in an integrated way. Many industries buy
materials, brought them to the plant, process and prepare finished products, and finally sell
the products. Customers get them and consume. For these activities various types of
materials are also required
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