Post on 04-Dec-2014
Business Time Managers Workshop at Unit IV; Jul./ Aug. 2011
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Quality Assurance,
A Systemic Approach for Effective Compliance.
Hemanth PanasaDGM – QA (Unit IV)
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Agenda…
Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward
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Agenda…
Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward
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Quality……Means to Public
Efficient/ Effective / Above average performance Flawless / nearly flawless The best of what you get Something we / I can depend on Some thing that will last Good workmanship Lives up to promise Tried and true / good reputation Really listening / responding / caring/ respecting Better than other Reliable/long lasting/ standard / better
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Quality……defined by ISO
The totality of features and characteristics of a product or service that bears on it the ability to satisfy stated or implied need.
Quality is…
“TO COMPLY WITH SPECIFICATIONS”
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GMPs…Good Manufacturing Practices (GMPs) are regulations (Law) that describe the methods, equipment, facilities and controls required for producing drugs.
To ensures that a drug...
• Is SAFE
• Is correctly IDENTIFIED
• Is of the right STRENGHT
• Has the PURITY it claims
• Has the overall QUALITY it claims
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GMPs…
The language of GMPs are sometimes very broad, with terms such as “adequate”, without providing details as to what is specifically required.
GMPs have evolved over time and are still evolving. As the industry adopts these improvements, they become the current industry standard.
Judges in court decide their cases frequently based on the interpretation of regulations relying both on the intent of the regulations and the current common industry practices in meeting the GMP requirements.
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CGMPs…The regulations are called ‘Current Good
Manufacturing Practices’…
…'Current' is to emphasize that the expectations are ‘Dynamic'.
The terms Current Good Manufacturing Practices (CGMPs) and Good Manufacturing Practices (GMPs)
are interchangeable.
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Origin of GMP…
Birth to GMP (First written GMP : (First written GMP :
USA, 1963)USA, 1963)
Concept of quality: Segregation between
good and bad
Concept of quality: Testing of finished
products
Lead to more failures and less consistent
quality product
Generation of need of quality building in the
product (QA/ QBD)(QA/ QBD)
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US
Japan
UK
India
Across the World…
Europe
Brazil S
A
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Regulatory Agencies…
USFDA – The USA MHRA – The UK MCC – South Africa TGA – Australia ANVISA – Brazil CDSCO – India
WHO EMEA
ICH PDA PIC/S ISPE
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Requirements of GMPs…Requirements of GMPs…At high level, GMPs of various nations are very similar. Most require things like,
Equipment and facilities being properly designed, maintained and cleaned.
Standard Operating procedures (SOPs) be written and approved.
An independent quality unit (Quality Assurance/ Control). Well trained personnel and management. Validated process/ practices.
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10 Commandments of 10 Commandments of GMP…GMP…
Principle # 1Writing detailed step-by-step procedures (SOPs) that provide a roadmap for controlled and consistent performance.
Principle # 2Carefully following written procedures to prevent contamination, mix-ups and errors.
Principle # 3 Promptly and accurately documenting work for compliance and
traceability.
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Principle # 4Proving that systems do what they are designed to do by validating work.
Principle # 5Integrating productivity, product quality, and employee safety into the design and construction of facilities and equipment.
Principle # 6Properly maintaining facilities and equipment.
Principle # 7Clearly defining, developing and demonstrating job competence.
10 Commandments of 10 Commandments of GMP…GMP…
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Principle # 8Protecting products against contamination by making cleanliness a daily habit.
Principle # 9Building quality into products by systematically controlling our components and product related processes such as manufacturing, packaging and labeling, testing, distribution, and marketing.
Principle # 10Conducting planned and periodic audits for compliance and performance.
10 Commandments of 10 Commandments of GMP…GMP…
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CGMPs Exist…To protect patients from dangerous, adulterated or misbranded products.
Adulterated product: Product that has not been manufactured according to CGMP’s, even it meets all specifications.
Misbranded product: Not labeled properly or making a false claim.
GMPs describes What to do, Not How to do.
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Agenda…
Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward
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Quality System…Quality System…
System is a network of interdependent components that work together to try and accomplish aim of the system.
Quality System is a network, by which an organization manages its quality aspects in a systematic and organized manner .
It provides a framework/ procedures for planning, implementation and assessment of it’s aim (i.e. quality) of a product/ service of an organization.
It can also describe the methodology on how to achieve compliance to regulations. Hence, GMPs are part of the Quality System.
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Quality System…Quality System…Quality System ensures that, products are consistently produced and controlled to the standards appropriate to their intended use.
Unlike buildings and equipments, quality systems are relative and indicator of compliance to GMPs.
Hence, quality system is the number one issue for regulatory inspectors, who will look how the Quality is Systematically addressed through out the company.
Implementation of robust Pharmaceutical Quality System is a key to comply with CGMPs
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Pharma. Quality System…Pharma. Quality System…International Conference on Harmonization (ICH), which is a consortium of US, EU and Japan with participation of Regulatory and Industry, released a guidance (ICH Q10) on Pharmaceutical Quality System (PQS).
Implementation of PQS should achieve three main objectives: Achieve Product Realization. Establish and Maintain a state of control. Facilitate Continual Improvement
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Pharma. Quality System…Pharma. Quality System…
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Pharma. Quality System…Pharma. Quality System…
The PQS is based on the concepts of Quality by Design (QbD). Implementation (developing a new system or modifying an existing one) of PQS should consider; Scope of the system to various stages of life cycle, i.e.
Pharmaceutical DevelopmentTechnology Transfer Commercial ManufactureProduct Discontinuation
The size and complexity of organization, i.e. across the site and/ or multiple sites/ countries etc.
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Knowledge Management:Knowledge management is a systematic approach to acquiring, analyzing, storing and disseminating information related to products, manufacturing processes and components.
Sources of knowledge include, but are not limited to: Prior knowledge (public domain or internally documented). Pharmaceutical development studies. Technology transfer activities. Process validation studies over the product lifecycle. Manufacturing experience. Innovation, Continual improvement and Change
management activities.
Enablers of PQS…Enablers of PQS…
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Quality Risk Management: Quality Risk Management (QRM) is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality.
It facilitates continual improvement of process performance and product quality throughout the product lifecycle.
ICH Q9 provides principles and examples of tools for QRM (e.g. FMEA) that can be applied to different aspects of pharmaceutical quality.
Enablers of PQS…Enablers of PQS…
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Management Commitment Quality Policy Quality Planning Resource Management Internal Communication Management Review Control on Outsourcing/ Purchase Managing Change in Ownership
Management Management Responsibility…Responsibility…
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Continuous Improvement…Continuous Improvement…Of Process Performance and Product Quality Life Cycle Stage Goals:
Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation
PQS Elements: Process performance and product quality monitoring system. Corrective action and preventive action (CAPA) system. Change management system Management review of process performance and product
quality.
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Of the Pharmaceutical Quality System Management Review of the Pharmaceutical Quality System. Monitoring of Internal and External Factors Impacting the
Pharmaceutical Quality System. Outcomes of Management Review and Monitoring
Continuous Improvement…Continuous Improvement…
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Pharmaceutical Manufacture…
USFDA’s Six Systems Model, An inspections approach.
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Manufacturing Systems…Facilities & Equipment: Describes the methods for controlled premises, facility and
equipment.Laboratory Systems: Describes the methods for laboratory controls for starting
material, in-process/ finished products. Material Systems: Describes the methods for material controls, i.e. receipt,
handling, storage and dispensing. Packaging & Labeling Systems: Describes the methods for handling of finished products with
required packing & Labeling.Production Systems: Describes the methods for formula, process and practices during
production, by using the supporting systems.
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Quality System…
Quality is everyone’s responsibility, typically monitored by QA through…
Qualifications/ Validations In-Process Checks and Batch Release Documentation Control QMS tracking & Quality Metrics Training, Audits & Compliance
… ensure the state of control in 5 P’s of manufacturing systems.
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5 P’s and QA Controls…Premises (Includes Facility and Equipment)
Approval of Design and Qualifications/ Validations
Personnel Training and Qualifications
Procedures Approval, Distribution, Change controls and Training
Practices(Includes Process)
Training, BR checks, Validations and Audits
Products (Includes starting material, in-process and final product)
QC testing and control of other P’s (Premises, Personnel, Procedures and Practices)
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Agenda…
Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward
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Definitions…
Validation: Establishing documented evidence, which provides a high degree of assurance, that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.
Qualification: All the actions, with a documented evidence, that an equipment is designed and commissioned, and is consistently performing, to meet the intended requirements. The word validation is sometimes widened to incorporate the concept of qualification.
Process Validation: Process validation is establishing documented evidence, which provides a high degree of assurance, that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.
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Prospective Validation: Is the establishment of documented evidence, with high degree of assurance, that a process, procedure, system, equipment or mechanism used in manufacture does what it purports to do based on a pre-planned validation protocol.
Concurrent Validation: Establishment of documented evidence that a process does what it purports to do, based on information generated during actual implementation of the process.
Retrospective Validation: A process for a product which has been marketed based upon accumulated manufacturing, testing and control batch data.
Definitions…
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As per the Guidance for Industry by USFDA “Process Validation: General Principles and Practices”, effective from January 2011 …
Process Qualification: Conforming that the manufacturing process as designed is capable of reproducible commercial manufacturing.
Process Validation: The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
This certainly challenge our philosophy & practices, wrt qualifications/ validations, we have adopted as on date!
Definitions…
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New Approach…This approach is based on the understanding that, Quality, Safety and Efficacy are designed or built into the
product. Quality cannot be adequately assured merely by in-process
and finished product inspection or testing.
This approach describes Process Validation (PV) activities in three stages; Process Design Process Qualification Continued Process Verification
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PV Stages…Process Design: Building and Capturing Process Knowledge and Understanding. Establishing a strategy for process control (CPPs & CQAs). Process Qualification: Design of a Facility and Qualification of Utility and Equipment Process Performance Qualification. Continued Process Verification: Trend Analysis & Quality Metrics Review of Key Performance Indicators (KPIs).
All regulatory agencies expects that, the principles of Quality Risk Management (QRM) are integrated into qualifications/ validations.
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Validation Master Plan ( VMP)
Impact Assessment
Qualification
Design Qualification (DQ)
Installation Qualification (IQ)
User Requirement Specifications (URS)
Operational Qualification (OQ)
Performance Qualification (PQ)
Final Qualification Report
Validation
Analytical Method Validation (AMV)
Cleaning Validation (CV)
Process Validation (PV)
Final Validation Report
Monitoring/ Maintenance/ Calibration
Re-Qualification
Change Control
VALIDATION LIFE CYCLE
Factory Acceptance Test (FAT)
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Agenda…
Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward
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Definitions…Risk: The combination of probability of the harm and the severity of that harm.
Risk Assessment: A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.
Quality Risk Management (QRM): A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle.
Reference: ICH Q9 – Quality Risk Management (QRM); Harmonised Tripartite Guideline .
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Typical QRM Process
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Approach for QRM…
The manufacturing and use of a drug product, including its components, necessarily entail some degree of risk.
The risk to its quality, in the entire product life cycle, is just one component of the overall risk. The protection of patient by managing the risk to product quality, during it’s manufacture and/ or distribution, should be considered as prime importance by all the stake holders.
QRM is a systematic process designed to coordinate, facilitate and improve science-based decision making with respect to risk.
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Approach for QRM…The success of this exercise depends on the involvement of representatives, with the working knowledge of various important areas of product life cycle (e.g. Logistics, Engineering, Manufacturing, QA, QC and RA).
A practical approach for QRM is to define the scope for each risk assessment exercise, and conduct training to concerned personnel, where the representatives are able to identify and make informed judgments on threats to the individual process steps.
The selection and implementation of improvements then be assigned to individuals and shall be reviewed for effectiveness, post implementation.
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Risk Assessment…QRM begins with a well defined problem description or risk in question. Based on the problem/ risk, we shall constitute a team of experts from user and applicable cross functions, to execute the QRM process.
When the risk in question is well defined, appropriate risk management tool and the types of information needed to address the risk in question will be more readily identifiable.
As an aid to clearly defining the risk(s) for risk assessment purposes, three fundamental questions are often helpful: What might go wrong? What is the likelihood (probability) it will go wrong? What are the consequences (severity)?
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Risk Assessment…
Raw Material & Packing Material Suppliers
Warehouse of Manufacturing Plant
Ro
ad
, S
ea
, A
ir
Dispensing
Equipment/ Component Cleaning and Sterilization
Production and Packaging
Storage and Distribution
Ro
ad
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Distributor/ Customer
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Risk Assessment…The QRM team shall carry out detailed process mapping of the activity, under scope of risk assessment. Particular attention shall be paid to interfaces along the product life cycle.
In the above process map, every entry and every arrow represents a risk points at which product threat could occur. Each process can be mapped separately and QRM can be effectively applied to all the stages of pharmaceutical manufacture.
All the risk areas and product sensitivities, i.e. customer complaints, deviations etc., and all the attributes related to facilities, equipment, personnel, environment, materials and practices/ procedures are considered for identifying the threats which could impact product quality and/ or safety.
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Agenda…
Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward
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Deviation:Departure from an approved procedure, process and/ or established standard. This can be an unexpected/ planned event in non-compliance with established standard, system and/ or procedure, at any stage of manufacturing/ its associated activities.
Correction:Action refers to repair, rework and/ or adjustment and relates to the disposition of an existing non-conformity.
Corrective Action:Action taken to eliminate the causes of an existing non-conformity, defect or other undesirable situation in order to prevent re occurrence.
Preventive Action:Action taken to eliminate the cause of a potential non-conformity, defect or other undesirable situation in order to prevent re occurrence.
Definitions…
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Terms in Industry… Deviation
Planned Deviation Un Planned Deviation
Out of Specification (OOS) Out of Limit (OOL) Out of Trend (OOT) Aberration Exception Un Usual Occurrence Incident
Something, which is a discrepancy/ abnormal, from the set standard and/ or routine occurrence.
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Reporting & Tracking of all the events in defined quality system framework.
Root cause investigation for all the failures/ non-conformances, with adequate impact assessment and CAPA.
Escalation mechanism and management responsibility/ involvement on handling these failures/ non-conformances.
Inspectors really look how well you handle any problems.
Hence, reviewing atypical event (deviations/OOS/ OOL/ OOT) reveals, just how well the quality system is working! (Ref. FDA News on PAIs).
Regulatory Perspective…
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Top 10 FDA 483 Items
*PAPC – Production and Process Controls
Source: QSIT – Presentation on CAPA during the workshop.
Regulatory Perspective…
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Identify all the unexpected/ atypical events in GMP areas. Acknowledge them as real deviations or whatever!. Thorough investigation to identify the root cause. Evaluate the impact, i.e. quality, regulatory, systemic and
business.
Identify the CAPAs, including responsibilities and time lines.
Decision on disposition of the batch and/ or move forward with routine operations.
Documenting all the events concurrently in a traceable manner.
Purpose of Notification…
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Challenge…The biggest challenge in any Quality System of the organization with respective to Deviations is…
Communication processes that are untimely, inefficient and lacking in ownership lead to identifying the True Root Cause and applying effective Corrective And Preventive Actions (CAPA).
Effective investigations for all atypical events, with adequate CAPAs, is an ultimate tool for any organization to comply with “Current” requirements of “GMPs”, which ensures continuous improvement.
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Is the most basic reason, which if eliminated, would Prevent Recurrence.
An identified reason for the presence of a defect or problem and/ or the source or origin of an event.
The goal of every deviation investigation is to identify the True Root Cause. This is critical to ensure that the most effective Corrective Action / Preventative Action is implemented.
Root Cause must be;Stated clearly and conciselyIs scientifically valid – the conclusion is based on the data and/or sound scientific
knowledge and principles.Stated with a level of confidence that is appropriate
True Root Cause…
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•In practice, the process is rarely sequential
• Not uncommon to go back to Generate Description after some level of problem analysis
• As significant new information becomes available, evaluate need to revise or update problem definition
At each stage, ask if the problem definition is still correct and complete
Define
Generate Description – Map the process, Brainstorm for causes, Identify what’s changed, organize information
Problem analysis and trouble-shooting
Test hypothesis
Drill down to the true root cause; Tools!
Evaluate after implementation
Product Impact
Problem Solving…
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Agenda…
Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward
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Flow charts, Check sheets, process mapping Statistical tools, i.e. control charts, histograms, Pareto
charts etc., 5 – Whys Technique Cause and Effect Diagrams (Ishikawa diagram or
fish bone diagram). Failure Mode Effects analysis (FMEA) Failure Mode, Effects and Criticality Analysis (FMECA) Fault Tree Analysis (FTA) Hazard Analysis and Critical Control Points (HACCP) Hazard Operability analysis (HAZOP) Preliminary Hazard analysis (PHA)
The Tools…
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Developed at Toyota and is critical component of the problem solving training in it’s production system.
Method of asking questions to determine the true root cause of the problem and has potential to uncover underlying design, procedure or organization issues.
Provides a structured and layered approach to go from the effect to the first cause.
Why 5? Not a magic number Rule of thumb! Based on experience, 5 questions are
believed to be sufficient to get to the true root cause
5 Why? Technique…
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Example (Deviation Event Information): During the first lot after shut-down, the temperature of the product in the holding tank exceeded the allowable 2 to 8 C range, triggering an alarm.
Operators found that the ball-valve controlling glycol flow to the tank jacket was in the closed position.
Valve was opened and the temperature returned to normal.
Cause:Temperature excursion due to closed glycol valve.
5 Why? Technique…
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Cause Effect Analysis…
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Cause Effect Analysis…
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Cause Effect Analysis…
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FMEA…
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FMEA…
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FMEA…
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FMEA…
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Agenda…
Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward
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Case Study…Group A:
Group B:
Group C:
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Agenda…
Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward
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Driving Force…
The driving force for implementation of a robust pharmaceutical quality system, to meet the CGMPs, is an effective “Documentation System”.
These documents are important…
To convey the commitments To define/ Implement systems and procedures For Reference during the operation Are legal and can be requested/ subpoenaed by a court of law. Can be used to prove GMP compliance.
…be sensitive towards them!
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Take Away…Refer to written instructions and Never Assume!
Understand your own processes and improve “out of box” thinking abilities.
Data collection should always accompanied with data analysis to make scientifically justified decisions.
Notifications are appropriate tools and enable us to comply with CGMPs. Do not scare of them!
Qualification/ Validation of every thing we do/ adopt.
Risk Assessment and CAPAs should be your daily mantras!
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GMPs will only work with the cooperation and understanding of the most important element and that is …
Critical Element…
…YOU
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THANK YOU