QC

• Quality Control (QC)


  Focuses on inspecting, testing, and correcting deviations or defects in products or processes to ensure they meet predefined quality standards
• Quality Assurance (QA)


  Involves establishing processes, procedures, and systems to prevent defects from occurring in the first place. It aims to ensure that the entire production process is capable of consistently delivering products or services that meet quality requirements
• Sampling in Quality Control (QC)

  1. Selecting a representative subset of products or components from a larger population for inspection or testing

  2. Sampling plans define the sample size, sampling method, and acceptance criteria based on factors such as product variability, production volume, and acceptable quality levels
• Repeatability


  A measure of the ability of the method to generate similar results for multiple preparations of the same sample
• Reproducibility


  Expresses the precision between laboratories (collaborative studies, usually applied to standardization of methodology)
• Principles of Good Document Practices

  • Accurate
  • Clarity and completeness
  • Timeliness
  • Traceability and audit trails
  • Consistency and standardisation
  • Legibility
  • Authorisation, approval, and accountability
  • Training and awareness
  • Retention and destruction
  • Protection, security and restricted access
• Benefits of GDP


  • Compliance to regulatory requirement – No observation/ warning letters/ import alert or ban
  • Build confidence on system and practice
  • Correct, complete, current and consistent information
  • Effectively meet customers' and stakeholders' requirements
  • Ensure traceability
  • Useful for review and investigation
  • Reduce or eliminate assumptions or second-guessing
  • Clear instructions to staff
• GLP


  Embodies a set of principles that provides a framework, within which laboratory studies are planned performed, monitored, reported and archived

  
• Objectives of GLP


  • GLP make sure that the data submitted are a true reflection of the results that are obtained during the study
  • GLP also make sure that data is traceable
  • Promotes international acceptance of tests
• Key elements of Good Laboratory Practices (GLP) guidelines

  • Equipment records
  • Personnel training and qualifications
  • Standard operating procedures
  • Study plans and protocols
  • Data recording and reporting
  • Quality assurance and audits
• Equipment records in GLP


  Should include name of the equipment, manufacturer, model, serial number, date received, and copy of manufacturers operating instructions
• Potential sources of contamination in the production of liquid drug products

  • Cross-contamination from other products
  • Microorganisms
  • Packaging material
• Analytical process of liquid drug products for quality control

  1. Sampling - Collect representative samples from different batches

  2. Physical tests - Conduct visual inspection, measure pH, viscosity, density, refractive index
• In Process Quality Control (IPQC) tests for emulsions

  • Appearance
  • Viscosity
  • Particle size and particle count
  • Determination of phase separation
  • Determination of electrolytic properties
  • Stability
  • Agitation
• Characteristics of parenteral, ophthalmics and types of water for injection

  • Parenteral: Sterile, Particulate-free, Pyrogen free, Stable for intended use, pH-not vary significantly, osmotic pressure similar to blood
  • Ophthalmics: Sterile, Particulate-free, Pyrogen free, Isotonic, Buffered, Preserved
  • Water for Injection: Highly purified, Sterile, Pyrogen free
• Key requirements for quality products as defined in USP Chapter <1206>

  • Capable and qualified personnel
  • Quality ingredients
  • Validated critical processes
  • Suitable production environment
  • Appropriate release checks and testing
  • Reliable stability evaluation
  • Processes carried out as intended
  • prevent mix-ups procedures
  • Effective investigation and correction failures
  • Adequate separation of quality and production functions

  
• Cleanroom environment for sterile preparations

  • Essential for preventing contamination by controlling environmental factors like airborne particles, temperatures and humidity
  • Importance of monitoring factors like microbial bioburden and aseptic technique
  • Process simulation testing for validation of sterile product preparation
  • Recommendations for environmental monitoring frequency based on risk levels
• cGMP


  A regulatory requirement for the pharmaceutical industry to ensure that products are consistently produced and controlled according to quality standards. It includes processes for quality control, assurance, and risk management to minimize the risks involved in pharmaceutical production.
• Steps in investigating a quality issue in a cGMP-compliant pharmaceutical facility

  1. Identifying the issues

  2. Determining root cause

  3. Implementing corrective and preventive actions

  4. Documenting the investigation process

  5. Reviewing the effectiveness of the actions taken to prevent recurrence

  
• Total Quality Management (TQM)


  A management approach focused on continuous improvement, customer satisfaction, and employee improvement. In the packaging materials industry, it can be implemented by establishing quality processes, training employees, and involving all stakeholders in the quality improvement process.

  
• Pareto chart


  Identifies the most significant factors affecting quality
• Upper control limit in a control chart

  Represents the highest value a process is allowed to have before action is taken
• Total Quality Management (TQM)


  • emphasis on understand and meeting customer needs and expectations
  • Recognizes the importance of teamwork and collaboration in achieving quality goals
  • Promotes the active involvement of employees in quality improvement efforts
  • Focuses on mastering and optimizing organizational processes to achieve quality excellence
• QA system is an integral part of TQM
• Tutorial last
• Secondary packaging materials


  • The dimensions should be appropriate to withstand the stress during transportation
  • It should not affect the primary packaging
  • It should have sufficient strength to hold the material
  • Thickness should be appropriate to have mechanical strength
• Question from Tutorial 6 memorize all
• Not necessarily it's registration procedures
• Generic registration process


  1. Screening of application received via QUEST 3+ online system to ensure completeness and basic requirements

  2. Acceptance of Dossier for full evaluation -Complete Common Technical Document (CTD) including stability studies complying with ASEAN stability guidelines, protocol of analysis & analytical method validation

  3. Evaluator review of the dossier including assessment of the BE data for generics

  4. Evaluation report present at NPRA Evaluation committee

  5. Approval (MAL no) or Rejection
• Unique characteristics of parenterals

  • =PSPSOP
  • Sterile
  • Particulate-free
  • Pyrogen-free
  • Stable for intended use
  • pH – not very significantly
  • Osmotic pressure similar to blood
• Principles of GDP


  • Accurate
  • Clarity and Completeness
  • Timeliness
  • Traceability and audit trails
  • Consistency and standardization
  • Legibility
  • Authorization, approval, and accountability
  • Version control and change management
  • Protection, security, and restricted access
  • Retention and destruction
  • Training and awareness
  • Validation
  • Review cycles
• GLP


  An FDA regulation that embodies a set of principles that provides a framework within which lab studies are planned performed, monitored, reported and archived
• QC Tests for Elixir

  1. Determination of alcohol conc.

  2. Viscosity Measurement
• Determination of alcohol conc.

  • Elixir usually contains 5 to 40% alcohol
  • Determination of alcohol unless specified in the individual monograph
  • Cloudy distillates can be clarified by agitation with talc, or calcium carbonate and filtration
  • For liquids it is presumed to contain less than 30% of alcohol
• Viscosity Measurement


  • Measure by diff viscometers
  • Higher the viscosity = Higher the stability
• Photo microscopic examination


  1. The particle size distribution and crystal habit of suspension should examined by using microscope

  2. Mainly: differentiate flocculated and deflocculated particles
• Suspension Evaluation


  • Appearance
  • Photo microscopic examination
  • Colour, odour and taste
  • PH value
  • Pourability
  • Viscosity
  • Redispersibility
  • Particle size
• Viscosity Measurement Methods


  • Cup and bob viscometer
  • Cone and plate viscometer
• Emulsion


  • Good looking elegant in appearance
• Viscosity


  Increases flocculation of globules will reduced