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Quality Assurance

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A Systemic Approach for Effective Compliance.

DGM – QA (Unit IV)

Hemanth Panasa

Agenda…
        Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward

Business Time Managers Workshop at Unit IV; Jul./ Aug. 2011

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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

Business Time Managers Workshop at Unit IV; Jul./ Aug. 2011

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Jul. 2011 4 ./ Aug.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 Business Time Managers Workshop at Unit IV.

2011 5 . Quality is… “TO COMPLY WITH SPECIFICATIONS” Business Time Managers Workshop at Unit IV.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. Jul./ Aug.

2011 6 ../ Aug. • • • • Is SAFE Is correctly IDENTIFIED Is of the right STRENGHT Has the PURITY it claims • Has the overall QUALITY it claims Business Time Managers Workshop at Unit IV. facilities and controls required for producing drugs. equipment.. To ensures that a drug.GMPs… Good Manufacturing Practices (GMPs) are regulations (Law) that describe the methods. Jul.

Business Time Managers Workshop at Unit IV. GMPs have evolved over time and are still evolving. Jul.GMPs… The language of GMPs are sometimes very broad. with terms such as “adequate”. 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. 2011 7 ./ Aug. without providing details as to what is specifically required.

/ Aug. The terms Current Good Manufacturing Practices (CGMPs) and Good Manufacturing Practices (GMPs) are interchangeable.CGMPs… The regulations are called „Current Good Manufacturing Practices‟… …'Current' is to emphasize that the expectations are „Dynamic'. Business Time Managers Workshop at Unit IV. Jul. 2011 8 .

/ Aug.Origin of GMP… 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) Birth to GMP (First written GMP : USA. Jul. 2011 . 1963) 9 Business Time Managers Workshop at Unit IV.

2011 10 ./ Aug.Across the World… UK US Europe India Brazil SA Japan Business Time Managers Workshop at Unit IV. Jul.

/ Aug.Regulatory Agencies…       USFDA – The USA MHRA – The UK MCC – South Africa TGA – Australia ANVISA – Brazil CDSCO – India  WHO  EMEA  ICH  PDA  PIC/S  ISPE Business Time Managers Workshop at Unit IV. 2011 11 . Jul.

 An independent quality unit (Quality Assurance/ Control). maintained and cleaned. Most require things like.  Standard Operating procedures (SOPs) be written and approved./ Aug.Requirements of GMPs… At high level. Business Time Managers Workshop at Unit IV.  Validated process/ practices. 2011 12 . GMPs of various nations are very similar.  Well trained personnel and management. Jul.  Equipment and facilities being properly designed.

10 Commandments of GMP… Principle # 1 Writing detailed step-by-step procedures (SOPs) that provide a roadmap for controlled and consistent performance./ Aug. Principle # 2 Carefully following written procedures to prevent contamination. 2011 13 . Business Time Managers Workshop at Unit IV. Jul. mix-ups and errors. Principle # 3 Promptly and accurately documenting work for compliance and traceability.

2011 14 . Principle # 5 Integrating productivity. Jul. developing and demonstrating job competence. Principle # 7 Clearly defining. Business Time Managers Workshop at Unit IV./ Aug. and employee safety into the design and construction of facilities and equipment. product quality.10 Commandments of GMP… Principle # 4 Proving that systems do what they are designed to do by validating work. Principle # 6 Properly maintaining facilities and equipment.

Principle # 10 Conducting planned and periodic audits for compliance and performance. packaging and labeling. and marketing. Jul./ Aug. 2011 15 . testing.10 Commandments of GMP… Principle # 8 Protecting products against contamination by making cleanliness a daily habit. Business Time Managers Workshop at Unit IV. Principle # 9 Building quality into products by systematically controlling our components and product related processes such as manufacturing. distribution.

/ Aug. Jul. GMPs describes What to do. Business Time Managers Workshop at Unit IV.CGMPs Exist… To protect patients from dangerous. even it meets all specifications. Misbranded product: Not labeled properly or making a false claim. Adulterated product: Product that has not been manufactured according to CGMP’s. adulterated or misbranded products. 2011 16 . Not How to do.

/ Aug. Jul. 2011 17 .Agenda…         Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward Business Time Managers Workshop at Unit IV.

Quality System… System is a network of interdependent components that work together to try and accomplish aim of the system. It can also describe the methodology on how to achieve compliance to regulations. by which an organization manages its quality aspects in a systematic and organized manner .e./ Aug. 2011 18 . Jul. Quality System is a network. Hence. It provides a framework/ procedures for planning. Business Time Managers Workshop at Unit IV. implementation and assessment of it’s aim (i. quality) of a product/ service of an organization. GMPs are part of the Quality System.

/ Aug. products are consistently produced and controlled to the standards appropriate to their intended use. who will look how the Quality is Systematically addressed through out the company. Hence. 2011 19 . Unlike buildings and equipments. Implementation of robust Pharmaceutical Quality System is a key to comply with CGMPs Business Time Managers Workshop at Unit IV.Quality System… Quality System ensures that. quality system is the number one issue for regulatory inspectors. quality systems are relative and indicator of compliance to GMPs. Jul.

EU and Japan with participation of Regulatory and Industry.  Establish and Maintain a state of control. released a guidance (ICH Q10) on Pharmaceutical Quality System (PQS). which is a consortium of US. 2011 20 ./ Aug.Pharma. Jul. Implementation of PQS should achieve three main objectives:  Achieve Product Realization.  Facilitate Continual Improvement Business Time Managers Workshop at Unit IV. Quality System… International Conference on Harmonization (ICH).

2011 21 . Jul.Pharma. Quality System… Business Time Managers Workshop at Unit IV./ Aug.

 Scope of the system to various stages of life cycle. Implementation (developing a new system or modifying an existing one) of PQS should consider.e. Quality System… The PQS is based on the concepts of Quality by Design (QbD). 2011 22 . across the site and/ or multiple sites/ countries etc. i.e. Business Time Managers Workshop at Unit IV. i. Jul.Pharma. Pharmaceutical Development Technology Transfer Commercial Manufacture Product Discontinuation  The size and complexity of organization./ Aug.

 Manufacturing experience. analyzing.  Process validation studies over the product lifecycle.  Innovation. but are not limited to:  Prior knowledge (public domain or internally documented).Enablers of PQS… Knowledge Management: Knowledge management is a systematic approach to acquiring. Sources of knowledge include.  Technology transfer activities. 2011 23 . Jul. storing and disseminating information related to products. Continual improvement and Change management activities./ Aug.  Pharmaceutical development studies. manufacturing processes and components. Business Time Managers Workshop at Unit IV.

It facilitates continual improvement of process performance and product quality throughout the product lifecycle. 2011 24 .Enablers of PQS… Quality Risk Management: Quality Risk Management (QRM) is integral to an effective pharmaceutical quality system. ICH Q9 provides principles and examples of tools for QRM (e. FMEA) that can be applied to different aspects of pharmaceutical quality.g. Business Time Managers Workshop at Unit IV. scientifically evaluating and controlling potential risks to quality. It can provide a proactive approach to identifying. Jul./ Aug.

Jul. 2011 25 ./ Aug.Management Responsibility…         Management Commitment Quality Policy Quality Planning Resource Management Internal Communication Management Review Control on Outsourcing/ Purchase Managing Change in Ownership Business Time Managers Workshop at Unit IV.

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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Continuous Improvement…
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

Business Time Managers Workshop at Unit IV; Jul./ Aug. 2011

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Pharmaceutical Manufacture…

USFDA’s Six Systems Model, An inspections approach.
Business Time Managers Workshop at Unit IV; Jul./ Aug. 2011 28

handling. i. Production Systems:  Describes the methods for formula. Material Systems:  Describes the methods for material controls.e. Jul./ Aug. in-process/ finished products. 2011 29 . Business Time Managers Workshop at Unit IV. process and practices during production. receipt. facility and equipment. by using the supporting systems. storage and dispensing. Packaging & Labeling Systems:  Describes the methods for handling of finished products with required packing & Labeling. Laboratory Systems:  Describes the methods for laboratory controls for starting material.Manufacturing Systems… Facilities & Equipment:  Describes the methods for controlled premises.

2011 30 .Quality System… Quality is everyone‟s responsibility. Business Time Managers Workshop at Unit IV./ Aug. Audits & Compliance … ensure the state of control in 5 P‟s of manufacturing systems. typically monitored by QA through…      Qualifications/ Validations In-Process Checks and Batch Release Documentation Control QMS tracking & Quality Metrics Training. Jul.

Personnel. 2011 . Distribution. Change controls and Training Training. Procedures and Practices) 31 Personnel Procedures Practices (Includes Process) Products (Includes starting material. BR checks.5 P’s and QA Controls… Premises (Includes Facility and Equipment) Approval of Design and Qualifications/ Validations Training and Qualifications Approval. Jul. Validations and Audits QC testing and control of other P’s (Premises. in-process and final product) Business Time Managers Workshop at Unit IV./ Aug.

2011 32 ./ Aug. Jul.Agenda…         Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward Business Time Managers Workshop at Unit IV.

2011 33 . and is consistently performing. with a documented evidence. which provides a high degree of assurance. Qualification: All the actions. Business Time Managers Workshop at Unit IV./ Aug. that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. Process Validation: Process validation is establishing documented evidence. Jul. that an equipment is designed and commissioned. to meet the intended requirements.Definitions… Validation: Establishing documented evidence. The word validation is sometimes widened to incorporate the concept of qualification. which provides a high degree of assurance. that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.

procedure. Jul. with high degree of assurance. Business Time Managers Workshop at Unit IV. Concurrent Validation: Establishment of documented evidence that a process does what it purports to do. system. testing and control batch data. based on information generated during actual implementation of the process. 2011 34 ./ Aug. equipment or mechanism used in manufacture does what it purports to do based on a pre-planned validation protocol.Definitions… Prospective Validation: Is the establishment of documented evidence. Retrospective Validation: A process for a product which has been marketed based upon accumulated manufacturing. that a process.

Definitions… As per the Guidance for Industry by USFDA “Process Validation: General Principles and Practices”. which establishes scientific evidence that a process is capable of consistently delivering quality products. Process Validation: The collection and evaluation of data. wrt qualifications/ validations. from the process design stage through commercial production. Jul. This certainly challenge our philosophy & practices. effective from January 2011 … Process Qualification: Conforming that the manufacturing process as designed is capable of reproducible commercial manufacturing./ Aug. 2011 35 . we have adopted as on date! Business Time Managers Workshop at Unit IV.

 Process Design  Process Qualification  Continued Process Verification Business Time Managers Workshop at Unit IV.  Quality./ Aug. Jul.  Quality cannot be adequately assured merely by in-process and finished product inspection or testing. Safety and Efficacy are designed or built into the product.New Approach… This approach is based on the understanding that. 2011 36 . This approach describes Process Validation (PV) activities in three stages.

Continued Process Verification:  Trend Analysis & Quality Metrics  Review of Key Performance Indicators (KPIs). Process Qualification:  Design of a Facility and Qualification of Utility and Equipment  Process Performance Qualification. 2011 37 . Jul.PV Stages… Process Design:  Building and Capturing Process Knowledge and Understanding./ Aug.  Establishing a strategy for process control (CPPs & CQAs). Business Time Managers Workshop at Unit IV. the principles of Quality Risk Management (QRM) are integrated into qualifications/ validations. All regulatory agencies expects that.

Jul. 2011 38 .Qualification Operational Qualification (OQ) Monitoring / Maintenance / Calibration Performance Qualification (PQ) Final Qualification Report Validation Analytical Method Validation (AMV) Cleaning Validation(CV) Process Validation(PV) Final Validation Report Business Time Managers Workshop at Unit IV./ Aug.VALIDATION LIFE CYCLE Validation Master Plan ( VMP) Impact Assessment User Requirement Specifications (URS) Qualification Change Control Design Qualification DQ) ( Factory Acceptance Test (FAT) Installation QualificationIQ) ( Re.

2011 39 . Jul./ Aug.Agenda…         Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward Business Time Managers Workshop at Unit IV.

/ Aug. control. Jul. Quality Risk Management (QRM): A systematic process for the assessment. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards. Harmonised Tripartite Guideline .Definitions… Risk: The combination of probability of the harm and the severity of that harm. communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. Business Time Managers Workshop at Unit IV. Reference: ICH Q9 – Quality Risk Management (QRM). 2011 40 . Risk Assessment: A systematic process of organizing information to support a risk decision to be made within a risk management process.

/ Aug. 2011 41 . Jul.Typical QRM Process Business Time Managers Workshop at Unit IV.

necessarily entail some degree of risk. QRM is a systematic process designed to coordinate. during it’s manufacture and/ or distribution. 2011 42 . Business Time Managers Workshop at Unit IV. The risk to its quality. in the entire product life cycle./ Aug. is just one component of the overall risk. should be considered as prime importance by all the stake holders. The protection of patient by managing the risk to product quality. including its components.Approach for QRM… The manufacturing and use of a drug product. facilitate and improve science-based decision making with respect to risk. Jul.

g. Jul./ Aug. Business Time Managers Workshop at Unit IV. The selection and implementation of improvements then be assigned to individuals and shall be reviewed for effectiveness. A practical approach for QRM is to define the scope for each risk assessment exercise. Engineering. Logistics. where the representatives are able to identify and make informed judgments on threats to the individual process steps. with the working knowledge of various important areas of product life cycle (e. QC and RA). QA. and conduct training to concerned personnel.Approach for QRM… The success of this exercise depends on the involvement of representatives. 2011 43 . Manufacturing. post implementation.

/ Aug. Jul. As an aid to clearly defining the risk(s) for risk assessment purposes. 2011 44 . three fundamental questions are often helpful:  What might go wrong?  What is the likelihood (probability) it will go wrong?  What are the consequences (severity)? Business Time Managers Workshop at Unit IV. When the risk in question is well defined.Risk Assessment… QRM begins with a well defined problem description or risk in question. Based on the problem/ risk. appropriate risk management tool and the types of information needed to address the risk in question will be more readily identifiable. we shall constitute a team of experts from user and applicable cross functions. to execute the QRM process.

Jul./ Aug. Air Distributor/ Customer Business Time Managers Workshop at Unit IV. 2011 45 . Sea. Air Warehouse of Manufacturing Plant Dispensing Production and Packaging Road. Sea.Risk Assessment… Raw Material & Packing Material Suppliers Equipment/ Component Cleaning and Sterilization Storage and Distribution sp Di e in ns g Road.

every entry and every arrow represents a risk points at which product threat could occur. customer complaints. and all the attributes related to facilities.. Particular attention shall be paid to interfaces along the product life cycle. under scope of risk assessment. environment. Jul. deviations etc. i.Risk Assessment… The QRM team shall carry out detailed process mapping of the activity. In the above process map.e. Business Time Managers Workshop at Unit IV. 2011 46 ./ Aug. Each process can be mapped separately and QRM can be effectively applied to all the stages of pharmaceutical manufacture. equipment. All the risk areas and product sensitivities. materials and practices/ procedures are considered for identifying the threats which could impact product quality and/ or safety. personnel.

Agenda…         Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward Business Time Managers Workshop at Unit IV. 2011 47 . Jul./ Aug.

/ Aug. Correction: Action refers to repair. rework and/ or adjustment and relates to the disposition of an existing non-conformity. defect or other undesirable situation in order to prevent re occurrence. Corrective Action: Action taken to eliminate the causes of an existing non-conformity. process and/ or established standard. Business Time Managers Workshop at Unit IV. 2011 48 . Preventive Action: Action taken to eliminate the cause of a potential non-conformity. system and/ or procedure. This can be an unexpected/ planned event in noncompliance with established standard. Jul. defect or other undesirable situation in order to prevent re occurrence. at any stage of manufacturing/ its associated activities.Definitions… Deviation: Departure from an approved procedure.

2011 49        ./ Aug. from the set standard and/ or routine occurrence. Jul.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. Business Time Managers Workshop at Unit IV. which is a discrepancy/ abnormal.

2011 50 . FDA News on PAIs). Escalation mechanism and management responsibility/ involvement on handling these failures/ non-conformances.Regulatory Perspective… Reporting & Tracking of all the events in defined quality system framework. Root cause investigation for all the failures/ non-conformances. Business Time Managers Workshop at Unit IV. Hence. just how well the quality system is working! (Ref. Inspectors really look how well you handle any problems./ Aug. with adequate impact assessment and CAPA. Jul. reviewing atypical event (deviations/OOS/ OOL/ OOT) reveals.

Jul. Business Time Managers Workshop at Unit IV./ Aug. 2011 51 .Regulatory Perspective… Top 10 FDA 483 Items *PAPC – Production and Process Controls Source: QSIT – Presentation on CAPA during the workshop.

 Identify the CAPAs./ Aug. i. Evaluate the impact.e. Thorough investigation to identify the root cause.Purpose of Notification…     Identify all the unexpected/ atypical events in GMP areas. including responsibilities and time lines. Acknowledge them as real deviations or whatever!. Business Time Managers Workshop at Unit IV. regulatory.  Decision on disposition of the batch and/ or move forward with routine operations.  Documenting all the events concurrently in a traceable manner. quality. Jul. 2011 52 . systemic and business.

2011 53 .Challenge… The biggest challenge in any Quality System of the organization with respective to Deviations is… Communication processes that are untimely. Effective investigations for all atypical events. Business Time Managers Workshop at Unit IV. Jul. inefficient and lacking in ownership lead to identifying the True Root Cause and applying effective Corrective And Preventive Actions (CAPA). is an ultimate tool for any organization to comply with “Current” requirements of “GMPs”./ Aug. with adequate CAPAs. which ensures continuous improvement.

/ Aug. 2011 54 . Stated clearly and concisely Is scientifically valid – the conclusion is based on the data and/or sound scientific knowledge and principles. The goal of every deviation investigation is to identify the True Root Cause. would Prevent Recurrence. Stated with a level of confidence that is appropriate Business Time Managers Workshop at Unit IV. Jul. which if eliminated. An identified reason for the presence of a defect or problem and/ or the source or origin of an event. This is critical to ensure that the most effective Corrective Action / Preventative Action is implemented.True Root Cause… Is the most basic reason. Root Cause must be.

evaluate need to revise or update problem definition Business Time Managers Workshop at Unit IV. Jul. Brainstorm for causes. Identify what’s changed./ Aug. 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. ask if the problem definition is still correct and complete •In practice. organize information Problem analysis and troubleshooting Test hypothesis Drill down to the true root cause. Tools! Evaluate after implementation Product Impact At each stage. 2011 55 .Problem Solving… Define Generate Description – Map the process.

/ Aug.Agenda…         Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward Business Time Managers Workshop at Unit IV. Jul. 2011 56 .

control charts.e..The Tools…     Flow charts. process mapping Statistical tools./ Aug. histograms. 2011 57 . 5 – Whys Technique Cause and Effect Diagrams (Ishikawa diagram or fish bone diagram). Check sheets. Effects and Criticality Analysis (FMECA) Fault Tree Analysis (FTA) Hazard Analysis and Critical Control Points (HACCP) Hazard Operability analysis (HAZOP) Preliminary Hazard analysis (PHA)       Business Time Managers Workshop at Unit IV. Jul. Pareto charts etc. i. Failure Mode Effects analysis (FMEA) Failure Mode.

5 questions are believed to be sufficient to get to the true root cause Business Time Managers Workshop at Unit IV. 2011 58 . 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 Why? Technique… Developed at Toyota and is critical component of the problem solving training in it’s production system. Jul. Method of asking questions to determine the true root cause of the problem and has potential to uncover underlying design. procedure or organization issues./ Aug.

Valve was opened and the temperature returned to normal. Cause: Temperature excursion due to closed glycol valve. Jul./ Aug. Operators found that the ball-valve controlling glycol flow to the tank jacket was in the closed position. triggering an alarm.5 Why? Technique… 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. 2011 59 . Business Time Managers Workshop at Unit IV.

2011 60 .Cause Effect Analysis… Business Time Managers Workshop at Unit IV./ Aug. Jul.

2011 61 . Jul.Cause Effect Analysis… Business Time Managers Workshop at Unit IV./ Aug.

/ Aug.Cause Effect Analysis… Business Time Managers Workshop at Unit IV. 2011 62 . Jul.

FMEA… Business Time Managers Workshop at Unit IV. Jul. 2011 63 ./ Aug.

/ Aug. 2011 64 . Jul.FMEA… Business Time Managers Workshop at Unit IV.

Jul. 2011 65 ./ Aug.FMEA… Business Time Managers Workshop at Unit IV.

/ Aug. Jul. 2011 66 .FMEA… Business Time Managers Workshop at Unit IV.

Agenda…         Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward Business Time Managers Workshop at Unit IV. 2011 67 ./ Aug. Jul.

2011 68 .Case Study… Group A: Group B: Group C: Business Time Managers Workshop at Unit IV. Jul./ Aug.

/ Aug.Agenda…         Basics of GMP Pharmaceutical Quality systems Qualifications/ Validations Quality Risk Management (QRM) Corrective & Preventive Actions (CAPA) RA/ Investigation Tools Case Study Moving Forward Business Time Managers Workshop at Unit IV. 2011 69 . Jul.

2011 70 . Can be used to prove GMP compliance. to meet the CGMPs. 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. Jul. is an effective “Documentation System”. …be sensitive towards them! Business Time Managers Workshop at Unit IV.Driving Force… The driving force for implementation of a robust pharmaceutical quality system./ Aug.

Do not scare of them! Qualification/ Validation of every thing we do/ adopt. 2011 71 . Jul. Data collection should always accompanied with data analysis to make scientifically justified decisions. Risk Assessment and CAPAs should be your daily mantras! Business Time Managers Workshop at Unit IV.Take Away… Refer to written instructions and Never Assume! Understand your own processes and improve “out of box” thinking abilities. Notifications are appropriate tools and enable us to comply with CGMPs./ Aug.

Jul. 2011 72 ./ Aug.Critical Element… GMPs will only work with the cooperation and understanding of the most important element and that is … …YOU Business Time Managers Workshop at Unit IV.

/ Aug. 2011 73 .THANK YOU Business Time Managers Workshop at Unit IV. Jul.