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Radiopharmaceutical Production. Job responsibilities and Authorities. STOP. 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
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Radiopharmaceutical Production Job responsibilities and Authorities STOP
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 Quality Assurance STOP
Job Responsibilities • 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 • 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 • Key personnel (which normally should be full-time) positions include: • Authorized person • 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
Shared Responsibilities 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.
Share the rewards Shared Responsibilities Heads of Production and Quality Control may share/jointly exercise some additional responsibilities relating to quality: • 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
Head of Production 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, in-process 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 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 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 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 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 self-inspections
Authorized Person 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 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 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 • 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 • 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 • 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.) • Company procedures take precedence over local legislationIf 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?
