Organization and Personnel: In the complex field of pharmaceutical manufacturing, it is important to have a sound quality system in place to make sure 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 is 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.
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A sufficient number of personnel must be present to perform as well as supervise the manufacture, processing, packing, and holding off 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
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 material. 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 material.
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.
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.
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 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 for 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 an independent judgment based on applying scientific thought to the problems that may be encountered while performing their responsibilities.
The authorized person is responsible to implement the quality system, perform an internal audit or self-inspection, and participate in validation programs. This person is ultimately held accountable for any non-compliance with regulatory requirements.
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 (washbasins, 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 themselves 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 understands 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.
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