QA= MPY 201
ADVANCED
QUALITY ASSURANCE TECHNIQUES-! (Regulatory guidelines for pharmaceutical
Quality management) Study of concepts of cGMP & Related documents of
following : 1.0 Personnel s
» Qualification,
Experience and Training
•
Key persons and their
responsibilities
•
Personnel hygien and clothing
•
Legal aspects and consultants
2.0
Building and facilities
•
Principal areas in a manufacturing
facility, Surround area
•
Building Management System
•
Plumbing and drainage system
•
Sewage, refuge and disposal of waste
•
Washing and toilet facilities
•
Sanitation and maintenance of
sanitation
•
Water System / HVAC
»
Requirements in facility to handlew special category molecules like, immunosupressants,
steroids, harmones, potent molecules,etc,
•
Environmental control / safety and
health requirement
i
•
Design, site, Location, construction
•
Equipment identification and Logs
»
Cleaning, Operation and maintenance of equipment.
•
Equipment qualification
4.0 Materials
® Qualification of vendors »
Purchasing, RM/PM/Int/Bulk and Finish Products
•
Rejected, returned and recovered
products. Reagents and culture media ® Reference and working standards
•
Miscellaneous materials, waste
materials
5,0
Quality Management
» Concept of QA, QC & cGMP
» Key activities in quality
management function as per cGMP guidelines. • Risk based approach to quality
management system. 6.0 Current Good Laboratory practice
•
Introduction and general provisions
of cGLP
•
Organisation and Personnel »
Facilities
•
Equipment
•
Testing facility Operation
•
Test and control articles
•
Protocol for conduct of a non
clinical laboratory study
•
Records and reports
•
Disqualification of Testing
Facilitation
•
Ref, 21 CFRpart58
• Out of specification results- handling and having CAPA
(Corrective and preventive action) plan in place.
7,0
cGMP Guidelines for biological Poducts
RECOMMENDED
BOOKS
1 „ Pharmaceutical Quality Assurance M.A. Potdar, Niral
PrakaShan, Pune
2,
International regulatory guidelines
on GMP by USA, Australia, S. Africa and WHO
3,
Good manufacturing Practices, S.R
Wills & J.R.Stoker, Marcel dekker Inc.
4,
C intent Good Manufacturing
Practices for Pharmaceuticals by Prof. M.A. Potdar BS Publications, Hyderabad.
QA-
MPY 202
ADVANCED
QUALITY ASSURANCE TECHNIQUES-II (Pharmaceutical Manufacturing and Quality
Control)
1.0 Manufacturing Operations and
Control
» Sanitation
of manufacturing premises
•
Control of mix ups and cross
contaminations
• Processing of intermediates and bulk products » Packaging and labelling operations
•
LP.Q.C.
• Release of finished products » Process deviations
» Charge
in of components
•
Time limitation on production
•
Drug poduct Inspection » Expiration
Dating
9 Calculation on Yield.
2.0
Out Sourcing
•
Out sourcing of Mfg and Planning
Operations
•
Out sourcing analytical services
•
Out sourcing other services
•
Confidentiality agreements
3.0 Post Operational Activities
• ' Distribution
•
Recalled, Returned & recovered
products
•
Product Complaints
® Annual product Quality renew
4.0
Sterile Pharmaceutical Activities
•
Manufacturing and Quality Control
Aspects of sterile pharmaceutical poducts
5.0
Inspection, Test; and Measurement
• The terminok gy of Inspection »
Conformance to specification and fitness for use
QA MPY 202
ADVANCED
QUALITY ASSURANCE TECHNIQUES-II {Pharmaceutical Manufacturing and Quality
Control)
1 0 Manufacturing Operations and
Control
» Sanitation
of manufacturing premises
•
Control of mix ups and cross
contaminations
•
Processing of intermeditates and
bulk products
•
Packaging and labelling operations
•
IJP.Q.C.
•
Release of finished products
•
Process deviations
« Charge
in of components
•
Time (imitation on production
•
Drug poduct Inspection
•
Expiration Dating
•
Calculation on Yield,
2.0
Out Sourcing
« Out sourcing of Mfg and Planning
Operations
•
Out sourcing analytical services
•
Out sourcing other services
•
Confidentiality agreements
3.0
Post Operational Activities
•
* Distribution
11 Recalled, Returned & recovered products
•
Product Complaints
3 Annual product Quality renew
4.0
Sterile Pharmaceutical Activities
•
Manufacturing and Quality Control Aspects of sterile pharmaceutical poducts
5.0
Inspection, Test, and Measurement
The
terminology of Inspection Conformance to specification and fitness for use Disposition
of Nonconforming product
QA
MPY 203
ADVANCED
QUALITY ASSURANCE TECHNIQUES III (Pharmaceutical Validation) Introduction to
Pharmaceutical Validation :
» Definition, Manufacturing Process
Model
•
Government regulation, scope of
Validation
•
Advantage of Validation
•
Organisation for Validation »
Validation Master plan
•
URS, D.Q., IQ, OQ & P.Q, of
Facilities.
•
Regulatory requirements for
validation
Calibration
Master plan
Validation Of Equipment:
•
Concept of URS, DQ , IQ , OQ &
PQ
•
Validation of following equipment
•
Dry Powder Mixers
•
Fluid Bed and Tray dryers.
•
Rapid Mixer Granulators
•
Lyophilizer
•
Film Coating Machine
•
Tablet Compression M/c,
•
Dry Heat Sterilizers / Tunnels
•
Autoclaves
•
Capsule filling machines.
•
Validation of Integrated lines by
media fill test
•
Validation of existing equipment
Vendor Certification : Utilities
Validation :
•
Validation of Pharmaceutical Water
System & pure steam « Validation of HVAC system
Cleaning Validation:
» Cleaning of Equipment
•
Cleaning of Facilities
Analytical Method Validation :
•
General principles of analytical
method validation
idation of following analytical
Instruments HPLC
Dissolution test apparatus U.V./
Visible spectrophotometers
•
Process
Validation ;
•
Prospective, Concurrent,
retrospective & revalidation
•
Process capability and statistacal
evaluation of process validation data
•
Process validation of following
formulation
i. Coated tablets
ii. Capsules
iii. Parenterals (Injectable)
iv. Ointments / Creams » Liquid Orals
•
Regulatoiy requirements for
validation
•
Computer System Validation :
»
ERP system/s used in Pharmaceutical Industry
Recommended Books ;
1.
Pharmaceutical Process Validation, Second Edition, Ira R.Berry & Robert
Nash, Marcel Dekker Inc.
Validation of Pharmaceutical Process
(Sterile Products), F.J. Carleton and J.P. Agalloco, Marcel Dekker Inc.
2,
Pharmaceutical Quality Assurance,
M.A. Potdar, Nirali Prakashan, Pune
3,
Current Good Manufacturing
Practices, M.A. Potdar, BS Publication, Hyderabad
4,
USFDA Guidelines
QA- MPY 204 ADVANCED QUALITY
ASSURANCE TECHNIQUE -,V (Quality
Planning and Analysis )
Basic concepts of Quality
•
Quality defined
•
The quality function
•
Managing
for quality
•
Perspective on Quality _ intema]
versus Extema)
Quality Improvement and Cost Reduction
•
Sporadic and chronic quality
problems
» Need for quality improvement & cost reduction
•
Causes of poor quality and high cost
1B for
improving quaBt,
» Institute Controls to hold the
Gains,
Control of Quality
•
Definition
of control
•
Self control
•
The control subject for quality
•
Units of measure
•
Setting a Goal for the Control
subject
•
The Sensor
•
Measuring Actual performance
•
Continuous process regulation
Developing a quality culture
•
Technology and culture
•
Theories of Motivation
•
Create and Maintain Awareness of
Quality
•
Provide Evidence of management and
empowerment
•
t rovide recognition and rewards
•
Time to change the culture
Manufacture
•
Self Inspection
» Automated manufacturing
•
Overall review of manufacturing
planning
•
Process quality audits
•
Quality and production floor culture
2,
Statistical Process control
•
Definition and Importance of SPC
•
Quality measurement in manufacturing
•
Statistical control charts- general »
Advantages of statistical control
•
Process capability
•
Estimating Inherent or potential
capability from a control chart analysis
•
Measuring process performance
•
Special process control and quality
improvement
•
Pursuit of decreased process variability
•
The Loss function
3,
Quality Assurance General Concepts
• Definition of quality assurance » Concept of quality assurance
» Quality audit- The concept
•
Subject matter of audits
•
Structuring the audit programme
•
Planning and performing audits of
activities
•
Human relations in auditing
•
Audit reporting
•
Essential ingredients of a quality
audit programme ( » Quality
surveys
•
Product audit
•
Sampling for product audit
•
Reporting the results of product
audit;
Recommended books
v. Quality planning and Analysis by J.M.Juran and F.M. Gryna Publisher
- Tata McGraw Hill - India
vi. Improving Quality through planned experimentation By Moen
:Tata McGraw Hill- India.
vii. Statistical. Quality Control by Grant - Publisher Tata
McGraw Hill- India
viii. Pharmaceutical Quality System : Oliver
QA- MPY 205 QUALITY ASSURANCE
TECHNIQUES (Practical) (16 hrs/weck)
ix.
Designing of following key documents
. Site master file SOP on SOP
x.
Mpcr/bpcr (For sterile and non
sterile products)
xi.
Change contract format
xii.
Product complaint document
xiii.
Internal audit document
xiv.
Product recall document
xv.
IPQC Document
xvi.
Material receipt, sampling,
dispensing and storage documents Experiment and documentation on Dissolution
Test I.P.Q.C, Tests for Tablets/ Capsules/Inj/Liquids/Ointments. Validation of
analytical method Validation of following equipment + Autoclave + Hot air oven +
Membrane filter + Powder Mixer (Dry) + Tablet Compression Machine Validation of
a processing area Validation of analytical instruments Cleaning validation of
one mixing equipment
QA- MPY 205 QUALITY ASSURANCE
TECHNIQUES -I (Practical) (16 hrs/wcek)
1.
Designing of following key documents, Site master file SOP on SOP
Mpcr/bpcr (For sterile and non
sterile products)
Change contract format f
Product complaint document
Internal audit document
Product recall document
IPQC Document
Material receipt, sampling, dispensing and storage documents
2,
Experiment and documentation on
Dissolution Test
2,
LP.Q.C. Tests for Tablets/ Capsules/
Inj/Liquids/Ointments.
2,
Validation of analytical method
2,
Validation of following equipment
+ Autoclave + Hot air oven +
Membrane filter + Powder Mixer (Dty) + Tablet Compression Machine 6„ Val
idation of a processing area
2,
Validation of analytical instruments
2,
Cleaning validation of one mixing
equipment
Hello! I simply wish to make a enormous thumbs up with the great info you’ve got here for this post. We are coming back to your site to get more detailed soon. American quality management company
ReplyDelete