QC 3

• The acceptance number is specified by the AQL
• Double Sampling

  The first acceptance number applies to the observed numbers of defectives for the first sample alone, and the second applies to the observed number of defectives for the first and second samples combined
• A sampling plan specifies lot or batch, random sample drawn from the lot, and acceptance number
• Six steps of the sampling process are involved
• Single Sampling


  Only a specified sample size is inspected before a decision is reached regarding the disposition of the batch, and the acceptance criterion is expressed as an acceptance number
• Requirements for a sampling plan include an acceptable quality level (AQL), an unacceptable quality level (UQL), alpha error risk, and beta error risk
• Sampling Plan


  A definite working rule regarding size and frequency of sample and the basis for acceptance or rejection
• Sampling Methods

  1. Single Sampling

  2. Double Sampling

  3. Multiple Sampling Method
• Double Sampling


  A second sample for inspection is permitted if the first fails, and two acceptance numbers are used
• AQL is defined as the maximum percent defective or the maximum number of defects per hundred units
• AQL of 2.5 should be used unless there is no specified AQL
• If proceeding to the second sampling, determine the second sample size to be drawn from the lot
• AQL


  Maximum percent defective (or the maximum number of defects per hundred units)
• QC inspector in a Pharmaceutical establishment, order size of 100,000 pcs of Alcohol Bottles, Double Sampling plan with Normal severity level II, AQL 1.5
• 1. TRUE: If the number of defective samples is greater than or equal to the specified rejection number, the whole lot is rejected
• 3. FALSE: Lot is not a small portion and representative of a sample
• 5. TRUE: Sampling is a statistical method used to find facts about a particular lot of items by checking the samples from that lot
• 7. TRUE: Sampling may pose a risk of accepting a bad lot which may cause a risk to the consumers
• • Tests are made on raw materials, packaging components, bulk product during processing, after packaging prior to release
• Control Functions

  • Analysis
  • Monitor
  • Record Review and Release
  • Audit Function
• 6. TRUE: Sampling increases time, cost, and effort needed in checking the quality of the products
• 4. TRUE: Conformance and non-conformance of the lot to the specifications can be ascertained by conducting an inspection of the samples
• 2. TRUE: If the number of defective samples is less than or equal to the specified acceptance number, the whole lot is accepted
• 8. TRUE: Rejecting a good lot upon sampling may pose a risk to the consumer
• • Responsibility to sample and examine materials during processing, environmental monitoring
• • Analytical function continues after distribution for shelf life studies and complaint analysis
• • Batch record review for completeness and accuracy
• • Designed to detect areas where SOP's are not followed and report findings to the supervisor
• Information in a Receiving Tally Report

  • Name of Report
  • Name of Drug/Cosmetic Company
  • Address
  • Receiving Number
  • Name of department receiving a copy
  • Name of the material
  • Item code number
  • Label claim
  • Purchase order number
  • Invoice number
  • Vendor (supplier/distributor)
  • Unit of measure
  • Number of containers received
  • Weight/ volume/ pieces contained in each container
  • Date the report was prepared
  • Date the shipment was received
  • Name of warehouse personnel receiving the shipment
  • Inspectors Report
  • Quantity of sample
  • Comments, if any
  • Name of inspector
  • Date inspected
  • Analysis
  • Analytical reference number
  • Name of analyst
  • Date of analysis
  • Disposition
  • Reason if rejected
  • If approved: Re-assay Date, Release number
  • Name of the person responsible receiving the report
  • Date of the review
• Raw materials are the ingredients intended for use in the manufacture of drugs and cosmetics
• Control of raw materials at different stages

  Handled through reception, quarantine, and testing
• Quarantine of raw materials


  Check for "Hold" or quarantine sticker, submit samples to QC laboratory for testing including physical and organoleptic examination and identification tests
• Audit Function


  Detect areas where established SOP's are not being followed and report findings to the supervisor for appropriate action
• CGMP requires all raw materials, active or inactive, to be assigned a meaningful reassay date for purity and potency at the time of use
• Material Control


  Each batch of incoming material is given a receiving number for identification in subsequent operations
• A copy of RTR is given to quality control, warehouse, purchasing, and accounting departments
• Material Control


  Prepare a Receiving Tally Report (RTR) for every shipment with specific information
• Material Control


  • Good raw material specifications must be written in precise terminology
  • Must be complete
  • Must provide specific details of test methods, type of instruments, and manner of sampling
  • Must be properly identified
• Classification of raw materials

  • Active or therapeutic
  • Inactive
• Re-assay date assignment

  • Monthly or prior to use
  • 6 months
  • 12 months
  • 24 months