Good Manufacturing Practices

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Good Manufacturing Practices
Technology Transfer

• Team 1
• Quality Business Consultants

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Lesson Objectives

• After completing this module, you will
• Understand the concept of technology transfer and
  its purpose
• Learn about writing process and technology
  transfer reports
• Learn how to correct an error in a document
• Learn about internal quality audits of laboratory
  operations

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Goal of Technology transfer activities

• Is to achieve product realization through the
  transfer of product and process knowledge
• This transfer is done between manufacturing and
  development, as well as between the manufacturing
  sites it consist of sharing all the knowledge,
  methods, samples of manufacturing in order that
  technological and scientific developments are
  accessible to a wide range of users.

http//www.emea.europa.eu/pdfs/human/ich/21473207e
n.pdf
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So, Why is this knowledge so important

• Because it forms the basis for
• Manufacturing process
• The sequence of operations necessary to
  producing the goods or wares by the labor and
  machinery
• Control Strategy
• The strategy incorporated by a company to
  improve the results by a dynamic process based on
  feedback.
• Ongoing continual improvement
• Recurring efforts aimed to increase the quality
  of the products and processes

http//www.profoundlearning.com/Content/EducationS
olutions/educationKnowledgeTransfer.html
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Technology Transfer

• Is also seen as the basis for
• Process control
• (If the data is not adequately transferred, how
  can we gain the correct feedback to control the
  processes?)
• Process validation
• (validation could not be done without checking
  the appropriate formulas and information )

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Process control

• A process is a sequence of activities that is
  intended to achieve some result
• Unless you change the process, why do you expect
  the results to change?

Out-of-control
Controlled process
Improvement
New zone of control
Time
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Process validation

• The processing results must be validated, when
  they reach a point of no further test or
  inspection
• Written evidence that the risk of contamination
  is reduced, must stem from a validated process
• Any change to a validated process must be
  carefully reviewed, assessed and revalidated

www.biotechlogic.com/pics/processvalidation.jpg
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Writing processes

• A specific and concise writing of processes helps
  in keeping a reliable record of operations
  necessary to reach a State of Control
• GMP regulations impose that the systems and
  processes be continuously managed to reach this
  state of control
• The way of keeping the information is just
  important as the information itself

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The regulation

• The Records and Reports section of CFR 21
  211.180(e) states
• Written recordsshall be maintained so that data
  therein can be used for evaluatingthe quality
  standards of each drug product.(2)
• Therefore, written procedures should include a
  review
• -on the batches, their representative number and
  the associated records
• -of complaints, recalls, salvaged or returned
  drug product

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Necessary documentation

• It is relevant for GMP documents to contain a
  signature, because that assures that what we have
  done is correct and adheres to the procedure
• In order to maintain the accuracy of information,
  it is necessary that GMP documentation be
  completed at the time of the performance
• The main purpose of GMP documentation is to
  provide a reliable history of the production of
  our products

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Completing Documents

• Heres a checklist for the completion of
  documents
• Accurate, complete information entered at the
  time of performance
• Signature or initials are entered according to
  procedure
• Never sign your name for work done by others
• In case of the involvement of more than one
  person in a task, ALL MUST SIGN
• Ballpoint ink is preferred in order to avoid
  smudging
• Use the approved color
• Restrain as much as possible from the use of
  abbreviations and acronyms

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Error Correction

• Keep the original entry legible, this could be
  done by entering a single line through the error
• The corrected information should be as near to
  the original one as possible
• In order to identify the corrector, enter your
  initials or signature next to the changed
  information
• Write down the date next to the change
• In case of ambiguity, clarify the reasons for the
  change
• If the original entry was signed by two persons,
  both of them should agree on the change

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• GMP are legal documents
• The signature means the work is correct
• and It is done according to procedures

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Internal quality audits of laboratory operations

• Each manufacturer shall establish procedures for
  quality audits and conduct such audits to assure
  that the quality system is in compliance with the
  established quality system requirements and to
  determine the effectiveness of the quality
  system
• -21 CFR  Part 820.22

• NOTE The laboratories that test or design
  components for a manufacturer are considered an
  extension for the manufacturers quality system
  and are not subject to GMP inspections

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Internal quality audits of laboratory operations

• Individuals that are going to conduct the audits
  of laboratory operations shouldnt have direct
  responsibility for the matters being audited
• When necessary, include re-audit of deficient
  matters and take any necessary corrective actions
• Make a review of the results of the internal
  quality audits
• Those reports shall be reviewed by the management
  system
• Document all the dates and results of those audits

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References

• 1)http//www.fda.gov/downloads/Drugs/GuidanceCompl
  ianceRegulatoryInformation/Guidances/ucm073517.pdf
  
• 2)http//www.skillsplusinc.com/PDF20File20Subweb
  /Kit/06b20Documentation20Rules.pdf
• 3) http//en.wikipedia.org/wiki/Key_Value_Pair
• 4) http//www.gmp-compliance.org/eca_news_957.html
  
• 5)http//www.fda.gov/MedicalDevices/DeviceRegulati
  onandGuidance/PostmarketRequirements/QualitySystem
  sRegulations/MedicalDeviceQualitySystemsManual/ucm
  122391.htmmanual_contents
• 6) http//www.gmp1st.com/mdreg.htm820.22