Revised Pharmaceutical Affair Law and Risk Management

Transcription

1 Pharmaceutical Quality Forum 3rd Symposium Revised Pharmaceutical Affair Law and Risk Management Q9 Topic Leader of JPMA Takayoshi Matsumura

2 Continuous Improvement Supplement/ Variation Change Control, Annual Review Manufacture Define Quality Risk Management Technology Transfer Customer Satisfaction Customer Requirement Pharmaceutical Development Design Regulatory Submission

3 Validation of Process Manufacturing facilities Manufacturing processes Design Qualification (DQ) Installation Qualification (IQ) Pharmaceutical Development Industrialization study Operational Qualification (OQ) Development stage or historical data ( 12.11) Performance Qualification (PQ) Optimization study Technology Transfer Process Validation (PV) Process Validation Protocol Actual production scale

4 Quality (Management) System Validation Process Validation Cleaning Validation Support System Validations Computer Validation Method Validation Deviation Out of Specification Failure Investigation Corrective Action Re-Validation Change Control Annual Product Review

5 Type of API pharmacopeial non aseptic aseptic Risk Classification Previous Evaluation High Middle Low Risk Classification Risk Classification

6 No. of deficiency many middle few High Priority Risk Classification Middle Priority Low Priority

7 Revised Pharmaceutical Affairs Law and Current GMP Communication Deviation Change Control Internal Audits / Self-inspection Validation

8 Three Responsible Person in Revised Pharmaceutical Affair Law Market Approval Holder Marketing Supervisor - General Final responsibility on product for marketing Head of Quality Unit Head of Safety Unit Primary responsibility on QA operations Manufacturer Manufacture Supervisor Manufacturing Unit Quality Unit Branch and Sales Offices Peron in charge of DI Responsible Person Peron in charge of DI Responsible Person Contract Receiver of PMS operations

9 Quality Management Organization and Communication Market Approval Holder Marketing Supervisor - General Management Head of Quality Unit Manufacturer Manufacture Supervisor Quality Unit Manufacturing Unit

10 Manufacturing & Release Procedures (Released by Quality Unit in Manufacturer) Market Supervisor - General Market Approval Holder Head of Quality Unit Periodical Audit Result of Product Release Reports of Deviation and Change Assignment of person in QU, and PMS information Procedures for mfg. And Q. control and product release Manufacturer Quality Unit Manufacturing and quality control results Shipment Final Product Intermediate Product Raw Materials IPC

11 Change Control System Processing Step Raw materials Specification Support System Change control committee in Manufacturer Change control committee in Manufacturer Change control committee in Market Approval Holder Decision Change Market Approval Holder

12 Subjects for Internal Audit / Self-inspection Market Supervisor - General Market Approval Holder Oversight Reporting Head of Quality Unit Self-inspection Periodic Audit (internal Audit) Report of Corrective action Manufacturer Quality Unit Self-inspection