The document provides an overview of quality assurance and related topics presented by Chandrashekhar Jain. It discusses quality assurance, the USFDA, WHO guidelines, and ISO 9000 standards. Key points include that quality assurance ensures pharmaceutical products meet quality standards for intended use, the USFDA regulates food, drugs, and other products, WHO sets global health standards and provides technical support to countries, and ISO 9000 provides internationally recognized quality management system guidelines.
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
Fundamental knowledge on pharmaceutical
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Quality management systems: Quality management & Certifications.
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Review of Manufacturing, Production and Sampling
Review of Lab Investigation Result
Supplementary Laboratory Testing Procedure
Analysis of Investigated Results
Quality Assurance and Regulatory Compliance for Pharmaceutical Product, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgaum/Belagavi
Stability Testing During Product DevelopmentAl Riyad Hasan
Stability Testing During Product Development:
Practical conduct of stability testing
Presentation and recording of results
Stability data handling and estimation of shelf life
Package Labelling
Fundamental knowledge on pharmaceutical
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Quality management systems: Quality management & Certifications.
Introduction to OOS
Identification of OOS: Reports of Laboratory Investigation
Responsibility of Analyst and Supervisor
Identification of OOS:
Reports of Full Scale Investigation
Review of Manufacturing, Production and Sampling
Review of Lab Investigation Result
Supplementary Laboratory Testing Procedure
Analysis of Investigated Results
Quality Assurance and Regulatory Compliance for Pharmaceutical Product, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgaum/Belagavi
Stability Testing During Product DevelopmentAl Riyad Hasan
Stability Testing During Product Development:
Practical conduct of stability testing
Presentation and recording of results
Stability data handling and estimation of shelf life
Package Labelling
Quality Management System including the Quality management and certificationAshwiniRaikar1
Concept of Quality, Total Quality Management, Quality by Design, Six Sigma concept, Out of Specification, Change control, Introduction to ISO 9000 Series of quality system standards, ISO 14000,NABL, GLP
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4. Introduction
Quality assurance is wide ranging concept covering all
matters that individually or collectively influence the
quality of a product
It is the totality of the arrengement made with the object
of ensuring that pharmaceutical products are of the quality
required for their intended use.
5. Definition
Quality assurance is heart and soul of quality control
QA = QC+ GMP
Quality assurance is the sum total of the organized
arrangement with the objective of ensuring that product
will be of the quality required for their intended use
6. Necessity
It is necessary for production of drug / drug formulation
with desired quality
It is important to provide drug dosage form with improved
and better quality
To avoid toxic effect of formulation and to remove toxic
impurities
For pre and post marketing quality control and for good
manufacturing practice
8. Introduction
The various guideline given by united state food and drug
administration are
for the maintenance and for conducting the toxicological
studies
Bioequivalence studies
Clinical trial and
In the field of radiology
9. Product regulated by FDA
Food
Drugs
Medical devices
Biologics
Animal food and drugs
Cosmetics
Radiation emitting products
Combination product
10. Guidelines for
Manufacturing of sterile product ( critical area & controlled
area)
Guideline for radiological health – MRI
Maintenance of storage temprature condition during transport
Food, seafood and perishables
Guideline for clinical trials
Phase I clinical pharmacology trial
Phase II exploratory trials
Phase III confirmatory trial
Phase IV
Protocol
11. REGULATORY
PROGRAMMES
Safety regulation varies by-
Type of product
Potential risk
Regulatory process
Regulates through set of published standards included with
facility inspections.
Inspection form 483.
12. FDA INSPECTION
Vaccines and drug manufacturers.
Blood banks
Food processing facilities(diary farms)
Facilities in clinical trials
Labs that conduct studies on animals or microorganisms
includes approval of medical products
Foreign manufacturing and processing sites for FDA
regulated product and imported products.
13. Contd..
Types of inspection-
I. PRE-APPROVAL INSPECTION
II. ROUTINE INSPECTION
III. FOR-CAUSE INSPECTION
In electronic reading room inspection records are made
available to public request .
14.
15.
16.
17. FORMS COMMONLY USED IN FDA
INSPECTIONS1. FDA FORM 482- Notice of inspection
2. FDA form 483- Inspectional observations
3. FDA form 484- Receipt for physical
evidence(eg.samples),but not for documentary
evidence(eg.label, copy).
18. RECALL?
Product is removed from the market or correction is
made,
Company can recall its products on its own
company recalls a product if FDA raises concern.
Three types of recall classes-
i. CLASS 1
ii. CLASS 2
iii. CLASS 3
19. CFR TITLE 21
Reserved for rules of the Food and Drug Administration.
Received from Government Printing Office.
PART 1 To 1499
50 Titles Chapter Parts Sections
Paragraph
21. Introduction
World health organization is united nation
organization for health policy and for control over
health products and their quality
22. RESPONSIBILTY
Global Health Matters
Shaping the Health research agenda (schedule)
Setting norms & standards Articulating evidence based
policy option
Providing technical support to countries
Monitoring & assessing health trends
23. ORGANISATION
The Executive Board is composed of 32 members,
technically qualified in the field of health.
Members are elected for three years .
The head is the Director-General who is appointed by the
Health Assembly on the nomination of the Executive Board.
24. WHO Member States are grouped into six regions . Each region
has a regional office .
Regional offices are in Africa, America, South-east Asia, Europe,
Eastern Mediterranean & Western Pacific.
The World Health Assembly is the supreme decision-making
body for WHO.
It meets each year in May at Geneva , and is attended by
delegations from all 192 Member States .
25. FUNCTIONS
To give worldwide guidance in the field of health.
To set global standards for health.
To cooperate with governments in strengthening national
health programs.
To develop and transfer appropriate health technology
information.
26. WHO Expert Committee
Is an official Advisory Body to Director-General of
WHO Governed though specific rules and procedures.
Participation in Expert Committee (EC) meetings:
Members ("Expert") selected from WHO Panel of
Experts Technical advisers Observers : - international
organizations , - NGOs , - professional associations
27. Report of the WHO Expert Committee:
Summarizes discussion Gives recommendations to
WHO and Member States Also includes newly adopted
guidelines And is presented to WHO Governing Bodies
for final comments, endorsement and implementation
by Member States
28. WHO Expert Committee on Specifications for
Pharmaceutical Preparations
WHO Expert Committee on the Selection and Use of
Essential Medicines WHO Expert Committee on Drug
Dependence
WHO Expert Committee on Biological Standardization
Joint FAO/WHO Expert Committee on Food Additives
29. WHO Expert Committee (EC) meeting if guideline adopted,
published in EC report as Annex Recommendation to Member States
for implementation WHO consultation process working
Step 1. Preliminary consultation and drafting
Step 2. Draft guidelines Step
3. Circulation for comments
Step 4. Revision process .......... (back to step 2 and 3 as often as
needed)
30. WHO guidelines:
WHO guidelines Covers guidelines for
Stability guidelines
Sampling guidelines
Production Quality Control Distribution
31. WHO stability guidelines
Title: “ guidelines for stability testing of pharmaceutical products
containing well established drug substances in conventional
dosage forms ”
It is for stability testing of final drug products -> those are well
established (e.g. generics) & -> in conventional dosage forms
(e.g. tablets)
Design of stability study includes guidelines for: -> test samples -
> test conditions - accelerated studies - real time studies -
>frequency of testing & evaluation of test results
32. WHO guidelines on sampling of pharmaceuticals
Contains :
Purpose of sampling Controls to be applied to the sample
Sampling operations and precautions Storage and retension
Sampling for regulatory purposes
Sampling plans for starting materials, packaging materials
and finished products
33. WHO’s guidelines for production Good Manufacturing Practices
(GMP)
1. Main principles for pharmaceutical products
2. for starting materials, including active pharmaceutical ingredients
pharmaceutical excipients
3. for specific pharmaceutical products: Sterile pharmaceutical products
Biological products Investigational pharmaceutical products for
clinical trials in humans Herbal medicines Radiopharmaceuticals
34. additional GMP texts:
1. Main principles for pharmaceutical products
requirement for the sampling of starting materials
(amendment)
2. water for pharmaceutical use heating, ventilation and
air-conditioning (HVAC) systems Validation
3. for specific pharmaceutical products: Herbal medicines
35. WHO’s guidelines for distribution
WHO Certification Scheme for Products Moving in International
Commerce
New scheme for pharmaceutical starting materials: - model certificate,
when inspected by national authority WHO model for self-assessment
for manufacture of pharmaceutical starting materials
Good Distribution and Trading Practices for pharmaceutical starting
materials (GTDP) Good Distribution Practices (GDP) (for products)
Good Storage Practices (GSP)
37. Introduction
The ISO 9000 family addresses various aspects of quality
management and contains some of ISO’s best known
standards. The standards provide guidance and tools for
companies and organizations who want to ensure that their
products and services consistently meet customer’s
requirements, and that quality is consistently improved.
53. How long will it take?
It has been done in less than 6 months…
It has taken longer than 18 months…
It can normally be done COMFORTABLY within 12 months
53
