Quality in Pharmaceutical Industry (GMP & GLP & GHP)
Aydan Ozden
3:38:27
Description
Pharma, Drug, Quality, GMP, GLP, GHP, Good Manufacturing Practice, Quality Assurance, Quality Management, Medicine
What You'll Learn?
- Define general scope of quality management in pharmaceutical industry
- Evaluate important points of Quality Management (QM) in pharmaceutical industry
- Understand and define main principles of Good Manufacturing Practices (GMP)
- Understand and define main principles of Good Laboratory Practices (GLP)
- Understand and define main principles of Good Hygiene Practices (GHP)
- Understand and define main principles of Good Documentation Practices (GDP)
- Understand and define main principles of Good Distribution Practices (GDP)
- Define roles of Quality Assurance, Quality Control and Production Departmants
Who is this for?
More details
DescriptionGood Manufacturing Practices (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production.
Quality Management (QM) is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Management (QM) therefore incorporates Good Manufacturing Practice (GMP).
Good Laboratory Practices (GLP) define the responsibilities of test facility management, study director, study personnel and quality assurance personnel that are operating within a GLP system, and minimum standards concerning the suitability of facilities and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports, the archiving of records, etc.
Good Hygiene Practice (GHP) is to include, upkeep of the facilities, pest control, waste control, use of protective clothing, cleaning and sanitization of equipment including maintenance, and the selection and use of chemicals etc.
COURSE AGENDA
1 INTRODUCTION
2 GENERAL DEFINITIONS
2_1 GENERAL DEFINITIONS-I
2_1_1 DRUG PRODUCT (PHARMACEUTICAL PRODUCT)
2_1_2 ACTIVE PHARMACEUTICAL INGREDIENT (API)
2_1_3 STARTING MATERIAL
2_1_4 INTERMEDIATE PRODUCT
2_1_5 PACKAGING MATERIAL
2_1_6 BULK PRODUCT
2_1_7 FINISHED PHARMACEUTICAL PRODUCT (FPP)
2_1_8 MANUFACTURING FLOW CHART
2_2 GENERAL DEFINITIONS-II
2_2_1 PRODUCTION
2_2_2 PACKAGING
2_2_3 MANUFACTURE (MANUFACTURING)
2_2_4 MANUFACTURER
2_2_5 MARKETING AUTHORIZATION (PRODUCT LICENCE) (REGISTRATION CERTIFICATE)
2_2_6 QUALITY ASSURANCE
2_2_7 QUALITY CONTROL
2_2_8 IN-PROCESS CONTROL
2_3 GENERAL DEFINITIONS-III
2_3_1 STANDART OPERATING PROCEDURE (SOP)
2_3_2 BATCH (LOT)
2_3_3 BATCH NUMBER (LOT NUMBER)
2_3_4 BATCH RECORD
2_3_5 MASTER RECORD
2_3_6 MASTER FORMULA
2_3_7 SPECIFICATION
2_3_8 AUTHORIZED PERSON
2_4 GENERAL DEFINITIONS-IV
2_4_1 CLEAN AREA
2_4_2 CONTAMINATION
2_4_3 CROSS CONTAMINATION
2_4_4 HVAC (HEATING, VENTILATION AND AIR CONDITIONING)
2_4_5 AIRLOCK
2_4_6 AIRLOCK TYPES (PERSONNEL&MATERIAL)
2_4_7 AIRLOCK TYPES (PRESSURE MOVEMENT)
2_5 GENERAL DEFINITIONS-V
2_5_1 CALIBRATION
2_5_2 QUALIFICATION
2_5_3 TYPES OF QUALIFICATION
2_5_4 VALIDATION
2_5_5 TYPES OF VALIDATION
3 PHARMACEUTICAL QUALITY SYSTEM
3_1 QUALITY MANAGEMENT
3_2 ROLES OF PHARMACEUTICAL QUALITY SYSTEM
3_3 GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS
3_3_1 GOOD MANUFACTURING PRACTICE (GMP)
3_3_2 BASIC REQUIREMENTS OF GMP
3_4 QUALITY CONTROL
3_4_1 QUALITY CONTROL
3_4_2 BASIC REQUIREMENTS OF QUALITY CONTROL
3_5 PRODUCT QUALITY REVIEW
3_5_1 PRODUCT QUALITY REVIEW
3_5_2 BASIC REQUIREMENTS OF PRODUCT QUALITY REVIEW
4 PERSONNEL
4_1 PERSONNEL
4_1_1 PERSONNEL
4_1_2 QUALIFICATION & PRACTICAL EXPERIENCE
4_1_3 ORGANIZATIONAL CHART
4_1_4 QUALIFICATION & RESPONSIBILITIES
4_1_5 JOB DESCRIPTION & RESPONSIBILITIES
4_2 KEY PERSONNEL
4_2_1 KEY MANAGEMENT PERSONNEL
4_2_2 RESPONSIBILITIES OF THE HEAD OF PRODUCTION DEPARTMENT
4_2_3 RESPONSIBILITIES OF THE HEAD OF QUALITY CONTROL DEPARTMENT
4_3 TRAINING
4_3_1 PERSONNEL TRAINING
4_3_2 BASIC TRAINING AND NEWLY RECRUITED PERSONNEL TRAINING
4_3_3 TRAINING FOR PERSONNEL WORKING IN HAZARDOUS AREAS
4_3_4 TRAINING FOR VISITORS OR UNTRAINED PERSONNEL
4_4 PERSONNEL HYGIENE
4_4_1 PERSONNEL HYGIENE
4_4_2 PERSONNEL HYGIENE PROCEDURES
4_4_3 PERIODIC MEDICAL EXAMINATION
4_4_4 PROTECTIVE GARMENTS
4_4_5 PROHIBITIONS IN GMP AREA
5 PREMISES AND EQUIPMENT
5_1 PREMISES-GENERAL
5_1_1 PREMISES AND EQUIPMENT
5_2 PREMISES-PRODUCTION AREA
5_2_1 FACILTY DESIGN FOR MINIMISING OF CROSS CONTAMINATION IN PRODUCTION AREA
5_2_2 QUALITY RISK MANAGEMENT FOR PREMISES AND EQUIPMENT PLACED IN PRODUCTION AREA
5_2_3 INTERIOR SURFACE REQUIREMENTS IN PRODUCTION AREA
5_2_4 HVAC DESIGN AND LIGHT FITTINGS IN PRODUCTION AREA
5_2_5 DRAINAGES IN PRODUCTION AREA
5_2_6 WEIGHING AREA IN PRODUCTION DEPARTMENT
5_2_7 CLEANING IN-PROCESS CONTROL IN PRODUCTION AREA
5_3 PREMISES-STORAGE AREA
5_3_1 STORAGE AREAS
5_3_2 CONDITIONS OF STORAGE AREAS
5_3_3 QUARANTINE STATUS OF STORAGE AREAS
5_3_4 SEGREGATED AREAS FOR REJECTED, RECALLED OR RETURNED AREAS
5_4 PREMISES-QUALITY CONTROL AREAS
5_5 EQUIPMENTS
5_5_1 EQUIPMENT
5_5_2 CLEANING OF EQUIPMENT
6 DOCUMENTATION
6_1 DOCUMENTATION
6_2 SPECIFICATIONS
6_2_1 SPECIFICATIONS
6_2_2 SPECIFICATIONS FOR STARTING AND PACKAGING MATERIALS
6_2_3 SPECIFICATIONS FOR FINISHED PRODUCTS
6_3 MANUFACTURING FORMULA
6_4 PROCESSING INSTRUCTIONS
7 PRODUCTION
7_1 PRODUCTION
7_2 PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION
7_2_1 PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION
7_2_2 TECHNICAL MEASURES FOR CROSS-CONTAMINATION IN PRODUCTION
7_2_3 ORGANISATIONAL MEASURES FOR CROSS-CONTAMINATION IN PRODUCTION
7_3 STARTING MATERIALS
7_4 PROCESSING OPERATIONS
7_4_1 PROCESSING OPERATIONS: INTERMEDIATE AND BULK PRODUCT
7_4_2 PROCESSING OPERATIONS: FINISHED PRODUCT
8 QUALITY CONTROL
8_1 QUALITY CONTROL
8_1_1 QUALITY CONTROL
8_1_2 RESPONSIBILITIES OF QUALITY CONTROL
8_1_3 FINISHED PRODUCT ASSESMENT
8_2 GOOD LABORATORY PRACTICE
8_2_1 GOOD LABORATORY PRACTICE
8_2_2 GOOD LABORATORY PRACTICE : DOCUMENTATION
8_2_3 GOOD LABORATORY PRACTICE : SAMPLING
8_2_4 GOOD LABORATORY PRACTICE : TESTING
8_2_5 GOOD LABORATORY PRACTICE : STABILITY
9 COMPLAINTS, QUALITY DEFECTS AND PRODUCT RECALLS
9_1 PERSONNEL AND ORGANISATION
9_2 PROCEDURES FOR HANDLING AND INVESTIGATING COMPLAINTS
10 CONCLUSION
Who this course is for:
- Learners who desire to take a part in Quality, Production and Research&Deveopment Departments in Pharmaceutical Industry
- Anyone who is looking to learn quality approaches / applications in pharmaceutical industry
- Anyone who interest GMP, GLP, GHP certification in pharmaceutical industry
- Existing pharma professionals who are looking to progress in their jobs
- Anyone who is looking to get entry in pharmaceutical industry
Good Manufacturing Practices (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production.
Quality Management (QM) is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Management (QM) therefore incorporates Good Manufacturing Practice (GMP).
Good Laboratory Practices (GLP) define the responsibilities of test facility management, study director, study personnel and quality assurance personnel that are operating within a GLP system, and minimum standards concerning the suitability of facilities and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports, the archiving of records, etc.
Good Hygiene Practice (GHP) is to include, upkeep of the facilities, pest control, waste control, use of protective clothing, cleaning and sanitization of equipment including maintenance, and the selection and use of chemicals etc.
COURSE AGENDA
1 INTRODUCTION
2 GENERAL DEFINITIONS
2_1 GENERAL DEFINITIONS-I
2_1_1 DRUG PRODUCT (PHARMACEUTICAL PRODUCT)
2_1_2 ACTIVE PHARMACEUTICAL INGREDIENT (API)
2_1_3 STARTING MATERIAL
2_1_4 INTERMEDIATE PRODUCT
2_1_5 PACKAGING MATERIAL
2_1_6 BULK PRODUCT
2_1_7 FINISHED PHARMACEUTICAL PRODUCT (FPP)
2_1_8 MANUFACTURING FLOW CHART
2_2 GENERAL DEFINITIONS-II
2_2_1 PRODUCTION
2_2_2 PACKAGING
2_2_3 MANUFACTURE (MANUFACTURING)
2_2_4 MANUFACTURER
2_2_5 MARKETING AUTHORIZATION (PRODUCT LICENCE) (REGISTRATION CERTIFICATE)
2_2_6 QUALITY ASSURANCE
2_2_7 QUALITY CONTROL
2_2_8 IN-PROCESS CONTROL
2_3 GENERAL DEFINITIONS-III
2_3_1 STANDART OPERATING PROCEDURE (SOP)
2_3_2 BATCH (LOT)
2_3_3 BATCH NUMBER (LOT NUMBER)
2_3_4 BATCH RECORD
2_3_5 MASTER RECORD
2_3_6 MASTER FORMULA
2_3_7 SPECIFICATION
2_3_8 AUTHORIZED PERSON
2_4 GENERAL DEFINITIONS-IV
2_4_1 CLEAN AREA
2_4_2 CONTAMINATION
2_4_3 CROSS CONTAMINATION
2_4_4 HVAC (HEATING, VENTILATION AND AIR CONDITIONING)
2_4_5 AIRLOCK
2_4_6 AIRLOCK TYPES (PERSONNEL&MATERIAL)
2_4_7 AIRLOCK TYPES (PRESSURE MOVEMENT)
2_5 GENERAL DEFINITIONS-V
2_5_1 CALIBRATION
2_5_2 QUALIFICATION
2_5_3 TYPES OF QUALIFICATION
2_5_4 VALIDATION
2_5_5 TYPES OF VALIDATION
3 PHARMACEUTICAL QUALITY SYSTEM
3_1 QUALITY MANAGEMENT
3_2 ROLES OF PHARMACEUTICAL QUALITY SYSTEM
3_3 GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS
3_3_1 GOOD MANUFACTURING PRACTICE (GMP)
3_3_2 BASIC REQUIREMENTS OF GMP
3_4 QUALITY CONTROL
3_4_1 QUALITY CONTROL
3_4_2 BASIC REQUIREMENTS OF QUALITY CONTROL
3_5 PRODUCT QUALITY REVIEW
3_5_1 PRODUCT QUALITY REVIEW
3_5_2 BASIC REQUIREMENTS OF PRODUCT QUALITY REVIEW
4 PERSONNEL
4_1 PERSONNEL
4_1_1 PERSONNEL
4_1_2 QUALIFICATION & PRACTICAL EXPERIENCE
4_1_3 ORGANIZATIONAL CHART
4_1_4 QUALIFICATION & RESPONSIBILITIES
4_1_5 JOB DESCRIPTION & RESPONSIBILITIES
4_2 KEY PERSONNEL
4_2_1 KEY MANAGEMENT PERSONNEL
4_2_2 RESPONSIBILITIES OF THE HEAD OF PRODUCTION DEPARTMENT
4_2_3 RESPONSIBILITIES OF THE HEAD OF QUALITY CONTROL DEPARTMENT
4_3 TRAINING
4_3_1 PERSONNEL TRAINING
4_3_2 BASIC TRAINING AND NEWLY RECRUITED PERSONNEL TRAINING
4_3_3 TRAINING FOR PERSONNEL WORKING IN HAZARDOUS AREAS
4_3_4 TRAINING FOR VISITORS OR UNTRAINED PERSONNEL
4_4 PERSONNEL HYGIENE
4_4_1 PERSONNEL HYGIENE
4_4_2 PERSONNEL HYGIENE PROCEDURES
4_4_3 PERIODIC MEDICAL EXAMINATION
4_4_4 PROTECTIVE GARMENTS
4_4_5 PROHIBITIONS IN GMP AREA
5 PREMISES AND EQUIPMENT
5_1 PREMISES-GENERAL
5_1_1 PREMISES AND EQUIPMENT
5_2 PREMISES-PRODUCTION AREA
5_2_1 FACILTY DESIGN FOR MINIMISING OF CROSS CONTAMINATION IN PRODUCTION AREA
5_2_2 QUALITY RISK MANAGEMENT FOR PREMISES AND EQUIPMENT PLACED IN PRODUCTION AREA
5_2_3 INTERIOR SURFACE REQUIREMENTS IN PRODUCTION AREA
5_2_4 HVAC DESIGN AND LIGHT FITTINGS IN PRODUCTION AREA
5_2_5 DRAINAGES IN PRODUCTION AREA
5_2_6 WEIGHING AREA IN PRODUCTION DEPARTMENT
5_2_7 CLEANING IN-PROCESS CONTROL IN PRODUCTION AREA
5_3 PREMISES-STORAGE AREA
5_3_1 STORAGE AREAS
5_3_2 CONDITIONS OF STORAGE AREAS
5_3_3 QUARANTINE STATUS OF STORAGE AREAS
5_3_4 SEGREGATED AREAS FOR REJECTED, RECALLED OR RETURNED AREAS
5_4 PREMISES-QUALITY CONTROL AREAS
5_5 EQUIPMENTS
5_5_1 EQUIPMENT
5_5_2 CLEANING OF EQUIPMENT
6 DOCUMENTATION
6_1 DOCUMENTATION
6_2 SPECIFICATIONS
6_2_1 SPECIFICATIONS
6_2_2 SPECIFICATIONS FOR STARTING AND PACKAGING MATERIALS
6_2_3 SPECIFICATIONS FOR FINISHED PRODUCTS
6_3 MANUFACTURING FORMULA
6_4 PROCESSING INSTRUCTIONS
7 PRODUCTION
7_1 PRODUCTION
7_2 PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION
7_2_1 PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION
7_2_2 TECHNICAL MEASURES FOR CROSS-CONTAMINATION IN PRODUCTION
7_2_3 ORGANISATIONAL MEASURES FOR CROSS-CONTAMINATION IN PRODUCTION
7_3 STARTING MATERIALS
7_4 PROCESSING OPERATIONS
7_4_1 PROCESSING OPERATIONS: INTERMEDIATE AND BULK PRODUCT
7_4_2 PROCESSING OPERATIONS: FINISHED PRODUCT
8 QUALITY CONTROL
8_1 QUALITY CONTROL
8_1_1 QUALITY CONTROL
8_1_2 RESPONSIBILITIES OF QUALITY CONTROL
8_1_3 FINISHED PRODUCT ASSESMENT
8_2 GOOD LABORATORY PRACTICE
8_2_1 GOOD LABORATORY PRACTICE
8_2_2 GOOD LABORATORY PRACTICE : DOCUMENTATION
8_2_3 GOOD LABORATORY PRACTICE : SAMPLING
8_2_4 GOOD LABORATORY PRACTICE : TESTING
8_2_5 GOOD LABORATORY PRACTICE : STABILITY
9 COMPLAINTS, QUALITY DEFECTS AND PRODUCT RECALLS
9_1 PERSONNEL AND ORGANISATION
9_2 PROCEDURES FOR HANDLING AND INVESTIGATING COMPLAINTS
10 CONCLUSION
Who this course is for:
- Learners who desire to take a part in Quality, Production and Research&Deveopment Departments in Pharmaceutical Industry
- Anyone who is looking to learn quality approaches / applications in pharmaceutical industry
- Anyone who interest GMP, GLP, GHP certification in pharmaceutical industry
- Existing pharma professionals who are looking to progress in their jobs
- Anyone who is looking to get entry in pharmaceutical industry
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Aydan Ozden
Instructor's Courses
Udemy
View courses Udemy- language english
- Training sessions 31
- duration 3:38:27
- Release Date 2023/03/16
