Personnel and Premises and Equipment (Group 1) PDF

Bio-Innovator CHAPTER 2 PERSONNEL GROUP 1- BSPHARMA -3A  PRINCIPLE The correct manufacturing of medicinal products depends on having a sufficient number of qualified personnel. Each person’s responsibilities should be clearly understood, documented, and aligned with G...

Bio-Innovator CHAPTER 2 PERSONNEL GROUP 1- BSPHARMA -3A  PRINCIPLE The correct manufacturing of medicinal products depends on having a sufficient number of qualified personnel. Each person’s responsibilities should be clearly understood, documented, and aligned with Good Manufacturing Practice (GMP) principles. Adequate training, including hygiene, is essential.  GENERAL 2.1 Manufacturers need enough qualified and experienced staff. Senior management must provide resources to maintain and improve the Pharmaceutical Quality System, ensuring quality isn't compromised by overburdening any individual.  GENERAL 2.2 An organization chart must show the relationships between key roles like Production, Quality Control, and Quality Assurance. 2.3 Responsibilities must be clearly defined in job descriptions, with proper authority given to carry them out. There should be no gaps or overlaps in GMP-related duties. GENERAL 2.4 Senior management is ultimately responsible for the Pharmaceutical Quality System, ensuring it meets quality objectives, is well- communicated, and remains effective through regular reviews.  KEY PERSONNEL Duties of Authorised Personnel An Authorised Person must ensure that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that country and in accordance with the requirements of the Marketing Authorisation  KEY PERSONNEL Duties of Authorised Personnel The Authorised Person(s) must meet the qualification requirements laid down in the national legislation, they shal be permanently and continuously at the disposal of the holder of the Manufacturing Authorisation to carry out their responsibilities;  KEY PERSONNEL Duties of Head of Production 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 to ensure their strict implementation; To ensure that the production records are evaluated and signed by an authorised person. KEY PERSONNEL 2.8 The head of Quality Control generally has the following responsibilities: To approve or reject, as he/she sees fit, starting materials, packaging materials, intermediate, bulk and finished products; To ensure that all necessary testing is carried out and the associated records evaluated; To approve specifications, sampling instructions, test methods and other Quality Control procedures; To approve and monitor any contract analysts; To ensure the qualification and 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 department personnel is carried out and adapted according to need. KEY PERSONNEL 2.9 The heads of Production, Quality Control and where relevant, Head of Quality Assurance or Head of Quality Unit, generally have some shared, or jointly exercised, responsibilities relating to quality including in particular the design, effective implementation, monitoring and maintenance of the Pharmaceutical Quality System. 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; KEY PERSONNEL The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities; The designation and monitoring of storage conditions for materials and products; The retention of records; The monitoring of compliance with the requirements of Good Manufacturing Practice; The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality; Participation in management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement; Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.  TRAINING The manufacturer should provide training for all the personnel whose duties take them into production and storage areas or into control laboratories , and for other personnel whose activities could affect the quality of the product. Besides the basic training on the theory and practice of the Pharmaceutical Quality System and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitising materials are handled, should be given specific training.  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 Pharmaceutical Quality System and all the measures capable of improving its understanding and implementation should be fully discussed during the training sessions. PERSONAL HYGIENE Detailed hygiene programmes should be established and adapted to the different needs within the factory. They should include procedures relating to the health, hygiene practices and clothing of personnel. All personnel should receive medical examination upon recruitment. Steps should be taken to ensure as far as is practicable that no person affected by an infectious disease or having open lesions on the exposed surface of the body is engaged in the manufacture of medicinal products. PERSONAL HYGIENE Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out. Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or personal medication in the production and storage areas should be prohibited. Direct contact should be avoided between the operator’s hands and the exposed product as well as with any part of the equipment that comes into contact with the products. PERSONAL HYGIENE Personnel should be instructed to use the hand-washing facilities. Any specific requirements for the manufacture of special groups of products, for example sterile preparations, are covered in the annexes. CONSULTANTS by these consultants. Consultants should have adequate education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records should be maintained stating the name, address, qualifications, and type of service provided by these consultants. CHAPTER 3 PREMISES AND EQUIPMENT GROUP 1- BSPHARMA -3A  PRINCIPLE Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt and, in general, any adverse effect on the quality of products. PREMISES General Premises should be situated in an environment which, when considered together. with measures to protect the manufacture, presents minimal risk of causing contamination of materials or products. Premises should be carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the quality of products. They should be cleaned and, where applicable, disinfected according to detailed written procedures. Lighting, temperature, humidity and ventilation should be appropriate and such that they do not adversely affect, directly or indirectly, either the medicinal products during their manufacture and storage, or the accurate functioning of equipment. Premises should be designed and equipped so as to afford maximum protection against the entry of insects or other animals. Steps should be taken in order to prevent the entry of unauthorised people. Production, storage and quality control areas should not be used as a right of way by personnel who do not work in them. Production Areas Cross-contamination should be prevented for all products by appropriate design and operation of manufacturing facilities. The measures to prevent cross- contamination should be commensurate with the risks. Quality Risk Management principles should be used to assess and control the risks. Depending of the level of risk, it may be necessary to dedicate premises and equipment for manufacturing and/or packaging operations to control the risk presented by some medicinal products.. Production Areas Premises should preferably be laid out in such a way as to allow the production to take place in areas connected in a logical order corresponding to the sequence of the operations and to the requisite cleanliness levels. The adequacy of the working and in-process storage space should permit the orderly and logical positioning of equipment and materials so as to minimise the risk of confusion between different medicinal products or their components, to avoid cross-contamination and to minimise the risk of omission or wrong application of any of the manufacturing or control steps. Where starting and primary packaging materials, intermediate or bulk products are exposed to the environment, interior surfaces (walls, floors and ceilings) should be smooth, free from cracks and open joints, and should not shed particulate matter and should permit easy and effective cleaning and, if necessary, disinfection. Production Areas Pipework, light fittings, ventilation points and other services should be designed and sited to avoid the creation of recesses which are difficult to clean. As far as possible, for maintenance purposes, they should be accessible from outside the manufacturing areas. Drains should be of adequate size, and have trapped gullies. Open channels should be avoided where possible, but if necessary, they should be shallow to facilitate cleaning and disinfection. Production areas should be effectively ventilated, with air control facilities (including temperature and, where necessary, humidity and filtration) appropriate both to the products handled, to the operations undertaken within them and to the external environment. Weighing of starting materials usually should be carried out in a separate weighing room designed for such use. In cases where dust is generated (e.g. during sampling, weighing, mixing and processing operations, packaging of dry products), specific provisions should be taken to avoid cross-contamination and facilitate cleaning. STORAGE AREA  STORAGE AREA Storage areas should be sufficient capacity to allow orderly storage of various categories of materials and products. Storage areas should be designed or adapted to ensure good storage condition. In particular they should be clean and dry and maintain within acceptable temperature limit where special storage conditions are required this should be provided, check and monitor. Receiving and dispatch base should protect material and product from the weather. Reception area should be designed and equipped to allow containers of incoming materials to be cleaned when necessary before storage.  Where quarantine status is ensured by storage and separate areas these areas must be clearly marked and their access restricted to authorized personnel system. Any replacing the physical quarantine should be given equivalent security. There should normally be a separate sampling area for starting materials if sampling is performed in a storage area it should be conducted in such a way as to prevent contamination or cross contamination. Segregated areas should be provided for storage or rejected recalled or return materials or products. Highly active materials or product should be stored in safe and secure areas. Printed packaging materials or considered critical to the conformity of the medical product and special attention should be paid to the safe and secure storage of this materials.  QUALITY CONTROL AREA Quality control laboratories should be separated from production areas. This is particularly important for laboratories for the control of biologicals, microbiologicals and radioisotopes, which should also be separated from each other. Control laboratories should be designed to suit the operations to be carried out in them. Sufficient space should be given to avoid mix-ups and cross-contamination. There should be adequate suitable storage space.  Primises for the packaging of medicinal products should be specifically designed and laid out so as to avoid mix-ups or cross-contamination. Production on areas should be a well lit, particularly where visual on-line controls are carried out. In-process controls may be carried out within the production ara provided they do not carry any riskto production.  ANCILLARY AREAS Maintenance workshops should as far as Rest and refreshment rooms possible be separated from production areas. Whenever parts and tools are stored should be separate in the production area, they should from other areas. be kept in rooms or lockers reserved for that use. Facilities for changing clothes and for washing and toilet purposes should be Animal houses should be well easily accessible and appropriate for the isolated from other areas, with number of users. Toilets should not separate entrance directly communicate with production or (animal access) and air handling storage areas. facilities. EQUIPMENT Manufacturing equipment should be designed, located and maintained to suit its intended purpose. Repair and maintenance operations should not present any hazard to the quality of the products. Manufacturing equipment should be designed so that it can be easily and thoroughly cleaned. It should be cleaned according to detailed and written procedures and stored only in a clean and dry condition. Washing and cleaning equipment should be chosen and used in order not to be a source of contamination. Equipment should be installed in such a way as to prevent any risk of error or of contamination. Production equipment should not present any hazard to products. Parts of production equipment that come into contact with the product must not be reactive, additive or absorptive to such an extent that it will affect the quality of the product and thus present any hazard. Balances and measuring equipment of an appropriate range and precision should be available for production and control operations. EQUIPMENT Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained. Fixed pipework should be clearly labelled to indicate the contents and, where applicable, the direction of flow. Distilled, deionised and, where appropriate, other water pipes should be sanitised according to written procedures that detail the action limits for microbiological contamination and the measures to be taken. Defective equipment should, if possible, be removed from production and quality control areas, or at least be clearly labelled as defective. Thank you www.reallygreatsite.com Resource page