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30/02/200830/02/2008 Dept. of PharmaceuticsDept. of Pharmaceutics 11
Salient Features of Quality AssuranceSalient Features of Quality Assurance
Dr. Basavaraj K. Nanjwade Dr. Basavaraj K. Nanjwade M.Pharm., Ph.DM.Pharm., Ph.D
Associate ProfessorAssociate Professor
Department of PharmaceuticsDepartment of Pharmaceutics
KLE UniversityKLE University
BELGAUM – 590 010BELGAUM – 590 010
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Quality AssuranceQuality Assurance
Quality assurance is a wide ranging concept Quality assurance is a wide ranging concept covering all matters that individually or collectively covering all matters that individually or collectively influence the quality of a product.influence the quality of a product.
It is the totality of the arrangements made It is the totality of the arrangements made with the object of ensuring that pharmaceutical with the object of ensuring that pharmaceutical products are of the quality required for their products are of the quality required for their intended use.intended use.
QA is the QA is the heart and soulheart and soul of quality control of quality control
QA = QC + GMPQA = QC + GMP
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The System of Quality AssuranceThe System of Quality Assurance
Pharmaceutical products are designed and Pharmaceutical products are designed and developed in a way that takes account of the developed in a way that takes account of the requirements of GMP and other associated requirements of GMP and other associated codes such as those of good laboratry practice codes such as those of good laboratry practice (GLP) and good clinical practice (GCP)(GLP) and good clinical practice (GCP)
Product and control operations are clearly Product and control operations are clearly specified in a written form and GMP specified in a written form and GMP requirements are adoptedrequirements are adopted
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The System of Quality AssuranceThe System of Quality Assurance
Managerial responsibilities are clearly specified Managerial responsibilities are clearly specified in job descriptionin job description
Arrangements are made for the manufacture, Arrangements are made for the manufacture, supply and use of the correct starting and supply and use of the correct starting and packaging materials.packaging materials.
All necessary controls on starting materials, All necessary controls on starting materials, intermediate products, and bulk products and intermediate products, and bulk products and other in-process controls, calibrations, and other in-process controls, calibrations, and validations are carried out.validations are carried out.
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The System of Quality AssuranceThe System of Quality Assurance
The finished products is correctly processed and The finished products is correctly processed and checked according to the defined procedures.checked according to the defined procedures.
Pharmaceutical products are not sold or Pharmaceutical products are not sold or supplied before the authorized persons have supplied before the authorized persons have certified that each production batch has been certified that each production batch has been produced and controlled in accordance with the produced and controlled in accordance with the requirements of the marketing authorization and requirements of the marketing authorization and any other regulations relevant to the production, any other regulations relevant to the production, control and release of pharmaceutical productscontrol and release of pharmaceutical products
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The System of Quality AssuranceThe System of Quality Assurance
Satisfactory arrangements exist to ensure, as far Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products as possible, that the pharmaceutical products are stored by the manufacturer, distributed and are stored by the manufacturer, distributed and subsequently handled so that quality is subsequently handled so that quality is maintained throughout their shelf-life.maintained throughout their shelf-life.
There is a procedure for self-inspection and/or There is a procedure for self-inspection and/or quality audit that regularly appraises the quality audit that regularly appraises the effectiveness and applicability of the quality effectiveness and applicability of the quality assurance systemassurance system
30/02/200830/02/2008 Dept. of PharmaceuticsDept. of Pharmaceutics 77
The System of Quality AssuranceThe System of Quality Assurance
Deviation are reported, investigated and Deviation are reported, investigated and recordedrecorded
There is a system for approving changes that There is a system for approving changes that may have an impact on product qualitymay have an impact on product quality
Regular evaluations of the quality of Regular evaluations of the quality of pharmaceutical products should be conducted pharmaceutical products should be conducted with the objective of verifying the consistency of with the objective of verifying the consistency of the process and ensuring its continuous the process and ensuring its continuous improvement.improvement.
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Quality Assurance-HighlightsQuality Assurance-Highlights
Quality assurance is independence of Quality assurance is independence of manufacturingmanufacturing
In process quality is checked during In process quality is checked during manufacturingmanufacturing
Validation of facilities, equipments, Validation of facilities, equipments, process, products and cleaning as per process, products and cleaning as per master planmaster plan
30/02/200830/02/2008 Dept. of PharmaceuticsDept. of Pharmaceutics 99
Quality Assurance-HighlightsQuality Assurance-Highlights
Complaint handlingComplaint handling
Storage of quality record and control Storage of quality record and control samplessamples
Stability studiesStability studies
Registration of documentsRegistration of documents
30/02/200830/02/2008 Dept. of PharmaceuticsDept. of Pharmaceutics 1010
Activities of Quality Assurance Dept.Activities of Quality Assurance Dept.
1.Technology transfer1.Technology transfer
2. Validation2. Validation
3. Documentation3. Documentation
4. Assuring quality of products4. Assuring quality of products
5. Quality improvement plans5. Quality improvement plans
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1. Technology Transfer1. Technology Transfer
Receipt of product design documents from Receipt of product design documents from research centreresearch centre
Distribution of documents received from Distribution of documents received from research centreresearch centre
Checking and approval of documents generated Checking and approval of documents generated based on research centre documents i.e. batch based on research centre documents i.e. batch manufacturing recordmanufacturing record
Scale-up and validation of productScale-up and validation of product
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2. Validation2. Validation
Preparation of validation plans for facility, Preparation of validation plans for facility, equipments/process including cleaningequipments/process including cleaning
Approval of protocol for validation of Approval of protocol for validation of facility/equipment/product/processfacility/equipment/product/process
Team member for execution of validation Team member for execution of validation of facility/equipment/product/processof facility/equipment/product/process
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3. Documentation Control3. Documentation Control
Controlled distribution and archiving of Controlled distribution and archiving of documentsdocuments
Control of changes made by proper Control of changes made by proper change control procedurechange control procedure
Approval of all documentsApproval of all documents
30/02/200830/02/2008 Dept. of PharmaceuticsDept. of Pharmaceutics 1414
4. Assuring Quality of Products4. Assuring Quality of Products
cGMP trainingcGMP training SOP complianceSOP compliance Audit of facility for complianceAudit of facility for compliance Line clearanceLine clearance In-process counter checksIn-process counter checks Critical sampling Critical sampling Record verificationRecord verification Release of batch for marketingRelease of batch for marketing Investigation of market complaintsInvestigation of market complaints
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5. Quality Improvement Plans5. Quality Improvement Plans
Feedback received from the compliance teamFeedback received from the compliance team
Proposals for corrective and preventive actionsProposals for corrective and preventive actions
Annual Products reviewAnnual Products review
Trend analysis of various quality parameters for Trend analysis of various quality parameters for products, environment and waterproducts, environment and water
30/02/200830/02/2008 Dept. of PharmaceuticsDept. of Pharmaceutics 1616
Flow Chart – RM/PM InspectionFlow Chart – RM/PM Inspection
30/02/200830/02/2008 Dept. of PharmaceuticsDept. of Pharmaceutics 1717
Flow Chart-Finished Product InspectionsFlow Chart-Finished Product Inspections
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Flow Chart- In Process CheckFlow Chart- In Process Check
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30/02/200830/02/2008 Dept. of PharmaceuticsDept. of Pharmaceutics 2020
