The pharmaceutical industry is one of the highly regulated industries with rules and regulations enforced by governments to protect public health. The industry aims to develop generic drug products that meet diverse market needs. Regulatory authorities ensure medicine quality, safety, and efficacy. The value chain includes raw material manufacturers, pharmaceutical companies, distributors, medical providers, and healthcare buyers. Pharmaceutical companies must follow Good Manufacturing Practices and other quality standards. Key personnel include quality assurance and quality control staff. Production sites must consider capacity, safety, productivity, and quality. New drug development follows a stage gate process involving research and development, testing, documentation, and registration.
The pharmaceutical industry is one of the highly regulated industries with rules and regulations enforced by governments to protect public health. The industry aims to develop generic drug products that meet diverse market needs. Regulatory authorities ensure medicine quality, safety, and efficacy. The value chain includes raw material manufacturers, pharmaceutical companies, distributors, medical providers, and healthcare buyers. Pharmaceutical companies must follow Good Manufacturing Practices and other quality standards. Key personnel include quality assurance and quality control staff. Production sites must consider capacity, safety, productivity, and quality. New drug development follows a stage gate process involving research and development, testing, documentation, and registration.
The pharmaceutical industry is one of the highly regulated industries with rules and regulations enforced by governments to protect public health. The industry aims to develop generic drug products that meet diverse market needs. Regulatory authorities ensure medicine quality, safety, and efficacy. The value chain includes raw material manufacturers, pharmaceutical companies, distributors, medical providers, and healthcare buyers. Pharmaceutical companies must follow Good Manufacturing Practices and other quality standards. Key personnel include quality assurance and quality control staff. Production sites must consider capacity, safety, productivity, and quality. New drug development follows a stage gate process involving research and development, testing, documentation, and registration.
The pharmaceutical industry is one of the highly regulated industries with rules and regulations enforced by governments to protect public health. The industry aims to develop generic drug products that meet diverse market needs. Regulatory authorities ensure medicine quality, safety, and efficacy. The value chain includes raw material manufacturers, pharmaceutical companies, distributors, medical providers, and healthcare buyers. Pharmaceutical companies must follow Good Manufacturing Practices and other quality standards. Key personnel include quality assurance and quality control staff. Production sites must consider capacity, safety, productivity, and quality. New drug development follows a stage gate process involving research and development, testing, documentation, and registration.
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Randy Kelana
UHAMKA – Agustus 2022 Who am I? apt. Randy Kelana, M. Farm. Ind.
….-10 10-16 17-18 19-20 21-22
Study Join KF Internship Sungwun Digitalization Share Knowledge And Join KFSP SAP Implementation Hannover Messe 2021 Best Practician Best Trainee Employee in IIoT in KFSP 3 usecases Industrial Transformation Compounding Lab PT. Kimia Farma 6-month Internship In Award Candidate ASIA-PASIFIC” Award Student GPA 3.5 (Persero)Tbk. II 2009 Sungwun Co. Ltd Implement Indi 4.0 International Research and 5th Grade PIMFI (Pekan Ass.Manager handle 1 Site Build API and HFC Facility Award Karya Anak Bangsa Scholarship Talk 2022. Ilmiah Farmasi Ass.Manager handle 2 Bonded Zone Award Indi 4.0 Indonesia) Site Implementation PHARMACEUTICAL INDUSTRY = HIGHLY REGULATED INDUSTRY
The pharmaceutical industry is one of the highly regulated industries, with many rules and regulations enforced by the government to protect the health and well-being of the public. Therefore, the aim of the pharmaceutical industry is to identify and develop a generic drug product which can be tailor made to meet the diverse market requirements. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. HIGHLY REGULATED INDUSTRY VALUE CHAIN PHARMACEUTICAL INDUSTRY Raw Material Pharmaceutical Drug Medical Service Healthcare Manufacturer Company Distribution Provider Buyer
Traditional Raw Material Active Hospital Government Distribution Pharmaceutical (Public/ Ingredient Army/Private) (API) Commercial Special Type Healthcare Intermediate Insurance Distribution
Pharmaceutical Drugstore API Direct Market PRIVATE PHARMACEUTICAL VALUE CURVE GM P Manufacture
1. GMP Robotic Storage
2. GSP 3. GDP GxP 4. GDPs 5. GAMP Documentation Distribution Basic Concept of GMP API in Pharmaceutical Industry PHARMACEUTICAL INITIAL GRADE GRADE
CLASIC CHEMICAL NATURAL BIOTECNOLOGY FERMENTATIO BASED BASED N BASED BASED Highlight API Industry in Indonesia BUSINE SS PROCES S API PHARMACEUTI CAL INDUSTRY Shell-like containment control concept AIRLOCK TYPE: 1. BUBBLE AIRLOCK 2. SINK AIRLOCK 3. CASCADE AIRLOCK PROSES REAKSI KIMIA
L1
Purification CLASS IN PRODUCTION UTILITY IN API PHARMACEUTICAL INDUSTRY
CRITICAL CONTACT WITH PRODUCT
UTILITY WATER SYSTEM (PW, Drinking Water) COMPRESS AIR, N2 HVAC
NOT CONTACT WITH PRODUCT
BOILER (PLANT STEAM) NON CHILLER HOTWATER SYSTEM CRITICAL WASTE WATER SYSTEM UTILITY BUBBLE DIAGRAM (EXAMPLE) KEY PERSON IN PHARMACEUTICAL INDUSTRY
QUALITY ASSURANCE WHAT IS THE DIFFECENCIES BETWEEN QA AND QC?
QA QC • Process Orientation • Process Orientation • Defect Prevention • Defect Identification • Analyse the data • Providing the data QUALITY SITE Validation
Quality Risk GDP/GMP
Management Compliance
QC Labs
QUALITY Retain ASSURANCE AMV Inspection Sample Preparation Training QUALITY Support CONTROL
Finished QP/RP SOP
Sampling Provision Development Product
Analysis PRODUCTION SITE CAPACITY STRATEGY
SAFETY PRODUCTIVITY
QUALITY
INPUT PROCESS OUTPUT
STAGE GATE PROCESS OF PRODUCT DEVELOPMENT RnD SITE RnD Packaging Pharmacovigil RnD Process Development ance
RnD Document Analytical and Development Registration REGULATION SITE FINISHED PRODUCT
Registration New Product
ACTIVE PHARMACEUTICAL INGGREDIENT
Registration Major Var.
Certification for Building Registration Minor Var. Certification for Item Product
SAS (Special Access Scheme)
NOTE : Document Proven :
Safety, Efficacy, Quality EMERGENCY USE AUTORIZATION
