qc

• Quality control


  Concerned with sampling, specifications and testing as well as the organization, documentation, and release procedures which ensure that the necessary and relevant tests are carried out and materials are not released for use, nor products released for sale or supply, until it has been judged to be satisfactory
• Quality assurance


  Any systemic process of determining whether a product or service meets specified requirements
• Quality control


  A product's actual review during production to ensure that it is created to the highest standards
• Quality assurance


  The guidelines, policies and procedures to make a high-quality product and avoid defects
• Benefits of quality control

  • Improved product quality
  • Reduced costs
  • Enhanced customer satisfaction
  • Compliance and regulatory adherence
  • Process optimization
  • Increase morale
• Quality control head duties


  • Establish, validate and implement all qc procedures
  • Keep the reference samples of materials and products
  • Ensure correct labelling of containers of materials and products
  • Ensure monitoring of the stability of the product
  • Participate in the investigations of complaints related to the quality of the product
• Good quality control laboratory practice

  • Quality control laboratories should be separated from production areas and with sufficient space
  • Control laboratories should be designed to suit the operations to be carried out in them. sufficient space should be given to avoid mix-ups and cross-contamination. there should be adequate suitable storage space for samples and records
  • Separate rooms may be necessary to protect sensitive instruments from vibration, electrical interference, humidity, etc.
  • Special requirements are needed in laboratories handling particular substances, such as biological and radioactive samples
• Laboratory documentation


  • Specifications
  • Procedures describing sampling, testing, records (including test worksheets and/or laboratory notebooks) recording and verifying
  • Procedures for and record of the calibration/qualification of instruments and maintenance of equipment
  • A procedure for investigation of out-of-specification and out-of-trend results
  • Testing reports and/or certificates of analysis
  • Data from environmental (air, water and other utilities) monitoring, where required
  • Validation records of test methods, where applicable
• Some kinds of data (e.g. test results, yields, environmental controls) should be recorded in a manner permitting trend evaluation
• Any out-of-trend or out-of-specification data should be addressed and subject to investigation
• In addition to the information which is part of the batch documentation, other raw data such as laboratory notebooks and/or records should be retained and readily available
• the equipment to be used

  Equipment 1<|>Equipment 2<|>Equipment 3<|>etc...
• the amount of the sample to be taken


  Amount
• instructions for any required sub-division of the sample


  1. Step 1

  2. Step 2

  3. Step 3

  4. etc...
• the type and condition of the sample container to be used

  Container type<|>Container condition
• the identification of containers sampled

  Identification method
• any special precautions to be observed, especially with regard of the sampling of sterile or noxious materials

  • Precaution 1
  • Precaution 2
  • Precaution 3
  • etc...
• the storage conditions


  Storage conditions
• instructions for the cleaning and storage of sampling equipment

  1. Step 1

  2. Step 2

  3. Step 3

  4. etc...
• Name


  Name of the material or product, and where appropriate, dosage form
• Batch number


  Batch number, and where applicable, the manufacturer and/or supplier
• References


  References to the relevant specifications and testing procedures
• Test results


  Test results, including observations and calculations, and references of certificates of analysis
• Dates


  Dates of testing
• Initials (performers)


  Initials of the persons who performed the testing
• Initials (verifiers)


  Initials of the person who verified the testings and calculations, where appropriate
• Approval/rejection


  A clear statement of approval or rejection (or other status decision) and dated signature of the designated responsible person
• Equipment


  Reference to the equipment used