This document discusses analytical method transfer between laboratories. It defines analytical method transfer as qualifying a receiving laboratory to use a test procedure that originated in another laboratory. There are different types of method transfers, including comparative testing between laboratories, covalidation where both laboratories participate in validation, and complete or partial revalidation of methods in the receiving laboratory. Successful method transfers require several key elements, such as a pre-approved transfer plan, detailed description of test methods and procedures, description of test requirements, rationale for test parameters, acceptance criteria, and documentation of results. The goal is to verify that analytical methods produce equivalent results in different laboratories.
This is the topic related to Product development and technology transfer. In this we will learn how the technology is transferred from R&D department to production department in Pharmaceutical company
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”
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
This is the topic related to Product development and technology transfer. In this we will learn how the technology is transferred from R&D department to production department in Pharmaceutical company
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”
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
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.
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
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
Analytical method validation as per ich and usp shreyas B R
Analytical method validation is a process of documenting/ proving that an analytical method provides analytical data acceptable for the intended use.After the development of an analytical procedure, it is must important to assure that the procedure will consistently produce the intended a precise result with high degree of accuracy. The method should give a specific result that may not be affected by external matters. This creates a requirement to validate the analytical procedures. The validation procedures consists of some characteristics parameters that makes the method acceptable with addition of statistical tools.
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.
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
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
Analytical method validation as per ich and usp shreyas B R
Analytical method validation is a process of documenting/ proving that an analytical method provides analytical data acceptable for the intended use.After the development of an analytical procedure, it is must important to assure that the procedure will consistently produce the intended a precise result with high degree of accuracy. The method should give a specific result that may not be affected by external matters. This creates a requirement to validate the analytical procedures. The validation procedures consists of some characteristics parameters that makes the method acceptable with addition of statistical tools.
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
Analytical control strategy - Part -4 : How the ACS Applies to the Product Lifecycle and How the modern concept of a lifecycle model can be applied to analytical procedures.
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.
Continuous Flow Chemistry And The Manufacture Of Active Pharmaceutical Ingr...Stuart Silverman
A Series Of Informative Disquisitions About Continuous Flow Chemistry
Part Three:
Translation of flow protocols from the bench to the plant
Reaction Classes
Workup and isolation
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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.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
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2. Outline
Introduction
The drug development process
Types of method transfer
Requirements and elements of analytical technology transfer
Technical transfer time line/project plan
Analysis of results/statistical packages
Analyst certification and training
Transfer of technical ownership
7/2/2018 By Gemmechu.H 2
3. Is the documented process that qualifies a laboratory (the receiving unit) to use an
analytical test procedure that originated in another laboratory (the transferring
unit),
o thus ensuring that the receiving unit has the procedural knowledge and ability to perform the
transferred analytical procedure as intended.
Is the verification that a method or test procedure works in an equivalent fashion
at two or more different sites or laboratories and meets all acceptance criteria.
In short, analytical method transfer qualifies a laboratory to use a test procedure.
The process is driven by compliance and can be governed by both a statistical and
practical treatment of the resulting data.
Introduction[1]
7/2/2018 By Gemmechu.H 3
4. Introduction[2]
The importance of analytical transfer was underscored by the Analytical Research
and Development Steering Committee (ARDSC) of the Pharmaceutical Research
and Manufacturers of America (PhRMA) during its annual workshop held in
September 2000.
At this meeting, representatives from PhRMA member companies met with
facilitators to draft an acceptable analytical practice (AAP) that can function as
a suitable first step guidance document for conducting successful method transfer activities.
The focus of the AAP is
to provide such guidance and to clarify the essential elements that embody a complete and
compliant transfer.
7/2/2018 By Gemmechu.H 4
7. The drug development process[1]
Although there are a plethora of internal initiatives targeted at reducing the time
line of drug development and hence the overall time to market, the basic process
of drug development has remained unchanged.
Analytical method evaluation ring test (AMERT) by Crowther, this process allows
the quality unit to make comments and suggestions to their R&D colleagues
before the final validation of the method.
The knowledge base surrounding a compound increases steadily.
At the junction between R&D and operations, it is important to ensure not only
that the analytical methods are successfully used by the quality unit, but also that
the applicable knowledge and data are transferred or are readily accessible by the
receiving laboratory.
Although the quality unit might not require excessive detail regarding all
scientific research performed during the R&D period, some information transfer is
necessary.
7/2/2018 By Gemmechu.H 7
8. The drug development process[2]
Figure 2 the phases of drug development from a clinical perspective.
7/2/2018 By Gemmechu.H 8
9. Types of method transfer
The most common variations of method transfer are
1. Comparative testing,
2. Covalidation between two laboratories or sites,
3. Complete or partial method
validation or revalidation, and
4. Omission of formal transfer processes, sometimes termed the transfer
“waiver.”
7/2/2018 By Gemmechu.H 9
10. 1.Comparative testing
It involves two or more laboratories or sites executing a preapproved protocol
that details the criteria by which the receiving laboratory is deemed to be
“qualified” to use the method(s) being transferred.
Requires the analysis of a predetermined number of samples of the same lot by
both the sending and the receiving units
The resulting data are analyzed statistically and compared to the acceptance
criteria.
In pharmaceutical industry other scenarios during development and after approval.
These include alliance partners, CROs, and other internal development groups, for
example, the movement of a project between functional areas or development
sites.
7/2/2018 By Gemmechu.H 10
11. 2. Covalidation between Two Laboratories
An alternative to comparative testing is to involve the receiving laboratory in
the validation of the method(s).
By definition, a laboratory or site that performs validation experiments is qualified
to use that method for its intended purpose.
To perform such a transfer, it is necessary to identify which validation parameters
are to be generated or challenged by each partner.
A reasonable approach is to involve the receiving laboratory in the interlaboratory
qualification, thereby generating a matrix of data that summarizes the effect of
testing site, analyst, date of analysis, and instrumentation.
By including these data in the method validation report and fully describing the
experimental design for the validation exercise,
it is possible to have this document stand as proof of the analytical transfer.
7/2/2018 By Gemmechu.H 11
12. 3. Method Validation and/or Revalidation
Before the performance of method transfer activities involving protocols and
acceptance criteria, it was customary for a receiving laboratory to repeat some or
all of the validation experiments.
The choice of validation parameter(s) depends highly on the type of method being
transferred.
For example, content uniformity assays to determine consistency of product
potency depend heavily on the method and system precision.
As a second example,
o a determination of trace impurities in an API could not be reproduced between two sites if
their instruments did not yield similar limits of detection and limits of quantitation.
7/2/2018 By Gemmechu.H 12
13. 4. Transfer Waiver
Certain situations might certainly warrant the omission of conventional transfer
qualification experiments.
To proceed without some manner of laboratory comparison between the two sites, it is
critical to document the reasons for making such a decision.
For line extensions involving dosage forms that are routinely tested by the receiving
laboratory, it may be possible to waive the transfer for the following reasons:
The receiving laboratory is already testing the product and is thoroughly familiar with
the procedure(s).
The new dosage form possesses either a comparable composition and/or
concentration of API relative to the existing product.
The analytical method(s) are the same as or very similar to those that are already in
use.
The method validation package encompasses the new methods.
7/2/2018 By Gemmechu.H 13
14. Requirements and elements of analytical
technology transfer
Components that necessary to complete a successful comparative
testing transfer includes;
A. Preapproved Test Plan/Standard Operating Procedure/Protocol
B. Description of Methods/Test Procedures
C. Description of Test Requirements
D. Rationale for Test Requirements
E. Acceptance Criteria
F. Documentation of Results
7/2/2018 By Gemmechu.H 14
15. A. Preapproved Test Plan/Standard Operating Procedure/Protocol[1]
Before the planning of any transfer, an approved document that describes both the
general transfer process as well as the specific acceptance criteria necessary for
the method(s) being transferred needs to be in place.
In many companies, it is common for both the R&D and quality units to have
general standard operating procedures (SOPs) that govern the transfer process.
These SOPs describe the details of a method transfer protocol that is specific to
the product and methods.
7/2/2018 By Gemmechu.H 15
16. The contents of such a protocol were,
Clearly define responsibilities of both the transferring and receiving
laboratories
A list of all methods to be transferred via comparative testing.
Rationale for any methods not included, i.e., transfer waiver, must also be
provided.
The scope of the transfer should be provided with respect to what laboratories
and analysts are affected by the transfer.
In some cases, direct analyst-to-analyst transfer might be necessary due to
method complexity or the use of new or unfamiliar equipment.
The selection materials and samples to be used in the transfer should be
described in detail
A. Preapproved Test Plan/Standard Operating Procedure/Protocol[2]
7/2/2018 By Gemmechu.H 16
17. B. Description of Methods/Test Procedures
It is imperative that copies of all methods used during the transfer are included.
Any validation data that are available should be given to the receiving laboratory.
A difficult method is not necessarily “nonrugged”rather, the developer must
stipulate very carefully the steps that need to be followed and any pitfalls that
might occur.
This can even be the case with compendial methods, which do not necessarily
need to be formally transferred.
Due to the general nature of descriptions of compendial methods, receiving
laboratories often run into difficulty executing them.
In all method procedures, step-by-step directions should be given, including “tips
and tricks,” safety considerations, and clear formulas
and calculations.
7/2/2018 By Gemmechu.H 17
18. C. Description of Test Requirements
As part of the specific transfer, the number of lots, replicates, and injections (in
the case of HPLC) should be expressly presented.
For dissolution transfers, the number of individual dosage forms that will be
tested should be stipulated.
It is necessary to spell out such details so that small differences in the everyday
analytical philosophies do not perturb the transfer process.
In the case of new techniques that may not be common to the receiving laboratory
(i.e., capillary electrophoresis or liquid chromatography/mass spectroscopy),
specific training may be necessary before the execution of a transfer protocol.
7/2/2018 By Gemmechu.H 18
19. D. Rationale for Test Requirements
As in any scientific document, one must provide a rationale for the parameters
chosen and their effect on the overall success of the transfer.
This includes an explanation for the system suitability parameters that have been
established for the method.
System suitability can be a powerful tool for troubleshooting method
discrepancies in addition to being a test of the conformance of the system to a set
of parameters before analysis.
7/2/2018 By Gemmechu.H 19
20. E. Acceptance Criteria
The transfer protocol must include suitable acceptance criteria relevant to the tests and specific
dosage forms.
It should be noted that giving hard and fast specifications for such criteria is not possible.
There would surely be more exceptions than norms.
Below table clearly shows that the discrete acceptance criteria vary considerably from company to
company.
It does illustrate, however, that having systems in place to challenge the performance of a method
during transfer is absolutely required.
7/2/2018 By Gemmechu.H 20
21. F. Documentation of Results
The results of the comparative testing experiments should be documented
in a report summarizing all experiments and results.
Considerable attention must be paid to details of all aspects, observations,
and results of the experiments.
In some cases, the results for the receiving laboratory may not meet the
established acceptance criteria.
Such situations should be addressed by a policy that must be in place to
describe how such data would be handled.
Regardless of whether such a policy is followed, an investigation into all
results that fall outside of the acceptance criteria should be performed and
summarized.
7/2/2018 By Gemmechu.H 21
22. Technical transfer time line/project plan
The time line for formal transfer most often has the process taking place in the middle to late
clinical phase III.
This assumes that the quality unit has given input via sample communication or the AMERT has
taken place.
The timing for the technical transfer must be flexible, depending on the specific product.
It must take into account the need to have methods in place within operations before regulatory
approval or product launch.
One must know that the receiving laboratory has met all criteria to be qualified to perform the
methods and associated testing before the arrival of actual samples.
7/2/2018 By Gemmechu.H 22
23. Analysis of results/statistical packages
The comparative testing type of technical transfer generates results that need to be
compared using one or more statistical tools.
Although one can certainly evaluate the data subjectively, the use of statistics will
build objectivity into the data analysis and allow unbiased comparison of the data
set(s).
Because comparative testing involves destructive testing of individual samples,
the strength of the transfer involves proving mathematically that the data sets are
equivalent.
The complexity of the data treatment is directly related to that of the
method transfer.
Many transfers are governed by the statistics of the standard Student’s t test.
7/2/2018 By Gemmechu.H 23
24. ANALYST CERTIFICATION AND TRAINING
If the personnel in the receiving laboratory do not speak the native language of personnel in the
developing laboratory, translation of the method procedures may be necessary.
It is also important to ensure that proper training of the analysts who will perform the method
procedures has taken place.
There are several options to certify analysts to perform the required test procedures.
One possibility is to qualify individual analysts on each method, thereby creating a matrix of
methods and analysts.
Compliance liability could also result if an analyst who was not “certified”
produced reportable GMP data.
Training records must include documentation that the individual is indeed competent to perform
routine tests using specific transfers.
In these cases, the supervisor or another qualified analyst can certify that the individual analyst is
competent to perform the test procedure in question.
Laboratory Analyst and Training Certification Program (LATCP)7/2/2018 By Gemmechu.H 24
25. Transfer of technical ownership[1]
At the heart of the technical transfer process is documentation.
The old adage “if it isn’t written, it isn’t done” certainly applies to analytical transfer.
The R&D component of the drug development process encompasses several years, during
which time the knowledge base surrounding a compound increases steadily.
At the junction between R&D and operations, it is important to ensure not only that the
analytical methods are successfully used by the quality unit, but also that the applicable
knowledge and data are transferred or are readily accessible by the receiving laboratory.
Although the quality unit might not require excessive detail regarding all scientific research
performed during the R&D period, some information transfer is necessary.
Rather than inundate the quality unit with a large number of lengthy reports, several concise
documents that meet the specific needs of an operations-based analytical unit are preferred.
In most companies, the most important reports are the method development/validation reports
and analytical development reports.
7/2/2018 By Gemmechu.H 25
26. A. Method Development Report
This report should provide a concise summary of the development of the key
analytical methods used to assure the identity, quality, purity, potency, and
composition of the test article.
For HPLC methods, the rationale for the column and conditions chosen should be
documented.
For discriminating dissolution methods, the choice of media, type of apparatus,
and detection method should be given.
In all cases, a description or tabular list of unsuccessful approaches should be
included.
A good method development/validation report will include sample chromatograms
for approaches that have been tried.
Transfer of technical ownership[2]
7/2/2018 By Gemmechu.H 26
27. B. Analytical Development Report
The analytical development report is a documented summary and logic flow of all
essential analytical information acquired during the R&D phase of the project.
It is a repository of all important analytical information pertaining to the project
and is
o therefore a source document for the quality unit, and
o it is also used in the preparation of the site inspection at the time of product approval.
All information contained in this report must be traceable to raw data and other
reports, if applicable.
The analytical development report is one of the most valuable documents written
by the R&D unit during the development process.
If properly composed and completed, it can serve as a powerful document for
many years after product approval.
Transfer of technical ownership[3]
7/2/2018 By Gemmechu.H 27
29. C. Transfer File
Used as a means of ensuring that all key documents and relevant information are imparted to
operations or the receiving laboratory.
This file is merely a collection of important reports.
For analytical methods, such documents include the method development and validation
reports, impurity profiling report, stability reports and tables, and specification archive.
The power of such an approach is that it ensures that all information is conveyed
to the receiving laboratory.
This strategy is useful if operations will be relied on to continue the development process.
Examples include development for new formulation strengths for “brand support” or life
cycle management or the support of phase IV clinical trials.
Transfer of technical ownership[4]
7/2/2018 By Gemmechu.H 29
30. References
1. Hand book of modern pharmaceutical analysis edited by Satinder
Ahuja and Stephen Scypinski,volume 3, Academic Press, 2001.
2. Scypinsk S, Roberts D. Acceptable Analytical Practice for Analytical
Method Transfer. Pharmaceutical Research and Manufacturers
Association. MARCH, 2002
7/2/2018 By Gemmechu.H 30