1. The document outlines requirements for modern pharmaceutical production facilities including location, building design, waste disposal, storage, production, and quality control. Key requirements include preventing contamination, ensuring hygienic conditions, and separating different categories of drugs. 2. Specific sections cover water treatment systems, warehousing, production area layout, quality control laboratory independence, personnel training, and inventory/raw material management. Equipment must be properly located, maintained and defective units removed. 3. Quality assurance systems must ensure pharmaceutical products meet GMP standards and are developed to requirements for design, development, manufacturing and quality management.

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SUBJECT: MODERN PHARMACEUTICS
PRODUCTION MANAGEMENT & INVENTORY MANAGEMENT

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1.INTRODUCTION

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1. Location and surroundings- The factory building(s) for manufacture of drugs shall be so situated to
avoid risk of contamination from external environmental including open sewage, drain, public lavatory or
any factory which product disagreeable or bad odor, fumes, dust, smoke, chemical or biological
emissions.
2. Building and premises- The building(s) used for the factory shall be designed, constructed, adapted
and maintained to suit the manufacturing operations so as to permit production of drugs under hygienic
conditions.
The premises used for manufacturing, processing, warehousing, packaging labeling and testing purposes
shall be
(i) compatible with other drug manufacturing operations that may be carried out in the same or adjacent
area / section.
(ii) adequately provided with working space to allow orderly and logical placement of equipment,
materials and movement of personnel so as to:
(a) avoid the risk of mix-up between different categories of drugs or with raw materials,
intermediates and in-process material.
(b) avoid the possibilities of contamination and cross- contamination

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Water System - There shall be validated system for
Treatment of water drawn from own or any other source to
render it potable in accordance with standards specified by
the Bureau of Indian Standards or Local Municipality, so as to produce Purified Water conforming to
Pharmacopoeia specification.
1.4. Disposal of waste -
(i) The disposal of sewage and effluents (solid, liquid and gas) from the manufactory shall be in
conformity(compliance) with the requirements of Environment Pollution Control Board.
(ii) All bio-medical waste shall be destroyed as per the provisions of the Bio-Medical Waste (Management
and Handling) Rules, 1996.
(iii) Additional precautions shall be taken for the storage and disposal of rejected drugs. Records shall be
maintained for all disposal of waste.
(iv) Hazardous, toxic substances and flammable materials shall be stored in suitably designed and enclosed
areas in conformity with Central and State Legislations.

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• It is a large building where the raw materials or manufactured,
goods may be stored.
• Adequate areas shall be designed to allow sufficient and orderly
warehousing of various categories of materials and products like
starting and packaging materials, intermediates, bulk and finished
products, products in quarantine, released, rejected, returned or
recalled, machine and equipment spare parts and change items.
• Warehousing areas shall be designed and adapted to ensure good
storage condition.
• They shall be clean, dry and maintained with acceptable
temperature limits, where special storage conditions are required
(e.g. temperature, humidity), these shall be provided, monitored and
recorded. Proper racks, bins and platforms shall be provided for the
storage of materials.

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• The production area shall be designed to allow the production preferably in unit flow and with sequence
of operations.
• In order to avoid the risk of cross-contamination, separate dedicated and self-contained facilities shall
be made available for the production of sensitive pharmaceutical products like penicillin or biological
preparations with live microorganisms.
• Pipe-work, electrical fittings, ventilation openings and similar services lines shall be designed, fixed and
constructed to avoid creation of recesses spaces. Services lines shall preferably be identified by colors
and the nature of the supply and direction of the flow shall be marked/indicated.

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Additional but less important
• Rest and refreshment rooms shall be separate from other areas.
These areas shall not lead directly to the manufacturing and storage areas.
• Facilities for changing, storing clothes and for washing and toilet purposes shall be easily
accessible and adequate for the number of users.
• Maintenance workshops shall be separate and away from production areas. Whenever spares,
changed parts and tools are stored in the production area, these shall be kept in dedicated rooms
or lockers. Tools and spare parts for use in sterile areas shall be disinfected before these are
carried inside the production areas.
• ANIMAL HOUSING AREAS shall be isolated from other areas. The other requirements
regarding animal houses shall be those as prescribed in Rule 150-C(3) of the Drugs and
Cosmetics Rules, 1945 which shall be adopted for production purposes.

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• Quality Control Laboratories shall be independent of the production areas. Separate areas shall
be provided each for physio-chemical, biological, microbiological or radio-isotope analysis.
Separate instrument room with adequate area shall be provided for sensitive and sophisticated
instruments employed for analysis.
• Quality Control Laboratories shall be designed appropriately for the operations to be carried out
in them. Adequate space shall be provided to avoid mix-ups and cross-contamination. Sufficient
and suitable storage space shall be provided for test samples, retained samples, reference
standards, reagents and records.
• The design of the laboratory shall take into account the suitability of construction
materials and ventilation.
• Quality Control Laboratory shall be divided into separate sections i.e. for chemical,
microbiological and wherever required, biological testing. These shall have adequate area for
basis installation and for ancillary purposes.

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• The manufacture shall be conducted under the direct supervision of competent technical staff with
prescribed qualifications and practical experience in the relevant dosage and / or active pharmaceutical
products.
• The head of the Quality Control Laboratory shall be independent of the manufacturing unit. The testing
shall be conducted under the direct supervision of competent technical
staff who shall be whole time employees of the licensee.
• Number of personnel employed shall be adequate and in direct proportion to the workload.
• The licensee shall ensure in accordance with a written instruction that all personnel in production
area or into Quality Control Laboratories shall receive training appropriate to the duties and
responsibility assigned to them.
• They shall be provided with regular in-service training.

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• All persons prior to and during employment shall be trained in practices which ensure personnel
hygiene.
• All employees shall be instructed to report about their illness or abnormal health condition to their
immediate supervisor so that appropriate action can be taken.
• Direct contact shall be avoided between the unprotected hands of personnel and raw materials,
intermediate or finished, unpacked products.
• All personnel shall wear clean body coverings appropriate to their duties.
• Smoking, eating, drinking, chewing or keeping plants, food, drink and personal medicines
shall not be permitted in production, laboratory, storage and other areas where they might
adversely influence the product quality.

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• All manufacturing operations shall be carried out under the supervision of technical staff
approved by the Licensing Authority. Each critical step in the process relating to the selection,
weighing and measuring of raw material addition during various stages shall be performed by
trained personnel under the direct personal supervision of approved technical staff.
• The contents of all vessels and containers used in manufacture and storage during the various
manufacturing stages shall be attractively labeled with the name of the product, batch number,
batch size and stage of manufacture. Each label should be dated by the authorized technical staff.
• Products not prepared under aseptic conditions are required to be free from pathogens.

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• The licensee shall keep an inventory(complete list of items) of all raw
materials to be used at any stage of manufacture of drugs and maintain
records as per Schedule U.
• All incoming materials shall be purchased from approved sources under
valid purchase vouchers. Wherever possible, raw materials should be
purchased directly from the producers.
• Authorized staff appointed by the licensee in this behalf, which may
include personnel from the Quality Control Department, shall examine
each consignment on receipt and shall check each container for integrity
of package and seal. Damaged containers shall be identified, recorded and
segregated(kept a part).
• If a single delivery of material is made up of different batches, each batch
shall be considered as a separate batch for sampling, testing and release.

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• Raw materials in the storage area shall be appropriately labeled. Labels shall be clearly
marked with the following information:
(a) designated name of the product and the internal code reference, where applicable, and
analytical reference number;
(b) manufacturers name, address and batch number;
(c) the status of the contents (e.g. quarantine, under test, released, approved, rejected); and
(d) the manufacturing date, expiry date and re-test date.
• Only raw materials which have been released by the Quality Control Department and which
are within their shelf-life shall be used.

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• Equipment shall be located, designed, constructed, adapted and
maintained to suit the operations to be carried out. Each
equipment shall be provided with a logbook, wherever necessary.
• To avoid accidental contamination, wherever possible, non-
toxic/edible grade lubricants shall be used and the equipment
shall be maintained in a way that lubricants do not contaminate
the products being produced.
• Defective equipment shall be removed from production and
Quality Control areas.

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• The system of quality assurance proper to the manufacture of pharmaceutical products shall
ensure that: -
(a) the pharmaceutical products are designed and developed in such a way that it meets the
requirement of Good Manufacturing Practices and other associated codes such as those of
Good Laboratory Practices and Good Clinical Practices.
(b) adequate arrangements are made for manufacture, supply and use of the correct starting
and packaging materials.
(d) the finished product is correctly processed and checked in accordance with established
procedures.

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• INVENTORY :
Inventories means the stock of the product of a company and components that makes up
the product. It includes the raw materials, work in progress and finished goods.
• INVENTORY MANAGEMENT :
Inventory management may be defined as a scientific method of finding out how much
stock should be maintained in order to meet the production demands and be able to
provide right type of material at right time, in right quantities and at competitive prices.

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OBJECTIVES :
1. Utilizing of scare resources (capital) and investment judiciously.
1. Keeping the production on as on-going basis.
2. Preventing idleness of men, machine and morale.
3. Avoiding risk of loss of life (moral and social).
4. Reducing administrative workload.
5. Giving satisfaction to customers in terms of quality-care, competitive price
and prompt delivery.
6. Inducing confidence in customers and to create trust and faith.

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INVENTORY CATEGORIES- SPECIAL CONSIDERATIONS :
• Inventory are categorized based on the nature of items :-
1.Production inventories :- material used are chemicals such as active ingredient and
excipients needed to manufacture the finished products.
2.MRO inventories :- Parts needed for the final assembly of the end product.
For example :- assembling arrangement made for packing the bulk tablets such as strip
packing and blister packing.
3.Work in process inventories :- these are semi-finished product. Example:- granules
waiting for compression and tablets waiting for coating.
4.Finished goods inventories :- such as saleable items, dosage forms, bulk drug,
physician’s sample.

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SELECTIVE INVENTORY CONTROL :
• Selective Inventory Control is defined as a process of classifying items into
different categories, thereby directing appropriate attention to the material in the
context of company’s viability.
Classification of material based on the inventory control:-
• A-B-C Classification.
• V-E-D Classification.
• H-M-L Classification.
• F-S-N Classification.
• S-D-E Classification.
• G-O-L-F Classification.
• X-Y-Z Classification.

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• A-B-C analysis states that when a large number of items are involved, relatively a
few item account for a major part of activity, based on annual value of consumption
of items.
According to A-B-C analysis, inventories and classified as follows :-
• A-items:- 15% of the items are of the highest value and their inventory accounts
for 70% of the total.
• B-Items:- 20% of the items are of intermediate value and their inventory accounts
for 20% of the total.
• C-Items:-65% of the items are of lowest value and their inventory accounts for
relatively small balance i.e., 10%

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• Based on the critical values and shortage cost of the item. Thus helps focus on vital items. Vital
items are critically needed in a manufacturing unit.
• V-E-D stands for:-
V – Vital.
E – Essential.
D – Desirable.
• V-E-D type of control is very important in hospital pharmacy :-
• V- Vital :- Items without which the activities will come into halt (EX:- adrenaline injection,
mephitine injection, etc.)
• E- Essential :- Items which are likely to cause disruption of (EX :- life supporting items like
transfusion fluids)
• D – Desirable :- In the absence of which the hospital works does not get hampered (EX :- aspirin,
other analgesics, vitamins, etc.)

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• H-M-L stands for
H – High.
M – Medium.
L – Low.
• H-M-L is similar to A-B-C analysis, which is based on the annual consumption.
• The Items ordered should be listed in the decreasing order of the unit value
(rupees) and management may fix limits for deciding the 3 categories.

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Classification based on frequency of issue or use.
• F = Fast moving items that are frequently issued in a manufacturing unit.
•S = Slow moving items in a manufacturing unit.
•N = Non moving item
This classification helps in establishing most suitable layout by locating all fast
moving items near the dispensing window to reduce the handling efforts.

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Classification based on lead time/ availability,
•S ( Scarce): those item which are imported or which need a lead time more than 6
months.
•D (Difficult): The items which require less than 6 months but more than a fort
night.
•E ( easily available): Items which are available easily in less than a fort night.
- Helps bring down lead time and out of stock cost.

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• G-O-L-F stands for :-
G – Government.
O – Ordinary.
L - Local.
F – Foreign.
• In this the imported items are normally procured through government
organization such as IDPL and MMTC.
• Special procedures are followed for procuring them, since ordinary procedure
of inventory may not work.

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• In India, inventory costs vary from 28 to 32% of the total cost.
• The purchase and holding of a one month supply of an item will give a better
return on Investment than a two-month supply. Apart from material cost, several
other costs are also involved in inventory.
• These are given below:
1) Ordering Costs:-
• Stationery.
• Clerical And Processing, Salaries/Rentals.
• Postage.
• Processing Of Bills.
• Staff Work In Expedition/Receiving/Inspection And Documentation.

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2) Holding / Carrying Costs:-
A. Storage Space (Rent/Depreciation).
B. Property Tax On Warehousing.
C. Insurance.
D. Deterioration/Obsolescence.
E. Material Handling And Maintenance, Equipment.
F. Stock Taking, Security And Documentation.
G. Capital Blocked (Interest/Opportunity Cost).
H. Quality Control.
3) Stock Out Costs:-
i. Loss Of Business/Profit/Market/Advice
ii. Additional Expenditure Due To Urgency Of Purchases.
A. Telegraph /Telex/ Telephone Charges.
B. Purchase At Premium.
C. Air Transport Charges.
D. Loss Of Labor Hours.

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• Significant Elements Of Production Management In Pharmaceutical Industry: A
Review (N.V. SATHEESHMADHAV, ABHIJEET OJHA, SHIVANGI BHASIN
Faculty Of Pharmacy, DIT University, Dehradun, Uttarakhand, India)
• C.V.S Subrahmanyam, pharmaceutical production and management, 1st
edition, Vallabh Prakashan, New Delhi, 2011, pp. 292-300.
• en.Wikipedia.org/wiki/inventory.
REFERENCES :