PC3M2

• sampling is when a small group of people or things is taken from a larger group and is used to represent the larger groups.
• Pharmaceutical Analysis, sampling is an operation designed to select a portion of a pharmaceutical product for a defined purpose.
• Sampling Plan?

  • Is a definite working rule regarding size and frequency of sample as basis for acceptance or rejection.
  • In short, it is the specification of sampling.
• Sampling plan requires 3 numbers to be specified:

  (N) number of items in the lot or batch

  from which the sample is drawn

  (n) number of items in the random

  sample drawn from the lot

  (c) acceptance number
• Square Root System

  • n = √N +1
  • acceptance criteria is specified by Acceptance Quality Limit (AQL)
• Types of Sampling Plan:

  • Square Root System
  • Government Sampling Plan (THE MILITARY STANDARDS)
• Government Sampling Plan (THE MILITARY STANDARDS)

  • widely accepted in the industry
  • consists of master tables first developed by engineers of Bell Telephone Laboratories and was further developed and adopted by the US Department of Defense
• Classes of Materials to be Sampled:

  • Raw Materials
  • Intermediates
  • Pharmaceutical Products (IP-FP)
  • Packaging Materials
  • Cleaning and Sanitizing Agents
• Statistical Quality Control

  • is the use of statistical methods in the monitoring and maintaining of the quality of products and services.
• SQC has been used to serve as:

  • basis for improved evaluation of material through more representative sampling techniques
  • means of achieving sharper control in certain manufacturing process
• Shewhart Control Chart by Dr. Walter Shewhart ofnthe Bell Telephone Laboratories

  • one of the most generally applicable and easily applied SQC techniques
  • can be used as a tool to:

  1. determine and define empirically acceptable levels of quality of laboratory performance
  2. achieve the acceptable leveldefined
  3. maintain performance at the acceptable level of quality
• Quality Control Charts

  • are graphical representations of the observed results plotted in relation to calculated limits, generally in the order of occurrence or sequentially in time.
  • If the process is in control, the forthcoming results should fall within the calculated control limits to the degree expected
• TWO BASIC TYPES OF CONTROL CHARTS:

  • Variable Charts: continuous distribution or measurements that can, in a sense measure the degree of unacceptability (eg. X and R Charts)
  • Attribute Charts: go or no-go situations (eg. P Charts)
• control chart is then a graphical representation of the observed results plotted in relation to calculated limits,

  generally in the order of occurrence or sequentially in time. If the process is “in control”, the forthcoming results

  should fall within the calculated control limits to the degree expected.
• Validation

  – determination of the degree of validity of a measuring device
• Method Validation

  – provides an assurance of reliability during normal use; referred to as 'the process of providing documented evidence that

  the method does what it is intended to do.
• Analytical Method Validation

  – method validations that is used to ensure that every future measurements in a routine analysis will be close enough to the

  unknown true value for the content of the analyte in the sample.