PRINCIPLE
The establishment and maintenance of a satisfactory system of quality
assurance and correct manufacture of pharmaceutical products relies upon
people. For this reason there must be sufficient qualified personnel to carry
out all the tasks which are the responsibility of the manufacturer. Individual
responsibilities should be clearly understood by the individuals and recorded.
All personnel should be aware of the principles of Good Manufacturing Practices
that affect them and receive initial and continuing training, including hygiene
instruction relevant to their needs.
GENERAL
The manufacturer should have an adequate number of personnel with the
necessary qualifications and practical experience. The responsibilities placed
on any one individual should not be so extensive as to present any risk to
quality.
The manufacturer must have an
organization chart. People in responsible positions should have specific duties
recorded in written job descriptions and adequate authority to carry out their
responsibilities. Their duties may be delegated to designated deputies of a
satisfactory qualification level. There should be no gaps or unexplained overlaps
in the responsibilities of those personnel concerned with the application of
Good Manufacturing Practices.
KEY PERSONNEL
Key Personnel includes the Head of
Production, the head of Quality Control, and the head of Quality Management
(Quality Assurance). Normally key posts should be occupied by full-time
personnel. The heads of Production and Quality Control as well as Quality
Management (Quality Assurance) must be independent from each other. In large
organizations, it may be necessary to delegate some of the functions listed in
Sections 2.5, 2.6, and 2.7.
ORGANIZATION, QUALIFICATION AND RESPONSIBLITIES
The organizational structure of the manufacturer shall be such that
production, quality control and quality management (quality assurance) are
headed by different persons, neither of whom shall be responsible to the other.
Each should be given full authority and facilities necessary to execute his/her
duties effectively. Neither should have any interests outside the manufacturer’s
organization that prevent or restrict their devotion to the assigned
responsibilities or which may be considered to entail a conflict of personal or
financial interest.
The head of Production should be a qualified pharmacist. He/she should be
adequately trained and possess good practical experience in the field of
pharmaceutical manufacture and managerial skill, which enable him/her to
perform his/her function professionally. The head of Production should have
full authority and responsibility to manage production of pharmaceutical
products, including:
to ensure that products are produced and stored according to the
appropriate documentation in order to obtain the required quality;
to approve the instructions relating to production operations and ensure
their strict implementation;
to ensure that the production records are evaluated and signed by the head
of Production before they are sent to the Quality Management Department;
to check the maintenance of his/her department, premises and equipment;
to ensure that the appropriate validations are done; and
to ensure that the required initial and continuing training of his/her
department personnel is carried out and adapted according to need.
Additionally the head of Production should have other responsibilities
which he/she should share with the head of Quality Control (see 2.8) and the
person responsible for engineering relating to quality.
The head of Quality Control should be a qualified pharmacist. He/she should
have adequate training and practical experiences which enable him/her to
perform his/her function professionally. The head of Quality Control should be
given full authority and responsibility in all quality control duties,
including:
to approve or reject, as he/she sees fit, starting materials, packaging
materials, and intermediate, bulk and finished products;
to ensure that all necessary testings are carried out; to approve
specifications, sampling instructions, test methods and other Quality Control
procedures;
to approve and monitor any contract analysis;
to check the maintenance of his/her department, premises and equipment;
to ensure that the appropriate validations are done;
to ensure that the required initial and continuing training of his/her
department personnel is carried out and adapted according to need.
Other duties of the Quality Control Department are summarized in CHAPTER 7.
The head of Quality Management (Quality Assurance) should be a qualified
pharmacist. He/she should have adequate training and practical experience which
enable him/her to perform his/her function professionally. The head of Quality
Management (Quality Assurance) should be given full authority and
responsibility in all quality system /assurance duties, including:
to ensure implementation (and, when needed, establishment) of the quality
system;
to participate in or initiate the development of the company’s quality
manual;
to initiate and supervise the regular internal audits or self-inspection;
to perform the oversight of the Quality Control Department;
to initiate and participate in external audit (vendor audit);
to initiate and participate in validation programmes
to ensure compliance with technical or regulatory requirements related to
the quality of finished products ;
to evaluate/review batch records;
to approve or reject, as he/she sees fit, finished products for sale;
The heads of Production, Quality Control and Quality Management (Quality
Assurance) generally have some shared, or jointly exercised responsibilities
relating to quality.
These may include, subject to any national regulations:
the authorization of written procedures and other documents, including
amendments;
the monitoring and control of the manufacturing environment;
plant hygiene;
process validation;
training;
the approval and monitoring of suppliers of materials;
the approval and monitoring of contract manufacturers;
the designation and monitoring of storage conditions for materials and
products;
the retention of records;
the monitoring of compliance with the requirements of GMP;
the inspection, investigation, and taking samples, in order to
monitor factors which may affect product quality.
TRAINING
The manufacturer should provide training for all the personnel whose duties
take them into production areas, storage or into control laboratories
(including the technical, maintenance and cleaning personnel), and for other
personnel whose activities could affect the quality of the product.
Beside the basic training on the theory and practice of Good Manufacturing
Practice, newly recruited personnel should receive training appropriate to the
duties assigned to them. Continuing training should also be given, and its
practical effectiveness should be periodically assessed. Training programmes
should be available, approved by either the head of Production or the head of Quality
Control, or both of them, as appropriate. Training records should be kept.
Personnel working in areas where contamination is hazard, e.g. clean areas
or areas where highly active, toxic, infectious or sensitizing materials are
handled, should be given specific training.
Visitors or untrained personnel should, preferably, not be taken into the
production and quality control areas. If this is unavoidable, they should be
given information in advance, particularly about personal hygiene and the
prescribed protective clothing. They should be closely supervised.
The concept of Quality Assurance and all the measures capable of improving
its understanding and implementation should be fully discussed during training
sessions.
Training should be conducted by qualified individuals.
