Personnel Basic Principles of GMP Workshop on GMP and Quality Assurance of TB products Kuala Lumpur Malaysia, 21 – 25 February 2005 Maija Hietava M.Sci.Pharm Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster Tel: +41.22.791.3598 Fax: +41.22.791.4730 World Health Organization E-mail: hietavam@who.int Part One, 9 - 11

Personnel Objectives To review general issues related to personnel To review requirements for key personnel To review the training of personnel To consider some specific issues

Personnel Principle Establishment and maintenance of satisfactory system of QA and manufacturing of products and actives rely on people. Must be sufficient qualified personnel to carry out tasks Individual responsibilities must be clearly understood by individuals concerned All personnel should be aware of the principles of GMP that affect them Part One 9.1

Personnel General - I Adequate number of qualified people with practical experience An individual’s responsibilities should not be so extensive as to present a risk to quality Part One 9.2

Personnel Individual written job description Organization Chart General - II Individual written job description Organization Chart No gaps or unexplained overlaps Adequate authority to carry out responsibilities Part One 9.3

Personnel What is the main resource of the pharmaceutical industry ??? Question no 1 What is the main resource of the pharmaceutical industry ??? Part One 9.3

Personnel General - III Individuals must receive training in GMP: initial training dedicated training for the job in question continuing training including hygiene standards Motivated to support the establishment of high quality standards maintain high-quality standards Part One 9.4

Personnel General - IV Prevent unauthorized access to production, storage, quality control Stop personnel who do not work in these areas using them as passageways Part One 9.5

Personnel Key Personnel - I Key personnel (which normally should be full-time) positions include: Head of Production Head of Quality Control Head of Sales and Distribution Heads of Production and Quality Control should be independent of each other Part One 9.6 – 9.7

Personnel Key Personnel - II Key personnel should posses the qualifications of: Scientific education. For example: chemistry, biochemistry, chemical engineering, microbiology, pharmaceutical sciences and technology, pharmacology and toxicology, physiology; or other related science subjects relevant to the responsibilities to be undertaken Practical experience. under professional guidance able to take difficult decisions in a professional and scientific way, resolve the problems encountered in manufacturing and QC. Part One 9.7

Shared Responsibilities – I Personnel Shared Responsibilities – I Heads of Production and Quality Control may share some responsibilities depending on national regulations: authorization of written procedures (SOPs) and other documents, including amendments environmental monitoring and control, and plant hygiene process validation and calibration training, including application and principles of QA approval and monitoring suppliers Part One 9.8

Shared Responsibilities – II Personnel Shared Responsibilities – II 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 Part One 9.8

Head of Production Responsibilities - I Personnel Head of Production Responsibilities - I Product production and storage according to appropriate documentation Approval and implementation of production instructions, in-process QC and ensure strict implementation Evaluate production records; signed by designated person before passing to QC Part One 9.9

Head of Production Responsibilities - II Personnel Head of Production Responsibilities - II Maintenance of production department, premises and equipment Process validation and calibration performed, recorded and reports made available Training of production personnel; initial and continuing Part One 9.9

Head of Quality Control Responsibilities - I Personnel Head of Quality Control Responsibilities - I Approval or rejection of materials, packing materials, intermediates, bulk and finished products Evaluation of batch records Carrying out of necessary testing Approval of quality control procedures: sampling instructions, specifications, test methods, and other QC procedures Part One 9.10

Head of Quality Control Responsibilities - II Personnel Head of Quality Control Responsibilities - II Approval and monitoring of all contract analysis Maintenance of quality department, premises and equipment Validation, including analytical procedure validation, and calibration of control equipment Initial and continuous training of QC personnel Part One 9.10

Personnel Useful reference documents for inspectors: Organization Chart Job descriptions

Personnel Training - I Training, in accordance with a written programme for 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 Part One 10.11 - 10.12

Personnel Training - II Staff in special areas clean areas; or working with highly active, toxic, infectious, sensitizing materials should be given specific training The concept of QA and its understanding and implementation should be fully discussed during training Part One 10.3 - 10.4

Personnel Training - III What can be a training session to be documented Seminar or congress – in or outside the company Training in the comapany Regular department meeting dealing with quality matters Training of SOPs Etc.

Training – IV- Assessment of training Personnel Training – IV- Assessment of training Training is successful when employee sees his/her work as part of the totality of quality work, which has a direct input in the safety and quality of medicines employee understands that she/he can cause a lot of trouble and damage for the users of medicines and also problems to her/his employer , if if she/he is careless and don't follow the guidelines and SOPs as a result of the training there is a knowledgeable, motivated and satisfied employee

Visitors or Untrained Personnel Preferable not to take them in. If this is unavoidable, for example GMP inspectors: Must be given information in advance; particularly about personal hygiene; and protective clothing requirements Must be accompanied and closely supervised at all times Part One 10.5

Personnel Question no 2 What has to be planned and continuous in pharmaceutical industry, which normally also motivates personnel??? Part One 10.5

Personnel Possible Problems Limited number of staff Inadequate qualifications Inadequate experience Owner interferes in quality decisions Lack of means to develop training materials

Personnel Possible Problems Company procedures take precedence over local legislation Unclear organisation chart Staff movement Inadequate training records Illness