level: Section 2
Questions and Answers List
Location, Construction, Design & Lay-out
level questions: Section 2
| Question | Answer |
|---|---|
| shall be of suitable size, design, construction and location to facilitate proper operation, cleaning and maintenance. The individual working areas shall be adequate so that any risk of confusion, cross-contamination and other mistakes that will adversely affect the quality of drugs and devices will be avoided. | The premises for manufacturing |
| Premises shall be so located and protected against __ from the environment. | contamination |
| Premises shall be constructed and maintained to protect against weather, flood, ground seepage and the access and harboring of vermin, rodents, birds, insects or other animals. True or False | True |
| In determining the design and lay-out of premises, consideration should be paid to: | 1 the compatibility of other manufacturing operations that may be carried out in the same or adjacent premises 2 allow the production to take place in areas connected in a logical order according to the sequence of the operations and to the requisite cleanliness levels 3 the adequacy of the working space, which shall allow orderly and logical placement of equipment and materials to suit the operation, efficient flow of work, effective communication and supervision to avoid crowding and disorder 4 avoid the use of production areas as a general traffic for personnel or materials or for storage other than the materials in process. |
| The layout of rooms, corridors, and spaces shall provide for logical movements of materials and personnel with minimal traffic for operations to be carried out in defined areas and to avoid cross contamination. The design and layout of premises shall fulfill the following requirements: | 1 the risk of mix-up between different drugs or their components, the possibility of cross-contamination by other drugs or substances and the risk of omission of any production step shall be prevented 2 penicillins shall be produced only in separate buildings, with separate air handling facilities dedicated to these products using dedicated equipment, including dedicated packaging lines. 3 cephalosporins shall be produced in separate buildings, with separate air handling facilities dedicated to these products using dedicated equipment, including dedicated packaging lines 4 cross contamination of products should be prevented |
| cross contamination of products by live biologicals, or by drug products, such as certain steroids or cytotoxic agents which in trace amounts may produce physiological effects should be prevented by the following methods: | 1 carrying out production operations in separate buildings or adequately isolating the operations by total enclosure 2 controlling airborne contaminants by the use of an appropriate air pressure differential in processing areas and adequate exhaust systems and filters, together with control of recirculated air 3 the setting and shielding of production equipment, and wherever possible, the use of equipment solely for one type of drug/product; 4 containment of contaminant-transfer by means of airlocks, clothing change and decontamination of containers and other articles prior to their removal from the isolated area 5 separate cleaning area for contaminated clothing 6 periodic testing of the environment around the production areas for the presence of the therapeutic substance being processed and 7 validation of cleaning procedures. |
| Separate space for: | 1 Cleaning mobile equipment 2 Storage of cleaning materials |
| Defined areas for the following operations are required: | 1 gowning/change rooms for all personnel 2 receiving of starting materials 3 incoming goods quarantine 4 sampling room for sampling of deliveries of starting materials 5 storage for approved materials (chemical & packaging) 6 storage of reject materials 7 laboratories 8 weighing / dispensing of materials 9 processing operations 10 equipment washing 11 storage of cleaned, idle/non-functional equipment 12 major repair and maintenance activities 13 storage of cleaning tools and supplies 14 staging/storage of bulk products 15 packaging / labeling operations (+5 MORE) |
| Storage areas shall be of adequate space, provided with suitable lighting, arranged and equipped to allow dry, clean and orderly placement of stored materials and products. : | 1 Special and secured areas shall be available for storage of flammable and explosive substances, highly toxic substances, narcotics and other dangerous drugs. 2 Storage areas shall be laid-out to permit effective and orderly segregation of the various categories of materials stored to allow FIFO system. 3 Segregated storage shall be provided for rejected, recalled or returned goods. 4 Storage arrangements shall permit separation of different labels, as well as other printed materials to avoid mix-up. 5 Materials require special storage conditions such as temperature and/or humidity controls. These conditions should be monitored and records of the monitoring retained. |