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Quality Assurance

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Ghulam Rasool
Ghulam Rasool

Quality assurance aims to ensure that pharmaceutical products meet the required quality standards for their intended use. It involves establishing standards and criteria for quality, collecting and analyzing information to assess quality, comparing the information to the criteria, making judgments about quality, and taking corrective actions if needed. Quality assurance considers all factors that can influence product quality, including raw materials, manufacturing processes, storage, distribution, and more. It is an ongoing cycle of evaluating and improving quality through research, development, documentation, facilities, equipment, and personnel. Quality assurance can be conducted internally or externally through independent assessors.

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PRESENTED BY: GHULAM RASOOL SABIR KHAN SHAHRUKH AHMED SIRAJ ALAM
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. QA is the heart and soul of quality control QA = QC + GMP QUALITY ASSURANCE
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration. Ensure that managerial responsibilities are clearly specified. Ensure that production and control operations are clearly specified and GMP is adopted. BASIC REQUIREMENTS OF QUALITY ASSURANCE
Organize supply & use of correct starting & packaging materials. Ensure that finished products are correctly processed & checked before release. Ensure that products are released after review by authorized person. Put in place a mechanism for regular self inspection / internal quality audit. BASIC REQUIREMENTS OF QUALITY ASSURANCE
Help patients by improving quality of care. Assess competence of medical staff, serve as an impetus to keep up to date and prevent future mistakes. Bring to notice of hospital administration the deficiencies and in correcting the causative factors. Help to exercise a regulatory function. Restricting undesirable procedures. PURPOSE OF QUALITY ASSURANCE
Quality assurance is a never ending process of creative destruction, with rapid advances in science and technology and medical knowledge continuous updating is essential. The emphasis is on establishing professional excellence patient satisfaction at a reasonable cost. Quality is not proportionate to the use of sophisticated technology or to be expense incurred. Technical imperative should not insist on prolonging life at any lost with no consideration to quality of life. PURPOSE OF QUALITY ASSURANCE
1. Establishment of standards or criteria 2. Identify the information relevant to criteria 3. Determine ways to collect information 4. Collect and analyze the information 5. Compare collected information with established criteria QUALITY ASSURANCE PROCESS
6. Make a judgment about quality 7. Provide information and if necessary, take corrective action regarding findings of appropriate sources 8. Determine ways to collect the information QUALITY ASSURANCE PROCESS
FACTORS IN DRUG QUALITY ASSURANCE DRUG PRODUCT QUALITY Labeling & Product Information Import & Export Control Raw Materials- Active & Inactive Manufacturing Processes & Procedures Storage Transport Distribution Dispensing & Use QC & Analysis Human Resources- Professionals Legislative Framework -Regulations Packaging
QUALITY ASSURANCE CYCLE Research Development Raw Materials Facilities Documentation Equipment Personnel
Quality Assurance
1. External quality assurance: Quality assurance can be evaluated by independent assessors (or) people from outside the institution/hospital. 2. Internal quality assurance: Quality assurance can be evaluated by local assessors (or) senior person from the same institution/hospital. TYPES OF QUALITY ASSURANCE
MODELS OF QUALITY ASSURANCE
QA, GMP & QC INTER RELATIONSHIP
The committee should consist of the following. Medical administrator Two senior clinicians Pathologist Radiologist Nurse administrator Medical records officer secretary Additional personnel such as super specialist and consultants can be QUALITY ASSURANCE COMMITTEE
Coordination:- Collecting information Consider activities that should be related, e.g. Quality appraisal and continuing education Communication across patient care disciplines Co ordinate actions of hospital authority groups. Information:- Provide a centralized source of reports to the board. Suggest head for intervention to hospital authority groups. Planning:- Establish priorities FUNCTIONS OF QAC
Consultation:- Provide specific assistance, usually through the coordinator. Response:- Internally, acknowledge issues of importance to individuals and departments when suggesting high priority areas for immediate attention. Externally, provide the organization home for responding to quality requirement of external agencies of any e.g. medical companies. Search for expertise:- Operate openly, not behind closed doors, seek out the specific clinical and or management expertise necessary to reach sound conclusions. Follow up:- Committee members must recognize that their major functions are To coordinate not to control To inform, not to scold To plan and suggests priorities not to do detailed studies in committee and To recommend report, not to intervene directly. FUNCTIONS OF QAC
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Quality Assurance

  • 1. PRESENTED BY: GHULAM RASOOL SABIR KHAN SHAHRUKH AHMED SIRAJ ALAM
  • 2. 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. QA is the heart and soul of quality control QA = QC + GMP QUALITY ASSURANCE
  • 3. Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration. Ensure that managerial responsibilities are clearly specified. Ensure that production and control operations are clearly specified and GMP is adopted. BASIC REQUIREMENTS OF QUALITY ASSURANCE
  • 4. Organize supply & use of correct starting & packaging materials. Ensure that finished products are correctly processed & checked before release. Ensure that products are released after review by authorized person. Put in place a mechanism for regular self inspection / internal quality audit. BASIC REQUIREMENTS OF QUALITY ASSURANCE
  • 5. Help patients by improving quality of care. Assess competence of medical staff, serve as an impetus to keep up to date and prevent future mistakes. Bring to notice of hospital administration the deficiencies and in correcting the causative factors. Help to exercise a regulatory function. Restricting undesirable procedures. PURPOSE OF QUALITY ASSURANCE
  • 6. Quality assurance is a never ending process of creative destruction, with rapid advances in science and technology and medical knowledge continuous updating is essential. The emphasis is on establishing professional excellence patient satisfaction at a reasonable cost. Quality is not proportionate to the use of sophisticated technology or to be expense incurred. Technical imperative should not insist on prolonging life at any lost with no consideration to quality of life. PURPOSE OF QUALITY ASSURANCE
  • 7. 1. Establishment of standards or criteria 2. Identify the information relevant to criteria 3. Determine ways to collect information 4. Collect and analyze the information 5. Compare collected information with established criteria QUALITY ASSURANCE PROCESS
  • 8. 6. Make a judgment about quality 7. Provide information and if necessary, take corrective action regarding findings of appropriate sources 8. Determine ways to collect the information QUALITY ASSURANCE PROCESS
  • 9. FACTORS IN DRUG QUALITY ASSURANCE DRUG PRODUCT QUALITY Labeling & Product Information Import & Export Control Raw Materials- Active & Inactive Manufacturing Processes & Procedures Storage Transport Distribution Dispensing & Use QC & Analysis Human Resources- Professionals Legislative Framework -Regulations Packaging
  • 10. QUALITY ASSURANCE CYCLE Research Development Raw Materials Facilities Documentation Equipment Personnel
  • 12. 1. External quality assurance: Quality assurance can be evaluated by independent assessors (or) people from outside the institution/hospital. 2. Internal quality assurance: Quality assurance can be evaluated by local assessors (or) senior person from the same institution/hospital. TYPES OF QUALITY ASSURANCE
  • 14. QA, GMP & QC INTER RELATIONSHIP
  • 15. The committee should consist of the following. Medical administrator Two senior clinicians Pathologist Radiologist Nurse administrator Medical records officer secretary Additional personnel such as super specialist and consultants can be QUALITY ASSURANCE COMMITTEE
  • 16. Coordination:- Collecting information Consider activities that should be related, e.g. Quality appraisal and continuing education Communication across patient care disciplines Co ordinate actions of hospital authority groups. Information:- Provide a centralized source of reports to the board. Suggest head for intervention to hospital authority groups. Planning:- Establish priorities FUNCTIONS OF QAC
  • 17. Consultation:- Provide specific assistance, usually through the coordinator. Response:- Internally, acknowledge issues of importance to individuals and departments when suggesting high priority areas for immediate attention. Externally, provide the organization home for responding to quality requirement of external agencies of any e.g. medical companies. Search for expertise:- Operate openly, not behind closed doors, seek out the specific clinical and or management expertise necessary to reach sound conclusions. Follow up:- Committee members must recognize that their major functions are To coordinate not to control To inform, not to scold To plan and suggests priorities not to do detailed studies in committee and To recommend report, not to intervene directly. FUNCTIONS OF QAC