The document discusses preparing for and handling FDA validation inspections. It provides tips for pre-inspection activities like internal audits and documentation reviews. It also offers guidance on activities during inspections, such as following SOPs, answering questions, and taking notes. The document concludes with recommendations for post-inspection activities like analyzing findings, developing corrective actions, and submitting a written response.
Good Documentation Practice (GDocP — or GRK for Good Recordkeeping) is an essential component of your overall pharmaceutical quality system (PQS) and quality risk management strategies (QRM).
new guidance on good data management was discussed and its development
recommended. The participants included national inspectors and specialists
in the various agenda topics, as well as staff of the Prequalification Team
(PQT)–Inspections
Good Documentation Practice (GDocP — or GRK for Good Recordkeeping) is an essential component of your overall pharmaceutical quality system (PQS) and quality risk management strategies (QRM).
new guidance on good data management was discussed and its development
recommended. The participants included national inspectors and specialists
in the various agenda topics, as well as staff of the Prequalification Team
(PQT)–Inspections
A risk-based CAPA process is a common goal of medical device manufacturers, but until recently “risk-based” was not clearly defined.
The biggest fundamental change in both ISO 9001:2015 and ISO 13485:2016 is an emphasis on risk-based process management.
The CAPA process is the heart of your quality system and one of the most important processes. Therefore, this presentation gives you a whole new set of tools for managing your CAPA process using risk-based approach
A risk-based CAPA process is more than prioritization.
This presentation includes:
-An outline of the CAPA process and proposed risk management activities
-Various risk control options that can be integrated with corrective actions
-How to reconcile conflicts between the definitions for risk in ISO 9001:2015 and ISO 13485:2016
-And more...
Watch the presentation here: https://www.greenlight.guru/webinar/risk-based-capa-process
Operating Excellence is built on Corrective & Preventive ActionsAtanu Dhar
You see an issue and you simply set it right, but do you make the effort to find out what is the "corrective" action behind it, so that it never re-occurs?
And, do you take another extra step to come up with a "preventive" action - so that there is no other manner that issue comes up?
GxP/GMP & its Consequences to Documentation and Information Technology Systems Galaxy Consulting
Documentation is a critical tool for ensuring GxP/GMP compliance.
In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down.
There are also GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements.
Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. In the regulated industries, manufactures are required to use a change control procedure.
In this presentation, we discuss the connection between GxP/GMP and document control. We describe details of document control procedures, and the role of Quality Assurance in the documentation systems. We review GMP requirements for information technology and how computer systems including documentation management systems must meet GxP/GMP requirements. We also review change control procedure and how it should be used in GxP/GMP environment.
ISO 9001-2015 clause 10.2 is different from ISO 9001-2008 corrective action requirements, i tried to capture the updated requirements and with a suggested format for deal with the updated requirements.
CAPA (Corrective & Preventive Action) in Pharma PlantM. Agung Sumantri
CAPA is very important for continuous improvement in pharma plant. We often give up when find a complicated situation. Please do not only find the probable cause. Challange our probable cause to become evidence-based root cause.
This presentation from IVT's 4th Annual reviews what to do when you have an exception, critical vs. non-critical exceptions, and learning how to prevent exceptions.
A risk-based CAPA process is a common goal of medical device manufacturers, but until recently “risk-based” was not clearly defined.
The biggest fundamental change in both ISO 9001:2015 and ISO 13485:2016 is an emphasis on risk-based process management.
The CAPA process is the heart of your quality system and one of the most important processes. Therefore, this presentation gives you a whole new set of tools for managing your CAPA process using risk-based approach
A risk-based CAPA process is more than prioritization.
This presentation includes:
-An outline of the CAPA process and proposed risk management activities
-Various risk control options that can be integrated with corrective actions
-How to reconcile conflicts between the definitions for risk in ISO 9001:2015 and ISO 13485:2016
-And more...
Watch the presentation here: https://www.greenlight.guru/webinar/risk-based-capa-process
Operating Excellence is built on Corrective & Preventive ActionsAtanu Dhar
You see an issue and you simply set it right, but do you make the effort to find out what is the "corrective" action behind it, so that it never re-occurs?
And, do you take another extra step to come up with a "preventive" action - so that there is no other manner that issue comes up?
GxP/GMP & its Consequences to Documentation and Information Technology Systems Galaxy Consulting
Documentation is a critical tool for ensuring GxP/GMP compliance.
In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down.
There are also GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements.
Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. In the regulated industries, manufactures are required to use a change control procedure.
In this presentation, we discuss the connection between GxP/GMP and document control. We describe details of document control procedures, and the role of Quality Assurance in the documentation systems. We review GMP requirements for information technology and how computer systems including documentation management systems must meet GxP/GMP requirements. We also review change control procedure and how it should be used in GxP/GMP environment.
ISO 9001-2015 clause 10.2 is different from ISO 9001-2008 corrective action requirements, i tried to capture the updated requirements and with a suggested format for deal with the updated requirements.
CAPA (Corrective & Preventive Action) in Pharma PlantM. Agung Sumantri
CAPA is very important for continuous improvement in pharma plant. We often give up when find a complicated situation. Please do not only find the probable cause. Challange our probable cause to become evidence-based root cause.
This presentation from IVT's 4th Annual reviews what to do when you have an exception, critical vs. non-critical exceptions, and learning how to prevent exceptions.
This presentation from the Institute of Validation Technology's first annual Validation and cGMP Compliance Week Singapore discusses the obstacles to quality such, the key components to improve quality, and the tools for strategic teamwork.
SSARI (Spreading Smiles Across Rural India) is a social initiative by "Smile Merchants" to improve national standards of oral health in India by targeting rural part of the country, which accounts for almost 70% of India's population. It's less capital intensive, highly scalable, high-impact model has the promise to change the dental landscape, thus innovating to become the "Dental Services 2.0" model.
Live at http://www.sparktherise.com/projectdetails.php?pId=8497
Vote for the campaign by giving a missed call on 022-61850708.
Connect to us on ssariproject@gmail.com
In this presentation from IVT's GMP Week, Journal of Validation Technology Editor-in-Chief, Paul Pluta, Ph.D., asks "can compliance be improved by using quality by design [QbD] concepts?" Pluta discussed the QbD application, development of validation master plans, and the lifecycle approach to process validation. Furthermore, he discusses how to incorporate these essential parts of the validation process to implement effective, and efficient, compliance by design into the quality system.
Auditing Manufacturing Process and Product and Process Information.pdfDr. Dinesh Mehta
Manufacturing process audits should ensure that procedures are properly followed, problems are quickly corrected, there is consistency in the process, and there is continuous improvement and corrective action as needed.
Computerized System Validation Business Intelligence SolutionsDigital-360
Executive Summary
Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation.
validation is an important documentation protocol used in most of the laboratories and industries which is used for validation and evaluating different research protocols and equipment used in product formulation and development
In this presentation from, Janeen Santorosa discusses the best practices for harmonization of GMP auditing, domestic and international regulations for supplier auditing, integration of risk-based practices, and supplier audit practice tools.
In this presentation from IVT's 4th Annual Validation Week EU, Paul Pluta, discussed the differences between the traditional approach to cleaning validation and the lifecycle approach, applicable regulatory guidance, current industry trends, the necessary phases of the lifecycle approach (design and definition, cycle development, validation, and implementation), how to continously monitor the process, change control, and common obstacles to compliance.
This session from the Institute of Validation Technology's 14th Annual CSV Conference looks at B. Braun’s journey in moving from an in-house validated training tracking system to learning management in the cloud.
In this session from the Institute of Validation Technology's Validation Week Europe, Kurtis Epp and John Kandl discuss how to implement QbD to all three stages of process validation.
This session from the Institute of Validation Technology's Contamination and Control Week discusses regulatory expectations and industry drivers for aseptic cleaning and environmental monitoring, regulatory expectations for cleanrooms, and current FDA and EU expectations during inspection of sterile and aseptic operations.
In this presentation from the Institute of Validation Technology's Life Sciences Aseptic Processing, Kim Van Antwerpen discusses collecting environmental data, methods for trending, and interpreting and sharing environmental monitoring data.
Regulatory inspections have had a significant impact on the number of drug shortages and companies facing adverse regulatory actions.
Review of the inspection trends can be useful in assessing the regulatory status of your own company and help aid in the preparation for upcoming inspections. This session from IVT's Contamination and Control Week provides an in-depth, practical look at some of the recent Warning Letters and discusses current trends.
The Validation Master Plan is a a valuable opportunity to provide an overview of your company’s validation process, including organization structure, content, and planning.
Regulatory guidelines on stability testing are mainly designed to address studies that will be applied to support NDAs. However, in any pharmaceutical development program, a number of other stability studies are also required, for example, to help select appropriate formulations and to support regulatory applications for clinical programs. This session from the Institute of Validation Technology's Stability Programs Forum outlines a number of examples of early development stability studies.
This presentation from IVT's 4th Annual Validation Week Europe provided a thorough explanation of developing a gap analysis, areas in validation that are issues of concern, and FDA expectations of a manufacturer's gap analysis.
In this presentation from Validation Week Europe, Karen Ginsbury discusses the rigors, preparations, strategies, and the do's and the don't of the FDA Inspection process.
This workshop examines the approach to Continued Process Verification and demonstrating that your product and process are operating in a state of control and continue to do so over the life of the product. Without any prior coordination, the theme was elaborated by the afternoon speakers once the conference itself was underway. The concept of “step up step down” for adjusting the level of product scrutiny both for process parameters monitoring and for sampling and testing quality attributes was explored and developed.
This presentation from IVT's 2nd Annual Validation Week Canada covers the 2011 FDA Process validation and the subsequent statistical processes. Statistics in process validation is introduced as well as the integration with six sigma and solutions to common mistakes.
A comprehensive presentation on GMP systems and integration. This includes validations, vendor qualification, preventative maintenance, audits, CAPA, and utilization of system results.
This presentation from IVT Network's Method Validation Conference covers required and suggested regulations and guidances for biological process specifications. It also covers dosage form considerations and specifications for other components.
This presentation from the Institute of Validation Technology's 7th Annual Method Validation covers regulatory expectations for deviations and out-of-specification results and protocol exceptions, change control, handing investigations and CAPAs, and avoiding common pitfalls.
Handling deviations & unexpected results during method validation
Fda validation inspections
1. Prepare for and
Handle FDA Validation
Inspections
William E. Hall, Ph.D.
President, Hall & Pharm. Associates, Inc.
2. Some Potential Triggers for an
Inspection of Your Validation
Program
— ‘For Cause’ inspection – e.g. from atypical number
of complaints or when field samples are subpotent
— As result of findings in a ‘Systems’ inspection
— On-site observations of deficiencies – e.g. operators
not apparently trained, poorly written procedures,
problems in the batch records
3. Phases of Activities
— Pre-Inspection Activities
— Activities During the Inspection
— Post-Inspection Activities
4. Pre-Inspection Activities
— Internal Audits – should be doing them anyway
— Are they by area or by subject (such as validation)?
— Could do a ‘gap analysis’ or a risk assessment of
validation program
— Perform using same team that will host the
inspection (QA/QC, Reg Affairs, Production,
Engineering)
5. Value of Self Audits or
Mock Inspections
— Gives you a chance to identify and fix problems
— Allows for ‘continuous improvement
— Permits identification of poor or incomplete
documentation
6. Pre-Inspection Activities
Review of Critical Documentation
— Validation Master Plan – A good place to start.
— Is it current?
— Does it follow traditional or new ‘life cycle’ approach?
— If ‘life cycle’ how is the monitoring data being collected and evaluated?
— Helpful to have a diagram showing the chronological sequences of
events in the execution or implementation of the validation program,
e.g. design equipment qual process qual monitoring
— Change Control Documentation
— Have any of the changes been indicated to have impact on the
validation status of processes, equipment, or critical utilities. If so,
have the appropriate follow-up activities (such as revalidation) been
completed and signed off?
— Review ‘as built’ drawings-do they accurately reflect any changed
made to equipment?
7. Pre-Inspection Activities
Review of Critical SOPs for Accuracy
— Do you know what are your critical SOPs in relation
to your SOPs?
— Calibration program (part of PM program) for critical
gages and instruments-take a ‘walkabout’ and see if
the stickers on critical instruments is current, i.e. are
any of the calibrations past due?
8. Pre-Inspection Activities
Review of Critical Documentation
— Review of Training Program & Records
Ø Are they up-to-date?
Ø Include laboratory personnel as well
Ø Have you captured the expertise of outside services
that calibrate, clean, advise (consultants)? i.e. do you
have a file of resumes on hand
9. Pre-Inspection Activities
Written Procedure for Handling the Inspection Itself
— Does one exist? Maybe not for smaller companies
— If not, there is still time to write one
— Allocation of resources during the inspection-who,
what, when, where?
— Practice what you are going to do- ”How do you get
to Carnegie Hall?” Practice, practice, practice!
10. Pre-Inspection Activities
Review of Critical Quality Systems that interface
with Validation
— Change Control Procedure
— Recall Procedure
— Annual Product Review Procedure
— Deviations/Exceptions Procedure
— Preventative Maintenance (PM) Program
12. Pre-Inspection Activities
Review Process Validation Documents
— Were there failures or deviations during the
execution of the validations?
Ø Review findings, follow-ups, actions
— Are there Summary Reports and Protocols readily
available?
13. Activities & Responsibilities
During the Inspection
— The inspection of the validation program or some
elements of it will probably occur during a regular GMP
or Quality Systems inspection
— Therefore, the actions would be the same, namely:
— Follow the SOP for handling inspections
— Provide documents to inspector(s) in a timely fashion
— Notify all employees that FDA is on-site and they should
follow protocol when asked questions; remember that “I
don’t know the answer to your question, but I will locate
someone who can answer it” is a valid response.
— Provide document reviewers prior to handing original
documents to inspector(s)
14. Activities & Responsibilities
During the Inspection
— Make lists of documents & doc numbers requested by FDA
and make 2 copies of every document (one to be retained)
— Request a daily debriefing of the day’s findings by the
inspector(s); during that debriefing, it is reasonable to
inquire about the next day’s inspection activities.
— Make sure the proper person answers the questions of the
inspectors (i.e. the person having the most intimate
knowledge of the issue)
— Create flow diagrams of the various manufacturing
processes (if they don’t already exist); numbered steps and
diagrams will facilitate the inspection and help inform the
inspector as to how the overall process is carried out.
Identify critical processes and provide a rational for
determining critical steps.
More…………
15. Activities & Responsibilities
During the Inspection
Have the validation-related information available such
as:
— Validation documentation for critical utilities, e.g.
Purified Water system
— Preventative Maintenance (PM) program
16. Activities & Responsibilities
During the Inspection
— Create good listening habits-Reading between the
lines-try to figure out the reason for the questions
and how the answers might lead to further
questions, i.e. the ‘art of understanding’
— Recognize the critical importance of taking good
and copious notes during the inspection
— Involve upper management in the findings and
directions of the ongoing inspection
17. Post-Inspection Activities
— Take very good notes during the exit interview, as
this will be a preview of events to come. Ask
questions of the inspector(s) to gather information
on any observation that you are not completely sure
of the meaning. Gather all the details.
— You will be left with any FDA 483 comments, but
will not receive the EIR (Establishment Inspection
Report) for quite some time. This is the detailed
findings of the inspector.
18. Post-Inspection Activities
— Appoint a group of subject matter experts (SMEs) to a
committee, who will be charged with responding to the
FDA findings. The group should be chaired by the QA or
Compliance representative and should meet
immediately (if not sooner).
— Evaluate the regulatory report (citations) and develop a
response with an appropriate time-line for completion of
corrective actions. A “working master plan” is
appropriate and should include time lines and the name
of the person responsible for completing the activity.
— Seek additional information and clarification by picking
up the phone and contacting the investigator-this is
welcomed by the investigator(s)/inspectors(s).
20. Case Study # 1
During an inspection of your validation program, an
inspector indicates that he is interested in seeing
more information to assure that the manufacturing
equipment is being properly cleaned and maintained.
What type of documentation would you suggest to the
inspector so that he/she could choose specific
documents to review?
21. Case Study # 2
During review of your validation data related to blend
sampling, an inspector notes that you have no
rationale for the sample sites, number of samples,
and justification for your sampling program. What
suggestions would you make, what groups or
departments should be contacted, and how would you
proceed?
22. Case # 3
An inspector indicates to you, as the host, that he is
not particularly pleased with some of the Corrective &
Preventative Action (CAPAs) investigations that he is
reviewing. Specifically, he has a problem with the root
cause analysis and the fact that the CAPA’s have not
all been closed out after a considerable period of
time. Who should be involved in responding and
answering the inspectors specific concerns and how
should they proceed?
23. Case Study # 4
An inspector arrives at your facility and immediately
begins a detailed inspection in a specific
manufacturing area and of records for a specific
batch of product. During the initial discussions, she
mentions that the FDA has received laboratory data
from testing of shelf samples that seem to indicate
that a certain batch of product has fallen below
specifications before the expiry date has been
reached. How would proceed? What is the potential
impact of the product validation as well as product
still on the market and how would you evaulate this
situation?
24. Case Study # 5
In reviewing your cleaning validation program, an
inspector is spending considerable time reviewing
your rationale for doing product grouping and “worst
case” approach to your cleaning validation studies.
Can you see any way to salvage the situation and give
the inspector more confidence in your approach prior
to his exiting the facility?