According to the WHO-
"GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification".
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.
Pharmaceutical Good Manufacturing PracticesPharmaceutical
When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
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.
Pharmaceutical Good Manufacturing PracticesPharmaceutical
When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Reference: WHO)
In contrast, cGMP i.e. ‘c’ before the GMP is indicative of the constantly changing technologies and systems which are up-to-date in order to comply with the regulations. These the dynamic changes in Good Manufacturing Practice to make Pharmaceuticals manufacture foul proof; assuring a high level of confidence in the safety and efficacy of the product.
Total quality management (TQM), and current Good Manufacturing Practice (cGMP...Dr. Ravi Sankar
TQM, cGMP, Introduction, Definition, Importance, TQM frame work, Key concepts (Principles) of TQM, specific steps in the cycle, Benefits of TQM, cGMP, principles of GMP, Improtance of GMP, why GMP established?, difference between GMP and cGMP, GMP and cGMP regulations, code of federal regulations.
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Reference: WHO)
In contrast, cGMP i.e. ‘c’ before the GMP is indicative of the constantly changing technologies and systems which are up-to-date in order to comply with the regulations. These the dynamic changes in Good Manufacturing Practice to make Pharmaceuticals manufacture foul proof; assuring a high level of confidence in the safety and efficacy of the product.
Total quality management (TQM), and current Good Manufacturing Practice (cGMP...Dr. Ravi Sankar
TQM, cGMP, Introduction, Definition, Importance, TQM frame work, Key concepts (Principles) of TQM, specific steps in the cycle, Benefits of TQM, cGMP, principles of GMP, Improtance of GMP, why GMP established?, difference between GMP and cGMP, GMP and cGMP regulations, code of federal regulations.
Shamisha Learning Center, Ahmedabad, Gujarat, India-Specialized Training, Workshops and courses on Quality, Regulatory, R & D, Supply Chain and Manufacturing
GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification.
(Ref. WHO)
Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Information received from patients and healthcare providers via pharmacovigilance reporting form as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place.
The pharmaceutical quality system “assures that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded...
CAREER OPPORTUNITIES OF PHARMACY GRADUATES IN THE PHARMACEUTICAL INDUSTRIES.pdfMd. Zakaria Faruki
Pharmacy is a very important profession, which deals with the manufacturing, handing, proper utilization, dispensing, and administration of life saving drugs.
Training means the process of increasing the knowledge and skills of an employee for doing a particular job. It seeks to improve the job performance and work behaviour of those trained.
Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
The U.S. Food and Drug Administration (FDA) has proposed guidelines with the following definition for process validation: – “PROCESS VALIDATION” is establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes.
Workshop on General Accident Prevention at The workplaces.pdfMd. Zakaria Faruki
Providing a safe environment for employees is one of the most important responsibilities of a management team. In industries with inherent risks, like construction and mining, it's crucial that employees understand and follow the proper safety protocols.
In addition, preventing job accidents call for various strategies. The organization should have a comprehensive education of the workers, proper risk management, introducing safety alerts in the establishments, security leaders, and ensuring that the workers are in a stable psychological and mental state.
Moreover, developing and enforcing safety plans in the organization can provide greater peace of mind for employees and help prevent accidents and injuries. In this Workshop, we discussed what accident prevention in the workplace is and provide tips for maintaining a safe workplace.
Therefore, please follow the safety guidelines accordingly to prevent the accident in the workplace.
The personnel is the most important asset of a company, and the easiest to neglect. The establishment and maintenance of a satisfactory system of quality assurance and GMP relies upon people who develop the system, the people who use the system and the people who examine the system to see if it has worked.
The technical people must have a knowledge and understanding of GMP to enable them to carry out their duties in accordance with GMP. These people must have the level of training and experience that will enable them to do their professional works respectively.
According to US FDA it is illustrated here that,
A recall is a method of removing or correcting products that are in violation of laws administered by the Drug Regulatory Authority.
Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.
21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.
Market or Customer complaint is “an expression of dis-satisfaction on a customer’s behalf to a responsible party” when their expectations have not been met! However, Complaint handling is a Good Manufacturing Practice (GMP) requirement, since all complaints concerning potentially defective products must be carefully reviewed according to a written procedure.
Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
The first generation of biological drugs, which
have introduced many revolutionary treatments to life threatening and rare illnesses, is currently facing patent expiration. As a result, research-based and generics pharmaceutical companies alike are pursuing the opportunity to develop “generic” substitutes to original biologics, which are also known as biosimilars.
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
Stability study of Pharmaceutical Products and Regulatory Requirements Md. Zakaria Faruki
A marketed product stability program fulfills registration
commitments and ensures that marketed product is
stable until expiry date stamped on product
label....
Stability studies should be planned on the
basis of pharmaceutical R&D and regulatory
requirements...
Post-marketing drug safety surveillance refers to the monitoring of drugs once they reach the market after clinical trials through a process which evaluates drugs taken by individuals under a wide range of circumstances over an extended period.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
Quality must be built into the product, it cannot be inspected into it. The Pharmaceutical industries are experiencing a “knowledge and experience deficit” regarding the use of QbD concepts.
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.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
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
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Best Ayurvedic medicine for Gas and IndigestionSwastikAyurveda
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
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
2. TRAINING
ON
Presented by:
MD. ZAKARIA FARUKI
Manager & Head of Quality Assurance
Silva Pharmaceuticals Limited
Date of Training: March 20, 2023
Good Manufacturing
Practice (GMP) for
Pharmaceutical
Products
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3. Quality Policy
Silva Pharmaceuticals Limited is
committed to deliver Quality, Safe &
Effective Medicines to its valued
customers through continuous
improvement in process, technology
& human resources complying with
the guidelines of current Good
Manufacturing Practices (cGMP) and
the requirements of ISO 9001:2015
Quality Management System (QMS)
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
4. Company Vision
We continually strive to improve
our core capabilities to address
the unmet medical needs of the
patients and to deliver
outstanding results for our
shareholders.
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
5. Company Mission
We are committed to
enhancing human health and
well-being by providing
contemporary and affordable
medicines, manufactured in
full compliance with global
quality standards.
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6. Company Values
Quality & Safety
Honesty, Integrity &Transparency
Innovation & Diversification
Commitment to Excellence
Respect for humanity
Think Differently
Never Give up
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
7. Quality & Quality Medicine
• Quality: Quality is the totality feature of the
characteristics of product.
-Fit for use
-Meets the predetermined specification
-Fulfill the customer requirements
• Quality Medicine:
A product that has good therapeutic efficacy and safe
for the patients/consumers
Attributes of quality medicine:
-Efficacy, Safety, Stability, Potency, Purity, Regulatory
compliance
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
8. Attributes of Qualified
Person
• Good knowledge about GMP
• Proper Training
• Have academic qualification
• Good Behavior /Good Conduct
• Time Management
• Fair & Impartial
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
The PDCA cycle can be briefly described as
follows:
• Plan: establish the objectives of the system and
its processes, and the resources needed to
deliver results in accordance with customers'
requirements and the organization's policies, and
identify and address risks and opportunities;
• Do: implement what was planned;
• Check: monitor and (where applicable) measure
processes and the resulting products and services
against policies, objectives, requirements and
planned activities, and report the results;
• Act: take actions to improve performance, as
necessary.
12. What is GMP?
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
13. GMP: (Good Manufacturing Practice)
GMP is the part of Quality Management which ensures
that the products are consistently produced and
controlled to the quality standard appropriate to their
intended use as required by the marketing authorization
and product specification. (Ref: WHO)
―GMP is the bundle of common sense‖
13
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
14. GMP: (Basic Principles) GMP
GMP Training Components: Ref.
WHO Technical Report Series, No. 908, Annex 4
1. Quality Management System
2. Good Manufacturing Practice for pharmaceutical products
3. Sanitation and Hygiene
4. Qualification and Validation
5. Complaints
6. Product Recalls
7. Contract production, analysis and other activities
8. Self-inspection, quality audits and suppliers’ audits and approval
9. Personnel
10. Introduction to the Training programs
11. Personal Hygiene
12. Premises
13. Equipment
14. Materials
15. Documentation
16. Good Practices in Production and
17. Good Practices in Quality Control
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
15. GxP & ‗c‘of GMP
The concept of GXP in Pharmaceuticals was
established by the United States Food and Drug
Administration.
GXP is a general term for Good Practice
Quality guidelines and regulations.
The G stands for "Good" and the P stands for
"Practice". The 'X' in the middle is a variable that can
be substituted with any word that appropriately
completes the acronym. For example, 'X' is replaced by
'M' to make it GMP which represents ‗Good
Manufacturing Practice‘.
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
16. GxP & ‗c‘of GMP
A ―c‖ is sometimes added to the front of the
acronym,. The preceding ―c‖ stands for
―current‖. For example, cGMP is an acronym
for ―current Good Manufacturing Practice.‖
The ‗C‘ before the GMP is indicative of the
constantly changing technologies and systems
which are up-to-date in order to comply with the
regulations. These the dynamic changes in Good
Manufacturing Practice to make Pharmaceuticals
manufacture foul proof; assuring a high level of
confidence in the safety and efficacy of the product
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
17. For GxP
GMP = Good Manufacturing Practice
GLP = Good Laboratory Practice
GCP = Good Clinical Practice
GAP = Good Auditing Practice
GAMP = Good Automated Manufacturing Practice.
GRP=Good Regulatory Practice
GDocP = Good Documentation Practice
GDP = Good Distribution Practice
GHP = Good Hygiene Practice
GEP= Good Engineering Practice
GSP = Good Safety Practice
GMiP = Good Microbiological Practice.
Basically the purpose of the GxP QUALITY GUIDELINES is to ensure a
product is safe and meets its specification for intended use. GxP guidelines
guide quality manufacture in regulated industries including Food. Drugs,
Medical devices and Cosmetics.
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
19. ATTITUDE
• Every problem has a solution, only if we
perhaps change our ATTITUDE.
• ATTITUDE is everything.
• It is our ATTITUDE towards LIFE and
WORK that makes our life 100%
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
20. Excellent Facilities Negative Attitude Poor Quality
Excellent Facilities Positive Attitude Good Quality
Limited Facilities Positive Attitude Maximizing
Efforts Good Quality
So in conclusion can say, Good quality can‘t be achieved
without positive attitude
ATTITUDE
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21. 21
1. I have a problem
2. I can‘t do it…..
3. I‘m so hungover (―really tired‖ or ―kind of sick‖)
4.Don‘t swear in front of your boss
5.I need a raise
6.I don‘t like working with
7.That‘s not my job
Some Things To Never Say
In Front of Your Supervisor /
Boss
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
22. Show respect for each others workspace. Knock before
entering
Don‘t take & see any documents from the desk or room of
any body without seeking prior permission
Don‘t talk with mobile in front of your superior without
seeking prior permission ‗Mute‘ your cell phone in the office.
No fancy ring tones
Do not cough or sneeze in anyone's direction. Use a tissue/
handkerchief, if possible, to contain the germs and then say
"Excuse me"
Wear appropriate office attire, for example correct footwear, not
thongs (flip flops) - they are strictly casual or beachwear.
Office Manners
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
23. Never blame someone else if it is your mistake
Don‘t gossip about any co-worker‘s private life
Make new employees feel welcome and comfortable
around you. Don't be a busy-body
Don‘t hover around while waiting for a co-worker/
superior to get off the phone. Leave a note for them to call
you or return later
Do not dominate the meeting. All communication must take
place through the Chairperson
One Should not be so rigid on his opinion/decision, it
should be remember that over confidence turns into
haughtiness
Office Manners
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cGMP
Trainer: Md. Zakaria Faruki, Manager & Head of QA
24. Keep your work area tidy. Try not to be messy
Be considerate of others
Be patient with other
Learn, remember and use people‘s names
Be courteous, kind, polite, and fair
Always act with honesty and dignity
We are put off by smelly people. So, be sure to shower
regularly and use a suitable deodorant .
Be helpful and co-operative with each other
Speak clearly without shouting. Loud people are a
vexation
Be discreet and compassionate in your criticism of a co-
worker
Never blame someone else if it is your mistake
Office Manners
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
26. As responses to tragic circumstances and to prevent future
tragedies:
Use of Diethylene Glycol as solvent in sulfanilamide
(antiinfective) in the 1937s. 107 people died.
Federal Food, Drug and Cosmetic Act (1938)
Sulfathiazole tablets contaminated with Phenobarbital
(sedative) in 1941. 300 people were killed.
Sleeping pill Thalidomide caused serious deformities in
developing fetuses in the 1960s in Europe (about 10,000
estiamted cases)
History of the GMPs
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
28. 1962: Kefauver-Harris Amendments to the
FD&C Act:
FDA given authority to establish GMPs
Failure to follow GMP = Drug Adulteration
Late 1960‘s through 1970‘s contaminated
IVs produced
Validation required for sterile products, then all drug products
1981: Tylenol package tampering – pills were laced
with cyanide, 7 people died
Tamper-resistant packaging requirements for OTC drugs
History of the GMPs
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GMP
Trainer: Md. Zakaria Faruki, Manager & Head of QA
29. In 1963, FDA in USA prepared the
guide-lines for GMP.
In 1975, WHO issued the guide-lines
for GMP.
In 1979, cGMP guidelines were
prevailed.
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GMP
Trainer: Md. Zakaria Faruki, Manager & Head of QA
History of the GMPs
30. Evolution of GMP: At a Glance
1500 Ebers Papyrus, Egyptian manuscript pertaining to pharmacy and therapy.
1546 The Nuremberg Pharmacopoeia (Dispensatory of Valerius Cordus) is perhaps the first to become ―official‖.
1618 First London pharmacopoeia is published.
1736 First law related to pharmacy in America is enacted in Virginia.
1821 Philadelphia College of Pharmacy is founded as the first local association and school of pharmacy in the United States.
1848 First American code of pharmaceutical ethics prepared by Philadelphia College of Pharmacy. First drug import law enacted by congress to
curt adulterations.
1852 American Pharmaceutical Association is founded as the first national organization.
1865 First international pharmaceutical conference is held in Brunswick, Germany.
1888 First National Formulary issued by American Pharmaceutical Association.
1902 First International Pharmacopeial Conference held at Brussels, Belgium.
1906 Federal Food and Drugs Act passed in the US.
1912 First Assembly of International Pharmaceutical Federation (The Hague, Netherlands).
1938 Federal Food, Drug and Cosmetic (FD&C) Act
Tragedy: Sulphanilamide made with poisonous solvent causes 107 deaths. Result: manufactures to prove the safety of products before
marketing.
1941 Two unrelated events
Insulin Amendment requires FDA to test and certify purity and potency of insulin. Tragedy: nearly 300 deaths and injuries from distribution
of sulfathiazole tablets tainted with phenobarbital. Result: FDA revises manufacturing and quality controls drastically, the beginning of what
will later be called GMPs.
1962 Kefauver-Harris Drug Amendments (Important amendments of the US Food, Drug, and Cosmetic Act). Tragedy: Thalidomide causes birth
defects in thousands of European babies. Result: Manufactures must prove efficacy of products before marketing them and ensure stricter
control over drug testing.
1975 Official drug standardization program is unified by Us Pharmacopeia absorbing National Formulary.
1978 CGMPs Final rules for drugs and devices (21 CFR 210-211 and 820)
Establishes minimum current good manufacturing practices for manufacturing, processing, packaging, or holding drug products and
medical devices.
1979 GLPs Final Rule (21 CFR 58)
Establishes good laboratory practices for conducting nonclinical laboratory studies that support application for research or marketing
permits for human and animal drugs, medical devices for human use, and biological products.
1982 Tamper-resistant Packing Regulations issued by FDA to prevent poisonings such as deaths from cyanide placed in Tylenol capsules. The
Federal Anti-Tampering Act passed in 1983 makes it a crime to tamper with packaged consumer products
2005 Formation of the Drug Safety Board is announced, consisting of FDA staff and representatives from the National Institutes of Health and the
Veterans Administration.
Trainer: Md. Zakaria Faruki, Manager & Head of QA
cGMP
31. 31 of 96
OBECTIVES OF GMP
To prevent –
Contamination
Cross-Contamination
Mix–up
Trainer: Md. Zakaria Faruki, Manager & Head of QA
GMP
32. 10 Golden rules of GMP (PICS)
1.Get the facility design right from the starting
2.Validate Process
3.Write good procedures and follow them
4.Keep good records
5.Identify who does what
6.Train and develop staff
7.Practice good hygiene
8. Maintain facilities and equipment
9.Build quality into the whole product lifecycle
10.Perform regular audit 32 of 96
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GMP
33. GMP
General
Provision
Organization &
Personnel
Building &
Facilities
Equipment
Control of Components,
Containers & Closures
Returned & Salvaged
Drug
Products
Records & Reports
Laboratory Controls
Holding & Distribution
Production &
Process Control
Packaging & Leveling
Control
Sub-Parts of the cGMP
21 CFR-Part-211
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GMP
35. Subpart A-General Provisions
Definitions
Scope
Subpart B-Organization and Personnel
Responsibilities of quality control unit
Personnel qualifications
Personnel responsibilities
Consultants
Subpart C-Buildings and Facilities
Design and construction features
Lighting
Ventilation, air filtration, air heating and cooling
Plumbing
Washing and toilet facilities
Sanitation
Maintenance 35 of 96
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GMP
36. • Subpart- D - Equipment
Equipment design, size and location
Equipment construction
Equipment cleaning and maintenance
Automatic, mechanical and electronic equipment
Filters
• Sub part E- Control, Components and Drug
product containers and closers
General requirements
Receipt and storage of untested components, drug product
containers and closures
Testing and approval or rejection of components, drug
product containers and closures
Use of approved components, drug product containers and
closures
Retesting of approved components, drug product containers
and closures
Rejected components, drug product containers and closures
Drug product containers and closures
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GMP
37. • Subpart F- Production and Process Controls
Written procedures; deviations
Charge-in of components
Equipment identification
Sampling and testing of in-process materials and drug
products
Time limitations on production
Control of microbiological contamination
Reprocessing
Subpart G-Packaging Labeling Control
Materials examination and usage criteria
Labeling issuance
Packaging and labeling operations
Tamper- evident packaging requirements for over the
counter (OTC) human drug products
Drug product inspection
Expiration dating
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GMP
38. Subpart H- Holding and Distribution
Warehousing procedures
Distribution procedures
Subpart I - Laboratory Controls
General requirements
Testing and release for distribution
Stability testing
Special testing requirements
Reserve samples
Laboratory animals
Penicillin contamination
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GMP
39. Subpart J-Records and Reports
General requirements
Equipment cleaning and use log
Component, drug product container, closure and labeling
records
Master production and control records
Batch production and control records
Production record review
Laboratory records
Distribution records
Complaint files
Subpart K- Returned and Salvaged Drug Products
Returned drug products
Drug product salvaging
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GMP
40. Why GMP ?
GMP is for
Quality product
Productivity
Higher quality attainment
Uniformity & consistency of the quality
Reduce Batch failure
Reduce rejection cost
Safety & Security
Good traceability
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GMP
41. Quality Products
Market Acceptability Regulatory Compliance
Quality
Products
P
O
T
E
N
C
Y
S
T
A
B
I
L
I
T
Y
E
F
F
I
C
A
C
Y
S
A
F
E
T
Y
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GMP
42. CFRs – Code of Federal
Regulations (USA)
• There are basically 5 Standards in the Food, Drug
and Cosmetic Act and the CFR
Safety
Quality
Identity
Purity
Potency
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GMP
43. Basic Requirements of GMP
► Suitable Premises & Equipment
► Adequate Cleaning procedures.
► Correct Materials, Labels & Containers
► Clearly Documented & Approved procedures
► Consistent Manufacturing procedures
► Practices regularly monitoring by Auditing
► Good Traceability.
► Accurate Testing methods
► Ability to Investigate & solve problems
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GMP
44. – Clearly defined and systematically
reviewed processes
– Validation of processes
– Appropriate resources
– Clearly written procedures
– Trained operators/personnel
Basic Requirements for GMP
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GMP
45. – Good documentation, complete
records
– Failure investigations
– Proper storage and Distribution
– Recall system
– Complaint handling
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GMP
Basic Requirements for GMP
46. Different GMP Guidelines
GMP guidelines are named in different ways in different countries based on
WHO-GMP and US FDA guideline.
USFDA = United States Food & Drug Administration
MHRA = Medicine and Healthcare Products Regulatory Agency- UK
PMDA = Pharmaceuticals and Medical Devices Agency
TGA = Therapeutic Good Administration- Australia
KFDA = Korea Food and Drug Administration-Korea.
MCC = Medicine Control Council -South Africa
ANVISA = Agencia Nacional de Vigilancia Sanitaria-Brazil.
EMEA = European Medicines Agency.
TPD = Therapeutic Product Directorate—Canada.
ICH = International Conference on Harmonization.
PIC/S = Pharmaceutical Inspection Convention &
Pharmaceutical Inspection Co-operation Scheme
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GMP
47. ICH-Guidelines
Q1A--Stability testing of new drug substances and products.
Q1B—Stability testing: Photo stability testing of new drug
substances and products.
Q2---Validation of Analytical Procedures: Text and Methodology.
Q3A—Impurities in new drug substances.
Q3B---Impurities in New Drug Products
Q4B---Evaluation and Recommendation of Pharmaceutical Texts for
use in the ICH region on Residue on Ignition/Sulphated Ash
Q5A---Viral Safety Evaluation of Biotechnology Products
Q6A---Specifications : Test procedures and acceptance criteria for
new drug substances and new drug products.
Q6B—Specifications: Test procedures and acceptance criteria for
Biotechnological / Biological products.
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GMP
48. ICH-Guidelines: Contd..
Q7 ---- GMP Guide for API.
Q8 ---- Pharmaceutical development.
Q9 --- Quality Risk Management.
Q10 --- Pharmaceutical Quality System‘
Q11 --- Development and Manufacture of Drug Substances
Q12 --- Lifecycle Management
Q13 --- Continuous Manufacturing of Drug Substances and Drug
Products
Q14 --- Analytical Procedure Development
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GMP
49. Quality Risk Management
ICH-Q9
Basic Risk Management Facilitation Methods
• FMEA = Failure Mode Effects Analysis
• FMECA=Failure Mode Effects Criticality Analysis
• FTA = Fault Tree Analysis.
• HACCP= Hazard Analysis on Critical Control
Points.
• HAZOP=Hazard Operability Analysis
• PHA =Preliminary Hazard Analysis
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GMP
50. Medicines and Healthcare Products
Regulatory Agency (MHRA)
• MHRA: MHRA is a UK government agency which
is responsible for ensuring that medicines and
medical devices work and are acceptably safe.
• MHRA was formed in 2003 with the merger of the
Medicines Control Agency (MCA) and the Medical
Devices Agency (MDA). In April 2013, it merged
with the National Institute for Biological Standards
and Control (NIBSC) and was rebranded, with the
MHRA identity being used for the parent
organization and one of the centres within the
group. It is an executive agency of the department
of health.
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GMP
51. MHRA: 9
Chapter/Appendixes
1.Q- Quality Management
2.P-Personnel
3.P-Premises & Equipment
4.D-Documentation
5.P-Production
6.Q-Quality Control
7.C-Contract Manufacture & Analysis
8.C-Complaint & Product Recall
9.S-Self Inspection
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GMP
52. United States Food and Drug
Administration (US-FDA)
FDA: The Food and Drug Administration (FDA or
USFDA) is a regulatory agency of the United States
Department of Health and Human Services, one of the
United States federal executive departments. The FDA
is responsible for protecting and promoting public
health through the regulation and supervision of food
safety, tobacco products, dietary supplements,
prescription and over-the-counter pharmaceutical
drugs (medications), vaccines, biopharmaceuticals,
blood transfusions, medical devices, electromagnetic
radiation emitting devices (ERED), cosmetics and
veterinary products.
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GMP
53. US FDA: SUB Part 11
1.G- General Structure
2.O-Organization Structure
3.B-Building & Facility
4.E-Equipment & Machineries
5.C-Control of Compliant
6.P-Production & Process Control
7.P-Packaging & Labeling
8.H-Holding & Distribution
9.L-Laboratory Control
10.R-Record & Report
11.R-Return & Service
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GMP
54. ISO
International Organization for Standardization
ISO has come from Greek word ISOS. The
meaning of ISOS is unique. Later the word
ISOS has changed into English word ISO.
It is an international body involved in
developing standards in various
industries, including the Pharmaceuticals.
ISO is an independent contractors who
inspect organizations for compliance with ISO
standards.
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GMP
55. 55 of 96
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GMP
ISO
International Organization for Standardization
• In 1946, 65 delegates from 25 countries gathered in London
for the future of world standardization.
• In 1947, Feb 23 ISO Head office was established in Geneva
Switzerland. Now the total member countries are 162.
• Till now it has published 19,500 standards. First ISO Standard
is ISO 1:1951. This standard is for Geometrical Product
Specification.
• The current standard for Quality Management System
(QMS) is ISO 9001:2015, and previously it was ISO
9001:2005.
• The ISO 9000 family of quality management systems (QMS)
is a set of standards that helps organizations to ensure they
meet customer and other stakeholder needs within
statutory and regulatory requirements related to a product
or service.
56. ISO VERSIONS
• First version: ISO 9001:1987
• Second version: ISO 9001:1994
• Third version: ISO 9001:2000
• Fourth version: ISO 9001:2008
• Fifth version: ISO 9001:2015
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GMP
ISO 9001:2015 is an international standard dedicated to Quality
Management Systems (QMS).
It outlines a framework for improving quality and a vocabulary of
understanding for any organization looking to provide products and
services that consistently meet the requirements and expectations of
customers and other relevant interested parties in the most efficient
manner possible.
57. ISO 9001:2015
A new version of ISO 9001 appears about every seven years. ISO
9001:2015 was published on 23 September 2015.
ISO 9001:2015 has ten (10) clauses instead of eight.
1.Scope
2.Normative references
3.Terms and definitions
4.Context of the organization
5.Leadership
6.Planning
7.Support
8.Operation
9.Performance operation
10.Improvement
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GMP
Trainer: Md. Zakaria Faruki, Manager & Head of QA
58. How can we implement the GMP in the
Manufacturing Plant?
Ø To appoint Trained personnel
Ø To appoint Qualified personnel
Ø To clean Premises and equipment
Ø To implement the Change-over activities properly
Ø To use correct Materials, Containers, and Labels
Ø To follow approved SOP
Ø To control Contamination & Cross-contamination
Ø To monitor the practices regularly by Auditing
Ø To follow accurate testing Methods
Ø To Investigate and identify the problems and positive actions for error
cause removal
Ø To eliminate the risk of Mix up‘s
Ø To establish proper batch Documentation
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GMP
Trainer: Md. Zakaria Faruki, Manager & Head of QA
59. Safety: First,
Last & Always
Read the material safety data sheets for all
materials that everyone works with.
Always wear safety glasses, safety shoes,
respirators, and personal protective
equipment.
Avoid situation that look potentially
dangerous and inform supervisors.
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cGMP
Trainer: Md. Zakaria Faruki, Manager & Head of QA
60. Contamination & Cross-contamination
Contamination
Contamination is presence of any external substances
in a product that was not intended to be part of it. A
contaminant could harm the process, the product and
YOU! also.
Cross-
Contamination
The term cross-contamination refers to product-to-
product contamination. It can be through careless
sharing of the manufacturing equipment & utensils,
sharing of space without proper cleaning, poor
production planning and particularly inadequate dust
control.
Types of
contamination
► Particulate Contamination
► Chemical Contamination
► Microbial Contamination
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cGMP
Trainer: Md. Zakaria Faruki, Manager & Head of QA
61. Source of Contamination
Main Source
► Personnel
► Premises
► Raw material and Packaging material
► Equipment
► Air, Water and Gas
► Garments
► Operational Systems
► Cleaning agents
► Control System
*Of above mention sources,
people are the single largest
source of contaminant
► Skin cells
► Dandruff, scalp flakes, hair
► Respiratory bacterial aerosols
► Coughs, colds, sneezes and Boils and wounds
► Splashes of saline droplets released while blinking
Other contaminants are Extrinsic
and which humans help carry.
Lint and fluff from clothing
Dirt under finger nails
►Street dust and Cross contamination through contact
-- Cosmetics
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cGMP
Trainer: Md. Zakaria Faruki, Manager & Head of QA
62. Cleaning & House-keeping
5S
Seiri Clearing up Sort out
Seiton Organizing Systematize
Seisu Cleaning Sweep
Seiketsu Standardizing SOP
Shitsuke Training & Discipline Self discipline
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cGMP
Trainer: Md. Zakaria Faruki, Manager & Head of QA
63. Cleaning
One of the first things that investigators or
visitors notice when they visit plant is the
facility’s general cleanliness.
Keep surfaces and equipment clean.
Follow approved cleaning
procedures, and use approved
cleaning solutions.
If possible, open the equipment and look
inside to make sure that no rinse water was
accidentally left behind. 63 of 96
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Trainer: Md. Zakaria Faruki, Manager & Head of QA
64. Read
&
observe
Caution and warning
signs which are located in
plant should be printed in
all languages spoken in the
manufacturing area.
All labels and signs.
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cGMP
65. GMP
During
Break time
GMP and safety violations occur most often
right before break times, before lunch, during
shift change, when it’s time to go home.
Be especially careful around breaks.
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GMP
66. lifting
Products
Because most common injuries in
pharmaceutical manufacturing area seem to
be hand and back injuries.
Use proper lifting techniques, and think
about what you are about to do before
putting your hands or back at risk.
Lifting Products
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GMP
67. Clothing
Some types of jewelry are not allowed
in certain areas.
Wear only appropriate clothing (such
as sterile gowning).
One common GMP error is not
wearing your lab coat while you are in
the laboratory.
Another common error is wearing lab
coat or plant uniform outside the
building.
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GMP
73. Personal Hygiene
Wash your hands Properly.
Most pharmaceutical plants have signs in the
Bathrooms reminding employee to wash their
hands before returning to the plant.
Disinfect hands by pressing the dispenser
containing disinfectant solution.
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GMP
74. Illness
Your illness may contaminate product as well
as other colleagues of you. So, it is a matter of
concern.
Report an illness.
It is a GMP requirement that employees and
temporary employee do this.
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GMP
75. About released
materials
A common error is to store expired materials
with current materials. So, be aware of it.
Use only released raw materials, packaging
materials and labels.
Use no expired materials.
Under GMP only released materials can be used
in all clinical and commercial lots of product.
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GMP
76. Slow & Steady
Every time anyone allowed himself/
herself to be rushed, he/she made a critical
mistake.
The pace in our industry is fast and
everyone has more to do than they can
possible get done; everyone deserves the
time to think through.
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GMP
77. Complete
the
Paperwork
•If pages or sections of forms are not
applicable, line through them, write N/A, your
initials and the date.
•Always fill in the blanks.
• Record all requested information.
• If it’s truly not applicable, write
N/A; your initials and the date.
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GMP
78. Proper Record
One common GMP error is to speed through
documents at the end of the day or at the end
of your shift, filling in all the blanks at one
time. But we all know that it is impossible to
remember what we did five minutes ago.
Record results as you get them.
Never backdate or falsify records. Always use
today’s date when documenting your work.
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GMP
79. Proper record
(Contd.)
Do not write original data on a scrap
paper, napkins or paper towels and transfer
the information to the appropriate form or
notebook.
Record data directly on the
appropriate form or notebook.
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GMP
80. Use of ink
Pencil is unacceptable because it
smears easily and can be erased.
Use indelible ink.
The industry standard is
blue/black indelible ink
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GMP
81. Responsibility
Be the responsible employee who picks the
piece of paper from the floor rather than
steps over it.
Take actions to make things
better.
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GMP
82. Calibration
Check to make sure that your equipment is
within calibration before you use it. Otherwise
your results or measurements could be
inaccurate.
Ensure that equipment
is calibrated before using
it.
Equipment that must be calibrated in a
manufacturing or laboratory environment
typically has an equipment calibration tag.
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cMP
83. Bring
No Food
Smoking, eating, and drinking are
prohibited in a GMP area.
Do not bring food, gum, and tobacco into
production and laboratory areas.
A common GMP error is bringing drinks
into a laboratory.
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GMP
84. Check !!!!!
In industry, a signature is a
legal and ethical responsibility.
While sign-
1. Check for accuracy.
2. Review it thoroughly and completely.
3. Make sure that all calculations are correct.
Never sign something that you know to be
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85. Double check !!
GMPs require that you have sufficient staff
to do this.
Double check is required in
every critical step.
A double check means that
one person performs the work
while another person observes
and makes any suggestions or
corrections. (4 eyes principle)
Individuals then sign or initial the batch
record where indicated.
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GMP
86. Reporting
• The truth is that we are all human
and human being make mistakes
as a Supervisor encourage your
people to tell the actual things.
• Report mistakes or suspected
mistakes as soon as possible to
your Supervisor.
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GMP
87. SOPs & STPs
?????
You must know your SOPs. If an
SOP needs to be revised, tell your
supervisor and offer to help revise it
and get it approved.
Read and become familiar with all
SOPs, STPs and other documents that
relate to your work.
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GMP
No analytical to be performed with
approved STP (Standard Operation
Procedure)
88. Record keeping
So when filling out a batch record or recording
your results, record equipment status, document
and revision numbers.
Record ID, lot, document,
revision, and other control
numbers.
The GMP require that-
you assign and use unique numbers on each
lot of your raw materials, reagents, documents,
and all lots of produced product to permit
traceability.
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GMP
89. Printing
Fill out all logs and other documents
completely. Handwriting must be clear and
legible.
Print clearly in logs, and
fill them out completely.
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GMP
90. Change control
Out of specification (OOS)
Deviation management
Market complaints handling
Product recall handling
Corrective & Preventive action (CAPA)
QMS
Risk Management
Quality Audit
Quality Management
System (QMS)
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91. 91
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GMP
Good Documentation
Practices (GDocP)
92. C.L.I.D.E Method:
a) Correct
b) Line through the complete erroneous
entry (single line)
c) Initial
d) Date
e) Explain
853.786
853.768
Remarks: Recording error
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GMP
Good Documentation
Practices (GDocP)
93. Good Documentation Practices
(for Test scripts)
• Do‘s
Do cross out any mistakes with a single
line
Do explain, initial and date where an
entry was crossed out (must be one
person who is making the change)
Do provide references to test procedures
if a long procedure is applied
Do sign and date on testing documents.
Do report numbers exactly (no ranges)
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GMP
94. • Don'ts
– Do Not type in results (write in ink)
– Do Not obliterate underlying results when
making changes
– Do Not leave any empty result boxes
– Do Not forget to initial and date results when
you write them down (for each line)
– Do Not report results as ―as expected‖ or
―conforms‖
– Do Not use ditto marks
– Do Not record entries on scraps of paper or
other non-permanent media
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GMP
Good Documentation Practices
(for Test scripts)
95. Documents & Record-keeping
• Two fundamental rules for recordkeeping in GxPs:
Rule #1
“ If it’s not documented, it wasn’t
done. ”
Rule #2
“ If it’s not signed and dated, it’s not
documented. ”
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GMP