Compliance, FDA Inspection and Product Quality. Jim Li, Ph.D. MBA

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1 Compliance, FDA Inspection and Product Quality Jim Li, Ph.D. MBA

2 Presentation Overview Regulations and Guidance: DP: 21 CFR Parts 210 & 211 DS: ICH Q7A System based approach FDA expectation in GMP compliance Types of FDA inspection Inspection process Common violations Examples of observation 2

3 GMP Regulations and Guidance 3

4 21 CFR Parts 210 and CFR Parts 210 and 211 Title 21 Food and Drugs, Code of Federal Regulations Issued by FDA GMP Regulations for finished pharmaceuticals: OTC, Rx, IND, NDA, medical gases Establish what to do, not how to Minimal standards Maximum flexibility Specific enough to address problems Technology neutral Scalable 4

5 Part 210: cgmp General 1. Status of current good manufacturing practice regulations minimum requirements for methods, facilities or controls, manufacture, processing, packing, or holding of a drug Failure to comply renders a drug adulterated 2. Applicability of cgmp regulations , and 1271 are supplement each other A person is subject to those regulations applicable to the operations in which he or she is engaged Phase 1 drug is subject to the 21 U.S.C. 351(a)(2)(B) but exempt from part 211. If used, in phase 2 or 3 study or lawfully marketed, must comply 3. Definitions 5

6 Part 211 Subparts A. General Provision B. Organization and Personnel C. Building and Facilities D. Equipment E. Control of Components and Drug Product Containers and Closures F. Production and Process Controls G. Packaging and Labeling Controls H. Holding and Distribution I. Laboratory Controls J. Records and Reports K. Returned and Salvaged Drug Product Paragraphs 6

7 Quality built into product By taking care in making medicine Can t test quality into product Without/inadequate cgmp Product adulterated (defects need not be shown) Non-compliance = eventual problems Current = dynamic Standards evolve over time Good practices Minimal standards, not best practices Feasible and valuable No percentage in practice threshold Enforceable even nobody is doing it General Principles 7

8 ICH Q7A: GMP Guidance for APIs For manufacturing of API used in human drug products Include receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage and distribution of APIs and the related controls. Scope: chemical synthesis, extraction, cell culture/fermentation, recovery from natural sources, or any combination. Sterile API: only up to the point prior to APIs rendered sterile. Excludes vaccines, whole cells, whole blood and plasma, blood and plasma derivatives, and gene therapy APIs. Specific guidance for APIs used in clinical materials GMP does not apply to steps prior to the introduction of the defined API starting material. 8

9 Content of ICH Q7A Quality Management Personnel Building and Facilities Process Equipment Documentation and Records Materials Management Production and In-Process Controls Packaging and Identification Labeling of APIs and Intermediates Storage and Distribution Laboratory Controls Validation Change Control Rejection and Re-Use of Materials Complaints and Recalls Contract Manufacturers (Including Laboratories) Agents, Brokers, Traders, Distributors, Repackers, and Relabelers Specific Guidance for APIs Manufactured by Cell Culture/Fermentation APIs for Use in Clinical Trials 9

10 Systems Based GMP Approach 11

11 Systems Based GMP Activities in drug firms can be organized into systems that are sets of operations and related activities Control of all systems helps to ensure the firm will produce drugs that are safe, have the identity and strength, and meet the quality and purity characteristics as intended 12

12 Six Systems 13

13 Inspection of Systems 2 systems, with QS as mandatory, System Based Inspection Numbers of systems covered depends on the purpose of an inspection Inspection of certain number of systems provide the basis for an overall cgmp decision Coverage of a system in sufficient details so that the outcome reflects the state of control in that system for every profile class If a particular system is adequate, it should be adequate for all profile classes Complete inspection of one system may necessitate further follow-up of some items within another system 14

14 Expectation to Systems Common to All Systems Written procedures Adherence to procedures verified through observation where possible Personnel qualification and training Investigation into any unexpected discrepancies Records for production, control and distribution Change control Computer qualification, validation, and security 15

15 Quality System This system assures overall compliance with cgmp, internal procedures and specifications Quality control unit and all of its review & approval duties (e.g. change control, reprocessing, batch release, annual record review, validation protocols & reports, etc.) All product defect evaluations and evaluation of returned and salvaged drug products See 21 CFR 211 Subparts B, E, F, G, I, J and K. 16

16 Pharmaceutical Quality System Model GMP 17

17 Quality System Inspection Coverage Product reviews Complaint reviews Discrepancy & failure investigations Change control Reprocess & rework Returns & salvage Rejects Stability failures Quarantine Validation status Training/qualificat ion 18

18 Facilities and Equipment System Measure & activities which provide an appropriate physical environment and resources used to produce drugs of drug products Buildings and facilities along with maintenance Equipment qualifications Equipment calibration & preventative maintenance Cleaning & validation of cleaning procedures Utilities that are not intended to be incorporated into the product such as HAVC, compressed gases, steam and water systems See 21 CFR Subparts B, C, D and J 19

19 Facilities and Equipment Coverage - Facilities Cleaning & maintenance HVAC to prevent cross contamination Layout to prevent mix-ups and contamination Lighting, sewage & refuse disposal, potable water, washing & toilet facilities Sanitation of the building 20

20 Facilities and Equipment Coverage - Equipment IQ/OQ Design, size, location Surface not reactive, additive, or absorptive Cleaning procedures and validation Calibration and maintenance Identification Controls to prevent contamination 21

21 Materials System Measures & activities to control finished products, components, including water or gases, that are incorporated into the product, containers and closures Validation of computerized inventory control processes Drug storage Distribution controls Records See 21 CFR 211 Subparts B, E, H and J 22

22 Materials System Coverage Identification & inventory Storage conditions Quarantine Sampling Testing Retesting FIFO Water & process gas Distribution records Rejection 23

23 Production System Measures & activities to control the manufacture of drugs and drug products Batch compounding Dosage form production In-process sampling and testing Process validation Establishing, following, and documenting performance of approved manufacturing procedures See 21 CFR Subparts B, F, and J 24

24 Production System Coverage Charge-in of components Identification of equipment status Formulation Master & batch records Yields Time limits Process validation Other validation Cleaning, sterilization, & depyrogenation Environmental control & monitoring In-process controls 25

25 Packaging and Labeling System Measures & activities that control the packaging and labeling of drugs and drug products Written procedures Label examination and usage Label storage and issuance Packaging and labeling operations controls Validation of these operations See 21 CFR Subparts B, G and J 26

26 Packaging and Labeling System Coverage Acceptance of materials Storage Control of different labeling Visual identification Control of filled unlabeled containers Packaging records Specimens of label Issuance of labeling Examination of finished labeled product 27

27 Packaging and Labeling System Coverage Lot numbers Separation between packaging and labeling lines Monitoring of printing devices Line clearance Expiration dates Temper-evident packaging requirements Validation 28

28 Laboratory Control System Measures & activities related to: Laboratory procedures Testing Analytical methods development and validation or verification Stability program See 21 CFR 211 Subparts B, I, J and K 29

29 Laboratory Control System Coverage Staff Equipment & facility Calibration & maintenance Reference standards System suitability Samples Raw data Methods validation & verification Procedures OOS Records Stability Reserve samples 30

30 State of Control If quality, identity, strength and purity of the products from a system cannot be adequately assured the system is out of control. If any system is out of control, the firm is considered out of control Findings of deficiency may be used as evidence for taking appropriate advisory, administrative and/or judicial actions If one or more systems is/are out of control The outcome will be classified official action indicated (OAI) Type of action is based on the seriousness and/or the frequency of the problem Significant and/or a trend of deficiencies may result in the issuance of a Warning Letter or other regulatory actions 31

31 Types of GMP Inspections 32

32 Type of Inspection Surveillance Inspections For-Cause Inspections Pre-approval Inspections 33

33 Surveillance Inspections Full Inspection A broad and deep evaluation of the firm s CGMP compliance Conducted when Little or no information is known There is doubt about the CMGP compliance in the firm Follow up to previous regulatory actions. At least four systems, one must be Quality System 34

34 Abbreviated Inspection Surveillance Inspections An update evaluation of a firm s CGMP Conducted when a firm has a record of satisfactory CGMP compliance no significant recall, product defect or incidents little shift in the manufacturing profiles within last two years At least two systems, one must be Quality System Optional systems are rotated in next Inspections. For a contract lab, two systems may be considered a Full Inspection 35

35 Post-Approval Inspection Surveillance Inspections Audit for changes in the production and control practices that occur after approval Confirm that the approved applications have been appropriately supplemented to reflect those changes Cover approved products regardless of whether or not these products were covered under the preapproval program 36

36 Common Problems Found in Post-Approval FDA Audit Scale up not documented/validated prior to commercial distribution Lack of data supporting processes and controls, and changes thereto Lack of controls and records Inadequate, or lack of, validation Inadequate change control procedures Unauthorized process changes Inadequate stability data, unfulfilled stability testing commitments, Unreported stability test failures 37

37 Common Problems Found in Post-Approval FDA Audit Unfulfilled application commitments Unreported/unapproved changes in manufacturing or testing/qa procedures Improperly reported or fraudulent changes Non-permitted change to new suppliers, testing, or contract laboratories Using unapproved suppliers, testing, or contract laboratories 38

38 For-Cause Inspection Evaluate corrective actions after a regulatory action Cover areas found deficient and subjected to corrective actions Focus on systems for determination on overall compliance Firm is expected to address all of its operations in its corrective action plan, not just the deficiencies in the FDA-483 Full Inspection is used for a compliance inspection, especially if Abbreviated Inspection was used during the violative inspection In addition, For-cause inspection may be conducted under following situations Field Alert Reports (FARs) industry complaints recalls indicators of defective products etc. 39

39 Pre-Approval Inspection Inspection conducted before approval of a NDA/ANDA and CMC supplement to assure 1. Readiness for commercial manufacturing 2. Conformance to application 3. Data integrity audit The objectives determine the scope of inspection coverage At least 1 objective will be addressed during a PAI 40

40 Pre-Approval Inspection (PAI) 41

41 Priority PAI criteria: 1. Firm first time in an application 2. First application filed by applicant for DP 3. First ANDA for an approved drug 4. Product containing a NME Priority PAI 5. Product content assay has narrow range, or requires titrated dosing 6. Product or API manufactured by a substantially different process 7. API deviation is high risk (from animal tissue) or intended use changed 8. Numerous submissions/changes 9. Profile class status not updated in last 2 years (3 years for testing lab, 4 years for packaging & labeling ) If any one of the criteria is met, a PAI may be performed. 42

42 Rationales for Not Conducting a Priority PAI Facility has an acceptable profile for a similar product with a higher manufacturing complexity Facility has an unacceptable profile and a withhold recommendation is appropriate without need for a follow-up inspection Another recognized regulatory authority s inspection report may be considered for international facilities 43

43 Discretionary PAI Rationales for a Discretionary PAI Multiple applications filed in short period of time involving a single establishment Significant deficiencies were found during the last PAI Additional potentially adverse information regarding the compliance status not yet known, i.e. an expected enforcement action recommendation during an ongoing inspection, multiple recalls, or new firm management District Office or ICB determine the objective(s) of Discretionary PAI 44

44 FDA Organization 45

45 Roles of ORA Responds to inspection requests Inspects sites in accordance with the PAI program Reports findings Provides a recommendation on site acceptability to the OC/CDER 46

46 Evaluates establishments Roles of DMPQ Receive and process EER and monitor inspection status Determines if a PAI must be conducted Reviews inspection reports and recommendations Provides a site acceptability decision to other CDER offices, including initiation of regulatory actions Assures uniform application of compliance decisions and CGMP policy For international establishments, the ICB serves as the compliance office Facilitate interaction between reviewers and investigators Provide technical assistance to ORA, and participate, as needed, as member of inspection team 47

47 Roles of Review Offices CDER ONDQA, OGD, OBP, NDMS, OC/BMT Perform review of submitted information: test methods, manufacturing and control strategy Establish specifications and other regulatory commitments where needed to support application approval decisions May participate inspection CDER OND Determines and issues the final decision on NDAs and BLAs CDER OGD Determines and issues the final decision on ANDAs 48

48 Inspection Team At least one investigator and one analyst, when possible Application reviewer or CGMP subject expert DFI national expert or Pharmaceutical Inspectorate 49

49 PAI Process: Initiation District Offices 1. Approval 2. Withhold 3. Assigned to IB Inspection -NDA -ANDA -Supplement Review Offices 1. Enter into EES 2. Generate EER Domestic OC DMPQ 1. Profile review day letter 3. Review EER for foreign firm International ORA DFI Inspection 50

50 PAI Process: Inspection & Response Acceptable Unacceptable District Office DMPQ/OC Response Follow-up Firm 51

51 Outcomes: NAI (No Action Indicated) VAI (Voluntary Action Indicated) OAI (Official Action Indicated) Outcomes of Inspection Regulatory and/or Administrative Actions Application Integrity Policy Application withdrawal FDA-requested recall Warning letter Import alert/detention Consent decree Seizure Injunction Prosecution 52

52 Case Example 1 FDA 483 Observation: There is no data to support the following steps/ parameters during manufacture and packaging: Process controls and acceptance limits have not been established for manufacturing steps, such as the pre-blend roll compaction and milling steps; There is a lack of scientific rationale and data to support the blend time parameters for the scale up manufacturing process from the submission batch size of 150,000 tablets to the proposed commercial size of 1,000,000 tablets. Recommendation: Withhold 53

53 Case Example 2 FDA 483 Observation: The firm failed to establish acceptance level and rejection level criteria for particles found in the NF-Parenteral XXXXX manufactured by the firm. For example, particles were observed in samples from batch numbers; ZZZZZ validation batches and YYYYY, a post validation batch. Recommendation: Withhold 54

54 Case Example 3 FDA 483 Observation: Laboratory records do not include complete data derived from all tests, examinations, and assay necessary to assure compliance with established specifications and standards Established test procedures are not followed and documented at the time of performance Recommendation: Withhold 55

55 Case Example 4 FDA 483 Observation: Changes to the validated process were not approved by the Quality Unit prior to production. Specifically, the production manager issued written procedures for the manufacture of batch XXXX that caused the batch to be manufactured below the specifications approved by the Quality Unit during the validation of the process.. Recommendation: Withhold 56

56 Case Example 5 FDA 483 Observation: The use of instruments not meeting established specifications was observed. Specifically, failure to qualify equipment prior to use for the following pieces of equipment used in the testing of XXXX API and stability samples. There are no calibration records for the Nicolet 360 FTIR spectrophotometer. There are no calibration records for Water HPLC instrument for years of 2006 and The VWR 1330G #1 oven used for analysis of non-volatile residue has not been calibrated. Recommendation: Withhold 57

57 Discussion & Question

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