How to overcome Non compliance (483) related To manufacturing of Drug Products and observations Found during the audits?

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1 How to overcome Non compliance (483) related To manufacturing of Drug Products and observations Found during the audits? IPA Maharashtra Seminar at SciTech Centre Jogeshwari Mumbai on By Sudhir Phatak MSc, DCM, DIM CEO Futurol Enterprises FUTUROL ENTERPRISES Pharmaceutical Consultancy Services SUDHIR PHATAK B.Sc., M.Sc., DCM, DIM, Lead Auditor ISO 9001:2008 (TUV) MOB N0: Mail ID: Office Address: S. NO. 5/3/7, Aditya Shagun Mall, Shop No. 63, Bawdhan, Pune This presentation is property of Futurol Enterprises GMP Consultant. The contents are for training purpose only. Any unauthorized copying is strictly prohibited.

2 All of us we are aware of promising Growth Pattern of Indian Pharmaceutical Industry! On one side we get excited about this exciting growth prospects and on other side many Indian Pharmaceutical companies are facing regulatory actions for Non Compliance

3 NEWS YEAR 2013 USFDA penalties for a Indian Pharmaceutical Company have been higher than $500 million May 19, 2013 The Times of India US FDA asks Indian drugmakers to comply or face action July 28, 2013 The Economic Times Indian drug companies need to shape up as US FDA tightens norms October 13, 2013 The Hindu

4 SWOT ANALYSIS OF INDIAN PHARMACEUTICAL BUSINESS Strengths Cost Effective Operations Developing Manufacturing Base Adequate Manpower Market Potential Weakness Poor Infrastructure Lack of sufficient Trained Manpower Lack of GMP Culture DPCO Pressure Quality Vs Quantity Imbalance Opportunities Possible Robust growth rate of 15 to 20% till Conducive atmosphere. Globalization Threats Increase in Non compliances Increase in Substandard Products, Increase in ADR, Product Recalls & their Impact on Export and Domestic Business

5 Why to study 483s and Warning Letters? Increase in Non compliances is a real threat to the Possible Robust growth rate of 15 to 20% till To avoid this possible impact, it is very important for Indian Pharmaceutical professionals to proactively study the 483s and Warning Letters issued recently to various Pharmaceutical companies. As you know Form FDA 483 is a form used by the FDA to document and communicate concerns discovered during these inspections. Warning Letters is a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations.

6 483s Classification Year Classification of 483 Year 2012 % QULITY CONTROL QUALITY ASSURANCE PRODUCTION ENGINEERING Series2 WAREHOUSE Total QC QA PROD ENGG WH

7 Year 2012 IT IS INTERESTING TO STUDY FIVE MOST COMMON CITATIONS IN PRODUCTION Cite Id Sr No Ref No Frequency Short Description Long Description CFR (a) CFR (a) CFR (b) CFR (a) CFR (b) 64 PRODUCTION: Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Specifically, *** Control procedures are not established which [monitor the output] [validate the performance] of PRODUCTION: those manufacturing processes that may be Control procedures are not responsible for causing variability in the established to monitor and characteristics of in-process material and the drug validate process performance product. Specifically, *** PRODUCTION: Written procedures not established/followed for Cleaning PRODUCTION: Cleaning / Sanitizing / Maintenance not performed PRODUCTION: SOPs not followed / documented Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. Specifically, *** Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent [malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug product. Specifically, *** Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance]. Specifically, *** TOTAL 407

8 Year s GLOBAL DATA REVIEW OF FIVE MOST COMMON CITATIONS IN PRODUCTION Key Issues: Written Procedures are not available. If available they are not comprehensive. Procedures are not validated considering all critical process parameters (CPP). Control procedures are not established to monitor and validate process performance. Procedures are without Logical Sequence and there is no provision to document all the In process control data, deviations and there is no link with CAPA. Written Validated Procedures are available but not followed. Critical variable are changed unofficially to get desired parameters like speed of machine etc.

9 Year s GLOBAL DATA REVIEW OF FIVE MOST COMMON CITATIONS IN PRODUCTION Key Issues: The deviations are not recorded and addressed in a systematic manner. If investigated the actual Root Cause is not identified but the root cause of convenience i.e. easy to address is considered and shown as addressed this results in ineffective CAPA. Cleaning Validations and Cleaning Procedures not in place. Equipment not cleaned as per the procedures. Preventive Maintenance is not effective.

10 Year s GLOBAL DATA REVIEW OF FIVE MOST COMMON CITATIONS IN PRODUCTION Cite Id Sr No Ref No Frequency Short Description and Long Description Compliance CFR (a) 116 PRODUCTION: Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Specifically, *** Corrective Action: To prepare new procedures or revise the existing procedures to ensure Correctness and Completeness followed by effective implementation. Preventive Action: To design comprehensive procedures considering QBD with Risk Based Approach as per various guidelines like ICH, PIC/s, 21 CFR etc

11 Written Procedures are not available. If available they are not comprehensive. How to write the comprehensive procedure? Let us study one example: ph adjustment step in the BMR Collect 200 L WFI. Add NaOH to adjust the ph to 8.5 A) This statement in the BMR is not providing the necessary details like Whether to use NaOH Solution or pellets? Procedure shall specify. What shall be grade of NaOH? Quality of Excipients If NaOH solution to be used, What is the concentration of NaOH Solution? Procedure How to prepare NaOH solution of desired concentration? Procedure Whether addition is Manually or with a pump? Procedure What is the Speed of addition? Critical Process Parameter With stirring or without stirring? Procedure

12 How to write the comprehensive procedure? If addition is with stirring at what RPM? Critical Process Parameter When to check ph? (Validated Stabilization time) IPQC Sampling position to check the ph. IPQC What to do if ph goes above target ph? Critical Process Parameter Record of destruction of excess NaOH solution. Documentation Whether BMR has provision to record all the details? Documentation Whether this step is in line with PDR? QBD Whether this procedure is validated? Process Validation To ensure ph of the final rinse after cleaning the vessel. Cleaning Validation etc

13 Risk Management Type A B BMR Step Failure mode Potential cause for failure Severity Occurrence Detectability RPN Comment Before NMT 250 ph adjustment ph Lack of Comprehensive Procedure High Risk After ph adjustment ph Lack of Comprehensive Procedure Acceptable Risk Risk Mitigation by CAPA To rewrite a comprehensive procedure NA

14 Year s GLOBAL DATA REVIEW OF FIVE MOST COMMON CITATIONS IN PRODUCTION Cite Id Sr No Ref No Frequency CFR (a) 89 Short Description and Long Description PRODUCTION: Control procedures are not established to monitor and validate process performance Control procedures are not established which [monitor the output] [validate the performance] of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Specifically, *** Long Description Corrective Action: To prepare new procedures or revise the existing procedures to incorporate in process controls Preventive Action: To validate the procedures considering CPCP and CQP as defined in various PV guidelines like PIC/s, 21 CFR, EU GMP etc

15 483 Sept 2012 It is observed the validated parameters are frequently changed without initiating a deviation form. Eg : Compression Speed Changed 483 observation: a target process parameter for Compression Machine Speed was not established (validated) to ensure desired thickness, hardness and avoid sticking of punches. The compression speed is selected is not a validated speed. This speed is selected to avoid sticking of the punches. QMS : To raise incident/ unplanned deviation and investigate to understand the root cause followed CAPA to eliminate the root cause. To ensure Process Validation in place for all the products.

16 Year s GLOBAL DATA REVIEW OF FIVE MOST COMMON CITATIONS IN PRODUCTION Cite Id Sr No Ref No Frequency CFR (b) 73 Short Description and Long Description PRODUCTION: Written procedures not established/ followed Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. Specifically, *** Long Description Corrective Action: To establish the existing procedures and to ensure that they are followed effectively. Preventive Action: To proactively ensure all the procedures are established and followed through self inspection/ Internal Audit or by GAP Analysis by external consultants

17 Production 483(R2014) Written procedures not established/ followed Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR (b)). Non-integral and non-sterile gloves are used for aseptic processing. New vendors for supply of gloves are not qualified Procedures to examine gloves prior to use are not with specific instructions. eg How to perform inspection? Disinfection procedure of the gloves is not established. In summary, we disagree with your response that your firm is in a state of control and the use of defective gloves is not a significant problem.

18 Written procedures not established/ followed Your media fill studies are inadequate. Significant number of media fill vials were rejected without justification. Please note that no amount of successful media fills can be used to validate poor aseptic design, operations, controls, and practices. Your firm failed to establish an adequate system/ procedure for monitoring environmental conditions in aseptic processing Your firm did not adequately assess contamination risk to determine the worstcase locations and timing for your active viable air monitoring sites. Investigation SOP not followed: Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already has already been distributed (21 CFR ).

19 Year s GLOBAL DATA REVIEW OF FIVE MOST COMMON CITATIONS IN PRODUCTION Cite Id Sr No Ref No Frequency CFR (a) 65 Short Description and Long Description PRODUCTION: Cleaning / Sanitizing / Maintenance Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent [malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug product. Specifically, *** Long Description Corrective Action: To Design and establish Cleaning, sanitization and maintenance procedures and ensure effective implementation. Preventive Action: To perform Cleaning and Sanitization Validations and incorporate the steps in BMR. To ensure periodic preventive maintenance of equipment.

20 Cleaning Validation issues! Written procedures for cleaning non-dedicated equipment do not adequately define methods, equipment and parameters (such as volume of water, time, pressure) used to ensure controlled, effective and consistent/reproducible cleaning results. Cleaning Validation is not performed considering the Worst Case Cleaning Validation Procedures are not derived based on Cleaning validation Study. Critical parameters in Cleaning SOPs like volume of water, time, pressure etc are not derived in cleaning Validations. There is no data to support that presumed hard to clean areas, where swab sampling occurs, were scientifically determined. Visible residual material from previous lot was observed during this inspection in the air inlet and exhaust areas of cleaned and company production.

21 Year s GLOBAL DATA REVIEW OF FIVE MOST COMMON CITATIONS PRODUCTION Cite Id Sr No Ref No Frequency CFR (b) 64 Short Description and Long Description PRODUCTION: SOPs not followed / documented Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance]. Specifically, *** Long Description Corrective Action: Training Preventive Action: Self Inspection and Document Review

22 Level 6 citation in Production Cite Id Sr No Ref No Frequency Short Description and Long Description BMR not prepared for each batch, include complete information. Long Description CFR Batch production and control records [are not prepared for each batch of drug product produced] [do not include complete information relating to the production and control of each batch]. Specifically, *** Corrective Action: BMR to be prepared for each Batch Preventive Action: To ensure that QMS demands for preparation of BMR for each batch.

23 Level 7 citation in Production Cite Id Sr No Ref No Frequency CFR Short Description and Long Description Equipment used in the manufacture, processing, packing or holding of drug products is not [of appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use] [cleaning and maintenance]. Specifically, *** Long Description Corrective Action: To replace existing equipment by equipment of suitable design. To perform cleaning and maintenance as per SOP Preventive Action: To arrange for equipment of suitable design. To design Preventive maintenance schedule to maintain each equipment with desired frequency.

24 Level 8 citation in Production Cite Id Sr No Ref No Frequency CFR (b) 47 Short Description and Long Description Procedures designed to prevent microbiological contamination of sterile drug products are not established, written and followed. Long Description Corrective Action: To write the procedures to prevent microbial contaminations and implement.

25 Year s GLOBAL DATA REVIEW OF THREE MOST COMMON CITATIONS IN QUALITY CONTROL Cite Id Sr No Ref No Frequency Short Description Long Description QC CFR (d) CFR (b) CFR (a) 62 QUALITY CONTROL Procedures not in writing, fully followed QUALITY CONTROL Scientifically sound laboratory controls not implemented QUALITY CONTROL Testing and release for distribution The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, *** Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity. Specifically, *** Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient] prior to release. Specifically, *** Above observations result in OOS results which are investigated thoroughly. It is observed that Investigators usually draw conclusions which are easy to address and actual Root Cause is not kept aside unaddressed. TOTAL 346

26 OOS in OOS in Related Substance: OOS concluded that the root cause for the detection the Related Substance was use of dirty glassware by the analyst. The investigation did not reveal the source of the un cleaned glassware. The OOS data was invalidated and the sample was retested and released. What is the root cause of the usage of unclean glassware is not identified. The investigation is inadequate and does not raise many questions like: Whether Glassware Cleaning Validation is in place? If Yes: Whether the Glassware Cleaning Validation is performed correctly? If No: Was there is any deviation if glassware Cleaning validation was in place? What is the impact on other analytical results? What is CAPA?

27 OOS in Total Organic Carbon (TOC) excursion OOS concluded that the root cause for the Total Organic Carbon (TOC) excursion of two water monitoring points was due to sample exposure in vial or undue contamination due to exposure of the sample vials. Interviews with the analyst did not indicate that the caps had been left off or improperly affixed to support this root cause. The OOS data was invalidated and new water samples were collected and analyzed. The investigation is inadequate and does not raise many questions like: Whether Sampling procedure was validated? Whether the sample are maintained in properly closed condition? Whether the vials used were clean? Whether cleaning procedure is validated?

28 Year s GLOBAL DATA REVIEW OF THREE MOST COMMON CITATION IN QUALITY CONTROL Cite Id Sr No Ref No Frequency Short Description Long Description QC CFR (d) 169 QUALITY CONTROL Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, ***

29 Year s GLOBAL DATA REVIEW OF THREE MOST COMMON CITATIONS IN QUALITY CONTROL Cite Id Sr No Ref No Frequency Short Description Long Description CFR (b) 115 QUALITY CONTROL Scientifically sound laboratory controls not implemented Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity. Specifically, ***

30 Year s GLOBAL DATA REVIEW OF THREE MOST COMMON CITATIONS IN QUALITY CONTROL Cite Id Sr No Ref No Frequency Short Description Long Description CFR (a) 62 QUALITY CONTROL Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient] prior to release. Specifically, ***

31 Year s GLOBAL DATA REVIEW OF THREE MOST COMMON CITATIONS IN QUALITY CONTROL Key issues: Procedures and Data Integrity Quality Control Systems are deficient especially for Sampling, Sample Handling, Validated Testing Procedures, Testing, Raw Data, COA, Release, Stability and CSV. OOS are investigated however Root Cause is not convincing

32 Year s GLOBAL DATA REVIEW OF TWO MOST COMMON CITATIONS IN QUALITY ASSURANCE Cite Id Sr No Ref No Frequency Short Description Long Description CFR CFR (a) 65 QUALITY ASSURANCE Inadequate Investigations of discrepancies, failures QUALITY ASSURANCE: Training--operations, GMPs, written procedures There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed. Specifically, *** Employees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices] [written procedures required by current good manufacturing practice regulations]. Specifically, *** TOTAL 184 Key Issues: Investigation Reports either not available or Inadequate There is no proper Impact Assessment, Root Cause Analysis, Risk Assessment, Correction, CAPA, Effectiveness of CAPA

33 Year s GLOBAL DATA REVIEW OF TWO MOST COMMON CITATIONS IN QUALITY ASSURANCE Cite Id Sr No Ref No Frequency Short Description Long Description CFR QUALITY ASSURANCE Inadequate Investigations of discrepancies, failures There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed. Specifically, *** Key Issues: Investigation Reports either not available or Inadequate There is no proper Impact Assessment, Root Cause Analysis, Risk Assessment, Correction, CAPA, Effectiveness of CAPA

34 Year s GLOBAL DATA REVIEW OF TWO MOST COMMON CITATIONS QUALITY ASSURANCE Cite Id Sr No Ref No Frequency Short Description Long Description CFR (a) 65 QUALITY ASSURANCE: Training--operations, GMPs, written procedures Employees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices] [written procedures required by current good manufacturing practice regulations]. Specifically, ***

35 Year s GLOBAL DATA REVIEW OF TWO MOST COMMON CITATIONS IN QUALITY ASSURANCE Key Issues: Investigation Reports either not available or Inadequate There is no proper Impact Assessment, Root Cause Analysis, Risk Assessment, Correction, CAPA, Effectiveness of CAPA

36 Investigations Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.

37 Year s GLOBAL DATA REVIEW OF MOST COMMON CITATIONS IN ENGINEERING Cite Id Sr No Ref No Frequency Short Description Long Description CFR (a) 69 TOTAL 69 Calibration/Inspection/Checking not done Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance. Specifically, ***

38 Review of Warning letters to Indian Companies Example 1 1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR (b)). 2. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing (21 CFR (c)(10)(iv)). 3. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas of such other control systems necessary to prevent contamination or mix -ups (21 CFR (c)) Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already has already been distributed (21 CFR ).

39 Review of Warning letters to Indian Companies Example 1 5. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR (b)). 6. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR (b)). Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition (21 CFR (a)).

40 Compliance Mantra. Be Proactive Follow cgmp Norms New Facility Design new Facility considering cgmp norms Design and Implement a comprehensive and robust QMS with Risk Based Approach Qualify Equipment, Instruments and Systems Perform Process Validations Follow GXP (GMP, GLP, GDP etc) Closely monitor the Process and address all the discrepancies and Deviations Ensure implementation of SOPs for all the operations Strengthen Investigation procedures Impart Training Old Facility Perform GAP Analysis of existing Facility by Experts Perform GAP Analysis of existing QMS by Experts Prepare a Road Map to bridge the GAPs To Bridge the GAPs Redesign QMS, Renew the facility as per c GMP with Risk Based Approach Closely monitor the Process and address all the discrepancies and Deviations Ensure implementation of SOPs for all the operations Strengthen Investigation procedures Impart Training Continual Improvement as per c GMP norms

41 Many Thanks!

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