Introduction
In the complex field of pharmaceutical manufacturing, it is
important to have a sound quality system in place to ensure that products
manufactured have the desired quality, safety, and efficacy. At the same time,
it is vital to recognize that even the best quality system is only as good as
the people who make it work. Personnel are the backbone of the manufacturing
unit, and there must be a sufficient number of adequately qualified and trained
staff to ensure one achieves the desired quality products. No person should be
so burdened with responsibilities that it presents a quality risk.
Organization
A sufficient number of personnel must be present to perform
as well as to supervise the manufacture, processing, packing, and holding of
every drug product. In any pharma unit, it is important to lay out individual
responsibilities in a manner that is clear enough to be understood by the
personnel who are to perform the respective tasks. Written job descriptions
must be available and an organization chart must be prepared to show the
hierarchical organization of employees.
Responsibilities of Key Personnel
|
Production Head responsibilities |
Quality Control Head
responsibilities |
Shared responsibilities |
|
Production
and storage of products as per requirements. |
Approval or
rejection of starting materials, intermediate and finished products, and
packaging materials. |
Monitoring
and approval of material suppliers and contract manufacturers. |
|
Approval of
instructions for processing operations. |
Evaluation of
batch records. |
Monitoring
and control of the environment in the production areas. |
|
Evaluation
and signing of production records. |
Approval of
specifications, test methods, sampling methods, and other QC procedures. |
Ensuring
validations are carried out. |
|
Verification
of maintenance of premises, equipment, and manufacturing and packing areas. |
Ensuring
testing is performed as per protocols. |
Training of
personnel. |
|
Ensure
periodic personnel training is performed. |
Monitoring
and approval of contract analysis. |
Monitoring
compliance with cGMPs. |
Responsibilities of QC Unit
Every pharmaceutical manufacturing unit should have a
quality control unit. There must be written procedures to describe the
functioning and responsibilities of this unit, and these procedures must be
followed.
The QC unit has the responsibility of testing all raw
materials, drug products, containers, closures, in-process materials, labeling,
and packaging materials. It also has the authority to accordingly approve the
materials that meet quality, safety, and efficacy specifications and reject the
ones that do not meet them.
The QC unit also has the authority to review the records
generated during the production of every batch to ensure that errors have not
occurred at any stage or that any errors that occurred have been completely
investigated. In case company A gets products manufactured under contract by
another company B, the QC unit of A has the authority to approve or reject
those products manufactured, packed, processed, or held by B for A.
The QC unit must have access to necessary laboratory space
and facilities to test and approve all raw materials, drug products,
containers, closures, in-process materials, labeling, and packaging materials.
Any procedures or specifications that are likely to impact
the strength, identity, purity, and quality of the drug product must be
approved by the QC unit.
Personnel Responsibilities
All persons involved with the manufacture, processing,
packing, or holding of drug products must wear clothing that is clean and
suitable for the work to be performed. Wherever required, personnel must wear
adequate protective apparel to cover their face, hands, arms, head, etc to
prevent contamination of the drug product.
Personnel must practice good health and sanitation habits.
They must enter only those areas of the premises that they have been authorized
to enter. Limited access areas can be entered only after due authorization by
the supervisory persons.
Personnel Qualifications
All persons engaged in the manufacturing, processing,
packing, or holding of drug products must have the necessary education,
training, and experience, or an acceptable combination of these to ensure they
are capable of carrying out the assigned work.
Personnel must be trained on the particular operations they
perform and on the current Good Manufacturing Practices (cGMP) that are
relevant to their area of work. cGMP training must be imparted regularly by
adequately qualified trainers to ensure the employees stay current in their
information about the relevant cGMP requirements.
Every person who supervises the manufacture, processing,
packing, or holding of drug products must have the necessary education,
training, and experience, or an acceptable combination of these to ensure they
are capable of carrying out the assigned supervisory work.
Key Personnel
Key positions must be held by full-time personnel. This
generally includes the heads of production and quality control and the
authorized person. The heads of quality control and production must be
independent of each other and they bear the responsibility of all actions
performed by their subordinates. The key personnel must have sufficient
scientific education and practical experience in the manufacture of drug
products in keeping with national regulatory guidelines. They must be capable
of making independent judgments based on applying scientific thought to the
problems that may be encountered while performing their responsibilities.
The authorized person is responsible for implementing the
quality system, performing internal audits or self-inspection, and participating
in validation programs. This person is ultimately held accountable for any
non-compliance with regulatory requirements.
Personnel Training
All personnel entering the manufacturing areas and quality
control laboratories (including housekeeping staff) must be trained according
to a written program. The training programs must cover technical aspects of
their work, and also the theory and practice of cGMP. Personnel working in
clean areas or areas where hazardous materials are being handled must be
imparted specific training on the precautions they must follow to avoid
contaminating the product or the environment and also for personal safety. Training
must be done at regular intervals and the effectiveness of the training must be
assessed. Records of personnel training must be maintained.
Personnel Health and Hygiene
Personnel to be employed in a drug product manufacturing
facility must undergo a health examination before being hired. Only those who
are free from contagious, communicable conditions, skin diseases, and
tuberculosis must be given employment. Persons to be employed in an area where
beta-lactam antibiotics are being manufactured must be tested for sensitivity
to penicillin before being employed.
Those employees who need to perform visual inspections must
have periodic eye checkups. Personnel handling cytotoxic drugs, sex hormones,
and other potent medicaments must be examined regularly for any adverse effects
of these substances. As a safety measure, it is good to rotate staff in these
special areas.
Personnel must be trained in personal hygiene aspects such
as washing their hands, donning appropriate protective clothing, using a face
mask and hair cap, etc before entering manufacturing areas. Change rooms must
be provided with facilities for storing personal belongings, and ensuring
personal hygiene (wash basins, running water, hand dryers, disinfectants, etc).
Employees must be instructed about not allowing direct
contact between their hands and any raw material, in-process goods, or
finished, unpacked drug product.
If any person is found to have an open lesion or an illness
(by observation of the supervisor or through a medical examination) that may
have an impact on the quality or safety of drug products, that person must be
kept away from coming into direct contact with drug product, containers and
closures and in-process materials until declared fit to do so by a medical
professional. Personnel must be instructed to report any such medical
conditions to their supervisors.
Personnel must not be allowed to eat, drink, smoke, or chew
anything in the production, laboratory, and storage areas.
A team of skilled and trained personnel is one of the
biggest factors that influence the production of quality products that are safe
and efficacious. Ultimately, it is the people handling the process who will
decide its success. When personnel understand their responsibilities, get
trained on cGMP, and perform their tasks in keeping with the SOPs, it ensures
that the product quality will be of the desired level and meet the
predetermined specifications.