ICH Q7A means the good manufacturing practice guidance for active pharmaceutical ingredients developed under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
Validation: Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
Qualification of Friability Test Apparatus.pptxGNIPST
Brief description of qualification of laboratory testing apparatus : Friability Test Apparatus.
share it with your friends also if they faced problem about this topic.
Thank you
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
This presentation describes outlines and discusses the regulations
applicable to the QA function and unit, structure, function and
application of the unit in the pharmaceutical manufacturing
environment. In addition, it discusses additional quality – related
responsibilities that may result when manufactures move toward a
quality system approach to quality that incorporates current quality
system models to further improve quality and harmonize with inter-
national quality requirements.
Validation: Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
Qualification of Friability Test Apparatus.pptxGNIPST
Brief description of qualification of laboratory testing apparatus : Friability Test Apparatus.
share it with your friends also if they faced problem about this topic.
Thank you
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
This presentation describes outlines and discusses the regulations
applicable to the QA function and unit, structure, function and
application of the unit in the pharmaceutical manufacturing
environment. In addition, it discusses additional quality – related
responsibilities that may result when manufactures move toward a
quality system approach to quality that incorporates current quality
system models to further improve quality and harmonize with inter-
national quality requirements.
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
This presentation explains about qualifications of HPTLC, types of qualifications, design qualification , installation qualification ,operational qualification, performance qualification ,documentation of qualification .
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
The presentation was an overview of the GMP regulations specific to cleaning validation for medicine manufacturers. New guidelines for Health Based Exposure Limits were discussed along with common GMP deficiencies observed during TGA inspections.
In this slide contains definition, validation plan, types of Qualification of Dry Powder Mixture.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
I am uploading this GMP presentation to make aware who are working in pharma and help to maintain high standards in products manufacturing .
GMP Vs cGMP: It is my understanding that , Ultimately GMP & cGMP both the aim is same, means to prevention of the product from bad quality entering the market to endover peoples's life.
GMP applies to pharmaceutical and healthcare products and help to maintain high standards in these products.
cGMP is to remind accepting countries that all guidelines must be followed with latest and current production processes i.e employ technologies and systems which are up-to-date in order to comply with the regulation.
FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products.
(the FDA have made their standards immediately identifiable i.e cGMP; Other international bodies such as the ICH, WHO use the term GMP, as do Canada, Japan and the EMEA (European authority). In FDA view cGMP means following 21 CFR 210 and 211 and no other.)
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
This presentation explains about qualifications of HPTLC, types of qualifications, design qualification , installation qualification ,operational qualification, performance qualification ,documentation of qualification .
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
The presentation was an overview of the GMP regulations specific to cleaning validation for medicine manufacturers. New guidelines for Health Based Exposure Limits were discussed along with common GMP deficiencies observed during TGA inspections.
In this slide contains definition, validation plan, types of Qualification of Dry Powder Mixture.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
I am uploading this GMP presentation to make aware who are working in pharma and help to maintain high standards in products manufacturing .
GMP Vs cGMP: It is my understanding that , Ultimately GMP & cGMP both the aim is same, means to prevention of the product from bad quality entering the market to endover peoples's life.
GMP applies to pharmaceutical and healthcare products and help to maintain high standards in these products.
cGMP is to remind accepting countries that all guidelines must be followed with latest and current production processes i.e employ technologies and systems which are up-to-date in order to comply with the regulation.
FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products.
(the FDA have made their standards immediately identifiable i.e cGMP; Other international bodies such as the ICH, WHO use the term GMP, as do Canada, Japan and the EMEA (European authority). In FDA view cGMP means following 21 CFR 210 and 211 and no other.)
documentation in pharmaceutical industry ppt.pptxashokgorja8
To define specifications and procedures for all materials and method of manufactured and control.
To ensure that all personal concern with manufacture know what to do and when to do it.
documentation in pharmaceutical industry ppt.pptxashokgorja8
DOCUMENTATION IN PHARMACEUTICAL INDUSTRY :
WORKING INSTRUCTIONS AND RECORD FORMATS
To define specifications and procedures for all materials and method of manufactured and control.
To ensure that all personal concern with manufacture know what to do and when to do it.
To ensure that authorized persons have all the information necessary to decide whether or not realize a batch of drug for sale.
To ensure the existence of documented evidence , trace ability and adult trail that will permit investigation.
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
Six system inspection is a part of pharmaceutical.management system.this presentation gives the information about production, facilities and equipment, quality, laboratory,packaging and material system.
The Sigma Test and Research Center provide testing and research facilities worldwide. Visit our website http://bit.ly/2HVkg21 and book your testing and research services. Our testing and research services rates are very cheap and our work is always quality work.
role of quality system and audit in pharmaceutical manufacturing environment....MridulBindra2
M. pharma quality assurance
role of quality system and audit in pharmaceutical manufacturing environment.
topics covered are as follows
cGMP regulation
quality assurance functions
quality system approach
management responsibility
resources
Quality control measures in pharmaceutical industryChemOnTheGo
QUALITY CONTROL
ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
OBJECTIVES OF QUALITY CONTROL
STEPS IN QUALITY CONTROL
COST OF QUALITY CONTROL
TOTAL QUALITY MANAGEMENT
QUALITY CIRCLE
Implants- B.Pharm SEM 7- Novel Drug Delivery Systemvedanshu malviya
Implantable drug delivery device classification is not a straightforward task as there are a number of complex implants that will fall into hybrid categories. Nevertheless, implantable drug delivery devices can be broadly classified in two main groups: passive implants and active implants. The first group includes two main types of implants: biodegradable and non-biodegradable implants. On the other hand, active systems rely on energy dependent methods that provide the driving force to control drug release. The second group includes devices such as osmotic pressure gradients and electromechanical drives.
Enzyme Immobilization- Biotechnology- B.Pharm SEM 5vedanshu malviya
Immobilization is a technical process in which enzymes are fixed to or within solid supports, creating a heterogeneous immobilized enzyme system. Immobilized form of enzymes mimic their natural mode in living cells, where most of them are attached to cellular cytoskeleton, membrane, and organelle structures.
Concept of Health and Diseases- B.Pharm Semester 7vedanshu malviya
health is a state of bodily equilibrium while disease is a state of homeostatic failure. But the process of human growth as Boorse observed is itself leading to homeostatic disequilibrium . Value: disease is undesirable while health is desirable. Health is thus a social value in human society.
Microencapsulation in Novel Drug Delivery Systemvedanshu malviya
Microencapsulation is a process in which tiny particles or droplets are surrounded by a coating to give small capsules, with useful properties. In general, it is used to incorporate food ingredients, enzymes, cells or other materials on a micro metric scale.
Pharmaceutical film coating is considered a key part in the production of solid pharmaceutical dosage forms since it gives superior organoleptic properties products. In addition, it can improve the physical and chemical stability of dosage forms, and modify the release characteristics of the drug. Several troubleshooting problems such as twinning mottling, chipping, etc., may arise during or after or even during the shelf life of the film coated dosage forms. These troubleshooting problems may be due to tablet core faults, coating formulation faults and/or coating process faults. These problems must be overcome to avoid unnecessary product problems. Film coating as well as other parts of the pharmaceutical technology is subjecting to continuous innovation. The innovation may be at different levels including pharmaceutical excipients, processes, software, guidelines and equipment. In fact, of particular note is the growing interest in process analytical technology, quality by design, continuous coating processing and the inclusion of new ready for use coating formulations. In this review, we tried to explore and discuss the status of pharmaceutical film coating, the challenges that face this manufacturing process and the latest technological advances in this important manufacturing process.
The most common tablet manufacturing process techniques are wet granulation, dry granulation, and direct compression.
Your active pharmaceutical ingredients’ (APIs) physical and chemical stability influences manufacturing.
For successful tablet manufacturing, you need granulators, mixing equipment, drying machinery, and coating systems.
Even if you’re using the right equipment to manufacture your product, there is a wide range of common tablet defects that can occur that affect quality.
There are several goals to aim for during the tablet manufacturing process:
Develop tablets that are strong and hard enough to hold up against mechanical shock during manufacturing, packaging, shipping, and dispensing
Formulate tablets that are uniform in weight and drug content
Manufacture bioavailable products according to indication requirements
Create chemically and physically stable tablets that last over long periods
Formulate products that are free of defects and have an elegant finish
Pharmacovigilance supports safe and appropriate use of drugs. Spontaneous reporting of adverse drug reactions (ADRs) is an essential component of pharmacovigilance. However, there is significant underreporting of ADRs. Adverse drug reactions have become a major problem in developing countries. Knowledge of pharmacovigilance could form the basis for interventions aimed at improving reporting rates and decreasing ADRs.
Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption.
Ayurveda, the knowledge of life, immortalized in the form of elegant Sanskrit stanzas in the samhitas describe diagnosis and therapy of disease as well as ways to maintain positive health. Although the technical term “Pharmacovigilance” does not feature in ayurvedic texts, the spirit of pharmacovigilance is vibrant and is emphasized repeatedly in all major texts. The major goals of pharmacovigilance, namely to improve patient care and safety in relation to drug use, and thus promote rational drug use are recurrent themes of ayurvedic pharmacology (dravyaguna vigyan) and therapeutics (chikitsa).
Pharmacokinetics (PK) is the study of how the body interacts with administered substances for the entire duration of exposure (medications for the sake of this article). This is closely related to but distinctly different from pharmacodynamics, which examines the drug’s effect on the body more closely. The four main parameters generally examined by this field include absorption, distribution, metabolism, and excretion (ADME). Wielding an understanding of these processes allows practitioners the flexibility to prescribe and administer medications that will provide the greatest benefit at the lowest risk and allow them to make adjustments as necessary, given the varied physiology and lifestyles of patients.
When a provider prescribes medication, it is with the ultimate goal of a therapeutic outcome while minimizing adverse reactions. A thorough understanding of pharmacokinetics is essential in building treatment plans involving medications. Pharmacokinetics, as a field, attempts to summarize the movement of drugs throughout the body and the actions of the body on the drug. By using the above terms, theories, and equations, practitioners can better estimate the locations and concentrations of a drug in different areas of the body.
The appropriate concentration needed to obtain the desired effect and the amount needed for a higher chance of adverse reactions is determined through laboratory testing. Using the equations given above, a clinician can easily estimate safe medication dosing over a period of time and how long it will take for a medication to leave a patient’s system. These are, however, statistically-based estimations, influenced by differences in the drug dosage form and patient pathophysiology. This is why a deep understanding of these concepts is essential in medical practice so that improvisation is possible when the clinical situation requires it.
Mixing is a general term that includes stirring, beating, blending, binding, creaming, whipping, and folding. In mixing, two or more ingredients are evenly dispersed in one another until they become one product.
The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan, and the United States.
What is ICH Q8 guidelines?
Image result for ICH Pharmaceutical development guideline-Q8
The ICH Q8 guideline is intended to provide guidance on the contents of Section 3.2. P. 2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4).
Tablet defects can come from any of the unit operations upstream and from the tablet press. The raw materials may be of poor quality or do not meet specifications, causing excessive fines that lead to a host of defects. The formulation may be the source of defects if the material does not compress well or the processing step specified within the formulation fail to produce a powder with a good flow, compressibility, and ejection properties. The processing and granulation of powder are often the sources of the defect.
Every product behaves differently on a tablet press, even if it‘s the same product run on a different day. The variation often
stems from changes in the properties of the raw materials—active ingredients and excipients- from batch to batch. Naturally,
the goal is to minimize these changes. Tablet press operators, however, don‘t have any control over formulation and
granulation. Tablet specifications are tight, and the list of possible defects is long: Variable weight, sticking, picking, capping, lamination, variable hardness, among others. This article focuses on these variations. It pinpoints the possible causes of these defects and offers advice on preventing and fixing the source of the problems.
The main principle involved in the FBP is the air suspension in which the material to be coated is suspended in the coating material with the help of an air stream. A fluid bed processor (fbp) is a popular material processing technique in different field industries.
The suspension dosage form has long been used for poorly soluble active ingredients for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts.
Distillation, or classical distillation, is the process of separating the components or substances from a liquid mixture by using selective boiling and condensation. Dry distillation is the heating of solid materials to produce gaseous products. Early evidence of distillation was found on Akkadian tablets dated c. 1200 BCE describing perfumery operations. The tablets provided textual evidence that an early primitive form of distillation was known to the Babylonians of ancient Mesopotamia.[8] Early evidence of distillation was also found related to alchemists working in Alexandria in Roman Egypt in the 1st century CE.
Polymorphism is the ability of solid materials to exist in two or more crystalline forms with different arrangements or conformations of the constituents in the crystal lattice. ... More than 50% of active pharmaceutical ingredients (APIs) are estimated to have more than one polymorphic form
Conductometry is a measurement of electrolytic conductivity to monitor the progress of the chemical reactions. Conductometry has notable application in analytical chemistry, where conductometric titration is a standard technique.
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.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
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
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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
1. ICH GMP GUIDELINES Q7
BY-
PROF. VEDANSHU MALVIYA
P.R. POTE PATIL COLLAGE OF PHARMACY,
AMARAVATI.
2. Content
> Introduction
> Members of ICH
> Purpose of ICH
> I
CH guidelines
> I
CH Q7 guideline GMP for API
> Conclusion
> References
3. Introduction
> The complete name of ICH is the "International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human use.
> ICH Established in 1990 between the European Union, Japan, and united
states.
> Committed to reducing duplication during research and development of
new drugs while safeguarding quality, safety and efficacy.
4. Purpose of ICH
> Safe, effective and high quality medicines are developed and registered in
the most efficient and cost effective manner.
> To Promote public health.
> Prevent unnecessary duplication of clinical test.
> Minimize the use of animal testing without compromising safety and
effectiveness.
> Identification elimination of the need to duplicate studies to meet different
regulatory requirements.
5. I
CH Guidelines
The ICH Topics are divided into four major categories and ICH Topic Codes
are assigned according to these categories.
6. I
CH Q7 Guidelines GMP for API
> GMP is that part of Quality assurance, which ensure that products are
consistently produce and controlled to the quality standards appropriate to
their intended use and as required by the marketing authorization.
> This document (Guide) is intended to provide guidance regarding good
manufacturing practice (GMP) for the manufacturing of active
pharmaceutical ingredients (APIs) under an appropriate system for
managing quality.
> Inthis Guide "manufacturing" is defined to include all operations of receipt
of materials, production, packaging, repackaging, labelling, relabeling,
quality control, release, storage and distribution of APIsand the related
controls.
7. Quality Management
> Quality should be the responsibility of all persons involved in manufacturing.
> There should be a quality unit(s) that is independent of production and that
fulfills both quality assurance and quality control responsibilities.
QC UNI
T:
• The quality unit(s) should be involved in all quality-related matters.
• Releasing or rejecting all APIs. Releasing or rejecting intermediates for use
outside the control of the manufacturing company.
• Establishing a system to release or reject raw materials, intermediates,
packaging, and labeling materials.
8. Cont…
> QA Unit –
1. Review & approve all quality related documents.
2. Review of batch production & quality control records.
3. Making sure that the premises and equipment are maintained and records kept.
4. Reviewing & Approving validation protocols.
5. Making sure that production facilities are clean and, when appropriate,
disinfected.
> I
nternal Audits (Self I
nspection) –
To verify compliance with the principles of GMP for APIs, regular internal audits should be
performed in accordance with an approved schedule.
> Product Quality Review –
A review of adequacy of corrective actions.
A review of any changes carried out to the processes or analytical methods;
A review of all batches that failed to meet established specification(s).
9. Personnel
> Personnel Qualifications
> Responsibilities
> Personnel Hygiene –
1. Personnel should practice good sanitation and health habits.
2. Personnel should avoid direct contact with intermediates or APIs.
3. Smoking, eating, drinking, chewing and the storage of food should be restricted
10. Buildings & Facilities
> Design & Construction
o Buildings & facilities should have adequate space for the orderly placement of
equipment & material top prevent mix ups & contamination.
o There should be defined areas or other control systems for the following
activities:
1. Receipt, identification, sampling, and quarantine of incoming materials, pending
release or rejection;
2. Storage of released materials.
3. Production operations.
4. Packaging and labelling operations.
5. Laboratory operations.
11. > Utilities
> All utilities that could impact on product quality (e.g. steam, gases, compressed
air, and heating, ventilation and air conditioning)
> Water
> Water used in the manufacture of APIs should be demonstrated to be suitable for
its intended use.
> Where water used in the process is treated by the manufacturer to achieve a
defined quality, the treatment process should be validated and monitored with
appropriate action limits.
> Containment
> Lighting
> Sewage & Refuse
> Sanitation & Maintenance
12. Process Equipment
> Design & Construction
1. Equipment used in the manufacture of intermediates and APIs should be of
appropriate design and adequate size, and suitably located for its intended use,
cleaning, sanitization (where appropriate), and maintenance.
2. Production equipment should only be used within its qualified operating range.
> Equipment Maintenance & Cleaning
1. Schedules and procedures (including assignment of responsibility)should be
established for the preventative maintenance of equipment.
2. Inspection of equipment for cleanliness immediately before use• Assignment of
responsibility for cleaning of equipment.
3. A complete description of the methods and materials, including dilution of cleaning
agents used to clean equipment.
13. > Calibration
> Control, weighing, measuring, monitoring and test equipment that is
critical for assuring the quality of intermediates or APIs should be
calibrated according to written procedures and an established
schedule.
> Computerized Systems
> GMP related computerized systems should be validated
> The depth and scope of validation depends on the diversity, complexity
and criticality of the computerized application.
> Appropriate installation qualification and operational qualification
should demonstrate the suitability of computer hardware and software
to perform assigned tasks.
14. Documentation & Records
> Documentation System and Specifications
> All documents related to the manufacture of intermediates or APIs should be
prepared, reviewed, approved and distributed according to written
procedures. Such documents can be in paper or electronic form.
> All production, control, and distribution records should be retained for at least 1
year after the expiry date of the batch. For APIs with retest dates, records should
be retained for at least 3 years after the batch is completely distributed.
15. > Equipment Cleaning and Use Record
> Records of major equipment use, cleaning, sanitization and/or sterilization and
maintenance should show the date, time (if appropriate), product, and batch
number.
> Records of Raw Materials, I
ntermediates, APILabelling and Packaging
Materials
> The name of the manufacturer, identity and quantity of each shipment of each
batch of raw materials, intermediates or labelling and packaging materials for
API's;the name of the supplier;the supplier's control number(s), if known, or other
identification number; the number allocated on receipt; and the date of receipt.
16. > Batch Production Records (Batch Productionand Control Records)
> Batch production records should be prepared for each intermediate and API and should
include complete information relating to the production and control of each batch.
> Batch production record should include,
> Name of API
> Batch No.
> Date
> Identity of majorequipment.
> Specific identification of each batch including weight, measures, & batch no. of raw
materials.
> Signature of the person performing &directly supervising the each critical steps in the
operation.
17. > Laboratory Control Records
> Description of samples received for testing which includes,
- Material name
- Batch No.
- Date of Sampling
- Quantity
- Date - the sample wasreceived for testing.
2) Reference to each test method.
3)Weight of sample used foreach test.
4)A complete record of all raw data generated during each test with graphs,
charts& spectra from laboratory instrumentation.
5)Signature of the person who performed each test & the date on which the
tests were performed.
18. Material Management
> General Controls: There should be written procedures describing the
receipt, identification, quarantine, storage, handling, sampling, testing and
approval or ejection of materials.
> Receipt and Quarantine: Upon receipt and before acceptance, each
container or grouping of containers of materials should be examined
visually.
> Sampling and Testing of Incoming Production Materials.
> Storage: Materials should be handled and stored in a manner to prevent
degradation, contamination, and cross-contamination.
> Re-evaluation: Materials should be re-evaluated as appropriate to
determine their suitability for use (e.g., after prolonged storage or exposure
to heat or humidity).
19. Production & In proccess Controls
> Production Operations
> Time Limits
> I-process Sampling and Controls
> Blending Batches of Intermediates or APls
> Contamination Control -Residual materials can be carried over into
successive batches of the same intermediate or API if there is adequate
control.
20. STORAGE AND DISTRIBUTION
> Warehousing Procedures - Facilities should be available for the storage of
all materials under appropriate conditions (e.g. controlled temperature
and humidity when necessary.
> Distribution Procedures -1)APIs and intermediates should only be released
for distribution to third parties after have been released by the quality unit.
2)APIs and intermediates should be transported in a manner that does not
adversely affect their quality.
3) Special transport or storage conditions for an API.
21. Conclusion
> ICH Q7 is very important in maintaining quality of the API.
> API manufacturer can improve output of the manufacturing process.
> Helps to enhance productivity as well as effectiveness of the manufacturing
process.
> ICH Q7 ensures less batch to batch variations and less chances of recalls.
> Following this guideline can also help during regulatory inspections.
22. References
> Good manufacturing practice guide for active pharmaceutical ingredients
Q7,current step 4 version dated 10 November 2000.
> Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical
I
ngredients Guidance for I
ndustry September 2016.
> Kuchekar B.S., Khadatare A.M., ItkarS.C., Forensic Pharmacy, Nirali
Publication, page no.16.16 to 16.25
> www.ich.org (official ICH Web site)