Radiopharmaceutical
Production
Job responsibilities and
Authorities
STOP
Quality Assurance
•
•
•
•
•
People are the key to the
establishment and maintenance of a
satisfactory system of Quality
Assurance for manufacture and control
of products.
There must be enough qualified people
to carry out all the tasks
Individual responsibilities must be
clearly defined and understood by the
individuals concerned
Written job descriptions should be in
place for all positions within the facility
All personnel should be aware of the
principles of GMP that affect them.
Contents
• Job responsibilities
• Key Personnel
• Shared Responsibilities
• Head of Production
• Head of Quality Control
• Authorized Person
• Training
• Potential Problems
STOP
Job Responsibilities
Radiopharmaceutical
Production
•
Job Responsibilities
Contents
Job responsibilities
Key Personnel
Shared Responsibilities
Head of Production
Head of Quality Control
Authorized Person
•
Training
Potential Problems
•
•
STOP
People are the most important asset of a facility,
and the easiest to neglect. The establishment
and maintenance of a satisfactory system of
quality assurance and GMP relies upon people
who develop the system, the people who use the
system and the people who examine the system
to see if it has worked. People are involved, no
matter how automated the process. The
behavior of the people is fundamental to any
system of GMP. Personnel policies must reflect
this.
There have to be enough people employed by
the facility to carry out the required work. These
people must have the level of training and
experience that will enable them to do their work.
The staff must have written job descriptions to
ensure that they understand clearly what it is
that they have to do, and what they are
responsible for.
Finally these staff must have a knowledge and
understanding of GMP to enable them to carry
out their duties in accordance with GMP.
General Employee Requirements
Radiopharmaceutical
Production
•
Job Responsibilities
•
Contents
Job responsibilities
Key Personnel
Shared Responsibilities
Head of Production
Head of Quality Control
Authorized Person
Training
Potential Problems
•
STOP
For successful and good quality pharmaceutical production, it is
essential to have people with sufficient knowledge and
experience to undertake the work. They must have the authority
and the means to do that work, and there must be enough of
them available to carry out tasks effectively.
In Summary, these requirements should be in place:
– All responsible staff should have specific duties recorded in
individual written job descriptions
– Have adequate authority to carry out responsibilities
– They should have practical experience in these tasks
– An individual’s responsibilities should not be so extensive
as to present a risk to quality
– May delegate to designated deputies with qualifications
– No gaps or unexplained overlaps
– There must be a clear Organizational chart outlining all lines
of authority
Personnel involved in QA/QC must have the authority to carry
out their responsibilities. This is very easy to say and
sometimes not so easy to ensure. Problems can emerge in
every size of company. They arise because of a combination of
human interactions, and the pressures placed on people by the
business considerations.
Key Personnel
Radiopharmaceutical
Production
•
Job Responsibilities
Contents
Key personnel (which normally
should be full-time) positions
include:
– Authorized person
– Head of Production
– Head of Quality Control
Job responsibilities
Key Personnel
Shared Responsibilities
Head of Production
Head of Quality Control
•
These positions may delegate
functions – They may not delegate
responsibility. The responsibility
will always be theirs.
•
Ideally, the heads of Production
and Quality Control should be
independent of each other
•
For specific qualifications, see the
section on Personnel
Authorized Person
Training
Potential Problems
STOP
Shared Responsibilities
Radiopharmaceutical
Production
Job Responsibilities
Contents
Job responsibilities
Key Personnel
Shared Responsibilities
Head of Production
Head of Quality Control
Authorized Person
Training
Potential Problems
STOP
Heads of Production and Quality Control may
share/jointly exercise some
responsibilities relating to quality:
– authorization of written procedures
(SOPs) and other documents,
including amendments
– monitoring and control of
manufacturing environment
– plant hygiene
– process validation and calibration
– training, including application and
principles of QA
– approval and monitoring of suppliers
and contract acceptors
• Clear written job descriptions must be
available for these positions, showing
where the shared responsibilities are.
Shared Responsibilities
Radiopharmaceutical
Production
Heads of Production and Quality Control may share/jointly
exercise some additional responsibilities relating to quality:
Job Responsibilities
Contents
Job responsibilities
Key Personnel
Shared Responsibilities
Head of Production
Head of Quality Control
Authorized Person
Training
Potential Problems
STOP
– Designation and monitoring of storage conditions for
materials and products
– Performing and evaluating in-process controls
– Retention of records. Since both have responsibility for the
generation of records relevant to batches, then the
arrangements for the storage of those records may be a
shared responsibility.
– Monitoring compliance with GMP. This has to be correct
because the achievement of GMP is everyone's
responsibility
– Inspection, investigation, and taking of samples to monitor
factors which may affect quality. Sampling should only be
done by persons trained in the methods to be used
Share the load
Share the rewards
Head of Production
Radiopharmaceutical
Production
Job Responsibilities
Contents
Job responsibilities
Key Personnel
Shared Responsibilities
Head of Production
Head of Quality Control
Authorized Person
Training
Potential Problems
STOP
Responsibilities
• Product production and storage according to appropriate
documentation. He or she must ensure that products are
produced and stored in accordance with appropriate
documentation to meet the required quality standards.
• Approval and implementation of production instructions, inprocess QC and ensure strict implementation. This will include
not only the production documentation itself, but also all the
other procedures and documentation that are essential for the
good operation of production. He/she will prepare many of
these documents in partnership with quality control and product
development staff. The in-process testing requirement must be
specified.
• Ensures that production records are evaluated and signed by
designated person. To do this, he/she must evaluate or
designate someone to evaluate every batch record in order to
satisfy himself/herself that all has gone as it should. He/she will
also need to ensure that the documents have been completed
correctly.
Head of Production
Radiopharmaceutical
Production
Job Responsibilities
Contents
Job responsibilities
Key Personnel
Shared Responsibilities
Head of Production
Head of Quality Control
Authorized Person
Training
Potential Problems
STOP
Responsibilities (cont.)
• Checks maintenance of production department, premises
and equipment. The production manager is responsible for
ensuring that all the facilities and equipment under his/her
control are properly maintained in accordance within a
planned preventative maintenance program.
• Ensures process validation and calibration performed,
recorded, and reports are made available. It is essential to
check regularly that the processes will routinely produce a
product that meets the registered specifications. The
production manager must therefore ensure that all
processes are validated and all equipment is calibrated in
accordance with the written procedures.
• Ensures initial and continuous training of production
personnel. The production manager is responsible for
ensuring that the people who carry out all this work are well
trained and motivated at the commencement of their work,
and that they receive regular refresher training.
Head of Quality Control
Radiopharmaceutical
Production
Job Responsibilities
Contents
Job responsibilities
Key Personnel
Shared Responsibilities
Head of Production
Head of Quality Control
Authorized Person
Training
Potential Problems
STOP
Responsibilities:
• Approval or rejection of materials, e.g. packing materials,
intermediates, bulk and finished products, in accordance with
specifications
• Evaluation of batch records. This should be done as part of the
product release process. The purpose is to be reassured that
products have been produced in accordance with the agreed
process, and meets specifications. If there have been any
deviations from the agreed process, these need to have been
authorized by responsible persons.
• Ensures carrying out of necessary testing
• Approval of quality control procedures, e.g. sampling and testing;
specifications. The QC manager will approve all the instructions
that are required for the organization and implementation of
testing. The development of all these instructions, policies and
procedures may well be done in co-operation with production and
development personnel.
Head of Quality Control
Radiopharmaceutical
Production
Job Responsibilities
Contents
Job responsibilities
Key Personnel
Shared Responsibilities
Head of Production
Head of Quality Control
Authorized Person
Training
Potential Problems
STOP
Responsibilities: (cont.)
• Approval and monitoring of all contract analysis. The QC
manager must be assured that the contract accepter:
– can conduct the testing to the required standard
– has all the necessary personnel
– has the necessary equipment to conduct the testing
– has a written contract specifying the responsibilities of
all parties to the agreement
• Checks maintenance of quality department, premises and
equipment.
• Ensures validation (including analytical procedure
validation) and calibration of control equipment. The QC
manager is responsible for the validation of analytical
methods and the calibration of laboratory equipment to
ensure that results achieved by following the validated
processes can be relied upon.
• Ensures initial and continuous training of QC personnel
Authorized Person
Radiopharmaceutical
Production
Job Responsibilities
Contents
Job responsibilities
Key Personnel
Shared Responsibilities
Head of Production
Head of Quality Control
Authorized Person
Training
Potential Problems
STOP
Responsibilities:
• The authorized person is responsible for compliance
with technical or regulatory requirements related to the
quality of finished products and the approval of the
release of the finished product for human use.
• The authorized person will also be involved in other
activities, including the following:
– implementation (and, when needed, establishment)
of the quality system;
– participation in the development of the company’s
quality manual;
– supervision of the regular internal audits or selfinspections
Authorized Person
Radiopharmaceutical
Production
Job Responsibilities
Contents
Job responsibilities
Key Personnel
Shared Responsibilities
Head of Production
Head of Quality Control
Authorized Person
Training
Potential Problems
STOP
Responsibilities: (cont.)
The authorized person will also be involved in other
activities, including the following:
– oversight of the quality control department;
– participation in external audit (vendor audit);
– participation in validation programmes.
• The function of the approval of the release of a finished
batch or a product can be delegated to a designated
person with appropriate qualifications and experience
who will release the product in accordance with an
approved procedure. This is normally done by quality
assurance by means of batch review.
Authorized Person
Radiopharmaceutical
Production
Job Responsibilities
Contents
Job responsibilities
Key Personnel
Shared Responsibilities
Head of Production
Head of Quality Control
Authorized Person
Training
Potential Problems
STOP
Responsibilities: (cont.)
The person responsible for approving a batch for release
should always ensure that the following requirements
have been met:
– the marketing authorization and the manufacturing
authorization requirements for the product have
been met
– the principal manufacturing and testing processes
have been validated
– all the necessary checks and tests have been
performed and account taken of the production
conditions and manufacturing records;
– any planned changes or deviations in manufacturing
or quality control have been notified in accordance
with a well defined reporting system before any
product is released.
Authorized Person
Radiopharmaceutical
Production
Job Responsibilities
Contents
Job responsibilities
Key Personnel
Shared Responsibilities
Head of Production
Head of Quality Control
Authorized Person
Training
Potential Problems
STOP
The person responsible for approving a batch for release
should always ensure that the following requirements have
been met:
• Additional sampling, inspection, checks and tests had been
done when required
• All production and control documents are completed and
endorsed
• Audits, inspections and spot-checks were done
• QC approval has been given
• All other relevant factors have been considered
Training
Radiopharmaceutical
Production
•
Job Responsibilities
Contents
Job responsibilities
Key Personnel
•
Shared Responsibilities
Head of Production
Head of Quality Control
Authorized Person
•
Training
Potential Problems
•
•
STOP
Each company should establish a written training program. New
employees need to understand what is expected of them and
the risks to patients and consumers if the products they make
do not conform to requirements. This initial training must be
given to all employees who have a direct impact on product
quality.
The training program may consist of at least two parts. The first
will be a general program that all employees should receive
which explains GMP and the importance of GMP to the
company. There may well be a second program, explaining the
specific issues about the individual’s department.
There should be a written re-training program for all employees
to ensure that their skills are continually brought up to date and
that they are introduced to changes in practice as these
develop.
As employees go through their training, records should be kept
of the training received and performance against tests. People
have to realise that good performance is required otherwise
retraining will be required.
All areas of GMP relevant to the individual must be covered.
Training
Radiopharmaceutical
Production
•
Job Responsibilities
Contents
Job responsibilities
Key Personnel
Shared Responsibilities
Head of Production
•
Head of Quality Control
Authorized Person
Training
Potential Problems
•
STOP
Training records must be kept to ensure that as employees
move around the company, they are not required to carry
out work for which they have not been trained 1. The
training program may consist of at least two parts. The first
will be a general program that all employees should receive
which explains GMP and the importance of GMP to the
company. There may well be a second program, explaining
the specific issues about the individual’s department.
People who work in special areas should receive additional
training in the special nature of their area of work. Those
people who work in sterile areas, with highly active or toxic
materials or sensitizing agents, should receive specific
instruction in the special nature and hazards associated with
this activity.
During training, every encouragement should be given to
employees to discuss fully all aspects of quality and GMP
with their trainers and among themselves. Staff should be
encouraged to contribute to increased quality and GMP.
Potential Problems
Radiopharmaceutical
Production
•
Job Responsibilities
Contents
Job responsibilities
Key Personnel
•
Shared Responsibilities
Head of Production
Head of Quality Control
•
Authorized Person
Training
Potential Problems
•
•
STOP
Limited number of staff. Limited staff numbers may mean
that people are under pressure to perform. They may be
trying to do too much. There may be a lack of deputies
during times of illness or holidays.
Inadequate qualifications. The people being recruited for
the facility may not have the necessary qualifications to
operate the facility under GMP regulations.
Inadequate experience. Recruited staff may have
inadequate experience or experience in an inappropriate
area.
Production interferes in quality decisions. The owner
may interfere with quality decisions, particularly if orders are
required urgently or are very valuable. Senior staff may
have difficulty in combating this, since it may cost them their
jobs.
Insufficient training materials. Smaller operations may
have no means to develop training materials to educate
their staff in the requirements of GMP.
Potential Problems (cont.)
Radiopharmaceutical
Production
•
Job Responsibilities
Contents
Job responsibilities
Key Personnel
•
•
Shared Responsibilities
Head of Production
Head of Quality Control
Authorized Person
•
Training
Potential Problems
STOP
•
Company procedures take precedence over local
legislation If this is claimed, it will be most unusual since all
multinationals require local companies to conform first to
local legislation.
Unclear organization diagram
Staff movement. Large organizations often move people
around through promotion, training, recruitment or
relocation. In so doing they can lose sight of the
requirements of GMP. Managers can be promoted into
positions for which they are not qualified or experienced.
Inadequate training records. Companies may not keep
adequate training records even though people are
apparently undergoing training.
Illness, The problem is that if people are not going to be
paid when sick or injured, they may work on under
circumstances that create a risk to the product. What
happens when they have an open wound, for example?
Return to Main Menu