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Premium member Presentation Transcript Quality, Quality Assurance & Quality Control, GMP and GLP In Pharma Industry: Quality, Quality Assurance & Quality Control, GMP and GLP In Pharma Industry By Nishit Patel Assistant Professor, Dharmaj Degree Pharmacy CollegePowerPoint Presentation: Quality The meaning of quality The traditional view of quality derives from the inspection /measurement approach used in quality control when quality consists of conformity with a pre-determined specification The view of quality, especially within the context of the pharmaceutical industry and quality assurance, has now moved away from this rather narrow view, and the definition more or less accepted at present tends to be fitness for purpose The International Organisation for Standardisation (ISO) has further refined this definition in the application of the ISO 9000 quality standards to mean fitness for purpose with customer satisfactionPowerPoint Presentation: Medicines are special because virtually no other product is consumed by the public on such utter trust – trust that the medicine will not do them more harm than the illness it is meant to cure. Their doctor prescribes the medicine; it is dispensed by a pharmacist and is taken by the patient in the belief that it will cure their ill health and that it will not make it worse! This trust can only be assured if the medicine has been adequately tested during development. This testing should assure that side effects have been established and that the medicine is efficacious. When the medicine is given to patients it must have been appropriately manufactured, tested and packaged to assure that: Medicines are specialPowerPoint Presentation: It is the correct product. It is the correct strength. It has not degraded. It is free from harmful impurities and micro-organisms. It has not been contaminated. It is correctly labelled. It is properly sealed in a suitable container Medicines are special cont…PowerPoint Presentation: End-product testing (quality control) is the reliance only on appropriate analytical tests to demonstrate the quality of a medicinal material. End-product testing alone is considered as testing quality into the product. You only accept those materials that pass specification. This is not adequate to ensure that the medicine is free from all manufacturing faults, that test methods employed are adequate to establish its purity and that a small proportion of defective materials would be detected. End-product testingPowerPoint Presentation: Example 1 All pharmaceutical industry regulators prohibit the manufacture of penicillins in the same facility as other medicinal materials. Example 1.2. (This example is taken from a real incident.) A solution of a chemical intermediate used for the production of an API was stored temporarily whilst waiting further processing. The storage containers used had previously contained a potent pesticide that had not been completely removed. I will give several examples to illustrate this point.PowerPoint Presentation: In conclusion, end-product testing is not adequate for the following reasons: You only test for what you expect to find. You only test a small portion of the bulk of the test material. (There could be a small proportion of defective material in a batch, which only 100% testing would detect, e.g. microbiological contamination of sterile vials.) It is doubtful whether, in the case of medicines, the consumer would detect defects.PowerPoint Presentation: To assure the quality of medicinal products, quality must be built in at each stage of the manufacturing process and not merely tested in. Any factor that could have an effect on the quality of the final medicinal product must be controlled. These factors could be anything from the design of the production facility used or the environment the material is isolated in, to the analytical test methods employed at each stage of production. The philosophy of quality assurance is that batch to batch consistency should be maintained by reducing variability of all supporting processes, sub-processes and procedures.PowerPoint Presentation: Quality relationships Quality Management Quality Assurance GMP Production and Quality ControlPowerPoint Presentation: This is a wide-ranging concept concerning all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that products are of the quality required for their intended use. QAPowerPoint Presentation: The system of quality assurance appropriate to the manufacture of pharmaceutical products shall ensure that: - (a) the pharmaceutical products are designed and developed in a way that takes account of the requirement of Good Manufacturing Practices (herein referred as GMP) and other associated codes such as those of Good Laboratory Practices (hereinafter referred as GLP) and Good Clinical Practices (herein after referred as GCP); (b) adequate arrangements are made for manufacture, supply and use of the correct starting and packaging materials. (c) adequate controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out.PowerPoint Presentation: (d) the finished product is correctly processed and checked in accordance with established procedures; (e) the pharmaceutical products are not released for sale or supplied before authorized persons have certified that each production batch as been produced and controlled in accordance with the requirements of the label claim and any other provisions relevant to production, control and release of pharmaceutical products.PowerPoint Presentation: GMP is that part of Quality assurance which ensures that the products are consistently manufactured and controlled to the Quality standards appropriate to their intended use GMP What is GMP ?PowerPoint Presentation: What is cGMP ? Usually see “cGMP” – where c = current, to emphasize that the expectations are dynamicPowerPoint Presentation: "GMP" - A set of principles and procedures which, when followed by manufacturers for therapeutic goods, helps ensure that the products manufactured will have the required quality. A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.PowerPoint Presentation: Some of the main risks are unexpected contamination of products, causing damage to health or even death. ‘Cross Contamination’ incorrect labels on containers, which could mean that patients receive the wrong medicine. ‘Mixup’PowerPoint Presentation: Why GMP is important A poor quality medicine may contain toxic substances that have been unintentionally added. A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect.PowerPoint Presentation: GMP helps boost pharmaceutical export opportunities Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP. Governments seeking to promote their countries export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements.PowerPoint Presentation: GMP Covers… ALL aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.PowerPoint Presentation: GMP guidelines GMP as per Schedule “M” in India www.cdsco.nic.in GMP as per WHO www.who.int GMP as per MCA now known as MHRA Medicines and Healthcare Products Regulatory Agency www.mhra.gov.uk GMP as per TGA ( Therapeutic Goods Administration ) www.tga.gov.au GMP as per US FDA www.fda.gov GMP as per ICH guidelines www.ich.orgPowerPoint Presentation: Certifying agencies ICH. www.ich.org WHO. www.who.int US FDA. www.fda.gov EU/EMEA. www.emea.europa.euPowerPoint Presentation: How do GMPs of different countries compare? At a 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 (like Quality Control and/or Quality Assurance) Well trained personnel and managementPowerPoint Presentation: cGMP For Finished Pharmaceuticals as per US FDA (21 CFR 210–226) Subpart A:General Provision B:Organization & Personnel C:Building & Facilities D:Equipment E:Control of Components & Drug Product Containers & Closures F:Production & Process Control G: Packaging & Labeling Control H:Holding & Distribution I:Laboratory Control J:Records & Reports K:Returned & Salvaged DrugsPowerPoint Presentation: Basic Requirements for GMP Clearly defined and systematically reviewed processes Qualification and validation is performed Appropriate resources are provided: Qualified and trained personnel Premises, space, equipment and services Materials, containers, labels Procedures, storage, transport Laboratories and in-process controlPowerPoint Presentation: Basic Requirements for GMP Clear, written instructions and procedures Trained operators Records of actions, deviations and investigations Records for manufacture and distribution Proper storage and distribution Systems for complaints and recallsPowerPoint Presentation: QC GMP QAPowerPoint Presentation: Is that part of GMP concerned with sampling, specification & testing, documentation & release procedures which ensure that the necessary & relevant tests are performed & the product is released for use only after ascertaining it’s quality QCQA and QC: QA and QC QC is that part of GMP which is concerned with sampling, specifications, testing and with in the organization, documentation,and release procedures which ensure that the necessary and relevant tests are carried out QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use.QA and QC: QA and QC Operational laboratory techniques and activities used to fulfill the requirement of Quality All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for qualityQA and QC: QA and QC QC is lab based QA is company basedICH Harmonised Tripartite Guideline: ICH Harmonised Tripartite Guideline Stability Testing of New Drug Substances and Products Stability Testing: Photostability Testing of New Drug Substances and Products Stability Testing for New Dosage Forms Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products Evaluation for Stability Data Stability Data Package for Registration Applications in Climatic Zones III and IV Validation of Analytical Procedures: Text and Methodology Impurities In New Drug SubstancesICH Harmonised Tripartite Guideline: ICH Harmonised Tripartite Guideline Impurities in New Drug Products Impurities: Guideline for Residual Solvents Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Microbial Enumerations Tests Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Test for Specified Micro-OrganismsICH Harmonised Tripartite Guideline: ICH Harmonised Tripartite Guideline Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral PreparationsICH Harmonised Tripartite Guideline: ICH Harmonised Tripartite Guideline Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Region on Dissolution TestICH Harmonised Tripartite Guideline: ICH Harmonised Tripartite Guideline Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions onTablet Friability Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal OriginICH Harmonised Tripartite Guideline: ICH Harmonised Tripartite Guideline Quality of Biotechnological Products: Analysis of the Expression Construct in Cells used for Production of r-DNA Derived Protein Products Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical SubstancesICH Harmonised Tripartite Guideline: ICH Harmonised Tripartite Guideline Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Pharmaceutical Development Quality Risk Management Pharmaceutical Quality System Quality Implementation Working GroupPowerPoint Presentation: Quality Assurance (QA) Management ProcedureHow to write Standard Operating Procedure: How to write Standard Operating Procedure SOP describes standard SOP format that you can use immediately for your quality procedure. SOP has instructions on how to write a formal operating procedure for your systems which your people can follow everyday.All Documents-Classifications, Definition and Approval Matrix : All Documents-Classifications, Definition and Approval Matrix In this SOP you will find all type of quality and Technical/Master file documents to build up a good quality management system for your manufacturing sites, definition of documents, their classification, approval requirements and retention requirements. This procedure has schematic diagrams for your understanding of how different types of documents are prepared and stored in a typical documentation.Quality Documentation Management and Change Control: Quality Documentation Management and Change Control This SOP describes how to generate new quality documents or change control of existing documents, review of quality documents, satellite file management, role of document author, approver, document control officer and satellite file administrator. In this SOP you will also find numbering systems of different quality documents like audit files, SOP’s, forms, manuals, training files, QA agreements, project files etc and their effective archiving system.Documentation Rule for GMP Documents: Documentation Rule for GMP Documents This SOP describes the principles to be followed in GMP documents, entry of data and information, signature requirements and correction technique of incorrectly entered data or information.Quality Documentation-Control, Tracking and Distribution: Quality Documentation-Control, Tracking and Distribution In this SOP you will find mainly the role of document control officer during the initiation, creation, circulation and approval of new quality related documents. It also describes the procedure of modification and review of existing document using a documentation database. Management of existing and superseded documents is also a art of this procedure. You will see all the forms referred during the instruction are attached at the end of the procedure.Preparation, Maintenance and Change Control of Master Documents: Preparation, Maintenance and Change Control of Master Documents This SOP particularly focused on the management of master file documents like specifications, control methods, raw materials, finished goods and packaging specification and test reports, formulation, stability files etc required to generate during the product registration in the market. This SOP gives instruction on their creation, change control, numbering system, approval requirements and maintenance in a simple master file database. You will see all the forms referred during the instruction are attached at the end of the procedure.Deviation Report System: Deviation Report System It is a regulatory requirement to capture all sorts of deviations evolves in your systems in order to maintain the continuous improvement to your processes and systems. This SOP describes how to categorize the deviations between production, audit, quality improvements, technical deviations, customer complaints and environmental, health and safety deviations. It describes the management responsibilities of initiating deviation, capture data, analysis, investigation, determination of assignable causes, generation of management report and initiatives to be taken on corrective and preventative actions.Shelf Life of Product: Shelf Life of Product This simple SOP describes the meaning of shelf life and provides on how to interpret shelf lives and storage conditions for your raw materials from the Certificate of Analysis, determining expiry date for your finished products by use of raw material date of manufacturing and their shelf lives.Vendor Selection and Evaluation: Vendor Selection and Evaluation This SOP describes the procedure to be followed during the vendor assessment and vendor evaluation for purchasing of raw materials, critical and non critical packaging components, laboratory supplies, engineering supplies and imported finished goods from the vendor. These instructions are essential for approving prospective vendor.Vendor Certification: Vendor Certification This procedure aim to describe the process by which a vendor may be certified to supply materials or services. This procedure applies to vendors that supply a material or service to be used at any stage of manufacture by operations. Here you will get the roles of each department in the process to certify an approved vendor.Product Complaint Procedure: Product Complaint Procedure This procedure covers the receipt, logging, evaluation, investigation and reporting system of all complaints received from customers for the marketed products. This SOP contains step by step instruction to be followed in the customer complaint management like numbering of complaint, registration, evaluation of complaints, determination of assignable cause for the complaint deviation, implementation of corrective and preventive actions, trending of complaints and handling of counterfeit products.Annual Product Review: Annual Product Review This procedure provides a guideline to annual product review which is required to be performed for each product produced for the commercial market to evaluate data, trends and to identify any preventative or corrective action that would lead to product quality improvements and report them to management.Rework Procedure: Rework Procedure This SOP contains the step by step instruction to be followed when the rework of an in-process or completed finished good is required. This SOP covers the reworks of in-process manufactured goods where new batch number is introduced for the reworked part and rework of manufactured finished good keeping the same batch number. This SOP also describes how to create rework protocols for each individual case.Authorized Person: Authorized Person This simple procedure describes the accreditation, accountabilities and responsibilities of an Authorized person, responsible for release of finished goods for sale.Product Identification and Traceability: Product Identification and Traceability The purpose of this SOP is to define the method used for the identification of all contributing materials that could affect product quality and to ensure their full traceability. Here you will find instruction on all the records and documents used for the identification and traceability of incoming raw materials and out going finished goods.Audits: Audits This SOP describes the process of planning, performing, reporting and follow-up of different audits for your systems like Internal Quality audit, Vendor audit, Environmental Health and Safety (EHS) audit, EHS workplace inspection, Housekeeping audit. This SOP also describes the process to be followed by manufacturing personnel during an audit from a Regulatory authority.Example-Checklist for Batch Documentation: Example-Checklist for Batch Documentation This SOP describes the identification of all documentation relevant to a production process in the form of “Batch Documentation Checklists” and to ensure their collection by completion of the checklists by Authorized Persons. This procedure is based on an example of tablet packaging process described in the ‘Manufacturing’ category.Evaluation of Batch Documentation and Release for Sale: Evaluation of Batch Documentation and Release for Sale This procedure describes the process of collection, evaluation and record of batch related document generated during the production of a batch before an authorized person can release the batch for sale. This procedure is based on an example of tablet packaging process described in the ‘Manufacturing’ category.GMP Training: GMP Training This SOP describes how to design and deliver GMP related training for your manufacturing staffs, training assessment design, recording of assessment and preparation of training reports.How to Write Training Materials: How to Write Training Materials This simple SOP contains instructions on how to write training materials, identification of training requirements, available resources, preparation of training aid checklists for your manufacturing staffs.House Keeping Audit Procedure: House Keeping Audit Procedure This SOP describes the requirements, checklists and reporting procedure on housekeeping audits. Individual checklist forms are attached at end of the procedure for different areas like process, laboratory, engineering stores, warehouses. This procedure also describes the handling of non-compliance found during the housekeeping audits.Management and Control of Contract Work: Management and Control of Contract Work The procedure describes the management and control of contract work provided by the contractors for packaging and finished products for your company as well as control of contract works done by your company on behalf of others.Criteria for Sourcing of RM, Critical Packaging Components and Imported Finishing Goods: Criteria for Sourcing of RM, Critical Packaging Components and Imported Finishing Goods The purpose of this SOP is to describe the process for approval of an external vendor/manufacturer supplying products to your company. It covers raw materials (including bulk products for subsidiaries and contract manufacturers), critical packaging components in contact with product and imported finished goods. The SOP also references affiliated documentation detailing the scope of active materials used and the approved manufacturers of these materials.Quality Concern Investigation Process: Quality Concern Investigation Process This procedure contains instruction to be followed when conducting Investigations and to raise and assess Deviation Report when an investigation or incident Investigation occurs. This procedure is to be used in conjunction with SOP, which covers the approval and follow-up activities associated with a Deviation Report. Here you will find collection of information for an incident or a deviation, steps to be followed for a cross functional investigation, reporting and implementing of the outcomes of investigation.PowerPoint Presentation: Quality Control Laboratory Procedures Retest Dating of Raw Materials : Retest Dating of Raw Materials The purpose of this procedure is to describe how to run the expired stock report; to describe how to define the requirements for the retesting and assignment of storage period for active ingredients, excipients and raw materials; to instruct retesting procedure and to determine the status of a finished goods batch with a shorter shelf life.Calibration Policies for Laboratory Instruments: Calibration Policies for Laboratory Instruments This SOP describes the calibration polices of laboratory instruments/equipments. It describes labeling and security requirements of laboratory instruments/equipments. This SOP also describes the investigational steps to be required in the case of failed calibrationArchiving Laboratory Documentation: Archiving Laboratory Documentation This procedure describes retention and disposal procedures of laboratory documentation, general laboratory documentation system that includes handling of rejected raw material and finished product reports, finished goods certificate of analysis, finished goods register, raw material certificate of analysis, register, trend cards, procedure for long term document retention.Management of Reference Substances: Management of Reference Substances This SOP describes the ordering referencing, storing, coding, use and general register maintenance of primary and impurity reference substances, primary reagent reference solutions, secondary raw material reference substance, assay testing procedure of secondary raw material reference substance, use of secondary raw material reference substance in the laboratory routine analysis, determination of expiry date and re-test date of reference substances.Laboratory Workbook: Laboratory Workbook This SOP describes types of laboratory workbooks, general and GMP requirements of using workbooks, analytical data entry in the workbook, formatting of laboratory workbooks for routine testing, experiments and trials, workbook retention policy, instruction on data entry for incomplete experiments and additional data.Creation of Certificate of Analysis: Creation of Certificate of Analysis The purpose of this procedure is to define the content and format of a Certificate of Analysis (C/A) and Certificate of Manufacture (C/M) and to provide guidance for issuing a Certificate of Analysis or Certificate of Manufacture and to locate the appropriate data required for this task.Managing Analytical Reagents: Managing Analytical Reagents This procedure identifies the need for all analytical reagents and solutions prepared from the reagents, to have an assigned expiry date and storage conditions recorded on the label. Here you will find the procedure for purchase and management of analytical reagents and laboratory prepared reagents.Laboratory Waste Management: Laboratory Waste Management This simple procedure describes how to dispose off laboratory generated wastes of toxic, explosive, flammable, corrosive, oxidizing and biologically damaging natures.Retention Samples-Laboratory: Retention Samples-Laboratory The purpose of this SOP is to describe the finished good and raw material sample retention procedures, products manufacture and/or received onsite and/or chemically tested by the laboratory.Laboratory Supplier Approval: Laboratory Supplier Approval In this simple SOP you will find the procedure for approving laboratory suppliers and criteria for the purchase of equipment, instrumentation, consumables, durables and glassware for the laboratory.Laboratory Results-Out of Specification Investigation: Laboratory Results-Out of Specification Investigation This procedure describes the actions to be taken by an analyst in the event the result of a test does not conform to raw material/components or finished products specifications for physical and chemical tests. An out of specification (OOS) result does not necessarily mean the batch under investigation fails and shall be rejected. The OOS result shall be investigated and the findings of the investigation, including re-test results shall be interpreted to evaluate the batch and reach a decision regarding release or rejection.Raw Materials-Laboratory Testing and Documentation: Raw Materials-Laboratory Testing and Documentation This SOP describes the procedure for sampling, location, pre-testing, testing and documentation of all raw materials and components subject to test, out of specification results, microbiological tests and release procedure for passed raw materials and components.Finished Goods-Laboratory Testing and Documentation: Finished Goods-Laboratory Testing and Documentation This SOP describes the procedure for sampling, location, pre-testing, testing and documentation of all finished products subject to test, reagents and standards to be used for analysis, management of out of specification results, microbiological tests and release procedure for passed finished goods.Preparation and Maintenance of Stability Protocols (Pharmaceuticals): Preparation and Maintenance of Stability Protocols (Pharmaceuticals) This procedure describes the preparation and management of stability protocols for marketed products. This procedure is applicable to all protocols for stability studies on commercial products. The responsibility of the commercial Site stability manager for creating and maintaining protocols that are required for studies that came as a result of validation or process deviation.Stability and Trial Testing Procedure (Pharmaceuticals): Stability and Trial Testing Procedure (Pharmaceuticals) To describes the steps necessary to ensure the effective control of stability and trial testing programs of new and existing products. This procedure is focused on setting up of stability programs, testing, reporting, general sampling procedure for stability programs, data generation and analysis, annual maintenance of stability, new product stability procedure, procedure for in-house trials, reporting and interpretation of trials and conclusion of the trail program.REFERENCES: REFERENCES www.ich.org www.fda.govPowerPoint Presentation: THANK YOU You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.