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  1.) Objectives
  2.) Principle
  3.) General
  4.) Key personnel
  5.) Training
  6.) Personal hygiene
  7.) References
1.) Objectives:
• To provide understanding regarding
  general requirements of the
  personnel in pharmaceutical
  manufacturing facilities.

• To be able to disseminate the
  information on the organization
2.) Principle:
• Establishment and maintenance of
  satisfactory system of QA and
  manufacturing of drug products relies on
• Sufficient qualified personnel to carry
  out tasks.
• Individual responsibilities must be
  clearly understood by individuals
• All personnel should be aware of the
      3.) General Requirement
• Adequate number of qualified people
  with practical experience versus
  procedures, processes &

• An individual’s responsibilities
  should not be so extensive as to
  present a risk to quality.
        Cont’n…General Requirement
• Individual written job description
• Adequate authority to carry out
• No gaps or unexplained overlaps
• Organization chart Director

     Head of
Sales & Marketing

                              Head of                  Head of
                             Production              Quality Control

Sales     Marketing
                      Processing    Packaging             IPQC
     Cont’n…General Requirement

• Prevent unauthorized access to
  production, storage, quality control.

• Stop personnel who do not work in
  these areas and from further using
  these as passageways.
4.) Key Personnel:
•   Key personnel (full time) positions include:

     Head of Quality
     Head of Production
     Head of Quality Control

•   Heads of Production and Quality Control
    should be independent of each other.
Cont’n....Key personnel:
• should be appropriately qualified and/or possess
  adequate practical experience
• Examples of desirable qualifications include:
    Pharmacy, chemistry, biochemistry, chemical
     engineering, microbiology, biotechnology,
     pharmacology and toxicology, physiology; or
    other related science or GMP-related subjects
• Practical experience
    Under professional guidance
    able to take difficult decisions in a professional and
     scientific way,
    resolve the problems encountered in manufacturing
     and QC.
             Head of Quality
The Head of Quality Assurance should ensure
• Production and control operations are clearly specified
  and GMP adopted.
• Managerial responsibilities are clearly specified.
• Arrangements are made for the manufacture, supply
  and use of the correct starting and packaging
• All necessary controls on intermediate products, and
  any other in-process controls and validations are
  carried out.
                Head of Quality
• The Finished product is correctly processed and
  checked according to the defined procedures.
• Certifies that each production batch has been
  produced and controlled in accordance with the MA.
• Satisfactory arrangements exists to ensure, as far as
  possible, that the medicinal products are stored,
  distributed and subsequently handled so that quality is
  maintained throughout their shelf-life.
• There is a procedure for self-inspection which
  regularly appraises the effectiveness and applicability
  of the quality assurance system.
                Head of Production
He should have authority and responsibilities to manage
production of medicinal products, which cover :
  Product production and storage according to
    appropriate documentation
  Approval and implementation of production
    instructions, in-process QC and ensure strict
  Evaluate production records; signed by designated
    person before passing to QC
  Maintenance of production department, premises and
  Calibration performed, recorded and reports made
  Training of production personnel (initial and continuing)
           Head of Quality Control
• Approval or rejection of materials, packing
  materials, intermediates, bulk and finished
• Evaluation of batch records
• Carrying out of necessary testing
• Approval of quality control procedures such as
 sampling instructions, specifications, test
 methods, and other QC procedures
• Approval and monitoring of all contract analysis
• Maintenance of quality laboratory, including
  equipments and laboratory apparatus
• Calibration of control equipments
• Initial and continuous training of QC personnel
            Shared Responsibilities
Heads of Production and Quality Control may share
some responsibilities, such as:
 • authorization of written procedures (SOPs) and other
   documents, including amendments
 • environmental monitoring and control, and plant
 • calibration
 • training, including application and principles of QA
 • approval and monitoring suppliers
 • designation and monitoring of storage conditions
 • retention of records
 • monitoring compliance with GMP
 • inspection, investigation, and taking of samples to
   monitor factors which may affect quality
 • corrective and preventive actions
               5.) Personnel Training
   Training, in accordance with a written programme
       all personnel whose duties take them into
        production; or
       into control laboratories; and
       for others whose activities could affect the
        quality of the product

   On induction and continuing
     on theory and practice of GMP;
     approved by either the head of Production or
        QC as appropriate
       training records should be kept
       training before undertaking any new task
          cont’n…Personnel Training
   Staff in special areas, e.g. working with
    hazardous materials should be given
    specific training

   Practical effectiveness should be
    periodically assessed e.g. assessment
    tests, number of rejects, product
    complaint, return product

 Must be given information in advance,
  particularly about
     personal hygiene; and
     protective clothing requirements
 Must be accompanied and closely
  supervised at all times
   All personnel must undergo health
   Trained in the practice of personnel
   Illness or open lesions – not
   Report to supervisors any
    conditions adversely affect the
    product quality
   Avoid direct contact of operator’s hands
    on products.
   Wear clean body covering.
   Smoking, eating, drinking, chewing and
    keeping materials not related to
    production not permitted.
   Use of protective clothing in production
            7.) REFERENCES
1. Administrative Order No. 43 s. 1999 –
   cGMP for Drugs (Section 1)
2. WHO Guide on GMP: Main Principles for
   Pharmaceutical Products (2005)
3. PIC/S Guide to GMP for Medicinal
   Products (2009)

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