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ORAL CAPSULES

TECHNICAL TRANSFER

CHAPTER 17

STANDARD OPERATING
PROCEDURES
SOP # P-TTD-01-01YY

TECHNICAL TRANSFER DOCUMENTATION FOR ORAL CAPSULES

Ø PHARMACEUTICAL

PART

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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 preformulation 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

Edition No. : 01 Ed. Status : New

Effective Date : DD/MM/YY

APPROVED
____________ Department _____________ R &D _____________ QC Lab _______________ QA

Handbook of Pharmaceutical

Sect: 17. 9 17

Generic Development

3 1. Environmental Impact Analysis Statement.0 1. Section [B].4 1.US Approved Suppliers. Raw Material . Statement from Container Manufacturers(s) indicating GMP status of MNF plant Market Packaging (Container-Liner-Closure) Specifications.6 Letter of Access from US Applicant authorizing Approved Supplier # 1 and # 2 Letter of Access from Active Supplier(s) authorizing referencing of DMF to FDA LOA notification of "Specification change statement" from Active Supplier/s #1 and #2 Active Ingredient Release Specifications (include particle size.Full Certificates of Analysis .0 1. Status : New Effective Date : DD/MM/YY APPROVED ____________ Department _____________ R &D _____________ QC Lab _______________ QA Handbook of Pharmaceutical Sect: 17.1 1.1 1. Component Drawing and Specifications of container-liner-closure. Certificates of Analysis of Drug Substance batches over past 12 months (6 copies). Section [D]. Patent Certification statement. from Approved Suppliers to US Applicant (ANDA Holder). 1.4 1.Container Closure System LOA.3 1. Comparison . Raw Material . Raw Material Release Specifications per Ingredient.2 1. Qualification of each non-active vendor (approval statement) GMP Certification of each non-active vendor.3 1.5 1.4 1. 10 17 Generic Development .0 1.ORAL CAPSULES TECHNICAL TRANSFER CHAPTER 17 STANDARD OPERATING PROCEDURES SOP # P-TTD-01-01YY TECHNICAL TRANSFER DOCUMENTATION FOR ORAL CAPSULES Ø PHARMACEUTICAL PART × Page: 2 of 3 GUIDELINE TO PHARMACEUTICAL TTD REQUIREMENTS Section [A]. Edition No. CFR / USP Certifications (as per Container-Closure SOP). : 01 Ed. Particle Size Specifications (and range).2 1. .2 1.7 LOA.Non-US Suppliers.5 Basis for ANDA Submission approved. .General ANDA Data (Prior to starting pharmaceutical work) 1. Section [C].6 1.Full Certificates of Analysis . from Approved Suppliers to US Applicant (ANDA Holder). Exclusivity Statement has no infringements.).0 1. No Process Patent infringement.3 1. .per Ingredient .1 1.4 . of A. Bulk Density Specifications (and acceptable range).Non active Ingredients 1.per Ingredient .5 1. Raw Material Data Safety Sheet per Ingredient.Active Ingredient 1. bulk density).1 1.Generic Drug and Reference Listed Drug composition performed. Confirmation from US on Local Raw Material Availability in US (with C.2 1.

6 Detailed Manufacturing Procedures / method Master Blank Batch Records for each batch size and strength Safety Procedures and special precautions / remarks Proposed Cleaning Validation Protocol Proposed Process Validation Protocol Manufacturing Standard Operating Procedures specific to new product Reprocessing Statement.0 1.Manufacturing Procedure. 1.0 1. Stability Reports and Tabulations on Development Batches. Section [J]. 1. Section [K] .ORAL CAPSULES TECHNICAL TRANSFER CHAPTER 17 STANDARD OPERATING PROCEDURES SOP # P-TTD-01-01YY TECHNICAL TRANSFER DOCUMENTATION FOR ORAL CAPSULES Ø PHARMACEUTICAL PART × Page: 3 of 3. 11 17 Generic Development .0 1.0 1.1 1.. . Section [I].1 1.Stability. 1.1 Master Formula and quantities (per unit dose and per 100 000 net units) Master Formula and quantities for each dosage strength.0 1.4 1. Section [E].5 1.Audit and Review. Statement on proposed expiration date for production labeling Stability Post Approval Commitments (given in Annual Reports). (signed and dated).Development Report. 1.Master Formula.3 1.Finished Product Controls. Section [F]. Stability Protocol.3 1.2 SOP Index and Checklists (read and understood .5 Stability Check Specifications for the proposed shelf-life.3 In-process Manufacturing Specifications Frequency of In-process Test Procedures for plant QC In-process Test Procedures for plant QC Sampling protocol for in-process and finished product. : 01 Ed.1 1.In-process Controls. . Section [H]. Status : New Effective Date : DD/MM/YY APPROVED ____________ Department _____________ R &D _____________ QC Lab _______________ QA Handbook of Pharmaceutical Sect: 17.signed and dated) Manufacturing and Control Audit Checklists (signed and dated) Pharmaceutical Development Completion Form.0 Pharmaceutical Development Report. Section [G].1 1.2 1. 1.4 1. .0 Finished Product Release Specifications. . 3 Edition No.2 1. 1. 1. .

4.4]. The outline of the TTD requirements is presented in the standard operating procedure format. Status : New Effective Date : DD/MM/YY APPROVED ____________ Department _____________ ______________ R &D QC Lab ______________ QA Handbook of Pharmaceutical Sect: 17. [4.1].2]. 13 17 Generic Development . 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 [End of Page] Edition No. Sections are numbered [A] to [G]. This documents is based on a Q&Q formulation development for solid oral dosage forms. : 01 Ed. The requirements of the Analytical Technical Transfer documentation will be part of the Product Development SOP for the specific dosage form.5]. PROCEDURE or SCOPE [4. method validations. [4. reports. 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. technical data. Each section of the TTD File is presented in a modular form for ease of updating. tabulations and summaries based on the analytical development work pertaining to the generic drug development from the pre-formulation to process qualification stage. RESPONSIBILITY The Head of Analytical Development together with the Responsible Researcher for the Generic Drug Development Project. 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. The Analytical TTD file will contain all necessary analytical methods. 2. [4.3]. An analytical TTD SOP will be prepared for each separate generic dosage form under product development.CAPSULES ORAL TECHNICAL TRANSFER CHAPTER 17 SOP # A-00-01-01YY STANDARD OPERATING PROCEDURES CONTENTS OF THE TECHNICAL TRANSFER DOCUMENTATION ANALYTICAL PART Page: 1 of 3 1. product specifications. 3. This SOP is specific for ANDA preparations of solid oral dosage forms. [4. FREQUENCY Each ANDA product formula under development intended for the US market.

Status : New Effective Date : DD/MM/YY APPROVED ____________ Department _____________ ______________ R &D QC Lab ______________ QA Handbook of Pharmaceutical Sect: 17. 1. 1.6 LOA. Patent Certification clear. 1. Innovator's Insert obtained via FDA FOI (latest edition).8 Certificates of Analysis of Drug Substance batches over past 12 months (6 copies). CFR / USP Certifications (as per Container-Closure SOP) Edition No.0 Letter of Authorization from US Applicant authorizing Approved Supplier # 1 and # 2 1. 1. Raw Material Release Specifications per Ingredient.Generic Drug and Reference Listed Drug composition.0 1.2 1.Full Certificates of Analysis .US Approved Suppliers.1 1.4 1. Confirmation from US on Local Raw Material Availability in US (with C. Comparison .). from Container Manufacturers(s) authorizing referencing of DMF to FDA Market Packaging (Container-Liner-Closure) Specifications.1 1.Non active Ingredients 1.(if assay is not USP). USP).7 Summary Report in Impurity Profile of active substance.5 Validated Assay Method and S-I Study Results .3 Active Ingredient Release Specifications (include particle size. .6 Limit Tests on Impurities and Method Validation (when required).per Ingredient . Statement that Inactive Ingredients (at max.5 Letter of Authorization (LOA) from US Applicant authorizing Approved Supplier LOA.4 1. 14 17 Generic Development . Section [B]. . Section [D].1 1. Side-by Side Comparison of Applicant and RLD Component Specifications. of A.3 1.0 1. per route) in FDA Inactive Ingredient Guide. Raw Material . bulk density). Raw Material Test Methods (Compendial and Non-compendial) per Ingredient.1 Letter of Authorization from Active Supplier(s) authorizing referencing of DMF to FDA 1.2 1. from US Applicant authorizing selected US Approved Suppliers. Raw Material .CAPSULES ORAL TECHNICAL TRANSFER CHAPTER 17 SOP # A-00-01-01YY STANDARD OPERATING PROCEDURES CONTENTS OF THE TECHNICAL TRANSFER DOCUMENTATION ANALYTICAL PART Page: 2 of 3 GUIDELINE TO ANALYTICAL TTD REQUIREMENTS Section [A]-General ANDA Data (prior to starting analytical work) 1. 1.per Ingredient .Full Certificates of Analysis .2 1.5 1.3 1. conc. Section [C]. 1.Non-US Approved Suppliers.4 Pharmacopoeia Assay method (if. .2 LOA notification of "Specification change statement" from Active Supplier(s) #1 & #2.3 1.0 1. Component Drawing and Specifications of container-liner-closure.Container Closure System 1. : 01 Ed.Active Ingredient 1.4 Basis for ANDA Submission approved. Exclusivity Statement clear .

Stability Protocol.6 Finished Product Release Specifications Finished Product Test Methods Pharmacopeial Assay method (if USP) Validated Assay (if not USP) .1 1.e.2 1.9 2. SOP Index and Checklists (read and understood . Section [G]. Stability Summary of Applicant's Generic Product. Statement on proposed expiration date Method for Drug Substance Assay.2 1.1 1.same as Stability Assay. 1.6 1. 1.3 1.1 1.2 1.1 1. .5 1.2 1. Certificate of Analysis of Innovator's / RLD Drug. . Section [F]. Stability Reports and Tabulations of Innovator's/RLD Drug. (2 or 3 lot #’s) Stability Reports and Tabulations on Drug Substance from Approved Supplier. Section [E]. Assay method validation Stability-Indicating Test Results Section [H].4 1.3 In-process Control Specifications (Bulk) In-process Test Procedures Results of In-process Control tests (including print-outs) Assay method statement .0 2.1 Stability Check Specifications for the proposed shelf-life.3 Vendor Compliance Audit .0 1. Stability Summary of Innovator's / RLD Drug. 1.i.8 1.Stability.In-process Controls. : 01 Ed. (signed and dated) 3 Edition No.signed and dated) Audit Checklists (signed and dated) Project Completion Form. Mail or Fax Audit).Audit and Review.4 1.5 1.0 1.Finished Product Controls. 15 17 Generic Development . Method for Drug Product Assay.0 1. Limit Tests on Impurities and Method Validation (where required).3 1. same as Release Assay. .0 1. 1.CAPSULES ORAL TECHNICAL TRANSFER CHAPTER 17 SOP # A-00-01-01YY STANDARD OPERATING PROCEDURES CONTENTS OF THE TECHNICAL TRANSFER DOCUMENTATION ANALYTICAL PART Page: 3 of 3. Stability Reports and Tabulations of Applicant's Product. Status : New Effective Date : DD/MM/YY APPROVED ____________ Department _____________ ______________ R &D QC Lab ______________ QA Handbook of Pharmaceutical Sect: 17.Approved Active Supplier/s (On-site. .7 1. Certificate of Analysis of Applicant's Product.