EMA · Guidance
EMA GMP·품질 가이드라인
유럽의약품청(EMA)이 공개한 GMP·품질 관련 문서를 발행일 순으로 선별해 정리했습니다. 실사 당국 품질 시스템, 품질 결함 보고·신속 경보 처리 등 규제 절차 가이드라인과 과학 가이드라인, 질의응답(Q&A)을 포함합니다. 법적 효력과 최신본은 반드시 공식 원문에서 확인하세요.
- ICH Q8, Q9 and Q10 - questions and answers
- ICH Q9 Quality risk management
- Co-ordinating good manufacturing practice (GMP) inspections for centrally authorised products
- Introduction to the Compilation of Union procedures on inspections and exchange of information
- Quality systems framework for Good Manufacturing Practice (GMP) inspectorates
- Management and classification of reports of suspected quality defects in medicinal products and risk-based decision-making
- Management of rapid alerts arising from quality defects risk assessment
- Conduct of inspections of pharmaceutical manufacturers or importers
- Outline of a procedure for co-ordinating the verification of the GMP status of manufacturers in third countries
- Guideline on training and qualifications of good manufacturing practice (GMP) inspectors
- Guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers, importers and distributors of active substances and manufacturers or importers of excipients used as starting materials
- The issue and update of good manufacturing practice (GMP) certificates
- A model for risk based planning for inspections of pharmaceutical manufacturers
- Procedure for dealing with serious good manufacturing practice (GMP) non-compliance information originating from third country authorities or international organisations
- Procedure for dealing with serious good manufacturing practice (GMP) non-compliance requiring co-ordinated measures to protect public or animal health
- Procedure for compliance management
- EU/EEA programme for maintenance of equivalence in supervision of good manufacturing practice compliance of pharmaceutical companies
- Interpretation of the Union format for manufacturer / importer authorisation
- Interpretation of the Union format for good manufacturing practice (GMP) certificate
- History of changes to the compilation of procedures
- ICH guideline Q13 on continuous manufacturing of drug substances and drug products
- Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container
- Questions and answers on implementation of risk-based prevention of cross-contamination in production and health-based exposure limits
- Guideline on manufacture of the finished dosage form - Revision 1
- Questions and answers: Improving the understanding of NORs, PARs, DSp and normal variability of process parameters
- Guideline on process validation for finished products - information and data to be provided in regulatory submissions - Revision 1
- Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
- Questions and answers on design space verification
- ICH Q8 (R2) Pharmaceutical development
- ICH Q10 Pharmaceutical quality system
- Note for guidance on start of shelf-life of the finished dosage form
- The use of ionising radiation in the manufacture of medicinal products
- Guidance on good manufacturing practice and good distribution practice: Questions and answers
