Current inspection trends

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This presentation will focus on the common types of deficiencies found by the TGA’s GMP Inspectors as well as some data on the number of inspections performed both locally and overseas and compliance rating outcomes for the inspections performed.

Health & Medicine

Current inspection trends
Jenny Hantzinikolas
Director, Inspections Section
Manufacturing Quality Branch
Medical Device and Product Quality Division, TGA
ARCS Scientific Congress 2016
11 August 2016

Presentation overview
• TGA Portfolio Budget Statement performance
• Outcome of Inspections
• 2016 Inspections trends
• 2015 Inspection trends
• Close out process
Current inspection trends 1

Portfolio Budget Statement
• KPI- Inspections closed out within target timeframes
• The target is 85%
Current inspection trends 2

Portfolio Budget Statement – 15/16 financial year
95.05%
87.35%
78%
80%
82%
84%
86%
88%
90%
92%
94%
96%
GMP Clearances using Overseas Approvals Inspections Closed Out within Target
Timeframes
Current inspection trends 3

Current inspection trends
Most common types of deficiencies in 2016 to date related to
• Poor investigations
• Computerised systems
• Validation
• QMS
• Quality control
Current inspection trends 4

2015 Overseas inspections: Top 10 most occurring deficiencies
0
5
10
15
20
25
30
35
40
Documentation - Quality Systems Elements/Procedures
Quality risk Management
Calibration of Measuring and Test Equipment
In-process Control and Monitoring of Production Operations
Equipment storage - contamination (potential)
Complaints and Product Recall
Investigation of Anomalies
Documentation - Manufacturing
Equipment Validation
Product Quality Review
Change Control
Personnel Issues - Training
Sampling Procedures and Facilities
Starting Material and Packaging Component Testing
Design and Maintenance of Premises
Status labelling - Work in Progress, Facilities, Equipment
Batch Release Procedures
Analytical Validation
Current Inspection Trends
5

2015 Overseas inspections: Top 5 major only deficiencies
0
1
2
3
4
5
6
Analytical Validation
Cleaning Validation
Quality risk Management
In-process Control and Monitoring of Production Operations
Process Validation
Documentation - Quality Systems Elements/Procedures
Batch Release Procedures
Computerised Systems - Documentation and Control
Validation Master Plan and Documentation
Equipment Validation
Product Quality Review
Sampling Procedures and Facilities
Starting Material and Packaging Component Testing
Documentation - Specifications and Testing
Supplier and Contractor Technical Agreements
Supplier and Contractor Audit
Investigation of Anomalies - Out-of-Specification
Sterility Assurance
Current Inspection Trends
6

2015 Domestic inspections: Top 10 most occurring deficiencies
0
10
20
30
40
50
60
70
80
Management and control of misc records
Documentation - Quality Systems Elements/Procedures
Personnel Issues - Training
Complaints and Product Recall
Change Control
Investigation of Anomalies
Quality risk Management
Equipment Validation
Product Quality Review
Calibration of Measuring and Test Equipment
Validation Master Plan and Documentation
Personnel Issues -Duties of Key Personnel
Supplier and Contractor Technical AgreementsCurrent Inspection Trends 7

2015 Domestic inspections: Top 5 major only deficiencies
8Current Inspection Trends
0
2
4
6
8
10
12
Batch Release Procedures
Change Control
Process Validation
Investigation of Anomalies
Sterility Assurance
Finished Product Testing - On-going Stability
Analytical Validation
Personnel Issues - Training
Validation Master Plan and Documentation
Equipment Validation
Cleaning Validation

Current inspection trends
New close out process
• Issue post-inspection letter.
• Responses received on a close out template with a
CAPA plan.
• Up to 3 responses then escalate to an internal review
process.
Current Inspection Trends 9

Current inspection trends
New close out process
• Objective evidence requested only under certain
situations e.g. initial, recurring issues
• Final inspection report sent once the inspection
responses are completed
• Addition of time at the next inspection for A2 and A3
manufacturers to review the evidence from the CAPA
PLAN.
Current Inspection Trends 10

Current inspection trends
Summary
• More than 85% inspections are closed out on time
• Types of deficiencies have been provided for 2015 and 2016
• The new close out process will facilitate inspections are closed out in a more
timely manner.
Current inspection trends 11

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chemistry investigatory project The development of nanogold-based cancer therapy could revolutionize oncology by providing a more targeted, less invasive treatment option. This project contributes to the growing body of research aimed at harnessing nanotechnology for medical applications, paving the way for future clinical trials and potential commercial applications. Cancer remains one of the leading causes of death worldwide, prompting the need for innovative treatment methods. Nanotechnology offers promising new approaches, including the use of gold nanoparticles (nanogold) for targeted cancer therapy. Nanogold particles possess unique physical and chemical properties that make them suitable for drug delivery, imaging, and photothermal therapy.

PGx Analysis in VarSeq: A User’s Perspective

Golden Helix

Since our release of the PGx capabilities in VarSeq, we’ve had a few months to gather some insights from various use cases. Some users approach PGx workflows by means of array genotyping or what seems to be a growing trend of adding the star allele calling to the existing NGS pipeline for whole genome data. Luckily, both approaches are supported with the VarSeq software platform. The genotyping method being used will also dictate what the scope of the tertiary analysis will be. For example, are your PGx reports a standalone pipeline or would your lab’s goal be to handle a dual-purpose workflow and report on PGx + Diagnostic findings. The purpose of this webcast is to: Discuss and demonstrate the approaches with array and NGS genotyping methods for star allele calling to prep for downstream analysis. Following genotyping, explore alternative tertiary workflow concepts in VarSeq to handle PGx reporting. Moreover, we will include insights users will need to consider when validating their PGx workflow for all possible star alleles and options you have for automating your PGx analysis for large number of samples. Please join us for a session dedicated to the application of star allele genotyping and subsequent PGx workflows in our VarSeq software.

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- Video recording of this lecture in English language: https://youtu.be/RvdYsTzgQq8 - Video recording of this lecture in Arabic language: https://youtu.be/ECILGWtgZko - Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html - Link to NephroTube website: www.NephroTube.com - Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html

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Gene Expression System-viral gene delivery Mpharm(Pharamaceutics)

MuskanShingari

Gene therapy can be broadly defined as the transfer of genetic material to cure a disease or at least to improve the clinical status of a patient. One of the basic concepts of gene therapy is to transform viruses into genetic shuttles, which will deliver the gene of interest into the target cells. Safe methods have been devised to do this, using several viral and non-viral vectors. In the future, this technique may allow doctors to treat a disorder by inserting a gene into a patient's cells instead of using drugs or surgery. The biggest hurdle faced by medical research in gene therapy is the availability of effective gene-carrying vectors that meet all of the following criteria: Protection of transgene or genetic cargo from degradative action of systemic and endonucleases, Delivery of genetic material to the target site, i.e., either cell cytoplasm or nucleus, Low potential of triggering unwanted immune responses or genotoxicity, Economical and feasible availability for patients . Viruses are naturally evolved vehicles that efficiently transfer their genes into host cells. Choice of viral vector is dependent on gene transfer efficiency, capacity to carry foreign genes, toxicity, stability, immune responses towards viral antigens and potential viral recombination. There are a wide variety of vectors used to deliver DNA or oligo nucleotides into mammalian cells, either in vitro or in vivo. The most common vector system based on retroviruses, adenoviruses, herpes simplex viruses, adeno associated viruses.

Dr. Tan's Balance Method.pdf (From Academy of Oriental Medicine at Austin)

GeorgeKieling1

Home Organization Academy of Oriental Medicine at Austin Academy of Oriental Medicine at Austin Academy of Oriental Medicine at Austin About AOMA: The Academy of Oriental Medicine at Austin offers a masters-level graduate program in acupuncture and Oriental medicine, preparing its students for careers as skilled, professional practitioners. AOMA is known for its internationally recognized faculty, award-winning student clinical internship program, and herbal medicine program. Since its founding in 1993, AOMA has grown rapidly in size and reputation, drawing students from around the nation and faculty from around the world. AOMA also conducts more than 20,000 patient visits annually in its student and professional clinics. AOMA collaborates with Western healthcare institutions including the Seton Family of Hospitals, and gives back to the community through partnerships with nonprofit organizations and by providing free and reduced price treatments to people who cannot afford them. The Academy of Oriental Medicine at Austin is located at 2700 West Anderson Lane. AOMA also serves patients and retail customers at its south Austin location, 4701 West Gate Blvd. For more information see www.aoma.edu or call 512-492-303434.

5 Effective Homeopathic Medicines for Irregular Periods

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Osvaldo Bernardo Muchanga-GASTROINTESTINAL INFECTIONS AND GASTRITIS-2024.pdf

Osvaldo Bernardo Muchanga

GASTROINTESTINAL INFECTIONS AND GASTRITIS Osvaldo Bernardo Muchanga Gastrointestinal Infections GASTROINTESTINAL INFECTIONS result from the ingestion of pathogens that cause infections at the level of this tract, generally being transmitted by food, water and hands contaminated by microorganisms such as E. coli, Salmonella, Shigella, Vibrio cholerae, Campylobacter, Staphylococcus, Rotavirus among others that are generally contained in feces, thus configuring a FECAL-ORAL type of transmission. Among the factors that lead to the occurrence of gastrointestinal infections are the hygienic and sanitary deficiencies that characterize our markets and other places where raw or cooked food is sold, poor environmental sanitation in communities, deficiencies in water treatment (or in the process of its plumbing), risky hygienic-sanitary habits (not washing hands after major and/or minor needs), among others. These are generally consequences (signs and symptoms) resulting from gastrointestinal infections: diarrhea, vomiting, fever and malaise, among others. The treatment consists of replacing lost liquids and electrolytes (drinking drinking water and other recommended liquids, including consumption of juicy fruits such as papayas, apples, pears, among others that contain water in their composition). To prevent this, it is necessary to promote health education, improve the hygienic-sanitary conditions of markets and communities in general as a way of promoting, preserving and prolonging PUBLIC HEALTH. Gastritis and Gastric Health Gastric Health is one of the most relevant concerns in human health, with gastrointestinal infections being among the main illnesses that affect humans. Among gastric problems, we have GASTRITIS AND GASTRIC ULCERS as the main public health problems. Gastritis and gastric ulcers normally result from inflammation and corrosion of the walls of the stomach (gastric mucosa) and are generally associated (caused) by the bacterium Helicobacter pylor, which, according to the literature, this bacterium settles on these walls (of the stomach) and starts to release urease that ends up altering the normal pH of the stomach (acid), which leads to inflammation and corrosion of the mucous membranes and consequent gastritis or ulcers, respectively. In addition to bacterial infections, gastritis and gastric ulcers are associated with several factors, with emphasis on prolonged fasting, chemical substances including drugs, alcohol, foods with strong seasonings including chilli, which ends up causing inflammation of the stomach walls and/or corrosion. of the same, resulting in the appearance of wounds and consequent gastritis or ulcers, respectively. Among patients with gastritis and/or ulcers, one of the dilemmas is associated with the foods to consume in order to minimize the sensation of pain and discomfort.

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Current inspection trends

1. Current inspection trends Jenny Hantzinikolas Director, Inspections Section Manufacturing Quality Branch Medical Device and Product Quality Division, TGA ARCS Scientific Congress 2016 11 August 2016

2. Presentation overview • TGA Portfolio Budget Statement performance • Outcome of Inspections • 2016 Inspections trends • 2015 Inspection trends • Close out process Current inspection trends 1

3. Portfolio Budget Statement • KPI- Inspections closed out within target timeframes • The target is 85% Current inspection trends 2

4. Portfolio Budget Statement – 15/16 financial year 95.05% 87.35% 78% 80% 82% 84% 86% 88% 90% 92% 94% 96% GMP Clearances using Overseas Approvals Inspections Closed Out within Target Timeframes Current inspection trends 3

5. Current inspection trends Most common types of deficiencies in 2016 to date related to • Poor investigations • Computerised systems • Validation • QMS • Quality control Current inspection trends 4

6. 2015 Overseas inspections: Top 10 most occurring deficiencies 0 5 10 15 20 25 30 35 40 Documentation - Quality Systems Elements/Procedures Quality risk Management Calibration of Measuring and Test Equipment In-process Control and Monitoring of Production Operations Equipment storage - contamination (potential) Complaints and Product Recall Investigation of Anomalies Documentation - Manufacturing Equipment Validation Product Quality Review Change Control Personnel Issues - Training Sampling Procedures and Facilities Starting Material and Packaging Component Testing Design and Maintenance of Premises Status labelling - Work in Progress, Facilities, Equipment Batch Release Procedures Analytical Validation Current Inspection Trends 5

7. 2015 Overseas inspections: Top 5 major only deficiencies 0 1 2 3 4 5 6 Analytical Validation Cleaning Validation Quality risk Management In-process Control and Monitoring of Production Operations Process Validation Documentation - Quality Systems Elements/Procedures Batch Release Procedures Computerised Systems - Documentation and Control Validation Master Plan and Documentation Equipment Validation Product Quality Review Sampling Procedures and Facilities Starting Material and Packaging Component Testing Documentation - Specifications and Testing Supplier and Contractor Technical Agreements Supplier and Contractor Audit Investigation of Anomalies - Out-of-Specification Sterility Assurance Current Inspection Trends 6

8. 2015 Domestic inspections: Top 10 most occurring deficiencies 0 10 20 30 40 50 60 70 80 Management and control of misc records Documentation - Quality Systems Elements/Procedures Personnel Issues - Training Complaints and Product Recall Change Control Investigation of Anomalies Quality risk Management Equipment Validation Product Quality Review Calibration of Measuring and Test Equipment Validation Master Plan and Documentation Personnel Issues -Duties of Key Personnel Supplier and Contractor Technical AgreementsCurrent Inspection Trends 7

9. 2015 Domestic inspections: Top 5 major only deficiencies 8Current Inspection Trends 0 2 4 6 8 10 12 Batch Release Procedures Change Control Process Validation Investigation of Anomalies Sterility Assurance Finished Product Testing - On-going Stability Analytical Validation Personnel Issues - Training Validation Master Plan and Documentation Equipment Validation Cleaning Validation

10. Current inspection trends New close out process • Issue post-inspection letter. • Responses received on a close out template with a CAPA plan. • Up to 3 responses then escalate to an internal review process. Current Inspection Trends 9

11. Current inspection trends New close out process • Objective evidence requested only under certain situations e.g. initial, recurring issues • Final inspection report sent once the inspection responses are completed • Addition of time at the next inspection for A2 and A3 manufacturers to review the evidence from the CAPA PLAN. Current Inspection Trends 10

12. Current inspection trends Summary • More than 85% inspections are closed out on time • Types of deficiencies have been provided for 2015 and 2016 • The new close out process will facilitate inspections are closed out in a more timely manner. Current inspection trends 11

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