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
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
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
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
This seminar basically explains about GMP and cGMP. It explains about thecode of federal regulation (CFR). After studying this seminar, the reader will get a detail knowldege pf what is GMP, cGMp, objectives and policies of cGMP. all the part of CFR part 21 is discussed in detail. Here in this seminar, main focus is given on the layout of the buildings and the equipment and its maintenant part. Layout of building includes the building design, construction of building and the plans. The life stage of equipments, how tp select a equipment befor epurchase i.e purchase specifications and the cleaninga nd the maintenance part of the equipments with examples are discussed in detail.
Master Formula Record (MFR) is a master document for any
pharmaceutical product. MFR contains all information about the manufacturing process
for the product. MFR is prepared by the research and development team of the
company. MFR is used as reference standard for preparing batch manufacturing record (BMR) by manufacturing units.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
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
The GMP Operations Manager is responsible for overseeing the implementation and sustained operations of world-class technical cleaning and sanitization programs to include cGMP space, semi-conductor, clean rooms, laboratory, data and other critical environments.
This seminar basically explains about GMP and cGMP. It explains about thecode of federal regulation (CFR). After studying this seminar, the reader will get a detail knowldege pf what is GMP, cGMp, objectives and policies of cGMP. all the part of CFR part 21 is discussed in detail. Here in this seminar, main focus is given on the layout of the buildings and the equipment and its maintenant part. Layout of building includes the building design, construction of building and the plans. The life stage of equipments, how tp select a equipment befor epurchase i.e purchase specifications and the cleaninga nd the maintenance part of the equipments with examples are discussed in detail.
Master Formula Record (MFR) is a master document for any
pharmaceutical product. MFR contains all information about the manufacturing process
for the product. MFR is prepared by the research and development team of the
company. MFR is used as reference standard for preparing batch manufacturing record (BMR) by manufacturing units.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
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
The GMP Operations Manager is responsible for overseeing the implementation and sustained operations of world-class technical cleaning and sanitization programs to include cGMP space, semi-conductor, clean rooms, laboratory, data and other critical environments.
“A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.
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.
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Title: Sense of Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
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2. CONTENTS
Introduction
Objectives and Policies of cGMP
Components of cGMP
Layout of buildings
Services
Equipments and their maintenance.
2
3. 1
INTRODUCTION
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA.
cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing
processes and facilities.
The cGMP requirements were established to be flexible in order to allow each manufacturer to
decide individually how to best implement the necessary controls by using scientifically sound
design, processing methods, and testing procedures. The flexibility in these regulations allows
companies to use modern technologies and innovative approaches to achieve higher quality
through continual improvement.
Accordingly, the “c" in cGMP stands for "current," requiring companies to use technologies and
systems that are up-to-date in order to comply with the regulations. Systems and equipment that
may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago
may be less than adequate by today's standards.
Current Good Manufacturing Practice (cGMPs) is the main regulatory standard for ensuring
pharmaceutical quality.
Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug
products by requiring that manufacturers of medications adequately control manufacturing
operations.
As per WHO GMP’s main function is to avoid mix-ups and contamination risk.
4. TRAGEDIES PRECEDING CGMP REGULATION
1902- development of biological control act
1906- development of pure food and drug act
1906 Pure Food and Drug Act
Creates one of the first government regulatory agencies (now known as FDA); the culmination of
25 years of lobbying, this act makes it illegal to sell “adulterated” or “misbranded” food or drugs.
1938 Federal Food, Drug and Cosmetic (FD&C) Act Tragedy:
Sulfanilamide made with poisonous solvent causes 107 deaths. Result: Requires manufacturers to
prove the safety of products before marketing.
1941 Two unrelated events
Insulin Amendment requires FDA to test and certify purity and potency of insulin. Tragedy:
nearly 300 deaths and injuries from distribution of sulfathiazole tablets tainted with phenobarbital.
Result: FDA revises manufacturing and quality controls drastically, the beginning of what will
later be called GMPs.
1962 Kefauver-Harris Drug Amendments Tragedy:
Thalidomide causes birth defects in thousands of European babies. Result: Manufacturers must
prove efficacy of products before marketing them and ensure stricter control over drug testing.
1978 CGMPs Final rules for drugs and devices (21 CFR 210–211 and 820)
Establishes minimum current good manufacturing practices for manufacturing, processing,
packing, or holding drug products and medical devices. 4
5. TRAGEDIES PRECEDING CGMP REGULATION
1979 GLPs Final Rule (21 CFR 58)
Establishes good laboratory practices for conducting nonclinical laboratory studies that support
applications for research or marketing permits for human and animal drugs, medical devices for
human use, and biological products.
1982 Tamper-resistant packaging regulations issued for OTC products Tragedy
Acetaminophen-capsule poisoning by cyanide causes seven deaths. Result: revision of GMPs to
require tamper-resistant packaging.
1983 Two unrelated regulatory events
The Guide to the Inspection of Computerized Systems in Drug Processing initiates tighter controls
on computers and computer validation. Federal Anti-Tampering Act makes it a federal crime to
tamper with packaged consumer products.
1987 Guideline on General Principles of Process Validation
Agency expectations regarding the need for process validation are outlined.
1992 Generic Drug Enforcement Act
Precipitated by illegal acts involving abbreviated new drug applications. Result: Creates debarment
penalty.
1996 Proposed Revision to US CGMPs for Drugs and Biologics (21 CFR 21–211)
Adds detail for validation, blend uniformity, prevention of cross-contamination, and handling out-of
specification results.
1997 Electronic Records Final Rule (21 CFR 11)
Requires controls that ensure security and integrity of all electronic data.
1998 Draft guidance's
Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients and Investigating Out-
of-Specification (OOS) Test Results for Pharmaceutical Production.
5
6. TRAGEDIES PRECEDING CGMP REGULATION
2001 ICH Q7AAPI Guidance ICH’s “Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients (APIs)”
2019 Ranitidine can rise cancer
Ranitidine have been caught of having NDMA ( nitrosodimethylamine) which is cancer causing
agent.
6
8. 1
OBJECTIVES
To understand where the regulation come from, who has
enforcement authority, and why u need to comply.
to understand the “Fundamentals” , “Benefits”, and “Key Parts” of
cGMP.
As a food handlers we have responsibility to our customers to
maintain high standards of food safety. To ensure , only safe and
high quality product are produced, employee must follow all GMP
listed.
8
9. COMPONENTS OF CGMP
a) cGMP is a part of Q.A.
b) cGMP’s main function is to produce quality product consistently.
c) cGMP must meet legal requirements of country.
d) cGMP must meet both production and Q.C. related issues.
9
16. BUILDING LAYOUT
Design pattern
Permit effective cleaning
Permit effective maintenance
Avoid cross contaminations, build-up of dirt and dust.
Minimize risk of errors
Maximum protection against entry of insects, birds and animals.
Separate facilities for other products such as some antibiotics, hormone, cytotoxic product.
Finishing of floors ,walls, ceilings should be smooth, impervious, hard wearing ,easy to clean.
Specific area
Production areas
Quality control area
Weighing areas
Storage areas
Ancillary areas
Hygiene
Eating , drinking , smoking should not be allowed in production areas
16
17. Construction feature :
Regarding buildings and facilities, there are two major areas of concern: the external environment and the
internal environment. The external environment must be amenable to the location of well-designed and
constructed buildings. It is insufficient that the building in which the production operations are to occur are
clean and orderly and of suitable size and construction. If the land, air, or water resources that surround the
plant offer the potential for water damage, infestation, or contamination of any type, the facilities are in
jeopardy of being judged unsuitable.
any building used in the manufacturing ,processing , packing or holding of drug product shall be of suitable
size, construction or location to facilitate cleaning , maintenance.
The orderly placement of equipment and materials to prevent mix-ups between different component and drug
product containers , closures , labeling, in process materials ‘or drug products or to prevent contamination.
Lightening: adequate lightening shall be provided in all areas.
Ventilation, air filtration ,air heating and cooling:
Equipment for adequate control over air pressure , micro organism dust , humidity and temperature shall be
provided when appropriate for the manufacturing , processing, packing or holding of a drug product.
Air filtration systems, including prefilters and particulate matter air filters ,shall be used when appropriate on
air supplies to production areas , there shall be adequate exhaust systems or other systems adequate to control
contaminants.
Plumbing:
Potable water shall be supplied under continuous positive pressure in a plumbing system. Potable water shall
meet the standard prescribed in the environmental protection agency’s primary drinking water regulations.
Drains shall be of adequate size and where connected directly to a sewer, shall be provided with an air break
to prevent back siphon age.
17
18. Sewage and refuse:
Sewage ,trash and other refuse in and from the building and immediate premises shall be
disposed of in a safe and sanitary manner.
Washing and toilet facilities:
Adequate washing facilities shall be provided including hot and cold water ,soap or
detergent, air driers or single service towels and clean toilet facilities easily accessible to
working areas.
Sanitation:
Building shall be free of infestation by rodents, birds, insects and other vermin trash and organic
waste matter shall be held and disposed of in a timely and sanitary manner .
There shall be written procedure for uses of suitable rodenticides , insecticides, fungicides,
fumigating agents and cleaning and sanitizing agents .
Maintenance:
Any building used in the manufacture, processing , packing or holding of a drug product shall be
maintained in a good state of repair.
18
19. 3
CGMP SERVICES:
19
o cGMP manufacturing of drug substances
and drug products
Stability testing of drug substances and drug
products
Release testing and issuance of certificate of
analysis (COA)
Identity
Purity
Assay
Related substances
Total impurities
Residual Solvents / Organic volatile
impurities (OVIs), USP <467>
Moisture by Karl Fischer
Potential genotoxicants
Loss on drying
Bioburden - microbial limits and total
endotoxins
Heavy metals
Specialized testing
Batch record writing
Batch record review
Batch disposition assessment
Corrective and Preventive Action Plans
(CAPA)
Out-of-specification (OOS) investigations
Deviation assessment and reporting
Vendor assessments / audits
SOP writing
Raw material procurement
Cleaning method development and
validation
Analytical method development and
validation
cGMP training
Chemistry, Manufacturing, and Controls
(CMC) regulatory writing
20. 4
CGMP SERVICES IN PRODUCTION AREA
Production of Tablets and Capsules
Packaging of Clinical Supplies
Labeling of Clinical Supplies
Study Randomization
Formulation Development for:
Oral Solids
Oral Liquids
Topical Creams and Ointments
Transdermal Products
Consultant Services for:
Technology Transfer
Formulation Development
Technical Operations
20
21. 1
EQUIPMENT HANDLING
Equipment handling and equipment control should be done by qualified personnel and proof of
qualification made available. The handling involves movement, storage and protection.
Standardization of all equipments and software makes it possible to perform a wide range of
tasks.
All equipment in the facility should be clearly identified using markings that are clearly visible.
The identification number allotted to equipment or an instrument should correspond with the entry
appearing in the equipment log.
The maintenance log should be kept near or on the equipment.
Equipment should be kept in a room that has sufficient air flow.
A measuring device such as a weighing balance must demonstrate its accuracy through
qualification. Qualification of instruments is done to determine if a device is suitable and is
normally done by quality control laboratories and other professionals trained in the provision of
such services.
21
22. EQUIPMENT DESIGN AND PLACEMENT
All the equipment used for the manufacture process or drug holding should be appropriately
designed and sized for the intended use.
There should be adequate and a clearly designated building or room where all the
equipment will be placed and should be under key and lock always. The storage facility
should comply with the set CGMP.
The location of all the equipment in the facility should be appropriate for each of them.
The surfaces of the machines should be made of materials that are non reactive, non-
additive and non-absorbent to the raw materials or finished product.
Design and operating precautions should be taken to ensure that operating substances such
as lubricants, coolants and others do not come in contact with the raw materials or final
product.
Asbestos filters should not be used for the production of any drug or product.
Any idle equipment should be stored in a designated area and its status clearly marked.
Written procedures should be available for all equipment that are in the facility that are
being used during the manufacturing, holding of raw materials or finished product.
22
23. EQUIPMENT MAINTENANCE AND CLEANING
All equipment should have written instructions for their maintenance as well as their maintenance
schedule and there should be proof that they are being followed to the letter.
A written procedure should be established that assigns the responsibility of cleaning and
maintenance of equipments to someone and should be adhered to.
Validation of the cleaning procedure should be properly done to ensure risks of contamination and
cross contamination are removed.
The cleaning and maintenance procedures should also identify disassembly or reassembly if any
that is required for the maintenance and cleaning.
All equipment must be cleaned after use and cleaning records kept as proof of the same.
Written procedures on calibration of equipments should be in place and availed as proof if
needed. Equipment calibration assures that the results obtained from the equipment are valid.
If production is automated by the use of computers, the computer’s program or software should
also be validated.
The Food and Drug Administration (FDA) requires that firms have written procedures on cleaning
validation, entailing aspects of the cleaning process, equipment design, sampling and analytical
methods used in a manufacturing factory. FDA is a body that protects the consumers’ health by
assuring safety, quality and efficacy of food and drugs.
23
24. CONCLUSION
“Pharmaceutical cGMPs for the 21st Century” is intended to jump-start progress into this future.
Pharmaceutical manufacturing is evolving from an art form to one that is now science and
engineering based.
Effectively using this knowledge in regulatory decisions in establishing specifications and
evaluating manufacturing processes can substantially improve the efficiency of both
manufacturing and regulatory processes.
This initiative is designed to do just that through an integrated systems approach to product
quality regulation founded on sound science and engineering principles for assessing and
mitigating risks of poor product and process quality in the context of the intended use of
pharmaceutical products. In this regard, the desired future state of pharmaceutical manufacturing
may be characterized as: Product quality and performance achieved and assured by design of
effective and efficient manufacturing processes Product specifications based on mechanistic
understanding of how formulation and process factors impact product performance Continuous
“real time” assurance of quality Regulatory policies and procedures tailored to recognize the level
of scientific knowledge supporting product applications, process validation, and process
capability Risk based regulatory scrutiny that relates to the level of scientific understanding of
how formulation and manufacturing process factors affect product quality and performance and
the capability of process control strategies to prevent or mitigate risk of producing a poor quality
product.
Inculcation of cGMP in the organization provides increased quality of products with less wastage
,more profit and customer satisfaction
24