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.
Objectives of CGMP
Layout of buildings, services, equipments & maintenance
Production organization
material management
handling and transportation
inventory management &control
Production and planning control
Sales forcasting
Budget and cost control
Industrial and personnel relationship
Total quality management
Objectives of CGMP
Layout of buildings, services, equipments & maintenance
Production organization
material management
handling and transportation
inventory management &control
Production and planning control
Sales forcasting
Budget and cost control
Industrial and personnel relationship
Total quality management
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
The presentation contains detailed information about the current GMP in the pharmaceutical industry. It has objectives , policies and principles of cGMP guidelines.
Pdf file is being attached in the link below- https://drive.google.com/file/d/11al8n8AqrkUR_Vnm-z4Mp6O0elzyniEz/view?usp=drivesdk
Presented By :- Raghav Sharma
Class :- M.Pharm, 1st sem.
Department :- Pharmaceutics
Institute :- Parul Institute of Pharmacy
Content :-
Current good manufacturing Practices
Equipment and their maintenance
Production Management
Conclusion
References
It is the part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by development of liable and practical procedure of manufacture.
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
Objectives and policies of c gmp, layout of building and servicesSharwari Sapate
Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.
gmp is the most important topic for the students of ayurveda specially for rasashstra.
so in my presentations knowledge of gmp given very elaborately and easy to understand manner.
please advise any suggestions. thank u
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
The presentation contains detailed information about the current GMP in the pharmaceutical industry. It has objectives , policies and principles of cGMP guidelines.
Pdf file is being attached in the link below- https://drive.google.com/file/d/11al8n8AqrkUR_Vnm-z4Mp6O0elzyniEz/view?usp=drivesdk
Presented By :- Raghav Sharma
Class :- M.Pharm, 1st sem.
Department :- Pharmaceutics
Institute :- Parul Institute of Pharmacy
Content :-
Current good manufacturing Practices
Equipment and their maintenance
Production Management
Conclusion
References
It is the part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by development of liable and practical procedure of manufacture.
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
Objectives and policies of c gmp, layout of building and servicesSharwari Sapate
Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.
gmp is the most important topic for the students of ayurveda specially for rasashstra.
so in my presentations knowledge of gmp given very elaborately and easy to understand manner.
please advise any suggestions. thank u
Premises’ refers to the buildings and facilities where pharmaceutical processing is done. These places must comply with cGMP requirements.
Premises must be located in a site that is of a size suitable to house all the different departments. The nature of manufacturing and testing to be performed, the magnitude of the operation in terms of daily production levels, the number of products that will be processed, and the storage space required for raw material, in-process and finished goods are some of the important factors to be considered when choosing a location. Other factors such as availability of power, water, labor workforce, and closeness to transport hubs may also impact this decision. From the GMP point of view, the most important factor is the climatic condition and hygiene levels in the surroundings. Pharmaceutical premises must ideally be located away from polluting industries as otherwise, it will burden the air handling and water handling systems.
According to Schedule M of the Drugs and Cosmetics Rules, factory buildings must be situated in a place that avoids contamination risk from the external environment (for example from open drains, public lavatory, open sewage lines, or industry that produces gaseous fumes or strong odors or generates smoke, dust or other chemical emissions).
The building used must be designed, constructed, and maintained in a manner that permits drug production under hygienic conditions. It must be suitable for the operations being performed. The layout of the premises must be such that it reduces the risk of errors, and also avoids the buildup of dirt and cross-contamination that may affect drug product quality. Construction and layout of the building must allow for a sequential and logical flow of the production process and movement of personnel and materials. It must also permit regular cleaning, repair, and maintenance work without harming product quality.
The walls, ceilings, and floors of the building must be smooth and crack-free, easy to clean and disinfect. Surfaces must not shed particles; they must be kept smooth and without any open joints where dust can accumulate.
utitlities
The building must be supplied with adequate light, water, power supply, and ventilation and must be fitted with systems to maintain the temperature and humidity of different areas at desired levels. There must be arrangements to protect against the entry of pests, insects, rodents, etc.
The fittings, ducts, pipes, and ventilation points must be designed in such a way that they do not produce difficult-to-clean recesses. Such points must be located to be easily accessible for maintenance work without having to enter the manufacturing areas.
Schedule T: (Schedule T describes the Good Manufacturing Practice for Ayurvedic, Siddha and Unani Medicines.)
The Good Manufacturing Practices (GMP) are prescribed as follows:
Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination.
The manufacturing process is as has been prescribed to maintain the standards.
Adequate quality control measures are adopted.
The manufactured drug which is released for sale is of acceptable quality.
pratik ghive cGMP According to schedule Mpratikghive82
Pratik Ghive Current Good Manufacturing Practices (cGMP) Guidelines According to schedule M Cover all guidelines as per Drug and cosmetic act 1940 and ICH guidelines
Similar to PHARMACEUTICAL PRODUCTION MANAGEMENT & INVENTORY CONTROL (20)
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
Follow us on: Pinterest
Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
8. 8
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
9. 9
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.
10. 10
• 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.
11. 11
• 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.
12. 12
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.
13. 13
• 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.
14. 14
• 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.
15. 15
• 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.
16. 16
• 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.
17. 17
• 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.
18. 18
• 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.
19. 19
• 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.
20. 20
• 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.
21. 21
• 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.
22. 22
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.
23. 23
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.
24. 24
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.
25. 25
• 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%
26. 26
• 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.)
27. 27
• 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.
28. 28
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.
29. 29
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.
30. 30
• 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.
31. 31
• 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.
32. 32
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.
33. 33
• 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 :