Pilot Plant:-
“Defined as a part of pharmaceutical industry where a lab scale formula is transformed into viable product by the development of liable practical procedure for manufacture”.
Scale-up:-
“The art of designing of prototype using the data obtained from the pilot plant model”
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
Pilot plant Techniques and Product consideration for liquid dosage forms.D.R. Chandravanshi
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
Quality management systems - INDUSTRIAL PHARMACY llJafarali Masi
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
Pilot Plant:-
“Defined as a part of pharmaceutical industry where a lab scale formula is transformed into viable product by the development of liable practical procedure for manufacture”.
Scale-up:-
“The art of designing of prototype using the data obtained from the pilot plant model”
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
Pilot plant Techniques and Product consideration for liquid dosage forms.D.R. Chandravanshi
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
Quality management systems - INDUSTRIAL PHARMACY llJafarali Masi
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
Function of community pharmacy, Organization and structure of retail and wholesale drug store, Legal requirement for establishment, Maintenance of records
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
A proper technology transfer (TT) is both essential and important to drug discovery and development for new medicinal products. It is also required to upgrade drug quality planned during research development and to final product during manufacturing as well as to guarantee that stable quality is transferred
Function of community pharmacy, Organization and structure of retail and wholesale drug store, Legal requirement for establishment, Maintenance of records
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
A proper technology transfer (TT) is both essential and important to drug discovery and development for new medicinal products. It is also required to upgrade drug quality planned during research development and to final product during manufacturing as well as to guarantee that stable quality is transferred
Technology transfer from Research and development to productionArchana Mandava
Technology transfer process from R&D to production, Granularity,Complete process from raw materials to finished products, analytical method transfer,Transfer protocol, responsibilities
Transfer from R & D to production.pptxDipeshGamare
Transfer from R & D to production :
(Process, packaging and cleaning)
Granularity of TT Process :
(API, excipients, finished products, packaging materials)
Technology transfer (TT) refers to the process of conveying results stemming from scientific and technological research to the market place and to wider society, along with associated skills and procedures, and is as such an intrinsic part of the technological innovation process.
Technology transfer is a complex process that involves many non-scientific and non-technological factors, and many different stakeholders. Good or high quality research results are not enough for successful technology transfer; general awareness and willingness both at the level of organisations and individuals, as well as skills and capacity related to specific aspects, such as access to risk finance and intellectual property (IP) management, are also necessary components.
Phụ lục 7. Hướng dẫn của WHO trong chuyển giao công nghệ sản xuất dược phẩm. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
Quality risk management is a systematic, risk-based approach to quality management. The process is composed of the assessment, control, communication, and review of quality risks. It is especially critical in the pharmaceutical industry, where product quality can greatly affect consumer health and safety.
Reproductive system
Anatomy of male and female reproductive system, Functions of male and female
reproductive system, sex hormones, physiology of menstruation, fertilization,
spermatogenesis, oogenesis, pregnancy and parturition
Human Anatomy and Physiology-II:
Endocrine System:
Classification of hormones, mechanism of hormone action, structure and functions of pituitary gland, thyroid gland, parathyroid gland,
adrenal gland, pancreas, pineal gland, thymus and their disorders.
BP201T. Human Anatomy And Physiology-II
Unit-III: - Urinary System.
Anatomy of urinary tract with special reference to anatomy of kidney and
nephrons, functions of kidney and urinary tract, physiology of urine formation,
micturition reflex and role of kidneys in acid base balance, role of RAS in kidney
and disorders of kidney.
Unit-III, Chapter-1- Respiratory System.pptAudumbar Mali
B. Pharm. First Year, Sem:II,
Unit III
Respiratory system 10 hours
Anatomy of respiratory system with special reference to anatomy of lungs,
mechanism of respiration, regulation of respiration
Lung Volumes and capacities transport of respiratory gases, artificial respiration,
and resuscitation methods.
Unit-I, Chapter_1 Nervous System Final PPT.pptAudumbar Mali
B. Pharm. Sem:-II,
BP 201T. HUMAN ANATOMY AND PHYSIOLOGY-II (Theory),
Nervous System:
Organization of nervous system, neuron, neuroglia, classification and properties of nerve fibre, electrophysiology, action potential, nerve impulse, receptors, synapse, neurotransmitters. Central nervous system: Meninges, ventricles of brain and
cerebrospinal fluid.structure and functions of brain (cerebrum, brain stem, cerebellum), spinal cord (gross structure, functions of afferent and efferent nerve tracts,reflex activity).
Unit-III, chapter-2- Lymphatic System,
Functions of Lymphatic System,
Major Parts of Lymphatic System,
Composition of Lymph,
Lymph and Lymphatic Capillaries,
Structure of lymph node,
Mechanisms of Lymph Flow,
Functions of Lymph Node,
Mucosa-Associated Lymphoid Tissue (MALT),
As per PCI syllabus,
B. Pharm. First Year,
Human Anatomy and Physiology-I.
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.
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.
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
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.
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
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
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
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!
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.
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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
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2. Transfer of technology is defined as “a logical procedure that controls
the transfer of any process together with its documentation and
professional expertise between development and manufacture or
between manufacture sites”.
Transfer of technology requires :
Documented, planned approach
Trained and knowledgeable personnel
Compliant quality system
Documentation of data covering all aspects of development, production and
quality control.
Usually there is a Sending unit (SU) , a receiving unit (RU) and the unit
managing the process, which may or may not be a separate entity.
2
3. Active pharmaceutical ingredient (API) :
Any substance or mixture of substances intended to be used in the
manufacture of a pharmaceutical dosage form and that, when so used
becomes an active ingredient of that pharmaceutical dosage form. Such
substances are intended to furnish pharmacological activity or other
direct effect in the diagnosis, cure, mitigation, treatment, or prevention
of disease or to affect the structure and function of the body.
Good manufacturing practices (GMP) :
That part of quality assurance which ensures that pharmaceutical
products are consistently produced and controlled to the quality
standards appropriate to their intended use and as required by the
marketing authorization.
3
4. Process validation :
Documented evidence which provides a high degree of assurance that a
specific process will consistently result in a product that meets its
predetermined specific actions and quality characteristics.
Quality assurance (QA) :
Quality assurance is a wide-ranging concept covering all matters that
individually or collectively influence the quality of a product. It is the
totality of the arrangements made with the objective of ensuring that
pharmaceutical products are of the quality required for their intended
use.
Quality control (QC) :
Quality control covers all measures taken, including the setting of
specifi cations, sampling, testing and analytical clearance, to ensure
that starting materials, intermediates, packaging materials and finished
pharmaceutical products conform with established specifications for
identity, strength, purity and other characteristics.
4
5. Quality risk management (QR) Quality risk management
is a systematic process for the asseM) ssment, control, communication
and review of risks to the quality of the pharmaceutical product
throughout the productlife-cycle.
Receiving unit (RU) :
The involved disciplines at an organization where a designated product,
process or method is expected to be transferred.
Sending unit (SU) :
The involved disciplines at an organization from where a designated
product, process or method is expected to be transferred.
Standard operating procedure (SOP) :
An authorized written procedure giving instructions for performing
operations not necessarily specific to a given product or material (e.g.
equipment operation, maintenance and cleaning, validation, cleaning of
premises and environmental control, sampling and inspection).
5
6. Technology transfer report :
A documented summary of a specific
technology transfer project listing procedures,
acceptance criteria, results achieved and
conclusions. Any deviation should be discussed
and justified.
Validation :
Action of proving and documenting that any
process, procedure or method actually and
consistently leads to the expected results.
6
7. The transfer protocol should list the intended sequential stages of the
transfer. The protocol should include:
objective
scope
key personnel and their responsibilities
a parallel comparison of materials, methods and equipment
the transfer stages with documented evidence that each critical stage has
been satisfactorily accomplished before the next commences
identification of critical control points
experimental design and acceptance criteria for analytical methods
information on trial production batches, qualification batches and process
validation
change control for any process deviations encountered
assessment of end-product
arrangements for keeping retention samples of active ingredients ,
intermediates and finished products, and information on reference
substances where applicable; and conclusion, including signed-off approval
by project manager. 7
9. The RU should be able to accommodate the intended production
capacity. If possible, it should be established at the outset whether the
intention is to perform single-batch manufacture, continuous
production or campaigns.
Consideration should be given to
The level and depth of detail to be transferred to support production
and any further process development and optimization at the RU as
intended under the transfer project plan.
The technical expertise, site technology and site capabilities for the RU.
It should be identified upfront by the SU of any process robustness
issues so that plans may be put in place at the RU.
The SU and the RU should jointly develop a protocol for the transfer of
relevant information related to the process under consideration from
the SU to the RU, as well as the development of a comparable process
at the RU.
9
11. The specifications and relevant functional
characteristics of the starting materials :
APIs and excipients to be used at RU
should be consistent with
materials used at the SU.
Any properties which are likely to
influence the process or product should
be identified and characterized.
11
12. The SU should provide the RU with the open part of the API master file
(APIMF) or drug master file (DMF) or active substance master file (ASMF)
or equivalent information and any relevant additional information on the
API of importance for the manufacture of the pharmaceutical product.
The following are examples of the information which may typically be
provided; however the information needed in each specific case should
be assessed using the principles of QRM:
Manufacturer and associated supply chain
Step of the API to be transferred
Flow chart of synthesis pathway, outlining the process, including entry
points for raw materials, critical steps, process controls and intermediates
where relevant, definitive physical form of the API (including
photomicrographs and other relevant data) and any polymorphic and
solvate forms
12
13. solubility profile
If relevant, pH in solution
Partition coefficient, including the method of determination
Intrinsic dissolution rate, including the method of determination
Particle size and distribution, including the method of
determination
Bulk physical properties, including data on bulk and tap density,
surface area and porosity as appropriate
Water content and determination of hygroscopicity , including
water activity data and special handling requirements
Microbiological considerations (including sterility, bacterial
endotoxins and bioburden levels where the API supports
microbiological growth) in accordance with national, regional or
international pharmacopoeial requirements
13
14. Specifications and justification for release and end-of-life limits
;
summary of stability studies conducted in conformity with
current
guidelines, including conclusions and recommendations on
retest date;
list of potential and observed synthetic impurities, with data to
support proposed specifications and typically observed levels;
information on degradants, with a list of potential and
observed degradation products and data to support proposed
specifications and typically observed levels;
potency factor, indicating observed purity and justification
for any recommended adjustment to the input quantity of
API for product manufacturing, providing example
calculations;
special considerations with implications for storage and or
handling, including but not limited to safety and
environmental factors (e.g. As specified in material safety data
sheets) and sensitivity to heat, light or moisture.
14
15. The excipients to be used have a potential impact on the final
product.
Their specifications and relevant functional characteristics
should, therefore, be made available by the SU for transfer to
the RU site.
The following are examples of the information which may typically
be provided; however, the information needed in each specific case
should be assessed using the principles of QRM:
Manufacturer and associated supply chain
Description of functionality, with justification for inclusion of
any antioxidant, preservative or any excipient
Definitive form (particularly for solid and inhaled dosage forms)
Solubility profile (particularly for inhaled and transdermal
dosage forms)
Partition coefficient, including the method of determination
(for transdermal dosage forms)
15
16. Intrinsic dissolution rate, including the method of determination
(for transdermal dosage forms)
Particle size and distribution, including the method of
determination (for solid, inhaled and transdermal dosage forms)
Bulk physical properties, including data on bulk and tap density,
surface
area and porosity as appropriate (for solid and inhaled dosage
forms)
Compaction properties (for solid dosage forms)
Melting point range (for semi-solid or topical dosage forms)
pH range (for parenteral, semi-solid or topical, liquid and
transdermal
dosage forms)
Ionic strength (for parenteral dosage forms)
Specific density or gravity (for parenteral, semi-solid or topical,
liquid and transdermal dosage forms)
16
17. Viscosity and or viscoelasticity (for parenteral, semi-solid or
topical, liquid and transdermal dosage forms)
Osmolarity (for parenteral dosage forms)
Water content and determination of hygroscopicity, including
water activity data and special handling requirements (for
solid and inhaled dosage forms)
Moisture content range (for parenteral, semisolid or topical,
liquid and transdermal dosage forms)
Microbiological considerations (including sterility, bacterial
endotoxins and bioburden levels where the excipient supports
microbiological growth) in accordance with national, regional or
international pharmacopoeial requirements, as applicable (for
general and specific monographs)
Specifications and justification for release and end-of-life limits
17
18. Information on adhesives supporting compliance
with peel, sheer and adhesion design criteria (for
transdermal dosage forms)
Sepecial considerations with implications for
storage and or handling, including but not limited
to safety and environmental factors (e.g. As
specified in material safety data sheets (MSDS))
and sensitivity to heat, light or moisture
Regulatory considerations, e.g. documentation to
support compliance with transmissible animal
spongiform encephalopathy certification
requirements (where applicable) .
18
19. The SU should provide a detailed characterization of the
product, including its qualitative and quantitative
composition, physical description, method of manufacture,
in-process controls, control method and specifications,
packaging components and configurations, and any safety and
handling considerations.
The SU should provide any information on the history of
process development which may be required to enable the
RU to perform any further development and or process
optimization after successful transfer. Such information may
include the following:
Information on clinical development
information on scale-up activities :
o process optimization, statistical optimization of critical process
parameters, critical quality attributes, pilot report and or
information on pilot-scale development activities indicating
the number and disposition of batches manufactured 19
20. The SU should provide to the RU information on any
health, safety and environmental issues associated
with the manufacturing processes to be transferred,
and the implications.
During the transfer process, the RU should identify any
differences in facilities, systems and capabilities and
communicate with the SU about these differences to
understand the potential impact on ability to run the
process to deliver good product quality.
Based on the information received from the SU, the RU
should consider its own capability to manufacture and
pack the product to the required standards and should
develop relevant plant operating procedures and
documentation before the start of production.
20
22. The transfer of packaging operations should follow the
same procedural patterns as those of the production
transfer.
Information on packaging to be transferred from the
SU to the RU includes:
Specifications for a suitable container or closure system ,
Any relevant additional information on design, packing,
processing or labelling requirements ,
Tamper-evident and anti-counterfeiting measures
needed for qualifi cation of packaging components at
the RU.
For QC testing of packaging components, specifications
should be provided for drawings, artwork and material (for
example, glass, card or fi bre board).
22
23. Based on the information provided, the RU should
perform a suitability study for initial qualification of
the packaging components.
Packaging is considered suitable if it provides :
It provides adequate protection (preventing
degradation of the
medicine due to environmental influences),
Safety (absence of undesirable substances released
into the product),
Compatibility (absence of interaction possibly
affecting medicine quality),
Performance (functionality in terms of drug delivery).
23
25. During the manufacturing process, pharmaceutical products
and APIs can be contaminated by other pharmaceutical
products or APIs if the plant is processing different products.
Tominimize the risk of contamination and cross-
contamination, operator exposure and environmental
effects, adequate cleaning procedures are essential.
Cleaning procedures and their validation are site-specific.
In order for the RU to define its cleaning strategy the SU should
provide information on cleaning at the SU to minimize cross-
contamination due to residues from previous manufacturing
steps, operator exposure and environmental impact, including:
Information on solubility of active ingredients, excipients and
vehicles;
Minimum therapeutic doses of active ingredients;
25
26. Therapeutic category and toxicological assessment;
Existing cleaning procedures.
Additional information should be provided, as appropriate and
where available, e.g.:
Cleaning validation reports
Information on cleaning agents used
Recovery studies to validate the sampling methodology.
Before the transfer, the SU should provide information on
limits for
product residues, and the rationale for limit selection.
Based on the information provided by the SU, cleaning
procedures should be designed at the RU, taking into
account relevant characteristics of the starting materials,
manufacturing equipment design and configuration,
cleaning agent and products residue.
26
27. The documentation required for the transfer project itself
is wide ranging.
The documented evidence that the transfer of technology has
been considered successful should be formalized and stated in
a technology transfer summary report.
This report should summarize the scope of the transfer, the
critical parameters as obtained in the SU and RU (preferably in
a tabulated format) and the final conclusions of the transfer.
Possible discrepancies should be listed and appropriate
actions, where needed, taken to resolve them.
27
28. Key task Documentation provided by
SU
Transfer documentation
Project definition Project plan and quality
plan(where separate
documents),
protocol, risk
assessments,
gap analysis
Project
implementationplan
TOT protocol
Quality agreement
Facility assessment
Plans and layout of facility,
buildings
(construction,finish)
Qualification status (DQ,
IQ,OQ) and reports
Side-by-side
comparison with RU
facility and buildings;
gap analysis
Qualifi cation protocol
and report
Health & Safety
assessment
Product-specific waste
management plans
Contingency plans
-
28
29. Skill set analysis and SOPs and training Training protocols,
training documentation assessment
(product-specific results
operations,
analysis, testing)
Analytical method Analytical method Analytical methods
transfer specifications and transfer protocol and
validation, report
including in-process
quality control
Starting material Specifications and
evaluation additional
information on APIs,
excipients
29
30. Equipment selection
and transfer
Inventory list of all
equipment and systems,
including makes, models,
qualification status (IQ, OQ,
PQ)
Drawings, manuals, logs,
SOPs (e.g. set-up, operation,
cleaning, maintenance,
calibration, storage)
Side-by-side comparison
with RU equipment
(makes, models,
qualification status)
Gap analysis
Qualification and
validation
protocol and report
Process transfer: Reference batches (clinical, History of process
manufacturing and dossier, biobatches) development at RU
packaging Development report Experiences at RU
(manufacturing process should be
rationale) recorded for future
History of critical analytical reference
data Provisional batch
Rationale for specifications manufacturing
Change control document (RU to
documentation develop)
30
31. Process transfer: Critical manufacturing Description of process
manufacturing process at RU(narrative,
and Parameters process map,
packaging Process validation reports flowchart)
Drug master file Process validation
API validation status and protocol and report
report
Product stability data
Current master batch
manufacturing and
packaging
records
List of all batches produced
Deviation reports
Investigations, complaints,
recalls
Annual product review
31
32. Cleaning Cleaning validation, including:
Solubility information;
therapeutic doses; category
(toxicology); existing cleaning
SOPs; validation reports —
chemical and micro; agents
used; recovery study
Product- and site-specifi
c
cleaning SOPs at RU
Cleaning validation
protocol
and report
32
33. The SU should provide information to the RU on the
layout, construction and finish of buildings and
services which have an impact on the product, process
or method to be transferred.
HVAC
Temperature
Relative humidity
Water
Power
Compressed air
33
34. The SU should provide information on relevant health,
safety and environmental issues, including:
Inherent risks of the manufacturing processes
(e.g. reactive chemical hazards, exposure limits, fire and
explosion
risks);
Health and safety requirements to minimize operator
exposure (e.g. atmospheric containment of
pharmaceutical dust);
Emergency planning considerations
(e.g. in case of gas or dust release, spillage, fire and firewater
run-off);
Identification of waste streams and provisions for re-use,
recycling and/or disposal.
34
35. The SU should provide a list of equipment, makes and
models involved in the manufacture, filling, packing and
or control of the product, process or method to be
transferred, together with existing qualification and
validation documentation.
Relevant documentation may include:
drawings
manuals
maintenance logs
calibration logs
procedures
35
36. The RU should review the information provided by
the SU together with its own inventory list including
the qualification status (IQ, OQ, PQ) of all equipment
and systems, and perform a side-by-side comparison
of equipment at the two sites in terms of their
functionality, makes, models and qualification status.
The RU should perform a gap analysis to identify
requirements for adaptation of existing equipment,
or acquisition of new equipment, or a change in the
process, to enable the RU to reproduce the process
being transferred.
GMP requirements should be satisfied and intended
production volumes and batch sizes (e.g. same,
scaled-up or campaign) should be considered. 36
37. Factors to be compared include :
minimum and maximum capacity
material of construction
critical operating parameters
critical equipment components (e.g. filters,
screens, and temperature/pressure sensors)
critical quality attribute
range of intended use.
The facility- and building-specific location of all
equipment at the RU should be considered at the
time of drawing up process maps or flow charts of
the manufacturing process to be transferred,
including flows of personnel and material .
37
38. The impact of manufacturing new
products on products currently
manufactured with the same equipment
should be determined.
Any modification of existing equipment that
needs to be adapted to become capable of
reproducing the process being transferred
should be documented in the transfer project
plan.
38
39. The extent of qualification and or
validation to be performed should be
determined on the basis of risk
management principles.
Qualification and validation should be
documented.
39
40. Transfer of analytical methods should accommodate all the
analytical testing required to demonstrate compliance of
the product to be transferred with the registered
specification.
Analytical methods used to test pharmaceutical products,
starting materials, packaging components and cleaning
(residue) samples, if applicable, should be implemented at
the testing laboratory before testing of samples for process
validation studies is performed by the RU.
The analytical methods transfer protocol should include ;
Description of the objective
Scope and responsibilities of the SU and the RU
A specification of materials and methods
The experimental design and acceptance criteria
Documentation
40
41. Procedure for the handling of
deviations
References
Signed approval
Details of reference
Samples (starting materials,
intermediates and finished
products)
41
42. provide method-specific trainingfor
analysts and other quality control
staff, if required
review analytical methods providedby
the SU
assist in analysis of QC testing results ensure that the necessary equipmentfor
QC is available and qualified at
the RU site
define all methods to be transferredfor
testing a given product
ensure that adequately trained and
experienced personnel are in placefor
analytical testing
define experimental design,sampling
methods and acceptancecriteria
execute the transfer protocol
provide details of the equipment used,as
necessary
perform the appropriate level of
validation to support the implementation
of the methods
provide approved procedures usedin
testing
generate and obtain approval of transfer
reports
review and approve transferreports
RU responsibilities
42
SU responsibilities
43.
44.
45.
46.
47.
48.
49. References:
1. A Textbook of Industrial Pharmacy-II, By,
Dr. K. P. Sampath Kumar,
Dr. Debjit Bhowmik, Rishab Bhanot,
Shambaditya Goswami, Nirali Prakashan,
age No. 2.1 to 2.14.
2. A Textbook of Industrial Pharmacy-II, By,
Dr. Ashok A. Hajare, Nirali Prakashan,
Page No. 2.1 to 2.54.
3. www.google.com.