features of quality assurance
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Salient Features of Quality Assurance
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Quality Assurance
Quality assurance is a wide ranging conceptcovering all matters that individually or collectivelyinfluence the quality of a product.
It is the totality of the arrangements made withthe object of ensuring that pharmaceuticalproducts are of the quality required for theirintended use.
QA is the heart and soulof quality control
QA = QC + GMP
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The System of Quality Assurance
Pharmaceutical products are designed and
developed in a way that takes account of the
requirements of GMP and other associated
codes such as those of good laboratry practice(GLP) and good clinical practice (GCP)
Product and control operations are clearly
specified in a written form and GMP
requirements are adopted
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The System of Quality Assurance
Managerial responsibilities are clearly specifiedin job description
Arrangements are made for the manufacture,supply and use of the correct starting andpackaging materials.
All necessary controls on starting materials,
intermediate products, and bulk products andother in-process controls, calibrations, andvalidations are carried out.
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The System of Quality Assurance
The finished products is correctly processed andchecked according to the defined procedures.
Pharmaceutical products are not sold orsupplied before the authorized persons havecertified that each production batch has beenproduced and controlled in accordance with the
requirements of the marketing authorization andany other regulations relevant to the production,control and release of pharmaceutical products
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The System of Quality Assurance
Satisfactory arrangements exist to ensure, as faras possible, that the pharmaceutical productsare stored by the manufacturer, distributed andsubsequently handled so that quality ismaintained throughout their shelf-life.
There is a procedure for self-inspection and/or
quality audit that regularly appraises theeffectiveness and applicability of the qualityassurance system
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The System of Quality Assurance
Deviation are reported, investigated andrecorded
There is a system for approving changes thatmay have an impact on product quality
Regular evaluations of the quality ofpharmaceutical products should be conducted
with the objective of verifying the consistency ofthe process and ensuring its continuousimprovement.
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Quality Assurance-Highlights
Quality assurance is independence ofmanufacturing
In process quality is checked duringmanufacturing
Validation of facilities, equipments,process, products and cleaning as permaster plan
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Quality Assurance-Highlights
Complaint handling
Storage of quality record and controlsamples
Stability studies
Registration of documents
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Activities of Quality Assurance Dept.
1.Technology transfer
2. Validation
3. Documentation
4. Assuring quality of products
5. Quality improvement plans
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1. Technology Transfer
Receipt of product design documents fromresearch centre
Distribution of documents received fromresearch centre
Checking and approval of documents generatedbased on research centre documents i.e. batch
manufacturing record
Scale-up and validation of product
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2. Validation
Preparation of validation plans for facility,
equipments/process including cleaning
Approval of protocol for validation of
facility/equipment/product/process
Team member for execution of validation
of facility/equipment/product/process
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3. Documentation Control
Controlled distribution and archiving of
documents
Control of changes made by proper
change control procedure
Approval of all documents
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4. Assuring Quality of Products
cGMP training SOP compliance
Audit of facility for compliance
Line clearance In-process counter checks
Critical sampling
Record verificationRelease of batch for marketing
Investigation of market complaints
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5. Quality Improvement Plans
Feedback received from the compliance team
Proposals for corrective and preventive actions
Annual Products review
Trend analysis of various quality parameters forproducts, environment and water
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Flow Chart RM/PM Inspection
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Flow Chart-Finished Product Inspections
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Flow Chart- In Process Check
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