INDUSTRIAL PHARMACY GMP for Pharmaceutical Products Wayan Redja FACULTY OF PHARMACY PANCASILA UNIVERSITY JAKARTA 2002 INDUSTRIAL PHARMACY OPERATION MANAGEMENT IN GMP INTRODUCTION QMS ISO 9001 : 2015 QUALITY ASSURANCE AND QUALITY CONTROL PRODUCTION AND OPERATION MANAGEMENT GMP FOR PHARMACEUTICAL PRODUCT CRITICAL SUPPORTING FACILITIES INTRODUCTION WHAT INDUSTRIAL PHARMACY WHY INDUSTRIAL PHARMACY HOW INDUSTRIAL PHARMACY DRUG DISCOVERY AND DEVELOPMENT DRUG REGISTRATION GMP IPLEMENTATION IN INDONESIA WHAT, WHY, HOW GMP IN INDUSTRIAL PHARMACY? WHAT? GMP Good Manufacturing Practices (Regulation of Food & Drug Control > > > > Agency (BPOM) GMP for Pharmaceutical Product (CPOB) GMP for Active Pharmaceutical Ingredient (CPBBOB) GMP for Traditional Medicine (CPOTB) GMP for Cosmetic (CPKB), Definition of CPOB (GMP for Pharmaceutical Product) Regulation issued by BPOM on GMP for Pharmarmaceutical Product (CPOB) as part of QA which ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. # quality standards = specified quality = specification. (WHO, Technical Report Series, No.961, 2011) WHAT, WHY, HOW GMP IN INDUSTRIAL PHARMACY? What? Pharmaceutical Industry (Wikipedia) An organization that trade and manufacture of pharmaceuticals including discovers, develops, produces, markets and distributes API and/or pharmaceutical products and/or medical equipment. Pharmaceutical Products (Sediaan Farmasi) > Medicine > Traditional Medicine > Cosmetic Pharmaceutical Supplies (Perbekalan Farmasi) > Pharmaceutical Products > Medical Equipment WHAT, WHY, HOW GMP IN INDUSTRIAL PHARMACY? Why GMP? To assure the quality of pharmaceutical products meet the quality standard according to their intended use. To assure the quality of pharmaceutical products fulfill the requirements. To follow the regulations, e.g. CPOB, drug registration, etc. To avoid errors due to: > > > > > > cross contamination, product degradation, mix up, resource error, process run error, health hazard. WHAT, WHY, HOW GMP IN INDUSTRIAL PHARMACY? HOW TO IMPLEMENT GMP? Follow the regulations / Good Practices in Pharmacy. Follow the QM/QA principles: > Build quality into the product. > Follow the PDCA cycle on “GMP Process Flow”. > Do it right from the first time and every time. > Write what will be done , do what is written , and write what is done. > Control, review, CAPA / continual improvement. Follow the “FDA’s Quality System Guidance.” QUALITY QES .> USTOMER REQUIREMENT Ability to Fulfill Requirements QA R&D GMP Supplay Chain / PPIC ResourcesProvision Storage Prod & IPC/QC PQR Seven Critical Concepts of the FDA’s Quality System Guidance Modern Quality System in CGMP Quality > the strength, purity, and other characteristics to ensure a drug product’s safety and effectiveness. Quality by Design (QbD) and Product Development > designing & developing a product and its manufacturing processes to ensure that the product consistently attains predefined quality Quality Risk Management > assessing the risk of quality issues, selecting and implementing QRM, evaluating the results of the risk management efforts. CAPA > investigating, understanding, correcting discrepancies to prevent their recurrence. Change Control > to prevent unintended consequence. Quality Unit > promotes quality in general practice. Six-System Inspection Model > 1. quality, 2. production, 3. facilities and equipment, 4. laboratory controls, 5. materials, and 6. packaging & labelling, GOOD PRACTICES IN PHARMACY Gevernment Pharmacy GGP Follows the rule of law, accountable, transparent, equitable and inclusive, responsive, participatory, consensus oriented, effective and efficient Pharmacy Practice Pharmaceutical Industry GCP GLP GMP GSP GDP QM QA GPP GSP GCP GDP Principle: Do it right from the first time, and every time! > PDCA Cycle GMP PROCESS FLOW PW = Pharmaceutical WholesalerMR MR = Marke FP, BP, ting Request ST = Stoc ( FP, BP, RM, PM), PPIC = Production Planning & Inventory Control PP = Production Plan PR = Purchase Request Pcs = Purchasing PO = Purchase Order RM = Raw Material Rcv = Receivin Qrt = Quarantine IPC = In Process Control QC = Quality Control JO = Job Order Wgh = Weighing, Mix = Mixing IP = Intermediate Product Fill = Fillingor or Tab =Tabletting BP = Bulk Product Pkg = Packaging FP = Finished Product GMP > QM > QUALITY ASSURANCE (QA ) * > QMS + FP PW (PBF) CR MR ST QUALITY CONYROL * (GLP} > Production Process (IPC) PPIC JO PR / PP PM Pcs GDP PO GDP PLANNING RM RM Rcv > Qrt STORAGE RM Wgh IP IP Mix Qrt / BP BP Qrt Fill /Tab PROCESSING > Wgh – Fill/Tab PRODUCTION * > Rcv - Pkg MANUFACTURING > Pcs - Pkg FP Pkg PACKAGING > BP-FP FP Qrt GMP FOR PHARMACEUTICAL PRODUCTS (CPOB) Management (1) Quality Management Processes (7) Resources (4) Personnel Premises & Facilities Equipment Document Production Quality control GSP & GDP Self Inspection Handling of Complaint and product recall Toll Manufacturing Validation and Qualification Annex (13) Mfg of: sterile product, material & biological product, medicinal gas, aerosol, blood product, drug for clinical studies, GMP of API, radiopharmaceuticals, use of ionizing radiation in drug mfg (9) real time and parametric release, reference and retained samples, QRM, computerized system (4).
