Description
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 AGENDA1 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
