Good Manufacturing Practices in 21st Century

By :Ady Sadek M.Sc. , P.Chem. proGamma Science Corporation 2011

proGamma Science Corporation

About Us
proGamma Science Corp: www.progamma.ca  Based in Montreal 1985. We provide implementation consulting and professional training in the following major divisions of the Pharmaceutical, biopharmaceutical , Natural Health Products and medical devices industries :  1.Quality assurance and Regulatory Affairs  2. Technical Operations : Product development, Manufacturing, Packaging, Validation services, Automation , Process Validation , Equipment qualification  3. Quality System Management , Risk Assessment  4. Computerization including: Software Engineering, PAT, Computer system validation services  5. Professional cutting edge training Partial Client List : Abbott Labs Ltd , AeternaLabs , Astra-Zenica, Apotex, Agilent Technologies , Bioniche , Confab Labs., Church & Dwight Canada, Delmar Chemicals , Dermtek Pharmaceuticals Ltd., DraxisPharma Inc. PharmaLab, Pharmetics, Galderma Production, Health Canada (TPD), MerckFrosstCanada ,Novopharm , Novartis Pharmaceuticals ,Omega ValtecLtd. , PharmaScience, Pfizer Canada ,ProDoc,RivaLabs , Sandoz , Sanofi-Aventis , Schering-Plough, Sandoz ,ratiopharm Inc, Tyco HealthCare, Valeant Pharma

proGamma Science Corporation

Ady Sadek M.Sc, P.Chem

is president of proGamma Science Corporation, previously he spent 20 years in the pharmaceutical industry with BioResearch, Schering-Plough and Novartis Pharmaceuticals, holding positions such as Manager of Analytical & Development Labs, Director of Quality and Director of QualityAudit. He holds two master degrees in Organic and analytical chemistry and is an ISO 9000 lead auditor . Ady’s vast experience in GMP compliance ,process design and validation started in 1981, when developing new formulations for FDA submissions. He has been involved in many Plant GMP training , Audits validations and his experience extends from formulation development to scale up commercial batches and technology transfer. He has consulted and lectured throughout Canada, USA and Europe to several multinationals.

proGamma Science Corporation Agenda       The History What is GMP? Why we need GMP? GMP sections Modern GMP progress in 21st century Pharmaceutical Plant management in the 21st Century .

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. During the past 30 years many new regulations passed into law have required drug and medical device industries to substantially modify their business methods One of the most well known sets of regulations that have had a major impact on the drug and medical device industries are called Good Manufacturing Practices (GMP) a document published by Health Canada which sets out the minimum activities required for drug manufacturers in Canada.proGamma Science Corporation What is GMP ?     Although quality assurance has its value in almost every industry. Legally enforced through the Canadian Food & Drugs Regulations. Division 2. Part C. it has special justification in the drug and medical device industries due to the nature of the product and complex government regulations.

veterinary drugs. packager/Labeller. The branch responsible for GMP of health Canada is : Health Products and Food Branch Inspectorate (HPFBI) These regulations. Importor and distributor of drug product take proactive steps to ensure that their products are :    Safe pure and effective . require that manufacturers. which have the force of law. or medical device products GMP refers to the Good Manufacturing Practice Regulations promulgated by Health Canada under the authority of the Food and Drug Act.proGamma Science Corporation     These regulations describe the minimum requirements that governments consider necessary for the production of human drugs.

 . Failure of firms to comply with GMP regulations can result in very serious consequences including recall. seizure and fines.proGamma Science Corporation  GMP regulations require a quality approach to manufacturing. protects the consumer from purchasing a product which is not effective or even dangerous. and errors. enabling companies to minimize or eliminate instances of contamination. This in turn. mix ups.

proGamma Science Corporation WHAT IS GMP?…. These regulations apply to: Buildings Equipment Personnel .

proGamma Science Corporation WHAT IS GMP?…. Ensures that: Procedures Controls (QA) Are available in place and followed .

process validation. allowing each manufacturer to decide individually how to best implement the necessary controls. sanitation.proGamma Science Corporation    GMP regulations address issues including recordkeeping. but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business. equipment verification. and complaint handling. cleanliness. . personnel qualifications. This provides much flexibility. Most GMP requirements are very general and open-ended.

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proGamma Science Corporation GMP sections .

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Processes.proGamma Science Corporation Quality Management   Determines and implements the “quality policy” The basic elements are:  an appropriate infrastructure or “quality system” encompassing the Procedures. and Resources  the systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for “Quality” The totality of these actions is termed “Quality Assurance” .

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Adopted Health Canada QA Systems
1. Drugs are designed and developed in a way that takes into account the GMP requirements 2. Managerial responsibilities are clearly specified 3. Systems, facilities and procedures are adequate 4. Production and control operations are clearly specified and validated 5. Arrangements are made for the supply and use of the correct raw and packaging materials; 6. All necessary controls on intermediates, and any other inprocess monitoring, and is carried out; 7. Outsourced activities are subject to appropriate oversight controls and meet GMP requirements;

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8. Fabrication, packaging/labelling, testing, distribution, importation, and wholesaling are performed in accordance with established procedures 9. Drugs are not sold or supplied before the quality control department has indicated certified that each lot has been produced and controlled in accordance with the marketing authorization and of any other regulations relevant to the production, control and release of drugs; 10. Satisfactory arrangements exist for ensuring that the drugs are stored, distributed, and subsequently handled in such a way that quality is maintained throughout their shelf life

proGamma Science Corporation

11.The effectiveness and applicability of the quality management system is ensured through regular self-inspection and management review 12. Annual product quality review of all drugs should be conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both raw materials and finished product to highlight any trends and to identify product and process improvements.

proGamma Science Corporation Quality Management GMP   Ensure that products are consistently produced and controlled Diminishes risks that cannot be controlled by testing of product  Cross-contamination  Mix-ups .

3. Basic Requirements for GMP Clearly defined and systematically reviewed processes Critical steps of manufacturing processes and significant changes to the process are validated. equipment. 5. Appropriate resources: personnel. materials Clearly written procedures Trained operators . buildings. 4. 2.proGamma Science Corporation Quality Management 1.

and transportation distribution of the drugs minimizes any risk to their quality 9. Recall system 10. Records of fabrication.Complaint handling . importation and wholesaling that enable the complete history of a lot to be traced are retained in a comprehensible and accessible form 8. handling. Records :  manually or by instruments  demonstrate that all the steps are followed  Deviations are investigated and documented. packaging.proGamma Science Corporation Quality Management 6. 7. testing. labelling. distribution. Control of storage.

proGamma Science Corporation Quality Management Quality relationships Quality Management Quality Assurance GMP Quality Control .

testing. specifications. documentation and release procedures .proGamma Science Corporation Quality Management Quality Control (QC)  QC is part of GMP that is concerned with sampling.

proGamma Science Corporation Quality Management Quality Control (QC) Department    Each holder of a Establishment Licence should have a QC Department Independence from production and other departments is considered to be fundamental Under the authority of an appropriately qualified and experienced person with one or several control laboratories at his or her disposal. .

proGamma Science Corporation Quality Management Basic Requirements for Quality Control Resources    Adequate facilities Trained personnel Approved procedures .

proGamma Science Corporation Quality Management Basic Requirements for Quality Control Tasks      Sampling Inspecting Testing Monitoring Releasing/rejecting .

5.proGamma Science Corporation Quality Management Basic Requirements for Quality Control 1. 2. 6. Sampling approved by QC department Validated test methods Records Review and evaluation of production documentation Failure investigations for all deviations Ingredients comply with the marketing authorization . 4. 3.

Proper containers 9. Retained samples of starting materials and products . Correct labelling 10.proGamma Science Corporation Quality Management Basic Requirements for Quality Control 7. Release of batches by the authorized person 11. Ingredients are of the required purity 8.

5. Establish QC procedures Reference standards Correct labelling Stability testing Complaint investigations Environmental monitoring . 2.proGamma Science Corporation Quality Management Other Duties of the Quality Control Department 1. 3. 4. 6.

For example:  production conditions  in-process test results  manufacturing documentation  compliance with finished product specification  examination of the finished pack .proGamma Science Corporation Quality Management Assessment of Finished Products Should embrace all relevant factors.

summary  QC is part of GMP  sampling  specifications  testing  release procedures  recalls and complaints  decision-making in all quality matters      authorization definition of product quality laboratory operations release decisions investigation and reporting .proGamma Science Corporation Quality Management Quality Control .

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.proGamma Science Corporation Sanitation Influence on quality:   Sanitation in a pharmaceutical plant influences the quality of drug products as well as employee attitude. The quality requirement for drug products demand that such products be fabricated and packaged in areas that are free from environmental contamination and free from contamination by another drug.

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proGamma Science Corporation Why is this Important? Hair nets are important for two reasons : They help keep hair out of products and help keep human hands away from hair .

a necklace could get caught in a mixing machine and cause harm to the operator. Jewelry can be a physical hazard and can be heavily contaminated with bacteria. For example.proGamma Science Corporation Jewelry is not allowed Jewelry should be limited to a plain wedding band. Wearing jewelry can also be dangerous to the employee. .

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proGamma Science Corporation Who is responsible  Integrates all your quality systems Training Validation CHANGE CONTROL Document Management State of Control .

proGamma Science Corporation Modern GMP progress in 21st century      FDA initiative 2002 Risk management approach Process Analytical Technology PAT  Goal to ensure final product quality  Enhance process understanding and control of manufacturing process World acceptance of FDA initiative ICH . FDA and EMEA new regulations .

proGamma Science Corporation Modern GMP progress in 21st century  ICH Q8 pharmaceutical development   Quality by design Design space  ICH Q9 quality Risk management    Risk Management process Risk Assessment and risk control Risk Management tools : FMEA...  ICH Q10 Pharmaceutical Quality System   Product Realization Knowledge Management and quality risk management . FTA ..

proGamma Science Corporation  Process Validation : the magic 3 is no longer magic    Process Design Process qualification Continued Process Verification  Quality by Design – CMC .

proGamma Science Corporation Why QBD? The future Pharmaceutical Quality System The Regulatory Quality System Quality Risk Management Quality Risk Management (Q9) For companies with : 1. Good Quality Systems Quality Systems Quality by Design (Pharmaceutical Development) Quality by Design Reduced regulatory burden: (Q8) • Reduction of Existing GMP ’ s Quality Systems (Q10) submissions on changes/variations • Inspection of quality systems 57 . Good Risk Management strategies 3. Good design and control strategies 2.

proGamma Science Corporation Tremendous Opportunity Pharmaceutical Development: + Quality by Design Q8 Quality Risk Management Q9 + Pharmaceutical Q10 Modern Effective Quality Systems Lower Risk Operations Innovation and Continual Improvement Optimized Change Management Process Flexible Regulatory Approaches 58 .

Perhaps our vision should be updated? Our vision: Quality By Design The Regulatory Quality System proGamma Science Corporation Quality Risk Management (Q9) Quality Risk Management Quality Systems Product & Process Dev (Q8)+ Quality by Design For companies implementin g Quality by Design Reduced regulatory burden: • Reduction of submissions on changes/variations Existing ’s GMP Quality Systems (Q10) • Inspection of quality systems 59 .

proGamma Science Corporation    Process Validation and product life cycle Progress in Quality system application in pharmaceutical industry  ISO 9000  Six Sigma Multivariate statistics to measure and better improve process performance .

Modern Facility Management in the 21st Century Overall Customer Satisfaction .

proGamma Science Corporation Pharmaceutical Plant Management in the 21st Century Course Outline 1. Technical Services 6. Human Resources 4. Supply Chain . Environment and Safety 8. Engineering 7. Business Development and Commercial 10. Business Processes and Systems 5. Regulatory Excellence 9. Operational Excellence 2. Compliance and Quality Control 3.

vi. v. Customer Satisfaction Capacity and Utilization Do it right the first time Improve Operational Efficiency Compliance and Regulatory Affairs Business Processes and Systems Measurement Philosophy of Continuous Improvement PAT .proGamma Science Corporation Pharmaceutical Plant Management in the 21st Century 1. ix. viii. vii. ii. Operational Excellence i. iii. iv.

viii. v. iv. ix. vii. Method Validations Paperless . vi. iii.proGamma Science Corporation Pharmaceutical Plant Management in the 21st Century 2. Compliance and Quality Control i. Finished Goods Testing Stability Programs Documentation Technical transfers. ii. Product Release Quality Systems CAPA Program Self Inspection Program Incoming. in-process.

ii.proGamma Science Corporation Pharmaceutical Plant Management in the 21st Century 3. v. iv. Succession Planning Personnel Development Action Plans Hi Potentials/Mentorship Programs Union Negotiations Employee Relations Employee Benefits Retention Programs Management Training Recognition Programs . Human Resources i. viii. vi. ix. iii. vii.

Warehousing/Logistics vii. Purchasing v. Inventory Control and Management vi. ERP ii. Shop Floor Control . Business Processes and Systems i. Planning/Forecasting iii. Finance viii.proGamma Science Corporation Pharmaceutical Plant Management in the 21st Century 4. Capacity Planning iv.

vii. iv. vi. xii. Validation Master Plan IQ/OQ/PQ Cleaning Validation Computer Validation ERP Validation Change Control Program Documentation Control New Product Introduction Process Label Control Process Development Scale Up Clinical Considerations Formulation . viii. ix. Technical Operations i. iii. xiii. ii. xi.proGamma Science Corporation Facility Management for the 21st Century 5. v. x.

II.proGamma Science Corporation Pharmaceutical Plant Management in the 21st Century 6. IV. IX. VI. VIII. Preventative Maintenance Predictive Maintenance Calibration Program Demand work orders Capital Programs Specialization Troubleshooting Utilities Daily Production Support Project Management . III. Engineering I. V. VII. X.

Inspections v. Employee Involvement vii. Regulations iii. Safety Programs . Recycle.proGamma Science Corporation Pharmaceutical Plant Management in the 21st Century 7. Environment and Safety i. Committees vi. Hazardous Waste iv. reduce ii. Training viii. reuse.

proGamma Science Corporation Pharmaceutical Plant Management in the 21st Century 8. Licenses iii. Regulatory Excellence i. Plant Master Files ii. Government Inspections .

Marketing of product portfolio 10. Business Development/Commercial Pipeline/New Sales ii. . Pricing/Contracts vi. New Product Management iv. Legal vii. Negotiation v. Current Account/Product Management iii. Market Research viii.proGamma Science Corporation Pharmaceutical Plant Management in the 21st Century 9. Supply Chain i.

proGamma Science Corporation Thank you for inviting me Ady Sadek .

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