:---
L2..
1.0 Personnel :
Qualification, Experience and Training
Key persons and their responsibilities
Personnel hygien and clothing
Legal aspect<; and con ultants
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, imrnunosupressants, steroids, harmones, potent molecules,etc.
Environmental control / safety and health requirement
3.0 Equipment
Design, site, Location, construction
s Equipment identification and Logs
" Cleaning, Operation and maintenance of equipment.
Equipment qualification
4.0 Materials
e Q lification of vendors
Purahasing, RM/PM/Int/Bulk and Finish Products
Rejlcted, returned and recovered products. Reagents and cllture media
Refi rence and working standards
Mis ellaneous materials, waste materials
5.0 Quality Management
Concept of QA, QC & cGMP
Key activities in quality management function as per cGMP guidelines.
111 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 CFR part 58
Out of specification results- handling and having CAPA (Corrective and preventive action) plan in place.
cGMP Guidelines for biological Poducts RECOMMENDED BOOKS
Pharmaceutical Quality Assurance M.A. Potdar, Niral Prakasban, Pune
International regulatory guidelines on GMP by USA, Australia, S. Africa and WHO
Good manufacturing Practices, S.H. Wills & J.R.Stoker, Marcel dekker Inc. 4,. Curl-ent Good Manufacturing Practices for Pharmaceuticals by Prof. M.A.
Potdar BS Publications, Hyderabad.
(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
I.P.Q.C.
Release of finished products
Process deviations
Charge in of components
Time limitation 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
Recalled, Returned & recovered products
Product Complaints
Annual product Quality renew
4.0 Sterile Pharmaceutical Activities
Manufacturing and Quality Control Aspects of sterile pharmaceutical poducts
I
5.0 Inspection, Test and Measurement
The tenninol1gy of Inspection
Conformance to specification and fitness for use
= -
.• Disposition QfNonconforming product
-
-- ,.....
QA- MPY202
ADVANCED QUALITY ASSURANCE TECHNIQUES-II
(Pharmaceutical Manufacturing and Quaiity 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
LP.Q.C.
Release of finished products
Process deviations
Charge in of components
Time limitation 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
Recalled, Returned & recovered products
Product Complaints
e Annual product Quality renew
4.0 Sterile Pharmaceutical Activities
Manufacturing and Quality Control Aspects of sterile pharmaceutical poducts
5.0 Inspection, Test, and Measurement
Thelterminology of Inspection
Corformance to specification and fitnes for use
Disposition of Nonconforming product
I
Inspection planning
9 Seriousness classification
Automated [nspection
,, • How much inspection is necessary ?
Inspection Accuracy
Errors of Measurement
6.0 Inspection and test sampling plans
The concept of acceptance sampling
Economics of Inspections
Sampling Risks: The operating characteristic curve
Analysis of some rule of thumb sampling plans
Evaluation of parameters affecting acceptance sampling plans
Quality indices for acceptance sampling plans
Types of sampling and Multiple sampling
Characteristics of a good acceptance plan
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 Mic.
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
Validation of following analytical Instruments
1. HPLC
ii.
111.
1Dissolution test apparatus
IU.V./ Visible spectrophotometers
i-
'
Process Validation :
Prospective, Concurrent, retrospective & revalidation
Process capability and statistacal evaluation of process validation data
Process validation of following formulation
1. Coated tablets
Capsules
Parenterals (Injectable) iv, Ointments/ Creams
Liquid Orals
Regulatory requirements for validation
9, Computer System Validation:
a ERP system.ls ed in Phannaceutical Industry
Recommended Books :
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.
Pharmaceutical Quality Assurance, M.A. Potdar, Nirali Prakashan, Pune
Current Good Manufacturing Practices, M.A. Potdar, BS Publication, Hyderabad.
USFDA Guidelines ...
,,:
' =
I
i -'CC
I
I , -- iI ...
-;:_- .,. ==
ADVANCED QUALITY ASSURANCE TECHNIQUE -rv
(Quality Planning and Analysis )
L Basic concepts of Quality
Quality defined
The quality function
Managing for quality
Perspective on Quality - Internal versus External
Quality Improvement and Cost Reduction
Sporadic and chronic quality problems
Need for qualit,yimprovement & cost reduction.
Causes of poor quality and high cost.
Providea remedy and prove its effectiveness for improvingquality.
Resistance to change
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
...
Interpreting the difference between Actual performance and the goal.
Taking action on the difference
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
Provide recognition and rewards
Time to chang'f the culture
Manufacture
Importance off anufacturing planning for quality
Initial plannin for quality
Concept of con rolJability, self-control
Defining qualify responsibilities on the Factory floor
1 --- ---_
-
' j-=
Selflnspection
Automated manufacturing
Overall review of manufacturing planning
Process quality audits
Quality and production floor culture
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 perfonnance
Special process control and quality improvement
Pursuit of decreased process variability
The Loss function
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
Quality planning and Analysis by J.M.Juran and F.M. Gryna Publisher - Tata McGraw Hill - India
Improving Quality through planned experimentation By Moen :Tata McGraw ill- India.
Statistical Quality Control,by Grant - Publisher Tata McGraw Hill- India
Pharmaceutical Quality System: Oliver
QA-MPY205
QUALITY ASSURANCE TECHNIQUES -I
{Practical) (16 hrs/week)
I • Designing of following key documents.
Site master file SOP on SOP
Mpcr/bpcr (For sterile and non sterile products) Change contract format
Product complaint document Internal audit document Product recall document IPQC Document
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-MPY205
QUALITY ASSURANCE TECHNIQUES -I
(Practical) (16 hrs/week)
I. Designing of following key documents. Site master file
SOP on SOP
Mpcr/bpcr (For sterile and non sterile products)
Change contract format t
Product complaint document Internal audit document Product recall document IPQC Document
Material receipt, sampling, dispensing and storage docwnents
Experiment and documentation on Dissolution Test
I.P.Q.C. Tests for Tablets/ Capsules/ Inj/Liquids/Ointments.
4, Validation of analytical method
5. Validation of following equipment
+ Autoclave
+ Hot air oven
+ Membrane filter
+ Powder Mixer (Dry)
6.
+ Tablet Compression Machine ...
Validation of a processing area
7. Validation of analytical instruments
8. Cleaning validation of one mixing equipment
f
•
I
•
-
-
= = --·-
+=-
'
I I
-
I
j ==---'= j '3
--
-
-
= ,. -- - - - ··-- -
= = ------- •=
c:-;
---
C
= c;c -
:---
L2..
1.0 Personnel :
Qualification, Experience and Training
Key persons and their responsibilities
Personnel hygien and clothing
Legal aspect<; and con ultants
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, imrnunosupressants, steroids, harmones, potent molecules,etc.
Environmental control / safety and health requirement
3.0 Equipment
Design, site, Location, construction
s Equipment identification and Logs
" Cleaning, Operation and maintenance of equipment.
Equipment qualification
4.0 Materials
e Q lification of vendors
Purahasing, RM/PM/Int/Bulk and Finish Products
Rejlcted, returned and recovered products. Reagents and cllture media
Refi rence and working standards
Mis ellaneous materials, waste materials
5.0 Quality Management
Concept of QA, QC & cGMP
Key activities in quality management function as per cGMP guidelines.
111 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 CFR part 58
Out of specification results- handling and having CAPA (Corrective and preventive action) plan in place.
cGMP Guidelines for biological Poducts RECOMMENDED BOOKS
Pharmaceutical Quality Assurance M.A. Potdar, Niral Prakasban, Pune
International regulatory guidelines on GMP by USA, Australia, S. Africa and WHO
Good manufacturing Practices, S.H. Wills & J.R.Stoker, Marcel dekker Inc. 4,. Curl-ent Good Manufacturing Practices for Pharmaceuticals by Prof. M.A.
Potdar BS Publications, Hyderabad.
(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
I.P.Q.C.
Release of finished products
Process deviations
Charge in of components
Time limitation 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
Recalled, Returned & recovered products
Product Complaints
Annual product Quality renew
4.0 Sterile Pharmaceutical Activities
Manufacturing and Quality Control Aspects of sterile pharmaceutical poducts
I
5.0 Inspection, Test and Measurement
The tenninol1gy of Inspection
Conformance to specification and fitness for use
= -
.• Disposition QfNonconforming product
-
-- ,.....
QA- MPY202
ADVANCED QUALITY ASSURANCE TECHNIQUES-II
(Pharmaceutical Manufacturing and Quaiity 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
LP.Q.C.
Release of finished products
Process deviations
Charge in of components
Time limitation 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
Recalled, Returned & recovered products
Product Complaints
e Annual product Quality renew
4.0 Sterile Pharmaceutical Activities
Manufacturing and Quality Control Aspects of sterile pharmaceutical poducts
5.0 Inspection, Test, and Measurement
Thelterminology of Inspection
Corformance to specification and fitnes for use
Disposition of Nonconforming product
I
Inspection planning
9 Seriousness classification
Automated [nspection
,, • How much inspection is necessary ?
Inspection Accuracy
Errors of Measurement
6.0 Inspection and test sampling plans
The concept of acceptance sampling
Economics of Inspections
Sampling Risks: The operating characteristic curve
Analysis of some rule of thumb sampling plans
Evaluation of parameters affecting acceptance sampling plans
Quality indices for acceptance sampling plans
Types of sampling and Multiple sampling
Characteristics of a good acceptance plan
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 Mic.
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
Validation of following analytical Instruments
1. HPLC
ii.
111.
1Dissolution test apparatus
IU.V./ Visible spectrophotometers
i-
'
Process Validation :
Prospective, Concurrent, retrospective & revalidation
Process capability and statistacal evaluation of process validation data
Process validation of following formulation
1. Coated tablets
Capsules
Parenterals (Injectable) iv, Ointments/ Creams
Liquid Orals
Regulatory requirements for validation
9, Computer System Validation:
a ERP system.ls ed in Phannaceutical Industry
Recommended Books :
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.
Pharmaceutical Quality Assurance, M.A. Potdar, Nirali Prakashan, Pune
Current Good Manufacturing Practices, M.A. Potdar, BS Publication, Hyderabad.
USFDA Guidelines ...
,,:
' =
I
i -'CC
I
I , -- iI ...
-;:_- .,. ==
ADVANCED QUALITY ASSURANCE TECHNIQUE -rv
(Quality Planning and Analysis )
L Basic concepts of Quality
Quality defined
The quality function
Managing for quality
Perspective on Quality - Internal versus External
Quality Improvement and Cost Reduction
Sporadic and chronic quality problems
Need for qualit,yimprovement & cost reduction.
Causes of poor quality and high cost.
Providea remedy and prove its effectiveness for improvingquality.
Resistance to change
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
...
Interpreting the difference between Actual performance and the goal.
Taking action on the difference
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
Provide recognition and rewards
Time to chang'f the culture
Manufacture
Importance off anufacturing planning for quality
Initial plannin for quality
Concept of con rolJability, self-control
Defining qualify responsibilities on the Factory floor
1 --- ---_
-
' j-=
Selflnspection
Automated manufacturing
Overall review of manufacturing planning
Process quality audits
Quality and production floor culture
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 perfonnance
Special process control and quality improvement
Pursuit of decreased process variability
The Loss function
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
Quality planning and Analysis by J.M.Juran and F.M. Gryna Publisher - Tata McGraw Hill - India
Improving Quality through planned experimentation By Moen :Tata McGraw ill- India.
Statistical Quality Control,by Grant - Publisher Tata McGraw Hill- India
Pharmaceutical Quality System: Oliver
QA-MPY205
QUALITY ASSURANCE TECHNIQUES -I
{Practical) (16 hrs/week)
I • Designing of following key documents.
Site master file SOP on SOP
Mpcr/bpcr (For sterile and non sterile products) Change contract format
Product complaint document Internal audit document Product recall document IPQC Document
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-MPY205
QUALITY ASSURANCE TECHNIQUES -I
(Practical) (16 hrs/week)
I. Designing of following key documents. Site master file
SOP on SOP
Mpcr/bpcr (For sterile and non sterile products)
Change contract format t
Product complaint document Internal audit document Product recall document IPQC Document
Material receipt, sampling, dispensing and storage docwnents
Experiment and documentation on Dissolution Test
I.P.Q.C. Tests for Tablets/ Capsules/ Inj/Liquids/Ointments.
4, Validation of analytical method
5. Validation of following equipment
+ Autoclave
+ Hot air oven
+ Membrane filter
+ Powder Mixer (Dry)
6.
+ Tablet Compression Machine ...
Validation of a processing area
7. Validation of analytical instruments
8. Cleaning validation of one mixing equipment
f
•
I
•
-
-
= = --·-
+=-
'
I I
-
I
j ==---'= j '3
--
-
-
= ,. -- - - - ··-- -
= = ------- •=
c:-;
---
C
= c;c -