技术性文件转移SOP(研发到生产)

ORAL CAPSULES TECHNICAL TRANSFER CHAPTER 17 STANDARD OPERATING PROCEDURES SOP # P-TTD-01-01YY TECHNICAL TRANSFER DOCUMENTATION FOR ORAL CAPSULES Ø PHARMACEUTICAL PART × Edition No. : 01 Effective Date : APPROVED Ed. Status : New DD/MM/YY ____________ _____________ _____________ _______________ Department R &D QC Lab QA HHandbook of PPharmaceutical Sect: 1717. 9 GGeneric DDevelopment Page: 1 of 3 1. PURPOSE The purpose of this Standard Operating Procedure is to establish the overall table of contents for the preparation of the pharmaceutical part or section of the technical transfer file for product information transfer to the selected commercial manufacturing site facility. This SOP is specific for ANDA preparations covering oral capsules. 2. RESPONSIBILITY The Head of Pharmaceutical Development together with the Responsible Researcher for the Generic Drug Development Project. 3. FREQUENCY Each ANDA product formula developed for the US market. 4. PROCEDURE or SCOPE [4.1].The responsible personnel for the product development will prepare the pharmaceutical section of the technical transfer file (TTD) for process and data information transfer to the commercial manufacturing site facility. [4.2].The Pharmaceutical TTD file will contain all necessary pharmaceutical master formula, manufacturing methods, validation criteria, product specifications, technical data, reports, tabulations and summaries based on the pharmaceutical development work pertaining to all strengths of the generic drug development from the pre- formulation to process qualification stage. This data is required for the manufacture and control the pivotal submission batch and the three initial full size validation batches produced at the commercial manufacturing site facility. [4.3].Each section of the TTD File is presented in a modular form for ease of updating. Sections are numbered [A] to [K]. The outline of the TTD requirements is presented in a standard operating procedure format. [4.4].The requirements of the Pharmaceutical Technical Transfer documentation will be part of the Product Development SOP for the specific dosage form. This documents is based on formulation development for oral tablet dosage forms. [4.5].An pharmaceutical TTD SOP will be prepared for each separate generic dosage form under product development. 3 ORAL CAPSULES TECHNICAL TRANSFER CHAPTER 17 STANDARD OPERATING PROCEDURES SOP # P-TTD-01-01YY TECHNICAL TRANSFER DOCUMENTATION FOR ORAL CAPSULES Ø PHARMACEUTICAL PART × Edition No. : 01 Effective Date : APPROVED Ed. Status : New DD/MM/YY ____________ _____________ _____________ _______________ Department R &D QC Lab QA HHandbook of PPharmaceutical Sect: 1717. 10 GGeneric DDevelopment Page: 2 of 3 GUIDELINE TO PHARMACEUTICAL TTD REQUIREMENTS Section [A]. - General ANDA Data (Prior to starting pharmaceutical work) 1.0 Basis for ANDA Submission approved. 1.1 Patent Certification statement. 1.2 No Process Patent infringement. 1.3 Exclusivity Statement has no infringements. 1.4Comparison - Generic Drug and Reference Listed Drug composition performed. 1.5Environmental Impact Analysis Statement. Section [B]. - Active Ingredient 1.0Letter of Access from US Applicant authorizing Approved Supplier # 1 and # 2 1.1 Letter of Access from Active Supplier(s) authorizing referencing of DMF to FDA 1.2LOA notification of "Specification change statement" from Active Supplier/s #1 and #2 1.3Active Ingredient Release Specifications (include particle size, bulk density). 1.4Particle Size Specifications (and range). 1.5Bulk Density Specifications (and acceptable range). 1.6Certificates of Analysis of Drug Substance batches over past 12 months (6 copies). Section [C]. - Non active Ingredients 1.0LOA. from Approved Suppliers to US Applicant (ANDA Holder). 1.1Raw Material Release Specifications per Ingredient. 1.2Raw Material - Full Certificates of Analysis - per Ingredient - US Approved Suppliers. 1.3Raw Material - Full Certificates of Analysis - per Ingredient - Non-US Suppliers. 1.4Confirmation from US on Local Raw Material Availability in US (with C. of A.). 1.5Raw Material Data Safety Sheet per Ingredient. 1.6 Qualification of each non-active vendor (approval statement) 1.7GMP Certification of each non-active vendor. Section [D]. - Container Closure System 1.0LOA. from Approved Suppliers to US Applicant (ANDA Holder). 1.1 Statement from Container Manufacturers(s) indicating GMP status of MNF plant 1.2 Market Packaging (Container-Liner-Closure) Specifications. 1.3 Component Drawing and Specifications of container-liner-closure. 1.4CFR / USP Certifications (as per Container-Closure SOP). ORAL CAPSULES TECHNICAL TRANSFER CHAPTER 17 STANDARD OPERATING PROCEDURES SOP # P-TTD-01-01YY TECHNICAL TRANSFER DOCUMENTATION FOR ORAL CAPSULES Ø PHARMACEUTICAL PART × Edition No. : 01 Effective Date : APPROVED Ed. Status : New DD/MM/YY ____________ _____________ _____________ _______________ Department R &D QC Lab QA HHandbook of PPharmaceutical Sect: 1717. 11 GGeneric DDevelopment Page: 3 of 3. Section [E]. - Master Formula. 1.0 Master Formula and quantities (per unit dose and per 100 000 net units) 1.1 Master Formula and quantities for each dosage strength. Section [F]. - Manufacturing Procedure. 1.0 Detailed Manufacturing Procedures / method 1.1 Master Blank Batch Records for each batch size and strength 1.2 Safety Procedures and special precautions / remarks 1.3 Proposed Cleaning Validation Protocol 1.4 Proposed Process Validation Protocol 1.5 Manufacturing Standard Operating Procedures specific to new product 1.6 Reprocessing Statement. Section [G]. - In-process Controls. 1.0 In-process Manufacturing Specifications 1.1 Frequency of In-process Test Procedures for plant QC 1.2 In-process Test Procedures for plant QC 1.3 Sampling protocol for in-process and finished product. Section [H].- Finished Product Controls. 1.0 Finished Product Release Specifications. Section [I]. - Stability. 1.0 Stability Check Specifications for the proposed shelf-life. 1.1 Stability Protocol. 1.3 Stability Reports and Tabulations on Development Batches. 1.4 Statement on proposed expiration date for production labeling 1.5 Stability Post Approval Commitments (given in Annual Reports). Section [J]. - Audit and Review. 1.0 SOP Index and Checklists (read and understood - signed and dated) 1.1 Manufacturing and Control Audit Checklists (signed and dated) 1.2 Pharmaceutical Development Completion Form. (signed and dated). Section [K] - Development Report. 1.0 Pharmaceutical Development Report. 3 CAPSULES ORAL TECHNICAL TRANSFER CHAPTER 17 SOP # A-00-01-01YY STANDARD OPERATING PROCEDURES CONTENTS OF THE TECHNICAL TRANSFER DOCUMENTATION ANALYTICAL PART Edition No. : 01 Effective Date : APPROVED Ed. Status : New DD/MM/YY ____________ _____________ ______________ ______________ Department R &D QC Lab QA HHandbook of PPharmaceutical Sect: 1717. 13 GGeneric DDevelopment Page: 1 of 3 1. PURPOSE The purpose of this Standard Operating Procedure is to establish the overall table of contents for the preparation of the analytical part or section of the technical transfer file for product information transfer to the selected commercial manufacturing site facility. This SOP is specific for ANDA preparations of solid oral dosage forms. 2. RESPONSIBILITY The Head of Analytical Development together with the Responsible Researcher for the Generic Drug Development Project. 3. FREQUENCY Each ANDA product formula under development intended for the US market. 4. PROCEDURE or SCOPE [4.1].The responsible personnel for the product development will prepare the analytical section of the technical transfer file (TTD) for method and data information transfer to the commercial manufacturing site facility. [4.2].The Analytical TTD file will contain all necessary analytical methods, method validations, product specifications, technical data, reports, tabulations and summaries based on the analytical development work pertaining to the generic drug development from the pre-formulation to process qualification stage. This data is required for testing and analyzing the pivotal submission batch and the three initial full size validation batches produced at the commercial manufacturing site facility. [4.3].Each section of the TTD File is presented in a modular form for ease of updating. Sections are numbered [A] to [G]. The outline of the TTD requirements is presented in the standard operating procedure format. [4.4].The requirements of the Analytical Technical Transfer documentation will be part of the Product Development SOP for the specific dosage form. This documents is based on a Q&Q formulation development for solid oral dosage forms. [4.5].An analytical TTD SOP will be prepared for each separate generic dosage form under product development. 4 [End of Page] CAPSULES ORAL TECHNICAL TRANSFER CHAPTER 17 SOP # A-00-01-01YY STANDARD OPERATING PROCEDURES CONTENTS OF THE TECHNICAL TRANSFER DOCUMENTATION ANALYTICAL PART Edition No. : 01 Effective Date : APPROVED Ed. Status : New DD/MM/YY ____________ _____________ ______________ ______________ Department R &D QC Lab QA HHandbook of PPharmaceutical Sect: 1717. 14 GGeneric DDevelopment Page: 2 of 3 GUIDELINE TO ANALYTICAL TTD REQUIREMENTS Section [A]-General ANDA Data (prior to starting analytical work) 1.0 Basis for ANDA Submission approved. 1.1 Patent Certification clear. 1.2 Exclusivity Statement clear . 1.3 Comparison - Generic Drug and Reference Listed Drug composition. 1.4 Innovator's Insert obtained via FDA FOI (latest edition). Section [B]. - Active Ingredient 1.0 Letter of Authorization from US Applicant authorizing Approved Supplier # 1 and # 2 1.1 Letter of Authorization from Active Supplier(s) authorizing referencing of DMF to FDA 1.2 LOA notification of "Specification change statement" from Active Supplier(s) #1 & #2. 1.3 Active Ingredient Release Specifications (include particle size, bulk density). 1.4 Pharmacopoeia Assay method (if, USP). 1.5 Validated Assay Method and S-I Study Results - (if assay is not USP). 1.6 Limit Tests on Impurities and Method Validation (when required). 1.7 Summary Report in Impurity Profile of active substance. 1.8 Certificates of Analysis of Drug Substance batches over past 12 months (6 copies). Section [C]. - Non active Ingredients 1.0 LOA. from US Applicant authorizing selected US Approved Suppliers. 1.1 Raw Material Release Specifications per Ingredient. 1.2 Raw Material - Full Certificates of Analysis - per Ingredient - US Approved Suppliers. 1.3 Raw Material - Full Certificates of Analysis - per Ingredient - Non-US Approved Suppliers. 1.4 Confirmation from US on Local Raw Material Availability in US (with C. of A.). 1.5 Raw Material Test Methods (Compendial and Non-compendial) per Ingredient. 1.6 Statement that Inactive Ingredients (at max. conc. per route) in FDA Inactive IngredientGuide. Section [D]. - Container Closure System 1.0 Letter of Authorization (LOA) from US Applicant authorizing Approved Supplier 1.1 LOA. from Container Manufacturers(s) authorizing referencing of DMF to FDA 1.2 Market Packaging (Container-Liner-Closure) Specifications. 1.3 Side-by Side Comparison of Applicant and RLD Component Specifications. 1.4 Component Drawing and Specifications of container-liner-closure. 1.5 CFR / USP Certifications (as per Container-Closure SOP) CAPSULES ORAL TECHNICAL TRANSFER CHAPTER 17 SOP # A-00-01-01YY STANDARD OPERATING PROCEDURES CONTENTS OF THE TECHNICAL TRANSFER DOCUMENTATION ANALYTICAL PART Edition No. : 01 Effective Date : APPROVED Ed. Status : New DD/MM/YY ____________ _____________ ______________ ______________ Department R &D QC Lab QA HHandbook of PPharmaceutical Sect: 1717. 15 GGeneric DDevelopment Page: 3 of 3. Section [E]. - In-process Controls. 1.0 In-process Control Specifications (Bulk) 1.1 In-process Test Procedures 1.2 Results of In-process Control tests (including print-outs) 1.3 Assay method statement - i.e. same as Release Assay. Section [F]. - Finished Product Controls. 1.0 Finished Product Release Specifications 1.1 Finished Product Test Methods 1.2 Pharmacopeial Assay method (if USP) 1.3 Validated Assay (if not USP) - same as Stability Assay. 1.4 Limit Tests on Impurities and Method Validation (where required). 1.5 Certificate of Analysis of Applicant's Product. 1.6 Certificate of Analysis of Innovator's / RLD Drug. Section [G]. - Stability. 1.0 Stability Check Specifications for the proposed shelf-life. 1.1 Stability Protocol. 1.2 Stability Summary of Applicant's Generic Product. 1.3 Stability Summary of Innovator's / RLD Drug. (2 or 3 lot #’s) 1.4 Stability Reports and Tabulations on Drug Substance from Approved Supplier. 1.5 Stability Reports and Tabulations of Applicant's Product. 1.6 Stability Reports and Tabulations of Innovator's/RLD Drug. 1.7 Statement on proposed expiration date 1.8 Method for Drug Substance Assay. 1.9 Method for Drug Product Assay. 2.0 Assay method validation 2.1 Stability-Indicating Test Results Section [H]. - Audit and Review. 1.0 Vendor Compliance Audit - Approved Active Supplier/s (On-site, Mail or Fax Audit). 1.1 SOP Index and Checklists (read and understood - signed and dated) 1.2 Audit Checklists (signed and dated) 1.3 Project Completion Form. (signed and dated)3