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Quality Assurance:

Quality Assurance gvrr416@gmail.com


Introduction 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. gvrr416@gmail.com

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QA is the heart and soul of quality control QA = QC + GMP Quality assurance - A must for pharmaceutical companies. QC generally means product testing, and QA an independent review of the results.


Definition Quality assurance is a wide ranging concept covering 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 pharmaceutical products are of the quality required for their intended use.

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Quality Control is defined as the way in which quality in a product is guaranteed. There are many stages during the process of manufacture. The stages of the manufacturing processes are therefore usually well planned so that the critical points of production can be analysed allowing the item to be checked at those points. gvrr416@gmail.com

Key Principles of QA:

Key Principles of QA Two key principles characterise QA are : "fit for purpose" (the product should be suitable for the intended purpose). "right first time" (mistakes should be eliminated).

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With regard to pharmaceuticals, quality assurance can be divided into four major areas: Quality control Production Distribution Inspections. gvrr416@gmail.com

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Quality assurance and quality control systems begin being established during early clinical trials and involve: equipment validation manufacturing controls and limits product specifications Process optimization continues through the development process, leading to identification of critical in-process control parameters. final product specifications for QC purposes final process validation.

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Stability Batches produced by the defined manufacturing process are studied at different storage conditions to verify consistent quality and performance of the product throughout shelf-life. The finished products is correctly processed and checked according to the defined procedures.

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Pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products. There is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system. gvrr416@gmail.com

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Deviation are reported, investigated and recorded There is a system for approving changes that may have an impact on product quality Regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement.

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In process quality is checked during manufacturing. Validation of facilities, equipments, process, products and cleaning as per master plan. Storage of quality record and control samples. Stability studies. Registration of documents.

Activities of Quality Assurance Dept.:

Activities of Quality Assurance Dept. 1.Technology transfer. 2. Validation. 3. Documentation. 4. Assuring quality of products. 5. Quality improvement plans.

1. Technology Transfer:

1. Technology Transfer Receipt of product design documents from research centre Distribution of documents received from research centre Checking and approval of documents generated based on research centre documents i.e. batch manufacturing record Scale-up and validation of product

2. Validation:

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

3. Documentation Control:

3. Documentation Control Controlled distribution and archiving of documents Control of changes made by proper change control procedure Approval of all documents

4. Assuring Quality of Products:

4. Assuring Quality of Products cGMP training SOP compliance Audit of facility for compliance Line clearance In-process counter checks Critical sampling Record verification Release of batch for marketing Investigation of market complaints

5. Quality Improvement Plans:

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 for products, environment and water

Flow Chart – RM/PM Inspection:

Flow Chart – RM/PM Inspection

Flow Chart-Finished Product Inspections:

Flow Chart-Finished Product Inspections

Relationship between Safety, Efficacy and Quality:

Relationship between Safety, Efficacy and Quality Every drug product (with its specifications) has been thoroughly tested in clinical trials for safety and efficacy. Specifications for release and stability testing may be equal to or tighter than the specifications for clinical trial batches. Therapeutic indication and QC are considerations in establishing specifications gvrr416@gmail.com


Conclusion Pharmaceutical quality is built-in through the entire drug development process validation is key element of ensuring quality in-process controls assure quality during manufacturing Specifications established based on thorough understanding of process The sum of all release parameters confirms the batch quality

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