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.
ICH Guideline Q9 - Quality Risk Managementmuna_ali
A presentation of the ICH guideline Q9 (Quality Risk Management). It discusses the basic risk management procedure, list of recognized risk management tools and its role in pharmaceutical industry.
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
ICH Guideline Q9 - Quality Risk Managementmuna_ali
A presentation of the ICH guideline Q9 (Quality Risk Management). It discusses the basic risk management procedure, list of recognized risk management tools and its role in pharmaceutical industry.
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceutic
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
Introduction to Change Control.
Definition of Change Control.
Function of Change Control.
Area of Change.
Written Procedures and Documentation.
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.
Technology Transfer and Scale-up in Pharmaceutical IndustryPranjalWagh1
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”.
In Pharmaceutical Industry, technology transfer refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full scale commercialization.
It is basically divided into three phases - Research Phase, Development Phase and Production Phase. The presentation elaborates on the technology transfer taking place in production phase. Production phase mainly concerns with validation studies and scale-up.
Validation studies such as performance qualification, cleaning validation and process validation is carried out by R&D department.
Scale-up involves the use of results obtained from lab studies for designing prototype of a product and pilot plant process, constructing pilot plant and further using pilot plant data for full-scale commercialization.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceutic
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
Introduction to Change Control.
Definition of Change Control.
Function of Change Control.
Area of Change.
Written Procedures and Documentation.
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.
Technology Transfer and Scale-up in Pharmaceutical IndustryPranjalWagh1
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”.
In Pharmaceutical Industry, technology transfer refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full scale commercialization.
It is basically divided into three phases - Research Phase, Development Phase and Production Phase. The presentation elaborates on the technology transfer taking place in production phase. Production phase mainly concerns with validation studies and scale-up.
Validation studies such as performance qualification, cleaning validation and process validation is carried out by R&D department.
Scale-up involves the use of results obtained from lab studies for designing prototype of a product and pilot plant process, constructing pilot plant and further using pilot plant data for full-scale commercialization.
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
Quality by design for Pharmaceutical Industries: An introductionCovello Luca
In this presentation, I have attempted to provide a quick introduction into the main concepts behind Pharmaceutical Quality by Design, an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of drugs.
ICH Q10 GUIDELINES (PHARMACEUTICAL QUALITY SYSTEM)
- Contents
- ICH
- ICH GUIDELINES
- Objective
Q10 GUIDELINE
- Introduction
- Scope
- Objective of Q10 Guideline
- Elements
- CAPA System
- Change Management System
- Continual improvement of pharmaceutical quality system
- References
THANK YOU :)
Diuretics are medicines that help reduce fluid buildup in the body. They are sometimes called water pills. Most diuretics help the kidneys remove salt and water through the urine. This lowers the amount of fluid flowing through the veins and arteries. As a result, blood pressure goes down.
Diuretics are drugs that increase the flow of urine. They are commonly used to treat edema, hypertension, and heart failure. Typically, the pharmacological group consists of five classes: thiazide diuretics, loop diuretics, potassium-sparing diuretics, osmotic diuretics, and carbonic anhydrase inhibitors.
There are three main types of diuretic: loop diuretics, thiazide diuretics and potassium-sparing diuretics.
Conjunctivitis, also referred to as pink eye or eye flu, is an eye condition that can make people feel uncomfortable, irritated, and have red eyes. The thin membrane that covers the white area of the eye and the inner surface of the eyelids, the conjunctiva, becomes inflamed, which is how it is identified.
Conjunctivitis, also referred to as pink eye or eye flu, is an eye condition that can make people feel uncomfortable, irritated, and have red eyes. The thin membrane that covers the white area of the eye and the inner surface of the eyelids, the conjunctiva, becomes inflamed, which is how it is identified.
Research is defined as the creation of new knowledge and/or the use of existing knowledge in a new and creative way so as to generate new concepts, methodologies and understandings. This could include synthesis and analysis of previous research to the extent that it leads to new and creative outcomes.
This definition of research is consistent with a broad notion of research and experimental development (R&D) as comprising of creative work undertaken on a systematic basis in order to increase the stock of knowledge, including knowledge of humanity, culture and society, and the use of this stock of knowledge to devise new applications.
This definition of research encompasses pure and strategic basic research, applied research and experimental development. Applied research is original investigation undertaken to acquire new knowledge but directed towards a specific, practical aim or objective (including a client-driven purpose).
These defects can cause serious injury and harm. When this occurs, you should speak with our product liability attorneys in Denver. You may have a viable claim to file a product liability lawsuit against the negligent manufacturer.Capsules are solid dosage forms in which the drug substance is enclosed within either a hard or soft soluble shell. Generally the shells are formed from gelatin. The capsule may be regarded as “container” drug delivery system, which provides a tasteless/odorless dosage form without the need of a secondary coating step, as may be required for tablets.Capsules are one of the essential components of the pharmaceutical sector. They are mainly used to hold dry powder or little pellets of medication and are made using specific machinery and techniques. The capsule's production method entails pharmaceutically active ingredients, additives, and a cover. Every pharmaceutical business understands capsule manufacturing takes time, and the reason is the critical measures.
Unani-tibb or Unani Medicine also spelled Yunani Medicine (in Arabic, Hindi-Urdu and Persian) means “Greek Medicine.” Its origin is traced back to the Greek literature, which has been a source of quite a lot of scientific contributions and also was developed by Arabs and Persians into an elaborate medical science.
A medical system from India that has been used for thousands of years. The goal is to cleanse the body and to restore balance to the body, mind, and spirit. It uses diet, herbal medicines, exercise, meditation, breathing, physical therapy, and other methods.
Homeopathy is a "treatment" based on the use of highly diluted substances, which practitioners claim can cause the body to heal itself. A 2010 House of Commons Science and Technology Committee report on homeopathy said that homeopathic remedies perform no better than placebos (dummy treatments).Homeopathic medicines are prepared by taking a substance (generally a plant, animal material or a chemical) and diluting that substance in water or alcohol repeatedly, often so that none of the original substance remains in the solution. These highly diluted preparations can be found in several forms, including tablets, liquids and creams.Homeopathic medicines taste sweet in the form of pills and powder, but they taste bitter in a liquid form. You may take liquid medicines with water. Pills and powder may be placed below the tongue for faster action. You may or may not drink water after consuming homeopathic pills or powder.
Supply chain redesign involves complex competencies such as integration with suppliers and customers to create value as well as the acquisition of external information and its transformation into practices capable of producing marketable outputs
Pharmaceutical care is a practice in which the practitioner takes responsibility for a patient's drug-related needs, and is held accountable for this commitment. In the course of this practice, responsible drug therapy is provided for the purpose of achieving positive patient outcomes.
National Pharmacy Strategy Information Pack PPT,,,,,,,1.pptxAbhishek Borkar15
The NPS information pack provides an overview of the 5 key strategic thrusts and details how people, process, information and technology can enable and empower the pharmacy profession to contribute to pharmaceutical care excellence. Your participation in the NPS is invaluable to help transform the delivery of care.
The skeletal system provides support and protection for the body’s internal organs and gives the muscles a point of attachment. Humans have an endoskeleton, where our bones lie underneath our skin and muscles. In other animals, such as insects, there is an exoskeleton on the outside of the body.
The possibility of drug interactions, direct toxicities, and contamination with active pharmaceutical agents are among the safety concerns about dietary and herbal supplements. Although there is a widespread public perception that herbs and botanical products in dietary supplements are safe, research has demonstrated that these products carry the same dangers as other pharmacologically active compounds. Interactions may occur between prescription drugs, over-the-counter drugs, dietary supplements, and even small molecules in food—making it a daunting challenge to identify all interactions that are of clinical concern.
Herbal drugs are made from the roots, stems, leaves, bark, fruit, seeds, or flowers of various plants known or believed to have medicinal properties. Many conventional drugs are also derived from plants. In fact, the word "drug" comes from the French word drogue, meaning "dried herb."
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.
TQM can have a beneficial effect on employee and organizational development. By having all employees focus on quality management and continuous improvement, companies can establish and uphold cultural values that create long-term success for both customers and the organization. TQM's focus on quality helps organizations identify skill deficiencies in employees, along with the necessary training, education or mentoring required to address those needs.
Pilot plant scale-up is a branch of the pharma companies in which a lab-scale formula is converted into a commercially viable product by creating a reliable manufacturing technique. The same techniques employed in dosage form Research and Development are adapted to multiple output volumes, frequently larger than those obtained during Research and Development. There is always a requirement for an intermediate batch scale describing techniques and imitating those in commercial manufacturing in any new or established pharmaceutical sector. This is accomplished by testing the formula’s ability to survive batch-scale and process changes.
A Novel Drug Delivery System (NDDS) can be defined as a new approach that combines innovative development, formulations, new technologies, novel methodologies for delivering pharmaceutical compounds in the body as needed to safely achieve its desired pharmacological effects
Spherical crystallization (SC) is a promising technique, which encompass the crystallization, agglomeration, and spheronization phenomenon in a single step. Initially, two methods, spherical agglomeration, and emulsion solvent diffusion, were suggested to get a desired result
The Principle of UV-Visible Spectroscopy is based on the absorption of ultraviolet light or visible light by chemical compounds, which results in the production of distinct spectra. Spectroscopy is based on the interaction between light and matter. When the matter absorbs the light, it undergoes excitation and de-excitation, resulting in the production of a spectrum.
When matter absorbs ultraviolet radiation, the electrons present in it undergo excitation. This causes them to jump from a ground state (an energy state with a relatively small amount of energy associated with it) to an excited state (an energy state with a relatively large amount of energy associated with it).
Pharmaceutical co-crystals can be defined as crystalline materials comprised of an API and one or more unique co-crystal formers, which are solids at room temperature. Co-crystals can be constructed through several types of interaction, including hydrogen bonding, p stacking, and vander Waals forces. fined as crystalline materials comprised of an API and one or more unique co-crystal formers, which are solids at room temperature.Co-crystals can be constructed through several types of interaction, including hydrogen bonding, p stacking, and vander Waals forces. Solvates and hydrates of the API are not considered to be co-crystals by this definition. However, co-crystals may include one or more solvent/water molecules in the crystal lattice. Co-crystals often rely on hydrogen-bonded assemblies between neutral molecules of API and other component. For nonionizable compounds co-crystals enhance pharmaceutical properties by modification of chemical stability, moisture uptake, mechanical behaviour, solubility, dissolution rate and bioavailability
(May 29th, 2024) Advancements in Intravital Microscopy- Insights for Preclini...Scintica Instrumentation
Intravital microscopy (IVM) is a powerful tool utilized to study cellular behavior over time and space in vivo. Much of our understanding of cell biology has been accomplished using various in vitro and ex vivo methods; however, these studies do not necessarily reflect the natural dynamics of biological processes. Unlike traditional cell culture or fixed tissue imaging, IVM allows for the ultra-fast high-resolution imaging of cellular processes over time and space and were studied in its natural environment. Real-time visualization of biological processes in the context of an intact organism helps maintain physiological relevance and provide insights into the progression of disease, response to treatments or developmental processes.
In this webinar we give an overview of advanced applications of the IVM system in preclinical research. IVIM technology is a provider of all-in-one intravital microscopy systems and solutions optimized for in vivo imaging of live animal models at sub-micron resolution. The system’s unique features and user-friendly software enables researchers to probe fast dynamic biological processes such as immune cell tracking, cell-cell interaction as well as vascularization and tumor metastasis with exceptional detail. This webinar will also give an overview of IVM being utilized in drug development, offering a view into the intricate interaction between drugs/nanoparticles and tissues in vivo and allows for the evaluation of therapeutic intervention in a variety of tissues and organs. This interdisciplinary collaboration continues to drive the advancements of novel therapeutic strategies.
Nutraceutical market, scope and growth: Herbal drug technologyLokesh Patil
As consumer awareness of health and wellness rises, the nutraceutical market—which includes goods like functional meals, drinks, and dietary supplements that provide health advantages beyond basic nutrition—is growing significantly. As healthcare expenses rise, the population ages, and people want natural and preventative health solutions more and more, this industry is increasing quickly. Further driving market expansion are product formulation innovations and the use of cutting-edge technology for customized nutrition. With its worldwide reach, the nutraceutical industry is expected to keep growing and provide significant chances for research and investment in a number of categories, including vitamins, minerals, probiotics, and herbal supplements.
Earliest Galaxies in the JADES Origins Field: Luminosity Function and Cosmic ...Sérgio Sacani
We characterize the earliest galaxy population in the JADES Origins Field (JOF), the deepest
imaging field observed with JWST. We make use of the ancillary Hubble optical images (5 filters
spanning 0.4−0.9µm) and novel JWST images with 14 filters spanning 0.8−5µm, including 7 mediumband filters, and reaching total exposure times of up to 46 hours per filter. We combine all our data
at > 2.3µm to construct an ultradeep image, reaching as deep as ≈ 31.4 AB mag in the stack and
30.3-31.0 AB mag (5σ, r = 0.1” circular aperture) in individual filters. We measure photometric
redshifts and use robust selection criteria to identify a sample of eight galaxy candidates at redshifts
z = 11.5 − 15. These objects show compact half-light radii of R1/2 ∼ 50 − 200pc, stellar masses of
M⋆ ∼ 107−108M⊙, and star-formation rates of SFR ∼ 0.1−1 M⊙ yr−1
. Our search finds no candidates
at 15 < z < 20, placing upper limits at these redshifts. We develop a forward modeling approach to
infer the properties of the evolving luminosity function without binning in redshift or luminosity that
marginalizes over the photometric redshift uncertainty of our candidate galaxies and incorporates the
impact of non-detections. We find a z = 12 luminosity function in good agreement with prior results,
and that the luminosity function normalization and UV luminosity density decline by a factor of ∼ 2.5
from z = 12 to z = 14. We discuss the possible implications of our results in the context of theoretical
models for evolution of the dark matter halo mass function.
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
The return of a sample of near-surface atmosphere from Mars would facilitate answers to several first-order science questions surrounding the formation and evolution of the planet. One of the important aspects of terrestrial planet formation in general is the role that primary atmospheres played in influencing the chemistry and structure of the planets and their antecedents. Studies of the martian atmosphere can be used to investigate the role of a primary atmosphere in its history. Atmosphere samples would also inform our understanding of the near-surface chemistry of the planet, and ultimately the prospects for life. High-precision isotopic analyses of constituent gases are needed to address these questions, requiring that the analyses are made on returned samples rather than in situ.
Cancer cell metabolism: special Reference to Lactate PathwayAADYARAJPANDEY1
Normal Cell Metabolism:
Cellular respiration describes the series of steps that cells use to break down sugar and other chemicals to get the energy we need to function.
Energy is stored in the bonds of glucose and when glucose is broken down, much of that energy is released.
Cell utilize energy in the form of ATP.
The first step of respiration is called glycolysis. In a series of steps, glycolysis breaks glucose into two smaller molecules - a chemical called pyruvate. A small amount of ATP is formed during this process.
Most healthy cells continue the breakdown in a second process, called the Kreb's cycle. The Kreb's cycle allows cells to “burn” the pyruvates made in glycolysis to get more ATP.
The last step in the breakdown of glucose is called oxidative phosphorylation (Ox-Phos).
It takes place in specialized cell structures called mitochondria. This process produces a large amount of ATP. Importantly, cells need oxygen to complete oxidative phosphorylation.
If a cell completes only glycolysis, only 2 molecules of ATP are made per glucose. However, if the cell completes the entire respiration process (glycolysis - Kreb's - oxidative phosphorylation), about 36 molecules of ATP are created, giving it much more energy to use.
IN CANCER CELL:
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
introduction to WARBERG PHENOMENA:
WARBURG EFFECT Usually, cancer cells are highly glycolytic (glucose addiction) and take up more glucose than do normal cells from outside.
Otto Heinrich Warburg (; 8 October 1883 – 1 August 1970) In 1931 was awarded the Nobel Prize in Physiology for his "discovery of the nature and mode of action of the respiratory enzyme.
WARNBURG EFFECT : cancer cells under aerobic (well-oxygenated) conditions to metabolize glucose to lactate (aerobic glycolysis) is known as the Warburg effect. Warburg made the observation that tumor slices consume glucose and secrete lactate at a higher rate than normal tissues.
A brief information about the SCOP protein database used in bioinformatics.
The Structural Classification of Proteins (SCOP) database is a comprehensive and authoritative resource for the structural and evolutionary relationships of proteins. It provides a detailed and curated classification of protein structures, grouping them into families, superfamilies, and folds based on their structural and sequence similarities.
Astronomy Update- Curiosity’s exploration of Mars _ Local Briefs _ leadertele...
QUALITY RISK MANAGEMENT (QRM) PPT.pptx
1. QUALITY RISK
MANAGEMENT (QRM)
Student Name:- Abhishek Borkar
Class- B- pharm 4th year
Shraddha Institute of Pharmacy Kondala zambre ,
Washim-444505
Guide by:
ASST.PROF .SHUBHADA BHOPALE
2. Introduction
In the life-cycle of any pharmaceutical product the quality aspect is
very important. The risk of quality variation in the pharmaceutical
product can be assessed, controlled and communicated by a
systematic process called QRM. It has been mentioned in ICH
guideline
Principle
The basic principle of QRM is the assessment and evaluation of the
associated risks based on scientific knowledge and evidence to
maintain the quality of the product and customer satisfaction.
4. Step (1) QRM initiation: To initiate the process of QRM the following
plan can be followed:
• Types of risk and problem.
• Questions regarding risks.
• Information regarding quality and potential hazards.
• Information of background and raw data.
• Assessment of required resources.
• Specification of time limit.
Step (2) Risk Assessment: This may include the following:
• Identification of Hazards: Systematic process to identify the risks and
hazards.
• Analysis of Risks: Qualitative and quantitative estimations of hazards.
• Evaluation of Risks: Comparison of identified and analyzed hazards.
5. Step (3) Risk Control: The basic purpose of risk control is to reduce or
eliminate the risks. It should be based on the following points:
• The acceptance level of risks.
• Possible steps to reduce or eliminate the risks.
• Balance among benefits, risks and resources.
(a) Reduction of Risks: The level of risk when exceeds the acceptance
criteria, the reduction of risks should be followed. Detection of risks,
risks assessment and the process control can reduce the level of risks.
(b) Acceptance of Risks: It is the decision to accept the risk.
Step (4) Results of QRM and Risk Reviews: The review of result
obtained from the QRM process is a part of quality management
system. Results of QRM process should be documented, reviewed,
inspected, audited and possible change control is suggested. The
unsatisfactory review process will suggest the failure of the
investigation and the process can be started from risk assessment step.
6. Step (5) Risk Communication: This is the communication process of the data
of risk management system. The risk management system can be
communicated at any step of risk management process (Risk assessment,
control and review process mentioned as dotted line). The well documented
result of QRM process should be submitted and communicated (in Fig. 2.1
mentioned as solid line) to the parties. This guideline is very important in
pharmaceutical industry with respect to QRM. The process is applicable for the
pharmaceutical product from manufacturing to inspection process.
INFORMATION REQUIRED FOR TECHNOLOGY TRANSFER For the
technology transfer from research and development section to production, the
RU should be capable of performing and accommodating the production
capacity. The detailed process development should be transferred. At RU,
expert personnel and facility available at the site are the primary
considerations. Development of protocol by SU and RU jointly for the
technology transfer is necessary.
7. Active Pharmaceutical Ingredients (API) :
• Details of API manufacturer and supplier.
• Detail scheme of synthesis, proc• Details of intermediate products.
• Complete information of API for formulation process. It includes:
- Physicochemical parameters like solubility, partition coefficient (method of
determination).
- Particle size distribution. - Bulk and tap density with detail method of
evaluation. - Disintegration profile.
- Nature of hygroscopicity.
- Water content.
- Loss on drying.
- Limit of impurities.
• Microbiological factors.
• Environmental factors.
• Pharmacopoeial standards with method of determination.
• Stability studies.
• Storage and handling guidance mentioned in Pharmacopoeias.ess
8. Excipients :
The excipients used in the process of manufacturing have an important role in
quality of the finished product. The duty of SU is to provide detail information of
excipients to RU. The following information is some of the examples of detail
information:
• Details of manufacturer and supplier.
• Category of excipients.
• Dosage form available.
• Descriptions.
• Solubility.
• For transdermal dosage form:
(a) Lipophilicity, Partition coefficient
(b) Particle size and distribution
(c) Specific gravity
(d) Water content and loss of drying
(e) Dissolution rate with detail process
9. For solid dosage form:
(a) Bulk and tap density profile with detail method of evaluation
(b) Compaction properties
(c) Particle size and distribution
(d) Water content and loss of drying
(e) Nature of hygroscopicity.
For semi-solid dosage form:
(a) Melting point
(b) Range of pH
(c) Viscosity
(d) Specific gravity
For liquid dosage form:
(a) Range of pH
(b) Viscosity
(c) Specific gravity
(d) Water content
10. For parenteral formulation:
(a) Range of pH
(b) Viscosity
(c) Specific gravity
(d) Water content
(e) Osmotic pressure
(f) Ionic strength
• For aerosol/inhaled dosage form:
(a) Solubility
(b) Bulk and tap density
(c) Particle size and distribution
(d) Surface area
(e) Water content
11. Process Information:
(a) Requirement of facility.
(b) Requirement of equipments.
(c) Requirement of skilled person.
(d) Detail information of raw materials.
(e) Storage guideline and handling of raw materials and finished goods.
(f) Availability of all SOPs.
(g) Manufacturing process
• Process flow charts
• Process optimization
• Detail master batch records
• Method of addition of raw materials and excipients
• Details of intermediate products
• Reaction conditions
• Environmental factors
12. (h) Analytical methods
• Standardization process
• Assay procedure
• Finished goods testing
(i) Validation protocols
• Process validation
• Equipment validation
(j) Annual audits and reviews
(k) Change control, critical control point and corrective actions
(l) Quality control and assurance
13. Finished Products
A finished pharmaceutical product is a final product that has
completed all stages of production and manufacturing. The finished product
should be stored in specific container and proper labeling is mandatory. All the
associated information in well documented manner should be informed and
transferred from SU to RU. The finished product storage and handling
guidelines are to be informed to RU along with the detail specification and
analytical test procedures. The predetermined specifications should be analyzed
and the detail standardization process should be transferred.
14. Packaging :
Information regarding packaging of finished product should be transferred to
RU. Some of the important instructions are given below:
• Suitable container
• Proper closure system
• Packing material
• Process of packaging
• Design of packaging
• Proper labeling
• Relevant information mentioned in package and label
.
15. Documentation
Some of the important documents required in technology transfer are:
• Technology transfer protocol, qualification protocol and report.
• Training protocols and report.
• Standard Operating Procedure (SOP).
• Technology transfer report.
• Analytical methods transfer protocol
• Validation report (VR).
• Process validation report.
• Cleaning validation protocol and report.
• Validation Master Plan (VMP).
• Master batch record.
16. Equipments :
The SU should provide the following to RU regarding equipments:
• List of equipments required.
• Specific model and makers of equipments.
• Manuals and SOPs.
• Set-up, maintenance, calibration and storage protocol.
• IQ, OQ and PQ status
