The document discusses investigations into a failed sterility test of a product. It describes the perspectives and concerns of different stakeholders when a sterility failure occurs, including the technician, lab director, quality assurance, manufacturer, and client. It then details the steps of a thorough investigation conducted by an expert to find the root cause, involving reviewing laboratory and production records, environmental monitoring data, personnel training, and sources of raw materials. The investigation found the likely cause was contamination from cardboard boxes used to package sterile containers in the laboratory rather than any issues with production, raw materials, or personnel.
It is difficult to maintain the sterility and It is more difficult to investigate when the status is Non sterile. So this ppt narrate the way for you to investigate the Non sterility.
Review of Quality Control Record and Analytical Data by Dr. A. AmsavelDr. Amsavel A
Review of Quality Control Record and Analytical Data
Objective and Requirement for Analytical data review
Role of Analyst and reviewer,
Procedure and checklist for review of records/data
Review of traceable /associated documents
Review of calibration, Reference standard record, sampling reports,
Review of Audit trail
Role of Analyst & Reviewer
Review of chromatograms& audit trail,
Data Integrity & Good Record Practice
FDA Citations
It is difficult to maintain the sterility and It is more difficult to investigate when the status is Non sterile. So this ppt narrate the way for you to investigate the Non sterility.
Review of Quality Control Record and Analytical Data by Dr. A. AmsavelDr. Amsavel A
Review of Quality Control Record and Analytical Data
Objective and Requirement for Analytical data review
Role of Analyst and reviewer,
Procedure and checklist for review of records/data
Review of traceable /associated documents
Review of calibration, Reference standard record, sampling reports,
Review of Audit trail
Role of Analyst & Reviewer
Review of chromatograms& audit trail,
Data Integrity & Good Record Practice
FDA Citations
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
Considering: Environmental monitoring guidance, Background to USP <1116>, Main changes and debates Method limitations, Incident rates, Frequencies of monitoring, Locations of monitoring, Other changes, Regulatory issues and Rapid methods
Self-inspection should be carried out in order to verify compliance by the enterprise with the requirements of these Rules and suggest the necessary corrective actions.
In this slide contains definition, validation plan, types of Qualification of Dry Powder Mixture.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Common ways to avoid frequent gmp errorsKiran Kota
Presentation on avoiding the GMP errors with some controls and actions which are mentioned in the same which may help the industry on current trends of regulatory inspections.
In this slide contains Investigation, reason, case study of OOS.
Presented by: K Venkatsai Preasad. (Department of pharmaceutical analysis and quality assurance).
RIPER, anantapur.
Analysis of Raw materials…..
This topic comes under Quality Control and Quality Assurance…….
This is useful for M.Pharm (Pharmaceutical Quality Assurance) Students who studying in Fist year sem I......
This Presentation Contain following...
#Definition
#Purchase Specification
#GMP & WHO guidelines for handling of raw materials
#Control on Raw Materials
#Sampling of Raw Materials
#Raw Materials Testing
Thanks for Help and Guidance of Dr. F. A. Tamboli Sir and Dr.Mrs. N.M.Bhatia Madam
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
Considering: Environmental monitoring guidance, Background to USP <1116>, Main changes and debates Method limitations, Incident rates, Frequencies of monitoring, Locations of monitoring, Other changes, Regulatory issues and Rapid methods
Self-inspection should be carried out in order to verify compliance by the enterprise with the requirements of these Rules and suggest the necessary corrective actions.
In this slide contains definition, validation plan, types of Qualification of Dry Powder Mixture.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Common ways to avoid frequent gmp errorsKiran Kota
Presentation on avoiding the GMP errors with some controls and actions which are mentioned in the same which may help the industry on current trends of regulatory inspections.
In this slide contains Investigation, reason, case study of OOS.
Presented by: K Venkatsai Preasad. (Department of pharmaceutical analysis and quality assurance).
RIPER, anantapur.
Analysis of Raw materials…..
This topic comes under Quality Control and Quality Assurance…….
This is useful for M.Pharm (Pharmaceutical Quality Assurance) Students who studying in Fist year sem I......
This Presentation Contain following...
#Definition
#Purchase Specification
#GMP & WHO guidelines for handling of raw materials
#Control on Raw Materials
#Sampling of Raw Materials
#Raw Materials Testing
Thanks for Help and Guidance of Dr. F. A. Tamboli Sir and Dr.Mrs. N.M.Bhatia Madam
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
This presentation gives an overview of : Validation of microbiological methods , Considering some of the limitations and
Key criteria that may be applicable for assessment.
Sterility Testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Sterility testing is very important for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms.
Understanding How Bioburden and Sterilization Affect Medical DevicesPacific BioLabs
This presentation covers:
Bioburden- what is it and how it can affect a device development program and sterilization validation program.
Sterilization: methods and the bioburden-sterilization connection.
Benefits of minimizing the sterilization dose for your device.
Importance of monitoring bioburden.
Case study: sterilization failure and tracking down root cause.
How to monitor and reduce bioburden levels.
This is a presentation that I developed and gave to the GMP constituency of a medium-sized biopharmaceutical company to satisfy one of the requirements for ongoing cGMP training. I feel that it very well epitomizes one of my central philosophies surrounding GXP and regulatory topic training -- STORYTELLING.
Dissolution and In Vitro In Vivo Correlation (IVIVC)Jaspreet Guraya
This presentation gives a bird's eye view on Dissolution in context with IVIVC. It discusses various levels of Correlations currently in practice. IVIVC are explained in light of biowaivers It also touches upon IVIVR, IVIVM etc.
Autoclave, types of autoclave, horizontal autoclave, vertical autoclave, vacuum type autoclave, pressure cooker type autoclave. their purpose, precaution, etc....
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
Good Laboratory Practices (GLP)
History
Reason behind GLP created
Advantages and disadvantages of GLP
Objectives of GLP
Practice of GLP
b pharma 6th sem
pharmaceutical quality assurance
Safety is the prime attention of regulatory bodies as it is the critical factor which can destroy even the humankind. Quality system like GLP has a lot tom play in the field of safety
assessments to reach its goal. There are various toxicity studies for assessing the degree of its toxicity. Academic research and peer reviewed journals has their own pitfalls as they could not
monitor or inspect the studies which has been conducted. This presentation speak about the Importance of safety assessment, various studies to evaluate the safety and Importance of GLP in safety assessment.
Good Laboratory Practices (GLPs) are standard regulatory programs that assure the quality and integrity of nonclinical safety test data submitted to regulatory agencies worldwide.
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10. Investigations into Sterility Failures The Manufacturer I can’t trust anyone Other products involved? There goes our incentive Now we have to spend money to do it right. Damn!
13. Investigations into Sterility Failures How do you reconcile all these concerns? Methodically Lab Manufacturer, supplier Management
14. Investigations into Sterility Failures The Lab Technician Spore strips (media run) First time alone Identified organism Not B. stearothermophilis Retest passed
15. Investigations into Sterility Failures The Lab Director Direct inoculation (cotton) Isolated Gram negative Could not find the source Notified client Lost the account
16. Investigations into Sterility Failures QA Spore strip (Bandage) B. subtilis found Lab investigation ETO sterilization review: Excursions in cycle Material rejected
18. Investigations into Sterility Failures The Client Sterile ampule sterility failure We panicked Manufacturer blamed the lab Lab blamed the manufacturer QA ready to reject Life was getting interesting
19. Investigations into Sterility Failures The Client Antibiotic in plastic ampule First failure ever (3 years) Propriobacterium acnes Lab investigation OK Recent merger
20. Investigations into Sterility Failures Product History Three year clean tract record Human-associated organism Product was inhibitory Did not make sense: validated Convinced management to wait
22. Investigations into Sterility Failures FDA Out-of-Specification (OOS) guidance? It essentially excludes microbiological and biological assays
23. Investigations into Sterility Failures ICH Q7A OOS guidance? States that OOS investigations are not necessary for in-process tests
24. Investigations into Sterility Failures USP <1117>? Discusses the difficulties associated with resolving a Microbial Data Deviation (MDD) Not much help
25. Investigations into Sterility Failures FDA Aseptic Processing Guidance Provides a rational, methodical, scientific approach to address the issue
26. Investigations into Sterility Failures “ Only if conclusive and documented evidence clearly shows that contamination occurred as part of testing should a new test be performed”
27. Investigations into Sterility Failures “ When available evidence is inconclusive batches should be rejected as not conforming to sterility requirements”
30. Investigations into Sterility Failures The initial steps Place product on hold Are other batches affected? Write an investigation protocol based on the criteria outlined in the Aseptic Processing Guideline
31. Investigations into Sterility Failures Detail exactly what should be done Seven specific areas that need to be investigated
40. Investigations into Sterility Failures 1. Identification : Propriobacterium acnes - associated with human activity Confirmed by GC analysis
41. Investigations into Sterility Failures 2. Review of laboratory tests and deviations Reviewed sterility test history of the contract laboratory for 3 years Sterility failure rate and false positive rate < 0.1% Organism not found in the past
42. Investigations into Sterility Failures 3. Production area environment 3 years of EM data reviewed Organism found 18 months ago on air sampling plate Not found in sterile shroud Not associated with any sterility or environmental issues
43.
44. Investigations into Sterility Failures 5. Product bioburden Past 3 years reviewed, one instance it exceeded limit of < 10 CFU/100 mL This organism was not isolated Bioburden found only once or twice a year; each time organism was Bacillus. All the other times bioburden < 10 CFU/100 mL Biofouling occurred 5 years ago, rectified with CIP 100 after media fills
45. Investigations into Sterility Failures 6. Review of Batch Records All records from the past 3 years All excursions addressed during the runs Current record was also re-reviewed and no excursions of any type were found
49. Investigations into Sterility Failures The microbiological history reviewed for 3 years and Propriobacterium acnes never found
50. Investigations into Sterility Failures Occasionally Bacillus found in API at levels below the specification of <15 CFU/gm and appeared infrequently in the pre-sterilization bioburden
51. Investigations into Sterility Failures 9. Excipients MLT done on every excipient lot Microbiological history reviewed for 3 years. P. acnes not found Other than WFI, excipients were corrosive or not conducive to growth of this organism
52. Investigations into Sterility Failures 10. W eighing facility (NJ) Every area thoroughly scrutinized: receiving area, holding area, weighing room, transfer area, shipping area, analytical labs Weighing room trend data < 2 CFU per settling plate site Organism not found in three years
54. Investigations into Sterility Failures Anything remotely associated with the product was scrutinized Organism not isolated, 3 year data Documentation provided complete cross referencing to media prep, sterilization, growth promotion, organism maintenance, EM, cleaning and (most importantly) training
59. Investigations into Sterility Failures Watched every step of the operation: Receiving and logging of FP Storing the product Preparing it for testing, staging it and transferring it into the sterility suite
60. Investigations into Sterility Failures I even gowned up with the technicians and stood behind them while they performed the sterility test
61. Investigations into Sterility Failures Everything was perfect I couldn’t find the smoking gun and was resigned to the fact that we would have to reject the batch without any definitive root cause
63. Investigations into Sterility Failures During the sterility test 20 ampules were pooled into a sterile container Sterile containers sterilized by gamma radiation Shipped in a large cardboard box containing a polyethylene bag filled with 1000 sterile containers
64. Investigations into Sterility Failures Why weren’t the containers individually wrapped? Less expensive to buy them in bulk
65. Investigations into Sterility Failures The lab recently switched from individually wrapped containers to bulk packaged containers
66. Investigations into Sterility Failures Sampled the inside, outside and flaps of the cardboard box, and the polyethylene bag
70. Investigations into Sterility Failures Residing in the cardboard box that contained the sample containers used to pool the product before filtration!
71. Investigations into Sterility Failures We had our evidence to invalidate the original test The lab purchased individually wrapped sample containers, invalidated the original sterility test, performed a successful retest
72. Investigations into Sterility Failures We released the product based upon the results of the retest, the completion of the investigation by my company, the contract manufacturer and the contract laboratory
73. Investigations into Sterility Failures Lessons learned: ● Don’t panic ● Let science be your guide ● Prepare a sound action plan ● Involve all stakeholders ● Keep searching for a cause ● Be brave ● Don’t give up