Quality assurance aims to maintain a high level of quality in products and services. It involves audits and assessments to detect and correct any issues that do not meet established standards. Quality assurance looks at all stages of development and production to ensure each aspect will deliver a quality customer experience, while quality control focuses more narrowly on checking the finished product. Good manufacturing practices also help ensure products are consistently manufactured to quality standards through documented processes, validated equipment and facilities, trained personnel, and other measures.

1. Quality assurance
• Maintenance of a desired level of quality in a service or product,
especially by means of attention to every stage of the process of
delivery or production
• An act or process of confirming that quality standards are being met
within an organization
• Through audits and other forms of assessment, QA efforts detect and
correct problems or variances that fall outside established standards
or requirements
• Ensures a high level of quality during the development of products or
services

2. QA cont’d
• There are different methods of quality assurance in diverse sectors
• Fast food outlets, hospitals, hotels, schools, universities, transporters,
farms, engineering companies, all have different quality assurance
standards specific to their sector
• Several organizations/bodies have been formed to develop QA
standards for particular sectors
• International Organization for Standardization (ISO), founded in 1947,
maintains an effective quality assurance system for manufacturing
and service industries

3. Quality assurance and quality control
• The QA team is involved at all stages of a product’s development:
production, testing, packaging, and delivery
• In contrast, quality control focuses on detecting mistakes, errors, or
missed requirements in a product
• QA team is proactive, seeks to uncover and address the sources of
quality problems, such as human error or a business using the wrong
materials
• Whereas the QC is reactive, checking the product for mistakes or
components not built to specification

4. QA and QC cont’d
• QC team performs their tests after production product
• QC aims to catch errors on a finished product before it goes to the
market
• QA team works throughout the development process, making sure
each aspect of the product is on track to deliver a high-quality
customer experience
• QC is much narrower at if focusses only on the finished product
• QA is broader, looking it all process involved in the production process

6. Good Manufacturing Practices (GMP)
• A system that consists of processes and procedures that ensures
manufacturing products are consistently produced according to set
quality standards
• Protects both the company and consumer from defective products
• Examine and cover every aspect of the manufacturing process to
guard against any risks that can be catastrophic for products
• Quality management, sanitation and hygiene, building and facilities,
equipment, raw materials, personnel, validation and qualification,
complaints, documentation and recordkeeping, inspections and
audits

7. Components of GMP

8. Components of GMP cont’d
• People
• All workers should follow manufacturing processes and regulations
• Training and upgrading
• Employ competent people to boost productivity and efficiency
• Products
• All products must undergo testing before release onto the market
• Raw materials have clear specifications that are adhered to
• Standard methods for testing, packaging and labeling

9. Components of GMP cont’d
• Processes
• Properly documented, clear, consistent and made aware to all
employees
• Regular evaluation to make sure employees are complying
• Procedures
• A set of guidelines for undertaking a process to achieve a consistent
result
• Deviations should be reported and investigated

10. Components of GMP cont’d
• Premises
• Must be clean, avoid cross-contamination
• Avoid accidents, injuries and fatalities
• Proper storage facilities
• Certified anti-fire equipment
• Regularly disinfected

11. GMP principles
• Create Standard Operating Procedures (SOPs)
• Enforce/implement SOPs and work instructions
• Document procedures and processes
• Validate the effectiveness of SOPs
• Design and use working systems
• Maintain systems, facilities, and equipment
• Develop job competence of workers
• Prevent contamination through cleanliness
• Prioritize quality and integrate into workflow
• Conduct GMP audits regularly

12. Measures to uphold GMPs
• Quality team
• Skilled workers to focus on improving manufacturing procedures and
complying with GMP
• Undertake quality assessments on operations to identify problems
and develop appropriate corrective measures
• Performing scheduled monitoring of instruments, equipment,
processes, and staff skills

13. Measures to uphold GMPs cont’d
• Validation
• Check if instruments and processes function according to
expectations
• Process validation
• Cleaning and sanitation validation
• Computer system validation
• Analytical method validation

14. Measures to uphold GMPs cont’d
• Surprise Audits
• Surprise audits help to gain a more accurate and realistic insight
• Identify root causes of non-compliance
• Gather an honest, unbiased and true status
• Compliance Training
• All employees should receive training on recordkeeping, sanitation,
proper equipment handling, and labeling, and SOPs to minimize
errors and maintain compliance

15. GMP guidelines
• Quality management
• Sanitation and hygiene
• Buildings/premises and facilities
• Equipment
• Raw materials
• Personnel
• Validation and qualification
• Complaints
• Documentation and record-keeping
• Inspections and quality audits