Quality in Pharmaceutical Industry (GMP & GLP & GHP)

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