Mr. Krushnakant K. Wable gave a presentation on current good manufacturing practices (cGMP) under the guidance of Dr. Sonali Mahaparale and Dr. D. Y. Patil. The presentation defined cGMP as regulations enforced by the FDA to ensure proper design, monitoring, and control of manufacturing processes and facilities. It also explained that cGMP helps assure the identity, strength, quality and purity of drug products. The presentation covered key components of cGMP like personnel, premises, equipment, standard operating procedures, raw materials, self inspections, and warehousing. It emphasized that cGMP helps prevent contamination, mix-ups, failures and errors to ensure products meet quality standards.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
In this slides you knowing about the current good manufacturing practices, there are playing crusial role in a pharmaceutical industry.
In which slides cover the cgmp objective and location of industry and follow guidelines
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
In this slides you knowing about the current good manufacturing practices, there are playing crusial role in a pharmaceutical industry.
In which slides cover the cgmp objective and location of industry and follow guidelines
The GMP Operations Manager is responsible for overseeing the implementation and sustained operations of world-class technical cleaning and sanitization programs to include cGMP space, semi-conductor, clean rooms, laboratory, data and other critical environments.
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
1. A
Presentation
On
“Current Good Manufacturing Practices”
BY
Mr. Krushnakant K. Wable
Under the Guidance of
Dr. Sonali Mahaparale
Dr. D. Y. Patil college of Pharmacy,
Department of Quality Assurance Technique,
(Semester-I)
Akurdi, district- Pune
Maharashtra
2017-2018
3. INTRODUCTION
cGMP refers to Current Good Manufacturing Practices regulation enforced by US
FDA.
cGMP provides system that assures proper design, monitoring and control on
manufacturing process and facilities.
cGMP regulation assure the identity, strength, quality and purity of drug product
by requiring that manufacturer of medication adequately control manufacturing
operations.
This includes establishing strong Quality Management System, obtaining
appropriate quality of raw material, detecting and investigating product quality
deviations and maintaining reliable testing laboratories.
3
4. cGMP adequately put into practice to prevent instance of contaminations, mix-
ups, failure and error.
These assures product meet their quality standard.
Definition of cGMP as per WHO :
GMP is the part of QA which assure that the product are consistently
produced and controlled to the quality standards appropriate to their intended use
as required by marketing authorization.
4
5. Components of cGMP:
a. GMP is a part of QA .
b. Main function of GMP is to produce quality product consistently.
c. GMP must meet both production and QA related issues.
d. GMP must meet legal requirements of country.
e. GMP further comments that main function of GMP is avoid mix-ups and
contamination. 5
6. cGMP covers :
General consideration
Personnel
Premises
Equipment‘s
Sanitization
SOP’s
Raw material
Self inspection and audits
Master formula records
Batch manufacturing
records
Warehousing area
Labels and other printed
material
QA
6
7. General consideration:
Compliance with GMP.
Consistent uniform batches.
Location and surrounding.
Water system.
Disposal of waste.
7
10. Point to be considered:
Location: Geography, climate, economical factor, neighbourers
Premises must be located to minimize the risk of cross contamination.
e.g. Not located next to Malting Factory with high airborne level of yeast.
Design:
Maintain risk of errors.
Permit effective cleaning.
Permit effective maintenance.
Avoid cross contamination.
Maximum protection against entry of insect, birds, animals.
Separate facilities for other products like antibiotics, hormones, cytotoxic substances.10
11. Hygiene and sanitization:
Eating, drinking, smoking should not be allowed in production area.
1. Design and construction .
2. Ventilation, air filtration, air handling and cooling.
3. Lightening.
4. Plumbing.
5. Sewage and refuse.
6. Washing and toilet facilities .
7. Sanitization.
8. Maintenance.
11
13. Equipment's shall be located, design and constructed to suit the
operation to be carried out.
Should be made up of non reactive material.
Equipment's should be-
a. calibrated .
b. Checked .
c. Labelled.
d. Sterilized.
e. Accompanied with SOP.
13
14. Standard Operating Procedure (SOP’s):
There shall be SOP’s for each operation .
a. For equipment.
b. For sampling.
c. For testing.
d. For processes.
e. For packaging. 14
15. Raw material :
Inventory should be maintained for raw material to be used at any stage
of manufacturing.
Record should be maintained as per schedule U.
Purchased from approved source.
Must checked by QC department.
Should be labelled.
15
16. Self Audit and Inspection:
Regular independent inspection is necessary to evaluate the
manufacturer’s compliance with GMP in all aspects of
manufacturing.
Procedure for self inspection shall be documented including:
Evaluation.
Conclusion.
Recommendation for corrective action.
There should be Batch Manufacturing Record (BMR) and Master
formulation record(MFR).
16
18. Packaging And Labelling Control:
1. Material examination and usage criteria:
Record shall be maintained for each different labelling and packaging material,
indicating receipt, examination tests whether accepted or rejected.
Labels and labelling material for different drug products, strength, dosage form shall be
stored separately with suitable identification.
2. Packaging and labelling operation :
Should examine for suitability and correctness.
Should be documented in batch production record.
18
20. The conditions satisfied by the warehousing area are as follows:
Good storage condition.
Clean and dry.
Acceptable temperature limit.
Good sanitization.
Separate Sampling area.
Fire prevention.
Properly labelled material.
20
21. GMP is good common sense
Quality Management
Quality Assurance
GMP
Production and Quality Control
21
22. Quality Assurance:
Main objective of QA is to ensure the products are of quality required for there
intended use .
Functions:
Adequate are made for manufacturing, supply and use of correct starting and
packaging material.
Adequate control on starting material, intermediate and bulk product.
Process of validation in accordance with established procedures.
22
23. Conclusion:
GMP compliance is not an option.
Quality should build into the product.
GMP are very similar and really good common sense.
Good practices covers all aspects of manufacturing activities prier to supply.
The role and involvement of senior is crucial.
23
24. References :
Manohar A Potdar “Pharmaceutical Quality Assurance” Nirali prakashan , Third
edition , page no. 5.10-5.11
Pharmaceutical press “Rules and guidance for pharmaceutical manufacturer
and distributors- Edition 2007”
24