1 Overview of Pre-Approval Inspections Presented by: Kelli F. Dobilas NWJ-DO Pre-Approval Manager
2 Pre-Approval Drug Inspections
3 What are Pre-Approval Inspections? One of the last reviews of the drug approval process, which may effect the availability to the consumer.
4 Compliance Program Objective- Assure that establishments involved in the manufacturing, testing, or other manipulation of new drug dosage forms and new drug substances are audited. (pg. 5 of CP)
5 Compliance Program Audited for: 1) compliance with CGMPs 2) for conformance with application commitments 3) authentic and accurate data 4) laboratory testing of products, including evaluations of the adequacy of analytical methodology
6 Other Compliance Programs Drug Manufacturing Inspections- as most of the time PAI will also incorporate GMP coverage of facility Center for Veterinary Medicine- CVM
7 History of Pre-Approval Inspections Generic Drug Scandal of 1980 s l990, when the agency instituted productspecific, pre-approval inspections of manufacturing sites listed in a sponsor's application.
8 Pre-Approval Acronyms PAM- Pre-Approval Manager PAI- Pre-Approval Inspection NDA- New Drug Application ANDA- Abbreviated New Drug Application IND- Investigational New Drug NADA- New Animal Drug Application (Issued through Centers Veterinary Medicine or CVM).
9 Pre-Approval Acronyms PDUFA- Prescription Drug User Fee Act User Fee Date- The date by which an agency decision on an application is due Why is this so important to the Agency?
10 PDUFA Prescription Drug User Fee Act of 1992 Allows FDA to charge for reviewing applications- in return, FDA commits to taking quicker actions in applications Provides FDA with increasing levels of resources
11 PDUFA II As a result of success, PDUFA was reauthorized extended through September 20, 2002 By 2002, PDUFA fees permitted FDA to spend an additional $161.8 million/year for the drug evaluation process Resources spent to hire personnel to review applications; update IT infrastructure
12 PDUFA Congress re-evaluates and considers renewal of PDUFA every 5 years
13 Pre-Approval Acronyms CMC- Chemistry, Manufacturing, and Controls (reviewed by investigator during inspection) Contained within CMC sections information about API; excipients; manufacturing process; reprocessing; analytical/micro testing; packaging/labeling; components; stability
14 Pre-Approval Acronyms Bioequivalence Study- A Bioavailability Study in which a comparison is made between two or more products. A generic drug (filed under an ANDA) must prove bioequivalence to the brand drug (NDA) for which it is compared. Comparison must be noted in application.
15 Generics are not required to replicate the extensive clinical trials that have already been used in the development of the original, brand-name drug. Instead, they must show they are bioequivalent to the pioneer/innovator drug and fall into acceptable parameters set for bioavailability, which is the extent and the rate at which the body absorbs the drug.
16 Pre-Approval Acronyms Biobatch for generic product (ANDA) - The batch of dosage form in which the bioequivalency study was conducted to demonstrate equivalence to the innovator product (NDA).
17 Pre-Approval Acronyms Biobatch for brand product (NDA)- the batch tested in the clinic in which the pivotal studies were conducted or the batch used in a bioequivalency study that was compared against the pivotal clinical batch.
18 Role of the PAI Manager
19 Role of the PAI Manager Liaison between Centers, Field & Applicants Physically manages 3 rd copy CMC & Correspondence Review of 3 rd copy to highlight inspectional concerns Issues PAI Inspections to District for assignment to CSOs
20 Role of the PAI Manager Receives Assignments from CDER/CVM Reviews firm s GMP history Contacts firm for clarification on operations related to application/general GMP Responds to Centers Responds to firms Schedules Post-Approval Inspections, if necessary (under CP )
21 Role of the PAI Manager Is the application for a new chemical entity? Is the application for the first generic drug? Was a GMP inspection conducted within the last year? Does the firm have an acceptable status?
22 Role of the PAI Manager What do we inspect? NDA s, ANDA s, NADA s & IND s which are manufactured, tested or packaged at either a Domestic or International Facility Inspectional coverage will include supplements (prior approval, CBE and SUPAC) All establishments listed within an application may be inspected
23 Role of the PAI Manager EES- Establishment Evaluation System- Computer system used for tracking the status of drug applications; assignments and associated firms; accessible only by the Pre-Approval Manager. (PDUFA dates and special comments for applications are noted within EES system).
24 Role of the PAI Manager Receives all third copies of applications. Issues pre-approval assignments. Tracks all district pre-approval activities. Enters District recommendations/information into EES.; Reviews inspection information (483, EIRs) for PAI, NAI- VAI inspections. Reviews inspection information (483, EIRs,) with Compliance Officer for OAI inspections which included PAI coverage. Communicates application status information to the inspected firms (District Status Notification letters).
25 Role of Firm-(manufacturing establishment)
26 Role of Firm-(manufacturing establishment Make records available to conduct the preapproval inspection Development Report Batch Records Laboratory Records Protocols/SOPs
27 Role of Firm-(manufacturing establishment The manufacturing and all associated facilities must be listed within the application (contract labs, packagers, etc.). Once an application is submitted to Center, firm and all facilities should be considered ready for inspection.
28 FDA Investigator s Role
29 FDA Investigator s Role Evaluate overall cgmp compliance Evaluate specific product and process - Is the facility adequate-building; equipment; water systems? - Is there data to justify the process? - Is there evidence/data to support the manufacturing process? - Review R&D information - Product Development Report
30 Product Development Report The data generated during product development which defines the drug product and targets the steps in the manufacturing process where variation is critical to quality and thereby focus the subsequent process validation effort.
31 Product Development Report API - Impurity Profile How is API characterized Excipients Formulation: Wet or Dry Granulation Solution or Suspension Sterile - Terminal/aseptic conditions Tablet/Capsule - Immediate/Modified Release/Extended Release
32 Product Development Report Processing: Equipment, order of addition of ingredients to the formulation, mixing times and speeds, drying time and temperature, nitrogen blankets, blending, hold times, compression, slugging, filling, polishing, imprinting, labeling and packaging. Product Report may not be a formal document
33 FDA Investigator s Role Development Data-look at all R&D batches Impurity Profile- note specifications Specifications (Data to support) Production Trends Change Control FDA Correspondence/ Deficiency Letters Stability Data
34 Equipment Qualification During the inspection the following areas should be covered: Installation Qualification Operational Qualification Performance Qualification
35 FDA Investigator s Role Sampling Plan-(SOPs outlining; techniques training of personnel) Laboratory-(SOPs; Personnel; Training) Test Methods-(Validated) Target Drug Product Specifications Reprocessing/Reworking Standard Operating Procedures Batch Records-submission batches
36 FDA Investigator s Role Reprocessing/Reworking- GMP regulations require reprocessing procedures to be in writing. If firm makes provisions for reprocessing drug product, details must be submitted as part of the application. Standard Operating Procedures Review all Batch Records-submission batches ;master batch records
37 Batch Records The batch records submitted in the application must be audited as part of the inspection to assure: That the proposed production process is the same process that was used for the manufacture of the bio/stability batches.
38 In summary the FDA Investigator s Role Conduct assigned pre-approval inspections in accordance with the compliance program and DO SOP. Conduct the pre-approval inspections by the due date listed in the assignment (or communicates the delay to the Pre-Approval Manager). Notifies Pre-Approval Manager with an Approve or Withhold recommendation. Collects profile samples per compliance program ; District policy/iom; and Profile Sample Memo issued in Completes all PDUFA assignments and gives recommendation by due date (no exceptions!!!).
39 In summary the FDA Investigator s Role Investigator should inform firm of the outcome of the inspection. Inspected firm will receive a Post Inspectional Letter from the inspecting district informing them of recommendation made to CDER. Firm should receive a copy of the establishment inspection report (FMD-145)
40 Examples of 483 Observations Analysts had access to all data which was stored on the hard drive. With no security measures taken, including no procedures for backup, no procedures for password usage, and no procedures for data file handling, analysts could overwrite, alter and delete original data.
41 Examples of 483 Observations Segregation of particles in a new hopper over the encapsulation operation resulted in a failure of the validation bulk capsule assay criteria. Validation personnel failed to notify Quality Assurance of the failure. The product was recalled from the market on.
42 Examples of 483 Observations Other examples have been related to: No raw data or missing data to support he application No investigation of batch failures or out-ofspecification (OOS) results Lack of validation for essential equipment Lack of validated analytical methods
43 Communicate Communicate findings with firm Discuss your recommendation with your supervisor; with PAM Within 2 days send recommendation to PAM (CDER EES Report- page 2)
44 NWJ-DO- Past examples for reasons to Withhold Ill defined API quality-particle size, potency failure, quality attributes No processing equipment qualification Inadequate manufacturing environment Manufacturing and Laboratory OOS and Deviation Investigations Ill defined processing procedures Laboratory Data & Results Reporting
45 40 Withhold Recommendation Categories Drug not made here Facility withdrawn from application Firm not ready Inadequate firm response Previous deviations persist
46 40 Withhold Recommendation Categories Insufficient development data Building & Facilities Contamination Pending regulatory actions Warning Letter Seizure Injunction
47 40 Withhold Recommendation Categories Inadequate change control procedure Component or intermediate controls Deviation from DMF/NDA/ANDA Deviation from monograph Environmental controls
48 40 Withhold Recommendation Categories Holding & distribution Lab controls Master record non-specific or deficient Packaging and labeling controls Production and process controls QA Functions
49 40 Withhold Recommendation Categories Organization Records/reports Reprocessing Specifications Stability program SOP s lacking or inadequate Training System Qualification (IQ/OQ)
50 40 Withhold Recommendation Categories Validation Issues API process validation computer validation HVAC validation Media Fills Water system validation Scale-up validation failure Validation protocol inadequate Equipment Qualification Equipment cleaning validation
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